Intervenciones psicológicas para la cardiopatía coronaria
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias de los estudios en curso
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: Netherlands. Dates participants recruited: July 1996 to April 2001. Maximum follow‐up: 18 months. Follow‐up schedule: 6 and 18 months. | |
| Participants | Inclusion criteria: aged 35‐68 years, who felt exhausted after being successfully treated by PCI, assessed via the Maastricht Questionnaire (MQ 1987; cutoff of 14) and the Maastricht Interview for Vital Exhaustion ('Maastricht Questionnaire'; cutoff of 7 positive responses). Exclusion criteria: severe somatic or mental comorbidity (e.g. kidney insufficiency, ≥ 3‐year history of major depression), somatisation disorder, fibromyalgia or chronic fatigue, participation in another behavioural rehabilitation programme, unsuccessful treatment for a recent depression or panic disorder, inability to speak Dutch. Indication (% participants): post PCI (100%) including stable angina (13%), unstable angina (57%), MI (18%), post‐MI angina (10%). Psychopathology: major depression (14%). Number randomised: total: 710; intervention: 366; comparator: 344. Age (mean ± SD): total: NR; intervention: 53.6 ± 7.2 years; comparator: 53.1 ± 7.4 years. Men: total: 77%; intervention: 80%; comparator: 74%. Ethnicity (% white) : NR. | |
| Interventions | INTERVENTION: group discussions were used to identify stressors in the family and work domain, and to assist participants in coping with these stressors. Recovery was promoted by discussing the minimum and maximum length of resting time, by doing relaxation exercises designed to make rest more efficient, by stimulating physical exercise, and by assigning homework. Group discussions were used as the main basis of the EXhaustion Intervention Trial intervention to ensure an optimal match between the needs and demands of the participants and the content of the programme. Counsellors acted mainly as facilitators of the group discussions. Treatment targets: exhaustion, stress, anxiety, Type A behaviours. Components: relaxation, client‐led discussion, empathy and social support, self‐monitoring/self‐awareness, and individually tailored relaxation. Treatment setting (number of sites): hospital (4). Modality (group size): group (6 participants). Dose:
Delivered by: experienced psychotherapists or clinical psychologists. Follow‐up further reinforcement: NR. Cointerventions: all groups were offered the possibility to meet with a cardiologist, dietitian, and a health educator if they wanted to have more information about medical aspects, nutrition, and smoking cessation. COMPARATOR: standard care. Cointerventions: referral to a physical rehabilitation programme at 1 centre. | |
| Outcomes | Revascularisation (CABG and PCI). HRQoL (MacNew Questionnaire). Vital exhaustion (Maastricht Questionnaire). | |
| Source of funding | Dutch Heart Foundation and the Netherlands Organization for Health Research and Development. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used a 'computerised random number generator'. Groups were unbalanced for sex and HRQoL score. |
| Allocation concealment (selection bias) | Unclear risk | Once a block of 12 qualifying participants was formed, participants were randomised to the intervention group or the usual‐care control group individually by a computerised random‐number generator maintained in the EXhaustion Intervention Trial coordination center (Maastricht). Treatment assignment was never unmasked by previous assignments to avoid selection bias that results from research staff being able to predict the next treatment assignment. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Morbidity results were obtained by an assessor blinded to group assignment; unclear for interview outcomes. |
| Incomplete outcome data (attrition bias) | Low risk | All treatment group comparisons were based on intention‐to‐treat approach principles. All participants allocated to the intervention group were included in the analyses, irrespective of their compliance. Missing values at 6 and 18 months were replaced by the last observed value. |
| Selective reporting (reporting bias) | High risk | Data on clinical diagnosis of depression were mentioned in the protocol as having been collected at baseline and 18 months, but 18‐month comparisons not reported ‐ it was unclear whether the authors considered depression as an outcome. 6‐month vital exhaustion data not reported. |
| Groups balanced at baseline | Low risk | "The groups were balanced in terms of all medical, demographic, and psychological characteristics except gender." |
| Intention‐to‐treat analysis | Low risk | "All treatment‐group comparisons were based on intention‐to‐treat approach principles." |
| Groups received same cointerventions | High risk | "Usual care consisted of the care regularly given in the 4 centres. It included routine check‐ups in all centres and referral to a physical rehabilitation programme in 1 centre." |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: USA. Dates participants recruited: NR. Participants recruited (number of sites): cardiac rehabilitation clinic (1). Maximum follow‐up: 21 months. Follow‐up schedule: programme exit, 3, 6, 9, and 21 months. | |
| Participants | Inclusion criteria: CAD documented by cardiac catheterisation or MI, hospitalisation for a coronary event such as unstable angina, AMI, PTCA, or CABG surgery within 3 months of referral into cardiac rehabilitation, and willingness to be screened and give informed consent to participate in the trial. Exclusion criteria: aged > 80 years, judged to be mentally incompetent, or currently undergoing treatment by a psychiatrist or psychologist. Indication: acute CHD events (MI, revascularisation, angina; % NR). Psychopathology: psychological distress, Global Severity Index SCL‐90‐R ≥ 63 (100%). Number randomised: total: 60; intervention: 30; comparator: 30. Age (mean ± SD): total: 60.2 ± 10.7 years; intervention: NR; comparator: NR. Men: total: 88%; intervention: NR; comparator: NR. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: 1‐7 weekly sessions dealing with issues identified in the treatment plan. Intervention included ≥ 1 of the following: individualised relaxation training; stress management; efforts to reduce behavioural risk factors; efforts to improve compliance with medical, dietary, and exercise regiments; and cognitive‐behavioural interventions for identified sources of distress, such as anxiety, depression, and hostility. Treatment targets: behaviour change, stress management, anxiety, depression, and Type A behaviour. Components: guidance on behaviour change, relaxation, cognitive challenge/restructuring, psychoactive pharmacological drugs as required. Treatment setting (number of sites): cardiac rehabilitation clinic (1). Modality (group size): individual. Unclear whether family included. Dose:
Delivered by: clinical behavioural psychologist. Follow‐up further reinforcement: NR. Cointerventions: consistent with a counselling model, psychoactive drugs that were considered essential were prescribed accordingly. Participants were also offered comprehensive cardiac rehabilitation as per usual care. COMPARATOR: usual care control consisting of comprehensive cardiac rehabilitation (8‐week programme) involving monitored exercise sessions 1‐3 times per week. The participants were also offered a series of educational lectures, which included information about Type A behaviour and stress management, a 2‐part support group meeting for participants and spouses or significant others, and individualised dietary counselling. Cointerventions: NR. | |
| Outcomes | Total mortality. Morbidity ‐ MI, CABG, PCI. Anxiety (distress/Global Severity Index from SCL‐90‐R). Depression (subscale from SCL‐90‐R). | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated that the participants were randomly allocated. No further details. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Selective reporting (reporting bias) | Unclear risk | Not described. |
| Groups balanced at baseline | Low risk | "There were no statistically significant differences between the experimental groups in terms of scores on the SCL‐90‐R sub‐scales, age, lipid profiles, smoking history at index event, diabetes, hypertension, family history of CHD before age 50, use of antilipidemics, anticoagulants (including aspirin), and betablockers (before or after MI), number of rehabilitation‐exercise sessions per week, educational level, marital status, or such cardiac factors as type of index event, number of diseased vessels, or left‐ventricular ejection fraction." |
| Intention‐to‐treat analysis | Low risk | Intention‐to‐treat analysis was not described, but was implied by the following sentence: "Because of the large number of crossovers, rehospitalization data were re‐analyzed by treatment status independent of experimental group." |
| Groups received same cointerventions | Unclear risk | It is unclear whether the intervention participants received usual care (including comprehensive cardiac rehabilitation) plus intervention, or just intervention. Methods: "The patients …. were randomised to either usual care (UC) or special intervention (SI)." Discussion: "our patients were already receiving considerable education and cognitive‐behavioral intervention from merely being involved in cardiac rehabilitation." |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: USA. Dates participants recruited: April 2010 to May 2014 (last event for medical event adjudication July 2015). Participants recruited (number of sites): Duke University's Center for Living and the University of North Carolina's Wellness Center in Chapel Hill (2). Maximum follow‐up: 5.3 years. Follow‐up schedule: 1, 2, 3, 4, and 5 years. | |
| Participants | Inclusion criteria: outpatients aged ≥ 35 years, with a documented history of CHD (ACS, stable angina, CABG, or PCI) who were eligible for cardiac rehabilitation in North Carolina, had capacity to provide informed consent and follow study procedures. Exclusion criteria: received a heart transplant or valvular repair surgery, LVEF < 30%, labile ECG changes prior to testing, current use of a pacemaker, resting blood pressure > 200/120 mmHg, left main disease > 50%, or were unable or unwilling to comply with assessment procedures or to be randomised into treatment groups. Indication (% participants): recent ACS, stable angina with angiographic evidence of coronary disease, and recent CABG or PCI: CABG (intervention: 25%; comparator: 13%), PCI (intervention: 38%; comparator: 31%), MI (intervention: 4%; comparator: 11%), MI + CABG (intervention: 3%; comparator: 3%), MI + PCI (intervention: 37%; comparator: 35%), angina (intervention: 4%; comparator: 8%). Psychopathology: clinically elevated levels of depression, BDI‐II ≥ 14 (34/151, 22.5%), clinically significant anxiety, STAI ≥ 40 (48/151, 32%), psychotropic medication at baseline (intervention: 34%; comparator: 35%). Number randomised: total: 151; intervention: 76; comparator: 75. Age (mean ± SD): total: NR; intervention: 61.8 ± 10.8 years; comparator: 60.4 ± 10.6 years. Men: total: NR; intervention: 59%; comparator: 68%. Ethnicity (% white): total: NR; intervention: 76%; comparator: 68%. | |
| Interventions | INTERVENTION: stress management training, based on CBT. Initial sessions: establish rapport, promote group cohesion and social support, and accentuate the importance of stress as a risk factor for adverse cardiovascular events. Strategies involved: prioritising, time management, establishing personal values, and avoidance of stress‐producing situations. Subsequent sessions: modifying responses to situations that could not be readily changed, and training in progressive muscle relaxation techniques and visual imagery to reduce stress. Emphasis was placed on the importance of cognitive appraisals in affecting stress responses, with recognition of irrational beliefs and cognitive distortions such as overgeneralisation, catastrophising, and all‐or‐nothing thinking. Later sessions: effective communication, assertiveness, anger management, and problem‐solving strategies. Sessions involved brief lectures, group discussion, role playing, instruction in specific behavioural skills, and weekly 'homework' assignments. Treatment targets: reduce stress‐linked demands (environmental, self‐imposed), increase coping abilities, problem solving. Components: education, group support, CBT, relaxation training, anger management, and problem‐solving strategies. Treatment setting (number of sites): Duke University's Center for Living and the University of North Carolina's Wellness Center in Chapel Hill (2). Modality (group size): group (4‐8 participants). Dose:
Delivered by: NR ‐ although delivered as part of comprehensive cardiac rehabilitation programme. Follow‐up further reinforcement: none. Cointerventions: comprehensive cardiac rehabilitation programme (including structured exercise). COMPARATOR: comprehensive cardiac rehabilitation: aerobic exercise 3 times a week for 35 minutes at a level of 70‐85% of their heart rate reserve as determined at the time of their initial exercise treadmill test, education about CHD, nutritional counselling based on American Heart Association guidelines, and 2 classes devoted to the role of stress in CHD. Cointerventions: none. | |
| Outcomes | Total mortality. Non‐fatal MI. Revascularisation (CABG). Hospitalisation for unstable angina. | |
| Source of funding | Grant HL093374 from the National Heart, Lung, and Blood Institute. | |
| Conflicts of interest | Authors declared no conflict of interest. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | NR. |
| Allocation concealment (selection bias) | Unclear risk | NR. |
| Blinding of outcome assessment (detection bias) | Low risk | "Medical records were reviewed and events, categorised based on ACC/AHA [American College of Cardiology/American Heart Association] criteria, 21 were adjudicated by a physician assistant and a study cardiologist blinded to treatment condition." |
| Incomplete outcome data (attrition bias) | Low risk | All cardiac events data were collected from routine records with data available from all 151 participants. |
| Selective reporting (reporting bias) | Low risk | All clinical events described in methods section reported in Table 4. |
| Groups balanced at baseline | Low risk | "The treatment groups were similar on background and demographic characteristics…" |
| Intention‐to‐treat analysis | Low risk | "Treatment effects were analyzed following the intention‐to‐treat (ITT) principle." |
| Groups received same cointerventions | Unclear risk | Both groups received comprehensive cardiac rehabilitation. |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: USA. Dates participants recruited: NR. Participants recruited (number of sites): cardiac rehabilitation centres (5), adverts. Maximum follow‐up: 15 months. Follow‐up schedule: 3, 9, and 15 months. | |
| Participants | Inclusion criteria: aged 43‐75 years; MI or bypass surgery (or both) occurred 4‐24 months before study; prognosis of no worse than 3.3 based on NYHA; stable cardiac status with no medical contraindications to increase physical activity; onset of depression or anxiety (or both) associated with the MI or bypass surgery based on the SADS‐C; score > 13 on BDI or > 70 on the SCL‐90‐R indicating clinically significant levels of depression and distress; spouses, friends, or relatives who were willing to participate in the treatment. Exclusion criteria: pre‐existing psychiatric disorders. Indication (% participants): MI only (30%), bypass only (38%), MI + bypass (32%). Psychopathology: eligibility criteria psychopathology (100%). Number randomised: total: 54; intervention: NR; comparator: NR. Age (mean ± SD): total: 60.7 (SD NR) years; intervention: 63.6 ± 7.4 years; comparator: 57.7 ± 7.8 years. Men: total: 73%; intervention: 55%; comparator: 90%. Ethnicity (% white): total: 100%. | |
| Interventions | INTERVENTION: individuals were shown how to increase the rate and intensity of their adaptive behaviours, including pleasant activities, relaxation, cognitive restructuring, assertion/anger management, and time management. In each session, the therapist provided a rationale for an adaptive behaviour, gave specific instructions in performing the behaviour, and demonstrated the behaviour. After the partner gave the participant specific, primarily positive feedback and reinforcement. The partner practised ignoring the participant's maladaptive behaviours. Finally, the therapist, participant, and partner collaborated and planned ways the participant and partner would practise the skills and monitor progress. Treatment targets: stress management. Components: relaxation, cognitive restructuring, assertion anger management, and time management. Partners were also trained to give positive feedback and reinforcement. Treatment setting (number of sites): hospital (5). Modality (group size): group (NR). Dose:
Delivered by: clinical psychologist and psychiatrist. Follow‐up further reinforcement: NR. Cointerventions: NR. COMPARATOR: control group had time with therapists where they received non‐specific treatment effects of encouragement and reassurance, excluding key behaviour therapies. Cointerventions: NR. | |
| Outcomes | Depression (BDI, SADS‐C). Psychological distress and depression (SCL‐90‐R Global Severity Index score). | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | NR. |
| Allocation concealment (selection bias) | Unclear risk | NR. |
| Blinding of outcome assessment (detection bias) | Unclear risk | NR. |
| Incomplete outcome data (attrition bias) | Unclear risk | NR. |
| Selective reporting (reporting bias) | Unclear risk | NR. |
| Groups balanced at baseline | High risk | Control participants were significantly younger than those in the intervention group. |
| Intention‐to‐treat analysis | Unclear risk | NR. |
| Groups received same cointerventions | Low risk | Control group had time with therapists where they received non‐specific treatment effects of encouragement and reassurance, but key behaviour therapies were not provided. |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: Sweden. Dates participants recruited: NR. Participants recruited (number of sites): hospital (14). Maximum follow‐up: 6.5 years. Follow‐up schedule: 6.5 years. | |
| Participants | Inclusion criteria: CABG 3‐12 months prior to recruitment, non‐smokers. Exclusion criteria: diabetes mellitus, other somatic or psychiatric disease or alcoholism, and non‐Swedish speakers. Indication (% participants): CABG (100%). Psychopathology: NR. Number randomised: total: 261; intervention: 128; comparator: 133. Age (mean ± SD): total: 57.5 (SD NR) years; intervention: NR; comparator: NR. Men: total: 86%; intervention: NR; comparator: NR. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: initial treatment (6 sessions) focused on education about CHD, surgical issues, risk factors and risk behaviours, psychological factors that influence wellbeing and Type A behaviour. From the first session, participants were given homework assignments related to observation of health behaviours. The remaining session focused on modifying Type A prone behaviours: developing and applying new reactions and behaviours that entailed less impatience, irritation, hostility, depression, and distress. Treatment targets: risk education, disease adjustment, and coronary prone behaviours (Type A behaviour, depressive reactions, anxiety). Components: risk information, guidance on behaviour change, self‐awareness/monitoring, relaxation, homework. Treatment setting (number of sites): NR (NR). Modality (group size): group (5‐9 participants). Dose:
Delivered by: cardiologist and nutritionist (1 session) and clinical psychologist (remainder of sessions). Follow‐up further reinforcement: 5 or 6 booster sessions in years 2 and 3. Cointerventions: access to rehabilitation programmes that were part of usual care. COMPARATOR: usual care, including access to rehabilitation programmes that were regularly offered by participating hospitals. Cointerventions: NR. | |
| Outcomes | Total mortality. Cardiac mortality. Non‐fatal MI. Revascularisation (CABG (reoperation) and PTCA). Self‐reported Type A behaviour. | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated participants were randomly assigned. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | Unclear risk | Insufficient information to judge, attrition appeared to be zero. |
| Selective reporting (reporting bias) | Unclear risk | Method did not fully specify the measures used. |
| Groups balanced at baseline | High risk | Control participants were significantly younger than those in the intervention group. |
| Intention‐to‐treat analysis | Unclear risk | Intention‐to‐treat analysis was not described, and no n values were provided in Table 1. |
| Groups received same cointerventions | Low risk | "Both experimental and control patients had access to rehabilitation programmes that were regularly offered by their hospitals." |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: USA. Dates participants recruited: NR (study conducted 1981‐1984). Participants recruited (number of sites): hospital (11). Maximum follow‐up: 13 months. Follow‐up schedule: 3 and 13 months. | |
| Participants | Inclusion criteria: men and women, aged 18‐62 years, employed ≥ 20 hours per week outside the home, and who met ≥ 2 of the following criteria for MI: typical symptoms of MI (e.g. prolonged chest discomfort, dyspnoea, arm pain, and diaphoresis); ECG evidence of MI; and diagnostic elevations of serum enzymes consistent with myocardial necrosis. Exclusion criteria: cardiac complications and other comorbid conditions considered to mitigate against re‐employment. Indication (% participants): AMI (100%). Psychopathology: NR. Number randomised: total: 180; intervention: 89; comparator: 91. Age (mean ± SD): total: 50.9 ± 7.4 years; intervention: 51.6 ± 7.1 years; comparator: 50.2 ± 7.7 years. Men: total: 86%; intervention: 85%; comparator: 86%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: programme had 3 aims: to limit participant psychological distress, using a cognitive‐behavioural intervention model; to minimise social network strain by providing guidance and moral support to participants and to a key member of each participant's primary social network; and to facilitate job re‐entry. Intervention strategies based on the cognitive behavioural model focused particular attention on how the nurses could alter assumptions and beliefs about MI and recovery. Participant, family members, and key people at the workplace were all assessed about their beliefs regarding the MI and related events. Information about the participant's postinfarction experiences was most useful in enhancing relaxation and reframing assumptions. Treatment targets: disease adjustment, anxiety, and depression. Components: cognitive challenge/restructuring and social support, client‐led discussion. Treatment setting (number of sites): participant home (NR), telephone. Modality (group size): individual. Dose:
Delivered by: team of specially trained, masters‐prepared nurse clinicians. Follow‐up further reinforcement: NR. Cointerventions: usual medical care, including access to comprehensive cardiac rehabilitation. COMPARATOR: usual hospital medical care, including access to comprehensive cardiac rehabilitation, although this was limited in scope as most services were only recently developed in the 11 participating hospitals. Cointerventions: NR. | |
| Outcomes | Total mortality. Anxiety (Taylor 1953). Depression (ZDS). Return to work. | |
| Source of funding | The Robert Wood Johnson Foundation, Princeton, New Jersey, USA. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described. |
| Allocation concealment (selection bias) | Unclear risk | Randomisation was conducted by telephone from the study's central office; stratified by sex. Research assistant opened sealed envelopes. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient detail provided. |
| Incomplete outcome data (attrition bias) | Unclear risk | Not described. |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Groups balanced at baseline | Low risk | "The absence of statistically significant differences between treatment groups on any key variables measured at the baseline attests to the effectiveness of the randomisation procedure." |
| Intention‐to‐treat analysis | Low risk | No intention‐to‐treat analysis was described, but Table 1 suggested that participants were analysed according to randomisation group. |
| Groups received same cointerventions | Unclear risk | Comparator group received "conventional hospital rehabilitation (usual care)" which was not described. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Sweden. Dates participants recruited: 1997‐2001. Participants recruited (number of sites): hospital discharge registers (NR). Maximum follow‐up: 1 year. Follow‐up schedule: 1 year. | |
| Participants | Inclusion criteria: woman aged < 80 years with first or recurrent AMI, or who had undergone coronary angioplasty or CABG surgery, or had angina pectoris with CAD confirmed by angiography and treated non‐invasively and given informed consent. Exclusion criteria: AMI, coronary angioplasty, or CABG surgery within the last 4 months; unstable CAD with a planned invasive investigation or treatment; any diseases that could interfere with trial participation or therapy (e.g. malignancy or psychiatric disease (depression excepted)); non‐Swedish speaking; other apparent obstacles making it difficult to participate in regular group activities (e.g. alcohol or drug abuse); and participation in another treatment study. Indication (% participants): AMI (70%), CABG (34%), PCI (40%), some participants ≥ 1 conditions at baseline. Psychopathology: NR. Number randomised: total: 198; intervention: 101; comparator: 97. Age (mean ± SD): total: 61.0 (SD NR) years; intervention: 59.0 ± 2.0 years; comparator: 62.0 ± 2.0 years. Men: total: 0%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: structured programme similar to CBT, including 5 key components: education, self‐monitoring, skills training, cognitive restructuring, and spiritual development. Treatment targets: risk reduction, stress, anxiety, depression. Components: coronary risk information, self‐monitoring/awareness, relaxation, cognitive challenge/restructuring; also some guidance on behaviour change. Treatment setting (number of sites): NR (NR). Modality (group size): group (5‐9 participants). Dose:
Delivered by: physiotherapist with specialist training. Follow‐up further reinforcement: NR. Cointerventions: all participants received general lifestyle advice on diet, physical training, and smoking cessation prior to randomisation, and usual medical care postrandomisation. COMPARATOR: usual medical care, including general lifestyle advice on diet, physical training, smoking cessation, and an introduction to stress management/relaxation training prior to randomisation. Postrandomisation, all participants received conventional care and follow‐up, including outpatient visits to cardiologists and cardiology nurses. Cointerventions: NR. | |
| Outcomes | Total mortality. Non‐fatal MI. Revascularisation (reportedClaesson 2005, note slightly different samples reported). Depression (Comprehensive Psychopathological Rating Scale Self‐Affective). Quality of life (3 rating scales). Self‐rated stress behaviour and reactions scale (The Everyday Life Stress scale). Vital exhaustion (Maastricht Questionnaire). | |
| Source of funding | The Vardal Foundation, the Swedish Medical Research Council (grant no. K2001‐27X‐13457‐02B), the Swedish Council for Social Research, the Swedish Heart and Lunch Foundation, foundations by the Faculty of Medicine, and Odontology at the Umea University, the Norrland Heart Foundation, the Vasterbotten County Council, the Arnerska Research Foundation, JC Kempe's and Golje's foundations. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation was stratified by geographical areas, but no mention was made of the method used to generate the sequence. |
| Allocation concealment (selection bias) | Low risk | "Randomisation was by sealed envelopes." |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | Low risk | For continuous outcomes, intention‐to‐treat was not performed because follow‐up data were not available for 27 women who withdrew; however, dropouts and reasons were provided. |
| Selective reporting (reporting bias) | Low risk | Analyses provided for all outcomes mentioned in methods (and protocol). Data only provided as figures, and not in tabular/numerical form. |
| Groups balanced at baseline | Low risk | "There was significantly younger age in the intervention group, as compared with the UC [usual care] group." But most ANCOVA analysis adjusted for baseline differences in age between groups. |
| Intention‐to‐treat analysis | High risk | "Intention‐to‐treat analyses were not suitable as there were no follow‐up data (psychosocial questionnaires, biochemical or biomedical measures) in the women who withdrew from the study." |
| Groups received same cointerventions | Low risk | "Before randomization, all participants in the present trial (also those in the control group)...received general lifestyle advice on diet, physical training and smoking cessation...All women received conventional care and follow‐up for women with IHD [ischaemic heart disease]." |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: USA. Dates participants recruited: 1 January 2005 to 29 February 2008. Participants recruited (number of sites): hospital (5). Maximum follow‐up: 15 months. Follow‐up schedule: 3, 5, 7, 9, and 18 months (note: randomisation at 3 months postbaseline). | |
| Participants | Inclusion criteria: diagnosis of ACS and with persistent depressive symptoms (BDI score ≥ 10 on assessments within 1 week of hospitalisation for ACS and 3 months later). Exclusion criteria: alcohol or drug dependency, dementia, current or past psychosis or bipolar disorder, terminal illness, unavailability for follow‐up, BDI score ≥ 45, or suicidality. Indication (% participants): ACS (100%) ‐ unstable angina (intervention: 73%; comparator: 78%), non‐ST‐STEMI (intervention 16%; comparator: 12%), ST‐segment elevation MI (intervention: 10%; comparator: 10%). Psychopathology: persistent depressive symptoms (100%). Number randomised: total: 157; intervention: 80; comparator: 77. Age (mean ± SD): total: NR; intervention: 59.3 ± 10.6 years; comparator: 61.1 ± 10.6 years. Men: total: NR; intervention: 46; comparator: 47. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: included: an enhanced care approach; participant choice of psychotherapy or pharmacotherapy (or both); problem‐solving therapy; a stepped‐care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and a standardised instrument used to track depressive symptoms. Treatment targets: depressive symptoms. Components: psychotherapy and pharmacotherapy. Treatment setting (number of sites): NR (NR). Modality (group size): NR, but presumed individual ("in person or by telephone"). Dose:
Delivered by: clinical nurse specialist, psychologist, social worker, psychiatrist, or a combination of these. Follow‐up further reinforcement: at the end of the trial, participants were provided with 6 further months of medication if they could not afford it but were referred to their usual care provider for follow‐up. Cointerventions: none described. Pharmacotherapy (antidepressant medication) offered as part of preference trial. Intervention participants choosing pharmacotherapy were initially seen at 1‐ to 2‐week intervals for dose titration and thereafter every 3‐5 weeks as needed for the remainder of the 6‐month trial period. COMPARATOR: usual care, as defined by the participant's treating physicians. Cointerventions: NR. | |
| Outcomes | Total mortality. Non‐fatal MI (as part of a composite indicator only). Anxiety (HADS‐A). Depression (BDI). | |
| Source of funding | The National Heart, Lung, and Blood Institute and the National Center for Research Resources, a component of the National Institutes of Health and National Institutes for Health Roadmap for Medical Research. | |
| Conflicts of interest | NR. | |
| Notes | Anxiety outcome data reported in Kronish 2012. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "At each site, eligible patients were randomised on a 1:1 basis within randomly ordered blocks of 4 or 6 patients according to a table of assignments prepared in advance by the trial statistician (J.E.S.)." |
| Allocation concealment (selection bias) | Low risk | "Using a Web‐based programme, project coordinators specified the strata, initials, and study identification number of the person to be randomised, and the programme issued the group assignment." |
| Blinding of outcome assessment (detection bias) | Low risk | "Interviewers and those collecting medical outcome data were blinded to intervention assignment." |
| Incomplete outcome data (attrition bias) | High risk | Lost to follow‐up: intervention: 20/80 (25%); control: 6/77 (8%). |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported for all time points. |
| Groups balanced at baseline | Low risk | "Patients randomised to the intervention and usual care groups were similar on all baseline variables." |
| Intention‐to‐treat analysis | Low risk | Results were reported as "intention‐to‐treat estimates." |
| Groups received same cointerventions | Low risk | No cointerventions were given to either group. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country : Netherlands. Dates participants recruited: NR. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 1 year. Follow‐up schedule: 2 months and 1 year. | |
| Participants | Inclusion criteria: admitted to hospital with an AMI. Exclusion criteria: aged > 70 years. Indication (% participants): AMI (100%). Psychopathology: NR. Number randomised: total: 60; intervention: 30; comparator: 30. Age (mean ± SD): total: 57 (SD NR) years; intervention: 55.6 ± 7.4 years; comparator: 58.8 ± 8.0 years. Men: total: 82%; intervention: 77%; comparator: 87%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: 2 individual counselling sessions and 2 group health education sessions focusing on medication, healthy habits, anxiety, and depression. Treatment targets: risk education and behaviour change; also attention paid to disease adjustment, anxiety, and depression. Components: risk information, guidance on behaviour change, self‐awareness/monitoring, client‐led discussion; some emotional support. Treatment setting (number of sites): hospital (1). Modality (group size): individual counselling + 2 group sessions (NR) while in hospital, and 6‐weekly telephone calls upon hospital discharge. Dose:
Delivered by: psychologist. Follow‐up further reinforcement: weekly telephone calls were made to participants for a period of 6 weeks after discharge, when participants were given the opportunity to talk about their psychosocial problems. Cointerventions: health education sessions. The topics of these were 'a new start after the myocardial infarction' including advice on physical exercise and healthy eating and risk factors. COMPARATOR: usual medical care (including physical rehabilitation), although systematic health education was not a standard component. Cointerventions: NR. | |
| Outcomes | Anxiety (Dutch version: STAI). Vital exhaustion and depression (Maastricht Questionnaire for Vital Exhaustion and Depression). | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Alternate allocation ‐ in a 2‐week period, all participants admitted to the hospital for an MI were invited to participate and were assigned to the experimental condition; in a subsequent 2‐week period, all participants admitted to the hospital for an MI were assigned to the control condition. |
| Allocation concealment (selection bias) | High risk | Quasi‐randomisation. See above. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | High risk | Dropouts in each group accounted for, but results not based on intention‐to‐treat analyses. |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Groups balanced at baseline | Low risk | "Chi‐square analyses performed on the data gathered in the pre‐test (see Table 1) revealed no statistically significant differences between patients in the experimental and control conditions in demographic characteristics." |
| Intention‐to‐treat analysis | High risk | Participants who dropped out were not included in the analyses. |
| Groups received same cointerventions | High risk | Intervention contained an education component which was not part of standard care. |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: USA. Dates participants recruited: October 1996 to October 1999. Participants recruited (number of sites): hospital (73) affiliated to clinical centres (8). Maximum follow‐up: 4.5 years. Follow‐up schedule: 3 (telephone), 6 (visit), 9 (telephone), 12 (telephone), and 18 (visit) months, then every 6 months thereafter, alternating telephone and visits, until April 2001. | |
| Participants | Inclusion criteria: men and women recruited during a hospitalisation for a verified AMI with either symptoms compatible with AMI or characteristic evolutionary ECG ST‐T changes or new Q waves, reporting depressive symptoms or a lack of social support (or both). Exclusion criteria: comorbidity, logistical barriers, and lack of informed consent. Indication (% participants): AMI (100%). Psychopathology: eligibility criteria depression only (39%), low social support only (26%), depressed and low social support (35%). Number randomised: total: 2481; intervention: 1238; comparator: 1243. Age (mean ± SD): total: 61 (SD NR) years; intervention: 61 ± 12.5 years; comparator: 61 ± 12.6 years. Men: total: 56%; intervention: 57%; comparator: 56%. Ethnicity (% white): total: 66%; intervention: 67%; comparator: 66%. | |
| Interventions | INTERVENTION: depressed people received CBT, focusing on behavioural activation, active problem solving, and efforts to modify depressogenic automatic thoughts or self‐talk. People with severe or unremitting depression received pharmacotherapy with a selective serotonin reuptake inhibitor if unresponsive to psychotherapy. People with low social support received a similarly targeted treatment that focused on social skill deficits and automatic thoughts or self‐talk that interfered with social engagement. The primary mode of treatment was individual therapy, supplemented with group therapy where feasible. Treatment targets: depression (and low social support), and secondary goals around behaviour change, disease adjustment, stress, anxiety, Type A behaviours, and exhaustion. Components: guidance on behaviour change, cognitive challenge/restructuring, homework. Also some self‐awareness/monitoring, relaxation, client‐led discussion, emotional support. Treatment setting (number of sites): individual sessions in the participant's home or counsellor's office (NR); group sessions NR (NR). Modality (group size): individual and group (minimum 3 participants) where deemed feasible. Dose:
Delivered by: therapist trained by study psychologists. Follow‐up further reinforcement: none. Cointerventions: participants in the intervention group meeting criterion for depression were offered antidepressant pharmacotherapy (sertraline hydrochloride) donated by the manufacturer, and provided without charge for up to 12 months. Alternative medications were offered where clinically appropriate and participants may have been referred to cardiac rehabilitation or support groups by their physician as part of usual care. COMPARATOR: referral to cardiac rehabilitation/support groups by participant's own physician was considered to be usual care. Pharmacotherapy was allowed for control group participants, but participants had to seek diagnosis and treatment from their own physician. Cointerventions: NR. | |
| Outcomes | Total mortality. Cardiac mortality. Non‐fatal MI. Depression (BDI, HAM‐D). HRQoL (SF‐12 Physical and Mental Component Scores). Life satisfaction (Ladder of Life Scale). | |
| Source of funding | The National Heart, Lung, and Blood Institute, National Institute of Health, Bethesda, Maryland. Pfizer provided sertraline (Zoloft) for the study. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stratified by clinical centre and used a permuted block algorithm. |
| Allocation concealment (selection bias) | Low risk | Study coordinators obtained treatment allocation using automated telephone randomisation system maintained at the ENRICHD Investigators 2000 Coordinating Center. |
| Blinding of outcome assessment (detection bias) | Low risk | All staff who collected, verified, or classified end point data or follow‐up assessments were masked as much as possible. |
| Incomplete outcome data (attrition bias) | Low risk | "All treatment group comparisons were based on the intention‐to‐treat principle that includes all randomised patients as randomised." |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Groups balanced at baseline | Low risk | "Treatment groups were balanced on key baseline characteristics and prognostic factors." |
| Intention‐to‐treat analysis | Low risk | "All treatment group comparisons were based on the intention‐to‐treat principles." |
| Groups received same cointerventions | Low risk | "Both groups receive usual care while in the hospital and written materials providing education on risk factors, based on the AHA [American Heart Association] Active Partnership@ Program." |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: USA. Dates participants recruited: December 2001 to August 2005. Participants recruited (number of sites): hospital (3). Maximum follow‐up: 9 months. Follow‐up schedule: 6 and 9 months. | |
| Participants | Inclusion criteria: aged ≥ 21 years, had undergone CABG surgery within the past year; current antidepressant medication was not an exclusion criterion, as long as a therapeutic dose had been taken for at least 6 weeks; BDI score ≥ 10 and who met DSM‐IV criteria for a current major or minor depressive episode, as determined by the DISH. Exclusion criteria: severe psychiatric comorbidities, such as schizophrenia or bipolar disorder, active alcoholism or substance abuse, severe cognitive impairment, non‐cardiac illnesses with a poor 1‐year prognosis, being too medically ill or living too far away to participate, being unable to communicate in English, or for receiving ongoing psychotherapeutic services. Indication (% participants): CABG (100%). Psychopathology: minor or major depression, ≥ 10 on BDI, met DSM‐IV criteria for a current major or minor depressive episode DISH (100%). Number randomised: total: 123; intervention 1 (CBT): 41; intervention 2 (SSM): 42; comparator: 40. Age (mean ± SD): total: NR; intervention 1 (CBT): 62.0 ± 11.0 years; intervention 2 (SSM): 59.0 ± 10.0 years; comparator: 61.0 ± 9.0 years. Men: total: NR; intervention 1 (CBT): 44%; intervention 2 (SSM): 50%; comparator: 57%. Ethnicity (% white): total: NR; intervention 1 (CBT): 88%; intervention 2 (SSM): 67%; comparator: 90%. | |
| Interventions | INTERVENTION 1 CBT: target problem identification, problem solving, behavioural activation, cognitive techniques (challenging distressing automatic thoughts and changing dysfunctional attitudes), consolidation of the self‐therapy and relapse‐prevention skills. Brief telephone contacts between treatment sessions as needed. Each case reviewed in a weekly supervision meeting with 1 of the investigators. Earlier sessions usually emphasised. INTERVENTION 2 SSM: a supportive therapeutic relationship setting, to improve participant's coping skills for stressful life events and daily stressors. Discussion of recent stressful experiences and impact on mood, progressive relaxation training and other techniques (controlled breathing and relaxing imagery). Participants asked to practise them daily and maintain a practice log. As proficiency in relaxation skills improved, they were asked to apply them to stressful or distressing situations in daily life. Weekly sessions (twice weekly permitted occasionally). Treatment targets: CBT: distressing automatic thoughts, dysfunctional attitudes, re‐engaging with routine activities; SSM: participant's ability to cope with stressful life events and daily stressors. Components: CBT: problem solving, behavioural activation, cognitive techniques; SSM: coping skills, relaxation training. Treatment setting (number of sites): outpatient research clinic (1). Modality (group size): individual. Dose:
Delivered by: CBT: 1 of 3 therapists (2 clinical psychologists and 1 clinical social worker) with training and experience in CBT; SSM: 1 of 3 therapists (2 clinical social workers and 1 counselling psychologist) with training and experience in counselling and stress management interventions. Follow‐up further reinforcement: brief telephone contacts between sessions as needed, and 2 weekly sessions were allowed when needed. Cointerventions: interventions were provided in addition to, not as a replacement for, any antidepressant medications that the participants may have been receiving from their physicians. COMPARATOR: usual care which may have included antidepressant medications that the participants may have been receiving from their physicians. Cointerventions: none. | |
| Outcomes | Anxiety (Beck Anxiety Inventory). Depression (HAM‐D, BDI). HRQoL (SF‐36 Physical and Mental component scores). Perceived stress scale (Cohen Perceived Stress scale). Beck Hopelessness Scale. | |
| Source of funding | National Institute of Mental Health, USA. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "We used a SAS programme (SAS Institute, Cary, North Carolina) to generate a random allocation sequence with block sizes of 3 and 6." |
| Allocation concealment (selection bias) | Low risk | "Group assignments were concealed in sealed envelopes and revealed to the study coordinator immediately after the participant completed all of the baseline assessments." |
| Blinding of outcome assessment (detection bias) | Low risk | "The outcome assessors were masked to the participants' group assignments." |
| Incomplete outcome data (attrition bias) | Low risk | Lost to follow‐up at 9 months: CBT: 1/40 (3%); SSM: 7/42 (17%); usual care: 4/40 (10%). |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Groups balanced at baseline | Low risk | "The proportion of African American participants randomly assigned to the SSM arm was higher than expected (P=.01). There were no other significant differences in the characteristics of the groups." |
| Intention‐to‐treat analysis | Low risk | "The outcome analyses conformed to the intention‐to‐treat principle." |
| Groups received same cointerventions | Low risk | "interventions were provided in addition to, not as a replacement for, any antidepressant medications that the participants may have been receiving from their physicians." |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: USA. Dates participants recruited: NR. Participants recruited (number of sites): media adverts, invitations from cardiologists, corporate and union executives (NR). Maximum follow‐up: 5 years. Follow‐up schedule: 1, 2, 3, 4, and 5 years. | |
| Participants | Inclusion criteria: experienced with their first or last documented AMI ≥ 6 months earlier; had either never smoked or had quit smoking cigarettes, cigars, or pipes for 6 months or longer; and had never been treated for or exhibited signs of diabetes. Exclusion criteria: NR. Indication (% participants): MI within 6 months (100%). Psychopathology: NR. Number randomised: total: 884; intervention (Type A behavioural counselling): 614; comparator (cardiology counselling): 270. Age (mean ± SD): total: NR; intervention: 53.1 ± 6.7 years; comparator: 53.4 ± 6.4 years. Men: total: NR; intervention: 90%; comparator: 95%. Ethnicity (% white): total: 98%; intervention: NR; comparator: NR. | |
| Interventions | INTERVENTION: Type A behavioural counselling including: relaxation training (progressive muscle relaxation and mental relaxation) and behavioural learning (recognition and modification of exaggerated arousal reactions, instruction in self‐observation and self‐assessment techniques, restructuring of environment, and cognitive‐affective learning). Treatment targets: behaviour change, cardiac risk reduction, disease adjustment, stress, Type A behaviours. Components: guidance on behaviour change, risk factor management, self‐awareness/monitoring, relaxation, cognitive challenge/restructuring, homework. Treatment setting (number of sites): NR (NR). Modality (group size): group (10 participants). Dose:
Section 2 groups initially met with their counsellors weekly for 2 months, every 2 weeks for 2 months, and were scheduled to meet monthly for the remainder of the study. They were visited every 3 months by a cardiologist who discussed specific cardiovascular problems possibly confronting participants. Delivered by: psychiatrists, clinical/counselling psychologists, and 2 cardiologists. Follow‐up further reinforcement: NR. Cointerventions: cardiological counselling on risk factor reduction delivered by a cardiologist and usual medical care. COMPARATOR: cardiology counselling ('Section 1') delivered by cardiologists in a group setting (12 participants per group). Groups met every 2 weeks for 3 months, monthly for 3 months, and twice monthly for the remainder of the study, and visited every 3 months by a psychiatrist or psychologist. Participants received risk factor counselling aimed at enhancing compliance with the dietary, exercise, and drug regimen prescribed for them by their personal physicians. Participants were informed of all advances in the diagnosis and treatment of CHD. Usual medical care was also available. Cointerventions: NR. | |
| Outcomes | Cardiac mortality. Non‐fatal MI. Type A behaviour (based on clinical checklist/observations). | |
| Source of funding | National Heart, Lung, and Blood Institute, Bank of America, Standard Oil of California, The Kaiser Hospital Foundation, The Zellerbach Family Foundation and the Mary Potishman Lard Foundation. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation, using a table of random numbers, was conducted in a ratio of 2:1 to intervention and control group. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Type A behaviour was assessed by 1 interviewer blind to treatment status. |
| Incomplete outcome data (attrition bias) | Low risk | "Analyses were conducted on an intention‐to‐treat basis." |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Groups balanced at baseline | Low risk | Table 1 showed that baseline characteristics and prognostic factors were similar for the intervention and comparator group. |
| Intention‐to‐treat analysis | High risk | Data from dropouts were not included in the analyses of year 1 data (Table 5) by group allocation, but presented separately as a 'drop‐out' group (including both Section 1 and 2 participants). |
| Groups received same cointerventions | Low risk | The only difference between intervention and comparator groups is the addition of Type A behaviour counselling. Both groups received risk factor education counselling and usual medical care. |
| Study characteristics | ||
| Methods | Design: RCT. Country: UK. Dates participants recruited: NR. Participants recruited (number of sites): general practices (30). Maximum follow‐up: 6 months. Follow‐up schedule: 6 months. | |
| Participants | Inclusion criteria: men aged < 70 years who were currently being prescribed nitrates (as tablets, sprays, or patches) or nifedipine (calcium antagonist) for angina. Exclusion criteria: NR. Indication (% participants): angina (100%). Psychopathology: NR. Number randomised: total: 452; intervention: 227; comparator: 225. Age (mean ± SD): total: NR; intervention: NR; comparator: NR. Men: total: 100%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: instruction in stress management was given in 3 group sessions each of about 1 hour. Stress management included identifying stress triggers, stressful thoughts and feelings, and relaxation techniques. The cognitive coping strategies of 'self‐talk' and cognitive challenge were taught. Participants were also asked to practise relaxation and read a course 'manual' at home. Treatment targets: stress reduction. Components: relaxation and homework assignments, plus some self‐monitoring/awareness and client‐led discussion. Treatment setting (number of sites): clinic (NR). Modality (group size): group (3‐8 participants). Dose:
Delivered by: psychologist. Follow‐up further reinforcement: NR. Cointerventions: NR. COMPARATOR: usual medical care. Cointerventions: NR. | |
| Outcomes | Stress (Derogatis Stress Profile). | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated that the participants were randomly allocated in a factorial design which included 8 groups (of which 4 were reported in this study). |
| Allocation concealment (selection bias) | Unclear risk | "Randomisation was achieved with 8 envelopes." |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | Unclear risk | "All analyses followed the 'intention‐to‐treat principle as far as the follow‐up data allowed." |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Groups balanced at baseline | Low risk | "Comparison of cardiovascular risk factors at baseline, using 't' test and Chi Square Test as appropriate, showed no differences between the two groups." |
| Intention‐to‐treat analysis | Low risk | "All analyses followed the 'intention‐to‐treat' principle as far as the follow‐up data allowed." |
| Groups received same cointerventions | Low risk | No cointerventions were reported. |
| Study characteristics | ||
| Methods | Design: single‐centre, parallel groups RCT. Country: Sweden. Dates participants recruited: 1 May 1996 to 31 August 2002. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 128 months (mean 94 months). Follow‐up schedule: 6, 12, 18, and 24 months. | |
| Participants | Inclusion criteria: aged ≤ 75 years; discharged from hospital (index event) after AMI, PCI, CABG; living in hospital catchment area; being healthy enough to be referred back to general practitioner within 1 year after admission; not having participated in similar programmes; Swedish speaking; willing to participate in study and accept random group allocation. Exclusion criteria: NR. Indication (% participants): AMI (51%), CABG (34%), PCI (15%). Psychopathology: NR. Number randomised: total: 362; intervention: 192; comparator: 170. Age (mean ± SD): total: NR; intervention: 62.0 ± 7.9 years; comparator: 61.0 ± 8.3 years. Men: total: 77%; intervention: 78%; comparator: 75%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: CBT programme delivered using a manual included 5 key components with specific goals: education, self‐monitoring, skills training, cognitive restructuring, and spiritual development. Each session had a specific theme, working material, and homework assignment. Simple diaries were used for self‐monitoring of behaviours and reactions. Behavioural exercises ("drills") were introduced early and were monitored and discussed in every session. The session format was: brief relaxation, reflections on the previous session, follow‐up of homework assignment, introduction of new themes, and preparation of homework. The communication style of the therapist was oriented towards motivational interviewing rather than educational. Treatment targets: stress management; coping with stress; and reducing experience of daily stress, time urgency, and hostility. Components: CBT, education, self‐monitoring, skills training, cognitive restructuring, and spiritual development. Treatment setting (number of sites): NR (NR). Modality (group size): group (5‐9 participants), separate groups for men and women. Dose:
Delivered by: clinical psychologists and nurses, experts in CHD and working with people with CHD. Follow‐up further reinforcement: NR. Cointerventions: NR. COMPARATOR: usual care, defined as traditional risk factor optimisation efforts during follow‐up. Cointerventions: NR. | |
| Outcomes | Total mortality. Time to first recurrent CVD event. Time to first recurrent AMI. | |
| Source of funding | Swedish Medical Research Council, the Var dal foundation, the Swedish Council for Working Life and Social Research, the Swedish National Board of Health and Welfare, the Swedish Heart and Lung Association, by the Uppsala Primary Health Care Administration, and by Uppsala University. | |
| Conflicts of interest | Authors declared no conflict of interests. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The group allocation was based on the SAS "ranuni" function, providing random numbers with equal probability." |
| Allocation concealment (selection bias) | Low risk | "The procedure resulted in pre‐prepared sealed envelopes, kept in a safe, with a serial number on the outside and a sheet of paper inside with the group allocation on the front and a blinding print on the back to prevent reading the group allocation sheet from the outside. After inclusion of a participant, the study monitor, a secretary who managed data handling and follow‐up appointments and who was the only person with access to the randomisation envelopes, opened the next envelope in turn and noted the group allocation in the computerized monitoring logbook." |
| Blinding of outcome assessment (detection bias) | Low risk | Not clearly described ‐ although all outcome data obtained from registries. |
| Incomplete outcome data (attrition bias) | Low risk | "…all "hard" outcome data were obtained from official registries, and the follow‐up was complete until death or end of follow‐up, minimizing the bias risk." |
| Selective reporting (reporting bias) | Low risk | All outcomes described in methods were reported in results. |
| Groups balanced at baseline | Low risk | "There were no significant baseline differences between the intervention and reference groups in the characteristics shown in Table 1 and no significant differences in the medical history variables (Table 2)." |
| Intention‐to‐treat analysis | Low risk | "All analyses were based on the intention‐to‐treat approach. As shown in Figure 1, most individuals participated in all follow‐up examinations, with a small group coming and going. The largest number of permanent dropouts from the study were attributable to death. In case of missed appointments among survivors, data from the most recent previous appointment were used until new values were available." |
| Groups received same cointerventions | Low risk | "The intervention group and the reference group both received traditional care, defined as traditional risk factor optimization efforts during follow‐up. In addition, the intervention group participants entered the CBT intervention programme as soon as they were included in the trial." |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: UK. Dates participants recruited: NR. Participants recruited (number of sites): hospital (6). Maximum follow‐up: 12 months. Follow‐up schedule: 6 and 12 months. | |
| Participants | Inclusion criteria: discharged home from hospital within 28 days of confirmed MI, irrespective of age, sex, or previous cardiac history. Exclusion criteria: prolonged hospital stay (> 28 days) and discharge to long‐term institutional care. Indication (% participants): AMI (100%). Psychopathology: clinically significant anxiety (32%) and depression (19%). Number randomised: total: 2328; intervention: 1168; comparator: 1160. Age (mean ± SD): total: NR; intervention: NR; comparator: NR. Men: total: NR; intervention: NR; comparator: NR. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: rehabilitation programmes comprising psychological therapy, counselling, relaxation training, and stress management training over 7 weekly group outpatient sessions for participants and spouses. Principal objectives were to: give information about the heart condition and treatment to allay fears and reduce anxiety; increase awareness of stress and stressful situations; teach relaxation skills; improve responses to stressful situations and develop coping skills; promote positive adjustment to illness; and rebuild confidence in participants and spouses. Sessions included teaching, practical exercises with participant participation, group discussion, and individual counselling. The importance of practice between sessions was emphasised and participants were asked to keep records of progress with diaries of activity, stress, and relaxation. Treatment targets: risk education, disease adjustment, stress, anxiety, depression. Components: risk information, self‐awareness/monitoring, relaxation, client‐led discussion. Treatment setting (number of sites): hospital outpatient clinic (6). Modality (group size): individual and group sessions (NR). Dose:
Delivered by: clinical psychologists and health visitors. Follow‐up further reinforcement: NR. Cointerventions: education. COMPARATOR: usual medical care. Cointerventions: NR. | |
| Outcomes | Total mortality. Non‐fatal MI. Revascularisation (CABG and PCI). Anxiety (STAI). Depression (DSSI/sAD 1976). | |
| Source of funding | British Heart Foundation and Welsh Office. | |
| Conflicts of interest | Authors declared no conflict of interest. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Only stated that participants were randomised. |
| Allocation concealment (selection bias) | Low risk | Participants randomised by a study coordinating centre, with knowledge only of the date of admission and eligibility for discharge, and no prognostic factors. |
| Blinding of outcome assessment (detection bias) | Low risk | Interviewers were blind to treatment status. |
| Incomplete outcome data (attrition bias) | Low risk | See Figure 1. Of 2328 participants randomised, 12‐month clinical follow‐up was available for 2042 (94%) of surviving participants (intervention: 1029/1168 vs comparator: 1013/1160). |
| Selective reporting (reporting bias) | Low risk | Results data for all outcomes described in results section. |
| Groups balanced at baseline | Low risk | "In this series there were no important differences by age, sex, hospital, or baseline anxiety or depression." |
| Intention‐to‐treat analysis | Low risk | "The intention‐to‐treat analysis might also dilute any true therapeutic effect…" |
| Groups received same cointerventions | High risk | The intervention included an education component that was not available to control participants. |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: Sweden. Dates participants recruited: August 1996 to January 2000. Participants recruited (number of sites): hospital (2). Maximum follow‐up: 2 years. Follow‐up schedule: 10 weeks, 1 year, and 1‐2 years. | |
| Participants | Inclusion criteria: women aged ≤ 75 years who had AMI, PCI, or CABG Exclusion criteria: unable to communicate in Swedish, participating in other research studies, not living in the hospital catchment area or had serious comorbidity that would preclude taking part in the 1‐year intervention programme (e.g. malignancy or psychiatric disease). Indication (% participants): AMI (57%), PCI (31%), CABG (32%). Psychopathology: vital exhaustion, Maastricht Questionnaire ≥ 14 (intervention: 78%; comparator: 69%) and depressive symptoms, BDI ≥ 10 (intervention: 55%; comparator: 52%). Number randomised: total: 247; intervention: 119; comparator: 128. Age (mean ± SD): total: 62 ± 8.9 years; intervention: 61.4 ± 9.1 years; comparator: 62.7 ± 8.7 years. Men: total: 0%; intervention: 0%; comparator: 0%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: the stress management programme was based on cognitive behavioural principles with various strategies to be practised between every session. All sessions had elements of both education and discussions. The initial sessions were focused on teaching links between CHD and lifestyle, and the physiological stress response. Subsequent sessions aimed at teaching how to identify the physical, cognitive, affective, and behavioural stress responses using cognitive behavioural strategies. Strategies include replacing negative and irrational thoughts with alternative ones, practising a relaxed behaviour style as opposed to Type A behaviour, practising progressive relaxation techniques, assertive communication, and strategic problem‐solving skills. Treatment targets: stress; also some attention to risk education, disease adjustment, anxiety, Type A behaviour, exhaustion, depression. Components: risk information, self‐awareness/monitoring, relaxation, cognitive challenge/restructuring, homework. Treatment setting (number of sites): hospital (2). Modality (group size): group (NR). Dose:
Delivered by: NR. Follow‐up further reinforcement: NR. Cointerventions: education and usual medical care. COMPARATOR: usual medical care, including referral to comprehensive cardiac rehabilitation. Cointerventions: NR. | |
| Outcomes | Total mortality. Stress (Everyday Life Stress Scale). Vital exhaustion (Maastricht Questionnaire). | |
| Source of funding | Ansgarius Foundation, the Belven Foundation, King Gustaf V's and Queen Victoria's Foundation, Swedish Heart and Lung Foundation, the Public Health Committee and EXPO‐95 of Stockholm County Council, the Swedish Medical Research Council (project 19X‐11629), the Vardal Foundation, Stockholm, Sweden. | |
| Conflicts of interest | The authors declared no conflict of interest. | |
| Notes | Stress data reported in Blom 2009. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A random number table was used to create group assignments. |
| Allocation concealment (selection bias) | Low risk | "A person not in contact with patients allocated them. The result of the procedure was kept in sealed envelopes and given to the patients by research nurses." |
| Blinding of outcome assessment (detection bias) | Low risk | The person entering participants' data (paper‐based questionnaires) in the computer had no knowledge about the study. |
| Incomplete outcome data (attrition bias) | Low risk | All missing data adequately accounted for, and similar numbers of participants were missing from control and treatment groups. |
| Selective reporting (reporting bias) | Low risk | All outcomes mentioned in the methods fully reported. |
| Groups balanced at baseline | High risk | "The patients in the intervention group had higher levels of vital exhaustion (intervention group: mean = 22.7 ± 10.6, median = 23.0, range = 0‐42, control group: mean = 19.4 ± 9.6, median = 19.0, range = 0‐42 P = 0.036, see Table 1." |
| Intention‐to‐treat analysis | Low risk | "Analyses on the effects of the intervention were based on intention‐to‐treat approach." |
| Groups received same cointerventions | High risk | Intervention included an education component and usual medical and pharmacological care. |
| Study characteristics | ||
| Methods | Design: single‐centre prospective RCT. Country: Norway. Dates participants recruited: August 2003 to 2004. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 6 months. Follow‐up schedule: 6 weeks and 6 months. | |
| Participants | Inclusion criteria: elective CABG participants, aged 18‐80 years, admitted to Ulleval University Hospital (Oslo, Norway) between August 2003 and 2004, physically and mentally capable of completing the study, read and understand the Norwegian language, resided within 3 hours of driving distance of Oslo. Exclusion criteria: undergone combined coronary and valve replacement surgery, emergency surgery, or repeat surgery; experienced complications related to surgery; required prolonged stay in intensive care units. Indication (% participants): elective CABG (100%). Psychopathology: recruitment not based on psychopathology. Anxiety, HADS‐A (intervention: 29%; comparator: 35%) and Depression, HADS‐D (intervention: 15%; comparator: 22%). Number randomised: total: 203; intervention: 101; comparator: 102. (18 (9%) lost to follow‐up at 6 months. All results based on: total: 185; intervention: 93; comparator: 92). Age (mean ± SD): total: NR; intervention: 62 years (range 39‐77); comparator: 62 years (range 42‐78). Men: total: NR; intervention: 90%; comparator: 89%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: home‐based intervention programme involved 2 nurse visits who had individualised the programme. First visit included: angina symptoms, medications, sexuality; contact details for further information or in an emergency; setting personal goals; and identifying coping strategies. The nurse suggested additional coping strategies and provided emotional support for participants struggling with anxiety or depression (or both). Information on coping strategies was documented in an intervention manual for the participants to consult before the second home visit. Second visit included: evaluation of goal attainment and to reassess anxiety, depression, and coping. Treatment targets: anxiety, depression, coping. Components: psychoeducation, goal setting, coping strategies. Treatment setting (number of sites): home‐based (NR). Modality (group size): individual, although significant others could be present. Dose:
Delivered by: critical care nurse. Follow‐up further reinforcement: NR. Cointerventions: NR. COMPARATOR: standard discharge care: a short talk with the nurse/doctor, participants received information, and asked questions. Cointerventions: NR. | |
| Outcomes | Hospitalisations. Anxiety (HADS‐A). Depression (HADS‐D). HRQoL (Seattle Angina Questionnaire, SF‐36 Physical and Mental component scores reported by Lie et al. 2009). | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A randomisation code was developed with a computer random number generator." |
| Allocation concealment (selection bias) | Low risk | "A randomization code was developed with a computer random number generator. Once the patient had completed the informed consent process, an opaque envelope with sequential numbering and instructions was opened." In an associated paper (Lie et al. 2009) the authors described the code being generated by a statistician independent from the recruitment team, with the allocated codes placed into envelopes by a secretary. |
| Blinding of outcome assessment (detection bias) | Low risk | "The questionnaires were mailed to the participants in both groups and returned to the investigator in pre‐stamped envelopes. Thereafter, all data entries and analyses were performed without knowledge of group assignment." |
| Incomplete outcome data (attrition bias) | Low risk | "Two hundred three patients were included in the study; after 18 patients were lost to follow‐up, 93 patients in the intervention group and 92 patients in the control group completed the study." |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Groups balanced at baseline | Low risk | "The characteristics of the patients included in the study did not differ significantly between the two groups (Table 1)." |
| Intention‐to‐treat analysis | Low risk | "ITT [intention‐to‐treat] analysis was also performed in the present study and demonstrated results similar to those of per‐protocol analysis." |
| Groups received same cointerventions | Low risk | No other cointerventions. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: UK. Dates participants recruited: January 1997 to March 1998. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 12 months. Follow‐up schedule: 1, 3, and 12 months. | |
| Participants | Inclusion criteria: living in the region, aged ≤ 70 years, with a first or secondary infarction (clinical diagnosis). Exclusion criteria: people unable to participate in trial procedures. Indication (% participants): AMI (100%). Psychopathology: NR. Number randomised: total: 114; intervention: 54; comparator: 56. Age (mean ± SD): total: 58.2 (SD NR) years; intervention: 57.9 ± 7.4 years; comparator: 58.3 ± 8.4 years. Men: total: 78%; intervention: 80%; comparator: 76%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: nurses applied behavioural techniques supported by a handbook. Individualised recommendations for lifestyle and secondary prevention were given, with advice on how they might best be achieved using cognitive behavioural principles. Individualised plans supplemented the more general information sheets that were provided. Partners were encouraged to attend. Treatment targets: risk education, behaviour change, disease adjustment; attention paid to anxiety and depression. Components: risk education, guidance on behaviour change, relaxation; some client‐led discussion. Treatment setting (number of sites): hospital (1). Modality (group size): individual. Dose:
Delivered by: cardiac nurses. Follow‐up further reinforcement: following discharge, participants were telephoned to review progress towards goals and to discuss any problems or questions. Readmitted participants were seen on their wards. Cointerventions: tailored education and usual medical care. COMPARATOR: usual medical care (structured exercise not available) including advice from medical and nursing staff, access to standard booklets, and a medical outpatient clinic follow‐up at 6 weeks. Structured exercise was not routinely offered. Cointerventions: NR. | |
| Outcomes | Anxiety and Depression combined score (HADS ‐ total score). HRQoL (Dartmouth COOP scales). | |
| Source of funding | British Heart Foundation. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number tables. |
| Allocation concealment (selection bias) | Low risk | Following completion of the baseline assessment, participants were randomised by the research nurse using a system of opaque sealed envelopes prepared using random number tables. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Research nurses (distinct from treatment team) took baseline measures, but follow‐up scores obtained via postal questionnaires, and unclear how these were handled. |
| Incomplete outcome data (attrition bias) | Low risk | "Throughout, an intention‐to‐treat approach was adopted." All dropouts reported. For dichotomous outcomes, a conservative analysis was conducted with missing data counted as poor outcomes. |
| Selective reporting (reporting bias) | Unclear risk | All outcomes fully reported. However, no numerical data provided for the combined Type A measure (only subscales, of which some were and some were not significantly different). |
| Groups balanced at baseline | Low risk | Table 1 showed that all baseline characteristics and prognostic factors were similar in both groups at baseline (although no P values were given). |
| Intention‐to‐treat analysis | Low risk | "Throughout, an intention‐to‐treat approach was adopted." |
| Groups received same cointerventions | Low risk | Risk education was provided to both groups. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: USA. Dates participants recruited: September 2001 to August 2003. Participants recruited (number of sites): hospital (2). Maximum follow‐up: 6 months. Follow‐up schedule: 2, 3, and 6 months. | |
| Participants | Inclusion criteria: ACS, aged ≥ 35 years, able to speak English, had access to a touch‐tone phone, and had symptoms of depressive illness or anxiety (> 7 HADS‐A or > 7 HADS‐D). Exclusion criteria: mental health care in the previous 3 months, psychoactive drug use or diagnosed substance abuse during the past year, or severe depression (> 15 HADS‐D). Indication (% participants): ACS (100%) including angina (9%), MI (37%), ischaemic heart disease (54%). Psychopathology: eligibility criteria anxiety and depression (47%), depression only (39%), anxiety only (14%). Number randomised: total: 100; intervention: 53; comparator: 47. Age (mean ± SD): total: 60.2 (SD NR) years; intervention: 59.9 ± 10.2 years; comparator: 60.7 ± 9.8 years. Men: total: NR; intervention: 69%; comparator: 65%. Ethnicity (% white): total: NR; intervention: 89%; comparator: 88%. | |
| Interventions | INTERVENTION: first telephone contact reviewed 8 fears commonly experienced by people living with chronic medical conditions: loss of control, loss of self‐image, dependency, stigma, abandonment, anger, isolation, and fear of death. With the counsellor, participants identified barriers to adjustment to medical illness and rank ordered these. In sessions 2‐6, participants and counsellors identified strategies to address these barriers. The counsellor reviewed progress toward goals with reinforcement and encouragement. A session log tracked the issues reviewed in each session. Treatment targets: disease adjustment; also some attention to anxiety, depression. Components: guidance on behaviour change, self‐awareness/monitoring; also some cognitive challenge/restructuring, client‐led discussion, emotional support, and homework. Treatment setting (number of sites): telephone‐based intervention (NR). Modality (group size): individual via telephone. Dose:
Delivered by: doctoral‐level clinicians (psychiatrist, clinical psychologist, and internist). Follow‐up further reinforcement: NR. Cointerventions: usual medical care. COMPARATOR: usual medical care. Cointerventions: control participants received a booklet on coping with cardiac illness typical of those given at hospital discharge. | |
| Outcomes | Total mortality. Anxiety (HADS‐A). Depression (HADS‐D). | |
| Source of funding | National Institute of Mental Health (Mental Health Services Research Program in Managed Care) and Robert Wood Johnson Foundation: McLaughlin Thomas. | |
| Conflicts of interest | Authors declared no conflicts of interest. | |
| Notes | There was a significant decrease in depression scores, but mean baseline scores in the intervention group were 2 points higher, indicating a potential selection bias. (Note from previous update.) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Coin flip. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Low risk | Baseline and follow‐up measures were obtained via an interactive telephone system. |
| Incomplete outcome data (attrition bias) | Unclear risk | "Statistical analyses consisted of descriptive and intent to treat modelling procedures." |
| Selective reporting (reporting bias) | High risk | Anger (State‐Trait Anger Expression Inventory) mentioned in the methods, but outcome data NR. |
| Groups balanced at baseline | Low risk | "Table 1 indicates that at randomisation groups were balanced." |
| Intention‐to‐treat analysis | Low risk | "Statistical analyses consisted of descriptive and intent‐to‐treat modelling procedures." |
| Groups received same cointerventions | Unclear risk | The control group received a booklet on coping strategies that was "typically provided upon hospital discharge." It did not state if this was also given to intervention group participants, although it is likely as they were not formally recruited until posthospital discharge. |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: Sweden. Dates participants recruited: May 2008 to December 2008. Participants recruited (number of sites): hospital (2). Maximum follow‐up: 6 months. Follow‐up schedule: 6 months. | |
| Participants | Inclusion criteria: aged ≤ 75 years, had a CHD, as defined by a history of MI or angiographically documented CHD, but no MI or ACS or CABG in last 3 months. Score ≥ 8 HADS‐A. Exclusion criteria: preplanned CABG in the 6 months after inclusion, manifest cardiac arrhythmias or pacemaker, implantable cardioverter defibrillator, severe heart failure LVEF < 35%), type 1 diabetes, chronic infections, alcohol or drug abuse, or a severe medical or psychiatric condition. Indication (% participants): CHD (100%). Psychopathology: elevated levels of anxiety, ≥ 8 HADS‐A (100%). Number randomised: total: 62; intervention: 30; comparator: 32. (10 participants lost to follow‐up so presented results are for complete data sets: total: 52; intervention: 25; comparator: 27). Age (mean ± SD): total: NR; intervention: 62.5 ± 8.3 years; comparator: 59.8 ± 7.5 years. Men: total: NR; intervention: 76%; comparator: 70%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: included: information on CHD management; information on symptoms of anxiety, stress, and bodily effects; teaching participants to monitor stress signs and stress management techniques; teaching techniques of cognitive restructuring to change the participants' distorted beliefs and interpretations of threatening symptoms and life situations; reflecting disease‐associated changes in social relationships; and practising social communication skills. Treatment targets: anxiety and stress. Components: risk education, stress management, cognitive restructuring, disease adjustment. Treatment setting (number of sites): NR (NR). Modality (group size): group (6‐8 participants). Dose:
Delivered by: 2 clinical psychologists and cardiologist. Follow‐up further reinforcement: none. Cointerventions: none. COMPARATOR: participants received no intervention. Cointerventions: none. | |
| Outcomes | Anxiety (HADS‐A). Depression (HADS‐D). | |
| Source of funding | NR. | |
| Conflicts of interest | Authors declared no conflict of interest. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation assignments were made using a simple randomisation strategy (random numbers table). |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | High risk | Not described. |
| Incomplete outcome data (attrition bias) | Low risk | Lost to follow‐up: intervention: 5/30 (17%); control: 5/32 (16%). |
| Selective reporting (reporting bias) | Low risk | All outcomes described in methods were reported in results. |
| Groups balanced at baseline | Low risk | "Intervention and control groups were comparable in most of the sociodemographic, disease‐related and psychological variables (table 1) except for significant differences in systolic blood pressure and use of calcium channel blockers and nitrates." |
| Intention‐to‐treat analysis | Low risk | Per‐protocol analysis presented. Intention‐to‐treat analysis not conducted for reported results, but: "we repeated all analyses based on the intention‐to‐treat principle applying LOCF [last observation carried forward] to replace missing values and did not find any change of our results." |
| Groups received same cointerventions | Unclear risk | Usual care not described so could not be sure what was a cointervention. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Germany. Dates participants recruited: July 2001 to December 2001. Participants recruited (number of sites): hospital (2). Maximum follow‐up: 1 year. Follow‐up schedule: 1 year. | |
| Participants | Inclusion criteria: documented CAD after coronary angiography PCI, or stationary treatment for CAD. Exclusion criteria: participants who had had ACS or CABG during the previous 3 months, type 1 diabetes, a body mass index > 33 kg/m2, manifest cardiac arrhythmias, heart failure, or a life‐threatening comorbid condition. Indication (% participants): CAD (100%) including ≥ 1 of MI (51%), coronary bypass (32%), PCI (55%), implanted stent (42%), and 3‐vessel disease (41%). Psychopathology: clinical diagnosis of depression (3.8%). Number randomised: total: 105; intervention: 51; comparator: 54. Age (mean ± SD): total: 59.4 ± 8.6 years; intervention: 59.0 ± 8.7 years; comparator: 59.8 ± 8.6 years. Men: total: 77%; intervention: 79%; comparator: 76%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: comprehensive lifestyle therapy/stress reduction group. Techniques taught included mindfulness meditation, guided imagery, yoga breathing techniques, and body scan. Further elements included CBT (cognitive restructuring) and psychoeducational approaches (coping skills training). CBT included monitoring irrational automatic thoughts and generating alternative interpretations of situations. Programme included practical exercises aimed at developing attitudes of non‐judging, acceptance, and patience. Each session included educational lectures about stress reduction, stress management, and nutritional therapy, followed by training and practising yoga, mindfulness meditation, body scan, and visualisations. Treatment targets: stress; also some attention paid to behaviour change. Components: risk information, guidance on behaviour change, self‐awareness/monitoring, relaxation, cognitive challenge/restructuring. Treatment setting (number of sites): initial retreat, then weekly sessions at hospital (2). Modality (group size): group (10‐12 participants). Dose: programme started with a 3‐day retreat followed by weekly 3‐hour sessions for 10 weeks and thereafter by twice weekly 2‐hour meetings.
Delivered by: personnel who had undergone training and who had experience teaching these programmes for at least 2 years. Follow‐up further reinforcement: NR. Cointerventions: Mediterranean‐type diet recommended. Physical activity and exercise encouraged, but not taught formally as part of intervention. COMPARATOR: written advice about stress management. Cointerventions: NR. | |
| Outcomes | Total mortality. Revascularisation. Anxiety (STAI). Depression (BDI). HRQoL (SF‐36 Physical and Mental component scores). Anger (STAXI). Perceived stress (Cohen Perceived Stress scale). | |
| Source of funding | The Alfried Krupp Foundation, Essen. | |
| Conflicts of interest | Authors declared no conflicts of interest. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central computer‐generated random assignments. |
| Allocation concealment (selection bias) | Unclear risk | "Randomization assignments were made by a central computer" but no mention made of concealment of allocation from investigators, e.g. during enrolment. |
| Blinding of outcome assessment (detection bias) | Unclear risk | No mention made of how self‐reported outcome assessments were collected and coded for analysis. |
| Incomplete outcome data (attrition bias) | Low risk | "Analyses included all patients for whom data were available at follow‐up (per protocol‐analysis)." Missing participants and reasons noted per‐group. |
| Selective reporting (reporting bias) | Low risk | Data presented for all measures mentioned in the methods section. |
| Groups balanced at baseline | Low risk | "Baseline characteristics were well balanced between groups (all p values for group dependence 1 0.1, except a trend (p = 0.06) for patients in the AOG [written advice only group i.e. controls] to have a higher body mass index (table 1)." |
| Intention‐to‐treat analysis | High risk | "We did not perform 'intention‐to‐treat' analysis." |
| Groups received same cointerventions | Low risk | Both groups received risk advice. |
| Study characteristics | ||
| Methods | Design: RCT. Country: Portugal. Dates participants recruited: NR. Participants recruited (number of sites): NR. Maximum follow‐up: 2 years. Follow‐up schedule: 2 years. | |
| Participants | Inclusion criteria: aged 40‐80 years, CAD (stable angina or AMI). Exclusion criteria: presence of neurological diseases; currently taking any antidepressive, antiepileptic, or relaxation medication. Participants who had a recurrent coronary event or who did not complete the programme were considered dropouts. Indication (% participants): stable angina (16%), AMI (84%). Psychopathology: NR, although people taking antidepressants were excluded. Number randomised: total: 81; intervention: 40; comparator: 41. Age (mean ± SD): total: NR; intervention: 59.5 ± 10.8 years; comparator: 59.6 ± 10.8 years. Men: total: 85%; intervention: 85%; comparator: 85%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: standard cardiac rehabilitation plus a hospital‐based relaxation therapy including: relaxation and imagery techniques, supervised group sessions, but no instructions were given for additional practice at home. Treatment targets: relaxation. Components: Mitchell's simple physiological relaxation and imagery techniques. Treatment setting (number of sites): NR (NR). Modality (group size): group (NR). Dose:
Delivered by: trained instructor. Follow‐up further reinforcement: NR. Cointerventions: standard cardiac rehabilitation programme offered as usual care. COMPARATOR: cardiac rehabilitation programme including 4 counselling sessions (1 stress management, 1 smoking cessation, and 2 nutrition), and 3 sessions per week of exercise training for 12 weeks. Cointerventions: NR. | |
| Outcomes | Cardiovascular‐related hospital admissions:
| |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information just "…patients were randomly assigned…" |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | Low risk | "Patients who had a recurrent coronary event or who did not complete the programme were considered dropouts. One patient initially assigned to the CPA [cardiac rehabilitation programme alone] group underwent cardiac revascularization surgery and was excluded from data analysis because of inability to participate. Thus, only 80/81 patients were subsequently considered for analysis." |
| Selective reporting (reporting bias) | Low risk | All outcomes listed in methods reported in results. |
| Groups balanced at baseline | Low risk | "There were no differences between the groups in the demographics and all parameters assessed at baseline." |
| Intention‐to‐treat analysis | Unclear risk | Not described. |
| Groups received same cointerventions | Low risk | All participants received the cardiac rehabilitation programme. |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: Australia. Dates participants recruited: December 2009 to February 2011. Participants recruited (number of sites): hospital (6). Maximum follow‐up: 12 months. Follow‐up schedule: 6 and 12 months. | |
| Participants | Inclusion criteria: aged 21‐85 years, a clinical diagnosis of ACS (MI ‐ ST elevation MI (STEMI) or non‐STEMI) or unstable angina with confirmed CAD on angiogram), available for the duration of the study via the telephone, fluent in English, and scored 5‐19 on PHQ‐9. Exclusion criteria: cognitive impairment or a diagnosis of a psychiatric condition interfering with study involvement (e.g. bipolar illness, psychotic illness of any type, dementia, acute suicidality, severe personality disorder), participation in regular psychotherapy with a mental health professional at the time of hospital admission, terminal illness, or any inability to participate in an unsupervised tele‐based mood and lifestyle intervention as confirmed by a treating clinician. Indication (% participants): 100% ACS. Psychopathology: 100% depression (PHQ‐9 score 5‐19). Number randomised: total: 121; intervention: 61; comparator: 60. Age (mean ± SD): total: 60 (SD NR) years; intervention: 61.0 ± 10.2 years; comparator: 58.9 ± 10.7 years. Men: total: NR; intervention: 74%; comparator: 77%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: within 2 weeks of screening, participants received information via telephone‐based structured intervention sessions including: short‐ and long‐term goal setting to improve mental health and CVD risk factor profiles using motivational interviewing, goal setting, behavioural activation, and cognitive restructuring. Participants received a handbook containing project‐specific and general health resources, session activities, CVD risk factor goals, and monitoring forms and recording sheets used for tracking mood and thoughts. Treatment targets: mental health, depression, and CVD risk profiles. Components: CBT, motivational interviewing, goal setting, behavioural activation, and cognitive restructuring. Treatment setting (number of sites): hospital (6). Modality (group size): individual, by telephone. Dose:
Delivered by: psychologists with a minimum of 2 years clinical CBT experience. Follow‐up further reinforcement: NR. Cointerventions: usual medical care. COMPARATOR: usual medical care via their healthcare providers. Cointerventions: NR. | |
| Outcomes | Depression (Cardiac Depression Scale, PHQ‐9). HRQoL (SF‐12 Physical and Mental component scores). | |
| Source of funding | Australian Government Department of Health and Ageing Grant under the Sharing Health Care Initiative and a grant from beyondblue: the national depression and anxiety initiative. Neither funding body had input into the conduct of the study. AO was supported by a Post Graduate Award from the Heart Foundation (PP 08M4079) while undertaking this work and was supported by a Fellowship from the National Health and Medical Research Council (#1052865). KS was supported by an Australian Research Council (ARC) Future Fellowship (FT991524). Trial Registration Number: ACTRN12609000386235. | |
| Conflicts of interest | David Hare developed the Cardiac Depression Scale, and received research, fellowship, and consultancy funds from the National Health and Medical Research Council, the National Heart Foundation of Australia, the Austin Medical Research Foundation, beyondblue, and Diabetes Australia. He has received payment for research projects, consultancies, travel, advisory board memberships and lectures from industry including Abbott, Amgen, AstraZeneca, Biotronic, BMS, Boehringer Ingelheim, CSL‐Biotherapies, Hoffmann‐LaRoche, Hospira, Lundbeck (Denmark), Medtronic, Menarini, Merck KA (Germany), Merck (US), MSD, Pfizer, Roche, Sanofi‐ Aventis, Servier and Wyeth. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Stratified randomization was performed using a separate block randomization list that was generated for each stratum or study group. Following the completion of Time 1 data collection, randomization occurred, which was integrated into the web‐based database." |
| Allocation concealment (selection bias) | Low risk | "The randomization schedule was concealed from investigators and was stratified by Composite International Diagnostic Interview (CIDI) assessment (current MDD [major depressive disorder] vs not MDD) to ensure that the distribution of MDD cases between groups was even." |
| Blinding of outcome assessment (detection bias) | Low risk | "The research assistants who administered telephone questionnaires were blinded to participants' study group and participants in turn were asked not to reveal the group to which they were randomized." |
| Incomplete outcome data (attrition bias) | High risk | 30/121 (25%) lost to follow‐up/withdrew by 12 months. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Groups balanced at baseline | Low risk | "At baseline, no statistically significant group imbalances were observed with two exceptions: a significantly higher proportion of intervention participants had visited a general practitioner (GP) in the past 6 months and they were born in Australia (Tables 1 and 2)." |
| Intention‐to‐treat analysis | Low risk | "Analyses were based on intention to treat." |
| Groups received same cointerventions | Low risk | As described in the study conditions. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Australia. Dates participants recruited: NR. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 12 months. Follow‐up schedule: 3‐6 and 12 months. | |
| Participants | Inclusion criteria: aged < 70 years admitted to hospital following first AMI over a 12‐month period. No identified levels of psychopathology prior to intervention. Exclusion criteria: NR. Indication (% participants): MI (100%). Psychopathology: NR. Participants randomised to 3 groups: intervention 1: counselling, education, and relaxation; intervention 2: Education; and comparator: relaxation group. Number randomised: total: 46; intervention 1: 16; intervention 2: 16; comparator: 14. Age (mean ± SD): total: 56 (SD NR) years; intervention 1: 55.4 ± 8.4 years; intervention 2: 56.7 ± 7.2 years; comparator: 53.9 ± 12.6 years. Men: total: 89%; intervention 1: NR; intervention 2: NR; comparator: NR. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION 1 'counselling group': received individual counselling, relaxation training, and education (see 'education group' below). The first session took place within 48 hours of admission when the relaxation audiotape was also provided. The 3 education tapes were given to participants on subsequent days. Each counselling session focused on the participant's fears and anxieties, and discussed progress made with the relaxation and education tapes as well as behavioural strategies that could be employed in changing coronary risk factors on discharge from the hospital. INTERVENTION 2 'education group': received standardised educational materials, delivered via audiotape, describing primary and secondary prevention coronary risk factors and strategies for modifying behaviours. Progress muscular relaxation tapes were also provided. Treatment targets: impact of MI on functioning and psychological wellbeing; risk factor modification (in particular, Type A behaviour), relaxation. Components: counselling, relaxation, and risk factor education. Treatment setting (number of sites): hospital inpatient (1). Modality (group size): individual. Dose: intervention 1 'counselling group':
Delivered by: therapist and audiotapes Follow‐up further reinforcement: NR. Cointerventions: education. Dose: intervention 2 'education group':
Delivered by: audiotapes. Follow‐up further reinforcement: NR. Cointerventions: NR. COMPARATOR: usual medical care. Cointerventions: NR. | |
| Outcomes | Total mortality. Revascularisation (cardiac surgery). Hospital admission (MI related, and unrelated acute admissions). Heart attack Inventory (including STAI), although no data reported at level of individual measures. Return to work. | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quasi‐randomisation. Alternative allocation of all participants in each month of the study. |
| Allocation concealment (selection bias) | High risk | Quasi‐randomisation. Alternative allocation of all participants in each month of the study. |
| Blinding of outcome assessment (detection bias) | Unclear risk | States therapists were not involved in any of the data collection, but no further details provided. |
| Incomplete outcome data (attrition bias) | Low risk | Of 46 participants randomised (intervention 1: 16; intervention 2: 16; comparator: 14), 5 died during the study and all but 1 of the survivors were interviewed at the final 12‐month follow‐up. |
| Selective reporting (reporting bias) | Low risk | Results for all outcomes collected were reported. |
| Groups balanced at baseline | Low risk | "Group means for measures of morbidity at admission are shown in Table 1. One‐way analysis of variance (ANOVAs) yielded no significant differences between means on any of these measures, although there were a number of trends to suggest that the counselling group and to a lesser extent the education group might have a worse prognosis than the control group." |
| Intention‐to‐treat analysis | Unclear risk | Analysis plan did not state how data would be analysed, and results did not indicate if participants were able to cross over between groups. |
| Groups received same cointerventions | Low risk | "Over the duration of this study, there was no other systematic, or routine, psychological or educational intervention provided to MI patients either in the hospital or after discharge." |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Finland. Dates participants recruited: September 2004 to January 2007. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 18 months. Follow‐up schedule: 6 and 18 months. | |
| Participants | Inclusion criteria: aged < 75 years, AMI, knowledge of Finnish to complete the questionnaires, troponin T level > 0.03 μg/L, and at least 1 of 3 criteria for an AMI: typical clinical presentation, presence of new ischaemic ECG changes, or new diagnostic findings in imaging, e.g. echocardiogram. Exclusion criteria: NR. Indication (% participants): MI (100%). Psychopathology: depressive symptoms, BDI ≥ 10 (36%). Number randomised: total: 103; intervention: 51; comparator: 52. Age (mean ± SD): total: 59.6 (SD NR) years; intervention: 58.1 ± 10.4 years; comparator: 61.2 ± 9.7 years. Men: total: 71%; intervention: 75%; comparator: 67%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: interpersonal counselling included: a starting, encouragement, and ending phase focusing on the participant's current psychosocial functioning. The intervention form included structured details of interpersonal counselling for follow‐up as well as notes on other considerations besides interpersonal counselling. In 90% of the cases, the focus was on role transition, including changes in life status. Treatment targets: depressive symptoms and distress. Components: interpersonal counselling, psychosocial functioning, role transition, and changes in life status. Treatment setting (number of sites): hospital, telephone (1). Modality (group size): individual. Dose:
Delivered by: psychiatric nurse. Follow‐up further reinforcement: NR. Cointerventions: standard care. COMPARATOR: standard care after MI included: spoken and written instructions for control visits and prescriptions after MI, and guidance on how to find non‐psychiatric and psychiatric healthcare services when needed. Cointerventions: NR. | |
| Outcomes | Depression (BDI). HRQoL (EQ‐5D). Distress (Symptoms Checklist‐25). | |
| Source of funding | NR. | |
| Conflicts of interest | Authors declared no conflict of interest. | |
| Notes | EQ‐5D results reported in Oranta 2013. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random sequence generation not described. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | Low risk | Lost to follow‐up: intervention: 3/51 (6%); control: 9/52 (17%). |
| Selective reporting (reporting bias) | Low risk | Results for all outcomes collected were reported. |
| Groups balanced at baseline | Low risk | "There was no significant difference between the intervention and control groups at baseline in marital status, living alone or with someone, depressive symptoms or number of depressive patients, distress or number of patients with distress, retirement, previous MI, profession, other long‐term diseases or smoking status." |
| Intention‐to‐treat analysis | Low risk | "The data from this study were analysed within an intent‐to‐treat framework." |
| Groups received same cointerventions | Low risk | Both groups received standard care; no cointerventions described. |
| Study characteristics | ||
| Methods | Design: RCT. Country: China. Dates participants recruited: January 1999 to December 2001. Participants recruited (number of sites): hospital (1). Maximum follow‐up : 1 year. Follow‐up schedule: 4 weeks (self‐reported measures), 1 year (unstable angina, MI, 'sudden' death). | |
| Participants | Inclusion criteria: inpatients with clinically established CHD. Exclusion criteria: people with a history of mental illness, a serious cognitive disorder, who have a serious condition, but uncooperative with physical examination, or too unwell to sign informed consent forms. Indication (% participants): MI (19%; 26/136), angina (45%; 61/136), arrhythmia (26%; 35/136), and heart failure (10%; 14/136). Psychopathology: none. Number randomised: total: 139; intervention: 72; comparator: 67. Age (mean ± SD): total: 67.0 ± 13.0 years; intervention: 66.0 ± 10.0 years; comparator: 64.0 ± 10.0 years. Men: total: 63%; intervention: 68%; comparator: 75%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: psychotherapy included: psychological support and explanation; relaxation measures to ease the negative emotions; instructions and corrections of wrong perception, bad behaviour mode, and coping method; and antianxiety medicine for participants with moderate and severe anxiety. Treatment targets: negative emotions associated with CHD, relaxation. Components: psychotherapeutic approach included relaxation, emotional support, and cognitive‐behavioural exercises in recognising unhealthy thought patterns and behaviours. Treatment setting (number of sites): NR. Modality (group size): NR. Dose:
Delivered by: physicians and nurses. Follow‐up further reinforcement: NR. Cointerventions: antianxiety medication (participants with moderate or severe anxiety, as required) and usual medical care. COMPARATOR: usual care. Cointerventions: NR. | |
| Outcomes | Coronary ischaemic‐related events as a composite of unstable angina, AMI, and sudden death (individual event rates NR). | |
| Source of funding | Not translated. | |
| Conflicts of interest | Not translated. | |
| Notes | The baseline characteristics were reported for 136/139 of the participant sample. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | Low risk | Only 3 participants lost to follow‐up across 1 year. |
| Selective reporting (reporting bias) | Low risk | Results for all outcomes collected were reported. |
| Groups balanced at baseline | Low risk | "Comparison of baseline data: There is no significant difference in the age, gender, course of disease, degree of education and profession (P>0.05)." |
| Intention‐to‐treat analysis | Low risk | Not stated explicitly, although 71 in psychotherapy and 65 in non‐psychotherapy were analysed (i.e. 3 participants lost to follow‐up) in the groups that they were assigned. |
| Groups received same cointerventions | Unclear risk | Unclear. Intervention group received antianxiety medication where indicated, but it was unclear whether this was part of usual medical care available to both intervention and comparator groups. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: USA. Dates participants recruited: October 1971 to June 1972. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 7 years. Follow‐up schedule: 6, 18, 36, and 48 months. | |
| Participants | Inclusion criteria: surviving first MI, aged < 60 years, able to return to work, who resided in the San Diego area, and planned to remain there for ≥ 3 years. Exclusion criteria: NR. Indication (% participants): first MI (100%). Psychopathology: NR. Number randomised: total: 44; intervention: 22; comparator: 22. Age (mean): total: NR; intervention 50.9 (SD NR) years; comparator: 55.2 (SD NR) years. Men: total: 75%; intervention: 85%; comparator: 94%. Ethnicity (% white): total: 100%. | |
| Interventions | INTERVENTION: material covered in the 6 sessions included: life stress and the onset of MI; the contribution of physical and psychological risk factors to CHD; coronary‐prone behaviour; home problems; and return to work. Group sessions were educational with active discussion centred upon the problems inherent in optimal rehabilitation. The sessions were supportive rather than critical of long‐standing lifestyles. Occasionally, "behavioural prescriptions" were given to encourage participants to develop new approaches to current life problems. Treatment targets: risk education; attention to behaviour change. Components: risk information, client‐led discussion; some guidance on behaviour change. Treatment setting (number of sites): hospital outpatient (1). Modality (group size): group (2‐8 participants). Dose:
Delivered by: therapists (including first‐year residents in internal medicine, hospital corpsmen, a medical student, and a chief cardiologist). Follow‐up further reinforcement: NR. Cointerventions: risk factor education and dietetic advice. COMPARATOR: usual medical care. Cointerventions: risk factor education and dietetic advice. | |
| Outcomes | Total mortality. Non‐fatal MI. Revascularisation (CABG). Depression (clinical judgement by a psychiatrist interviewer). Return to work. | |
| Source of funding | Naval Medical Research and Development Command, Department of the Navy, under Research Work Unit. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated that the participants were randomly allocated; no further details. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) | Low risk | Of the original 61 participants, 3‐ to 4‐year morbidity data were available for 52/54 (95%) of those who had not died. |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Groups balanced at baseline | Low risk | "Analysis of age, cigarette smoking, height, weight, Norris Prognostic Index* (all by one‐way analysis of variance), location of infarct and other demographic dimensions (all by chi‐square) indicated no significant differences between the 3 groups." |
| Intention‐to‐treat analysis | High risk | Data from dropouts were not included in the analyses. |
| Groups received same cointerventions | Low risk | Both groups received risk factor education and dietetic advice. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Poland. Dates participants recruited: NR. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 2.5 years. Follow‐up schedule: 10 weeks, 1 year, and 2.5 years. | |
| Participants | Inclusion criteria: diagnosis of first non‐fatal MI; having increased levels of perceived stress in connection with psychosocial stress‐related problems; and willingness to receive psychological help to control psychosocial stress‐related problems. Exclusion criteria: severe mental problems (e.g. alcohol dependence or a psychosis). Indication (% participants): 100% MI. Psychopathology: 100% high or moderate levels of stress. Number randomised: total: 81; intervention: 41; comparator: 40. Age (mean ± SD): total: NR; intervention: 53.6 ± 4.9 years; comparator: 53.4 ± 4.3 years. Men: total: NR; intervention: 58%; comparator: 62%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: brief strategic therapy based on cybernetics: general strategy of solving psychosocial problems is to prevent people from using their problem‐maintaining ineffective solutions by getting them to behave in a way opposite to the ineffective one. First, the most disruptive, stress‐producing problem and the problem‐maintaining behaviours were identified by the participant. Then the behaviour that is opposite to the participant's problem‐maintaining behaviour was identified by the therapist. Participants had homework assignments. When a problem was solved, the therapists used relapse techniques to prevent reoccurrence of the problem. Treatment targets: chronic stress levels and ineffective coping skills. Components: cybernetics, problem solving using counterintuitive methods. Retraining participant's natural 'ineffective' responses to psychosocial problems. Treatment setting (number of sites): hospital (1). Modality (group size): individual. Dose:
Delivered by: 4 clinical psychologists, supervised by a senior brief strategic therapist. Follow‐up further reinforcement: NR. Cointerventions: usual care including medication therapy, educational materials, and offered participation in structured exercise (see below). COMPARATOR: usual care including postdischarge medication therapy according to their participant‐focused care plan, written information about cardiac risk factors, and guidance on unhealthy behaviour change. All participants also offered 12‐week exercise training that included 1 weekly supervised session. Cointerventions: none. | |
| Outcomes | Total cardiovascular events. Fatal or non‐fatal (or both) MI. HRQoL (SF‐36 Physical and Mental components scores). Perceived stress (Cohen Perceived Stress Scale, PSS‐10). | |
| Source of funding | Faculty of Psychology, University of Warsaw, Poland, for statutory research (grant number 144525/2009). | |
| Conflicts of interest | Authors declared no conflict of interest. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A random number table was used to create group assignments." |
| Allocation concealment (selection bias) | Low risk | "The outcome of the randomization was put in a sealed envelope, and patients who were admitted to the current study received these envelopes after the baseline interview." |
| Blinding of outcome assessment (detection bias) | Low risk | "A pair of investigators, blind to condition, conducted outcome assessments." |
| Incomplete outcome data (attrition bias) | Low risk | 6/81 participants withdrew from the study. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Groups balanced at baseline | Low risk | Table 1 data. |
| Intention‐to‐treat analysis | Low risk | "All analyses were based on intention‐to‐treat approach principles. Scores of all patients were included in the analyses. Missing scores were replaced by the last observed score." |
| Groups received same cointerventions | Low risk | "Most of them were offered attendance at a 12‐week exercise training that included one weekly supervised session; 48.78% of patients in the BST [brief strategic therapy] condition and 40.00% patients in the UC [usual care] condition underwent the training." |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Italy. Dates participants recruited: June 2005 to January 2011. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 1 year. Follow‐up schedule: 6 months and 1 year (although only 1‐year data reported). | |
| Participants | Inclusion criteria: aged ≤ 70 years, admitted with an AMI receiving treatment with primary or urgent PCI of the culprit lesion, within 12 hours of the onset of a STEMI (primary PTCA), or within 48 hours in people with a non‐STEMI (urgent PTCA). In cases of multivessel disease, complete revascularisation had to be achieved before discharge from hospital. Exclusion criteria: NR. Indication (% participants): STEMI: 77.7%; non‐STEMI: 22.3%. (note only STEMI reported ‐ the figures for non‐STEMI extrapolated). Psychopathology: 40% had ≥ 10 on BDI at baseline. Number randomised: total: 94; intervention: 49; comparator: 45. Age (mean ± SD): total: NR; intervention: 55.0 ± 9.0 years; comparator: 55.0 ± 8.0 years. Men: total: 89%; intervention: 91%; comparator: 87%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: short‐term psychotherapy based on the ontopsychological method included individual and group sessions. Individual meetings included: personal history, as emotionally lived by the participant, and on understanding basic expression of the unconscious dimension, through the interpretation of body and oneiric language. Group sessions to which partners were invited included: educational cardiological therapy (which included a broader explanation of MI and atherosclerotic processes, while accentuating the importance of cardiac risk factor prevention/reduction and lifestyle changes); music‐guided breathing and muscular relaxation; comprehension of body signals; elements of oneiric language; and attention to specific partner/relationship issues. Treatment targets: "a psychotherapeutic intervention must improve global health to be considered effective." Components: short‐term psychotherapy based on the ontopsychological method, education, relaxation. Treatment setting (number of sites): NR (NR). Modality (group size): individual for months 1‐3; group for months 4‐6 (NR). Dose:
Delivered by: psychotherapist. Follow‐up further reinforcement: NR. Cointerventions: usual cardiac rehabilitation care. COMPARATOR: usual care included: being offered cardiac rehabilitation involving educational training and lifestyle change recommendations. Cointerventions: none. | |
| Outcomes | Total mortality. Cardiac mortality. Non‐fatal MI. Depression (BDI). HRQoL (MacNew Questionnaire). Measures of stress (self‐evaluation test, assessing global psychological distress). Vital exhaustion (Modified Maastricht Questionnaire). | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | Study primary outcome was the net cumulative incidence of new cardiological events (MI death, stroke, any revascularisation procedure, life‐threatening ventricular arrhythmias, and recurrence of typical angina pectoris) and occurrence of any clinically significant new comorbidity. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "To minimize potential imbalance between the two groups and resultant confounding that might affect outcomes, randomization was performed in blocks (according to patient age, and the type and location of the infarction) within one week after discharge from the intensive care unit." |
| Allocation concealment (selection bias) | Low risk | "To conceal the sequence of allocation, individual allocation to treatment was reported in case‐report forms, which were sealed in envelopes and subdivided into different boxes according to randomization blocks. At the time of randomization, the relevant envelope was then given to the attending physician and the case‐report form could then be unsealed revealing treatment allocation." |
| Blinding of outcome assessment (detection bias) | Low risk | "All data were collected using specific case‐report forms and peer reviewed at one‐year follow‐up, with clinical adverse events adjudicated by a committee composed of three cardiologists (CP, VP, and FP) blinded to study arm allocation." |
| Incomplete outcome data (attrition bias) | Low risk | 49/54 intervention and 45/47 comparator provided data at 1 year follow‐up. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Groups balanced at baseline | Low risk | "The two groups were balanced in terms of demographics, as well as in clinical, angiographic and psychometric characteristics." |
| Intention‐to‐treat analysis | Low risk | "Unless otherwise specified, all study data were analyzed on an intention‐to treat basis." |
| Groups received same cointerventions | Low risk | "The choice of drug therapy in the acute and chronic phases was left to the treating physician's discretion. Administration of psycho‐active drugs was not part of the protocol; but, in patients already being treated, psychiatric drugs were not discontinued after enrolment." |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: USA. Dates participants recruited: March 1998 to April 2003. Participants recruited (number of sites): hospitals, disease registers (NR). Maximum follow‐up: 9.3 years. Follow‐up (mean ± SD): total: 5.4 ± 2.4 years; intervention: 5.3 ± 2.3 years; comparator: 5.4 ± 2.5 years. Follow‐up schedule: 3 and every 6 months for clinical events and annually for psychosocial distress. | |
| Participants | Inclusion criteria: black men and women with angiographic evidence of at least 1 coronary artery with > 50% stenosis. Exclusion criteria: AMI, stroke, or coronary revascularisation within the previous 3 months; chronic heart failure with ejection fraction < 20%; cognitive impairment; and non‐cardiac life‐threatening illness. Indication (% participants): CAD (100%). Psychopathology: NR. Number randomised: total: 201; intervention: 99; comparator: 102. Age (mean ± SD): total: NR; intervention: 59.9 ± 10.7 years; comparator: 58.4 ± 10.5 years. Men: total: NR; intervention: 59%; comparator: 56%. Ethnicity (% white): total: 0%; intervention: 0%; comparator: 0%. | |
| Interventions | INTERVENTION: the transcendental meditation technique was described as a simple, natural, effortless procedure that was practised 20 minutes twice a day while sitting comfortably with eyes closed. During the practice, it was reported that ordinary thinking processes settle down, and a distinctive wakeful hypometabolic state characterised by neural coherence and physiological rest was gained. Standard teaching materials and format were used. The transcendental meditation technique was taught in a 7‐step course of instruction comprising 6 × 1.5‐ to 2‐hour individual and group meetings. Treatment targets: stress reduction. Components: transcendental meditation. Treatment setting (number of sites): NR (NR). Modality (group size): individual and group (NR). Dose:
Delivered by: instructor certified by Maharishi Foundation USA. Follow‐up further reinforcement: follow‐up and maintenance meetings were held weekly for the first month, twice weekly for the 2 months, and monthly thereafter for the remainder of phases 1 and 2. Cointerventions: access to usual medical care. COMPARATOR: the control intervention was a cardiovascular health education programme designed to match the format of the experimental intervention for instructional time, instructor attention, participant expectancy, social support, and other non‐specific factors. The content was based on standard, published materials. The instructors were professional health educators. The health education participants were advised to spend at least 20 minutes a day at home practising heart‐healthy behaviours (exercise, healthy meal preparation, and non‐specific relaxation). Cointerventions: NR. Participants continued usual medical care. | |
| Outcomes | Total mortality. Cardiac mortality. Revascularisation (CABG and PTCA, with or without stenting). Fatal and non‐fatal MI. Other fatal or non‐fatal (or both) cardiovascular events. Depression (Center for Epidemiological Studies Depression Scale). | |
| Source of funding | National Institutes of Health‐National Heart, Lung and Blood Institute. | |
| Conflicts of interest | Dr Schneider served as an investigator on research grants from the National Institutes of Health and US Department of Defense and is a consultant to Maharishi Foundation USA, a non‐profit educational organisation. Dr Grim's spouse was president and sole owner of Shared Care Research and Education Consulting. Dr Rainforth served as an investigator on research grants from the National Institutes of Health and US Department of Defense and his spouse was an independent contractor to Maharishi Foundation, USA. Dr Nidich served as an investigator on research grants from the National Institutes of Health, US Department of Defense and David Lynch Foundation and his spouse was an independent contractor to Maharishi Foundation, USA. Dr Gaylord‐King served as an investigator on research grants from the National Institutes of Health, US Department of Defense and GMDO, a non‐profit organisation. Dr Salerno served as an investigator on research grants from the National Institutes of Health and US Department of Defense. The other authors reported no conflicts. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Subjects were randomly assigned to either the TM [transcendental meditation] or health education (HE) arms using a stratified block design." |
| Allocation concealment (selection bias) | Low risk | "Random allocation was performed by the study biostatistician who concealed the allocation schedule and conveyed the assignments to the study coordinator." |
| Blinding of outcome assessment (detection bias) | Low risk | "Investigators, data collectors, and data management staff were blinded to group assignment." |
| Incomplete outcome data (attrition bias) | High risk | Lost to follow‐up: intervention: 25/99 (25%); comparator: 23/102 (23%). The number and reasons for dropouts and withdrawals were properly described, but were relatively high in number. |
| Selective reporting (reporting bias) | Low risk | All outcomes described in methods were reported in the results section. |
| Groups balanced at baseline | Low risk | "The groups were generally similar at baseline; …Significant baseline differences were education level and CESD [Center for Epidemiologic Studies Depression Scale] score." |
| Intention‐to‐treat analysis | Low risk | "All primary and secondary outcomes were analyzed using the intention‐to‐treat principle." |
| Groups received same cointerventions | Low risk | No cointerventions were included. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Netherlands. Dates participants recruited: February 1996 to November 1997. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 1 year. Follow‐up schedule: 8 weeks and 1 year. | |
| Participants | Inclusion criteria: aged < 70 years with a confirmed diagnosis of AMI, CABG, or both, and who were able to participate in the regular physiotherapy exercise programme. starting early after discharge. Exclusion criteria: non‐Dutch speaking, illiterate, or experiencing a psychiatric disorder that would severely disturb participation in the intervention. Indication (% participants): AMI CABG (100%) including: MI only (70.1%), MI + CABG (7.6%), or CABG only (22.4%). Psychopathology: major depression, SCID (11.8%) (intervention: 14.9%; comparator: 9.0%). Number randomised: total: 204; intervention: 106; comparator: 98. Age (mean ± SD): total: 55.6 (SD NR) years; intervention: 55.6 ± 8.0 years; comparator: 55.2 ± 9.7 years. Men: total: 86%; intervention: 86%; comparator: 87%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: during the group sessions, participants and their partners (whose participation was encouraged) were informed about coronary risk factors and risk factor modification by a multidisciplinary team. Sessions included didactic teaching and group discussion. Each session concluded with breathing and relaxation exercises. Participants were offered an audiotape to use at home to practise breathing and relaxation exercises. Participants were also given homework and written information on course materials. Treatment targets: risk education, behaviour change, stress, Type A behaviours. Components: risk education, guidance on behaviour change, relaxation, homework; also some self‐awareness/monitoring, client‐led discussion. Treatment setting (number of sites): NR (NR). Modality (group size): group (6‐10 participants). Dose:
Delivered by: psychologist, and either a social worker or a pastor present as cotherapist. Follow‐up further reinforcement: after the last session, 3 follow‐up sessions were scheduled at 3, 6, and 9 months, to discuss the achievements that participants had made with respect to risk factor modification. Cointerventions: usual medical care, including education and exercise programme. COMPARATOR: usual medical care, consisting of regular cardiologist check‐ups, and postdischarge exercise training sessions. Cointerventions: NR. | |
| Outcomes | Total mortality. Revascularisation (CABG and PCI). Depression (BDI). Type A behaviour (clinical observation of behaviours). Vital exhaustion (Maastricht Questionnaire). | |
| Source of funding | Netherlands Heart Foundation (Nederlandse Hartstichting). | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "To allocate men and women... a stratified randomization procedure was developed by a person not involved in the study." "Patients randomised to the intervention group had higher scores on ...BDI depression than the control group." |
| Allocation concealment (selection bias) | Low risk | The outcome of the [stratified] randomisation was put in a sealed envelope, and participants received this envelope after the baseline interview. |
| Blinding of outcome assessment (detection bias) | Low risk | "The interviewers remained unaware of patient groups assignment." |
| Incomplete outcome data (attrition bias) | Low risk | Analysis is intention‐to‐treat with dropouts reported for both groups. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Groups balanced at baseline | High risk | "On average, patients randomised to the intervention group had higher scores on vital exhaustion (P=.05) and BDI depression (P=.07) than did patients in the control group (Table 2)." |
| Intention‐to‐treat analysis | Low risk | "Analyses were performed according to the intention‐to‐treat principle." |
| Groups received same cointerventions | High risk | Intervention includes structured education around risk reduction not available to comparator group. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: USA. Dates participants recruited: NR. Participants recruited (number of sites): hospital (1) and community referrals (NR). Maximum follow‐up: 1 year. Follow‐up schedule: 3 months, 6 months, and 1 year. | |
| Participants | Inclusion criteria: aged 30‐69 years, with a documented MI within past 6 weeks to 1 year. In addition, eligibility based on 1 or both of the following: work capacity level < 7 (men) or < 6 (women) during treadmill exercising to 85% of the predicted age‐adjusted maximum, or appearance of symptoms/abnormal responses causing termination of exercise prior to attaining the heart rate end point; and anxiety (≥ 19 Taylor Manifest Anxiety Scale) or depression (≥ 40 ZDS). Exclusion criteria: people with unstable cardiovascular condition present or required treatment for any physiological or psychological reason. Indication (% participants): documented MI within past 6 weeks to 1 year (100%). Psychopathology: anxiety/depression (43.8%) (intervention: 40.0%; comparator: 48.3%). Number randomised: total: 64; intervention: 35; comparator: 29. Age (mean ± SD): total: 54 (SD NR) years (range 30‐69); intervention: NR; comparator: NR. Men: total: 83%; intervention: 89%; comparator: 76%. Ethnicity (% white): total: 83%; intervention: 80%; comparator: 86%. | |
| Interventions | INTERVENTION 'counselling': initial session acquainted people with general problems encountered during convalescence. Sessions 2 and 3 were educational focusing on the aetiology and coronary risk factors. The fourth session examined stress and the role of Type A behaviour. Participants were taught the Jacobsen relaxation exercise and encouraged to do these at least twice daily. Sessions 5‐11 were devoted to discussing general areas of stress. The final session was a summary discussion. Treatment targets: cardiac risk education, behaviour change, stress and Type A behaviour. Components: risk information, guidance on behaviour change, relaxation training, client‐led discussion, homework; also some self‐awareness/monitoring. Treatment setting (number of sites): NR (NR). Modality (group size): group (4‐6 participants). Dose:
Delivered by: psychiatrist/social worker and nurse clinician. Follow‐up further reinforcement: NR. Cointerventions: education. COMPARATOR: usual medical care, participants were requested not to join an exercise programme or attend counselling. Cointerventions: NR. | |
| Outcomes | Total mortality. Non‐fatal MI. Revascularisation (CABG). Anxiety (Taylor 1953; data incomplete). Depression (ZDS; data incomplete). Return to work. | |
| Source of funding | National Institute of Handicapped Research, Department of Education, Washington, DC. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomly assigned in blocks of 6; no further details provided. |
| Allocation concealment (selection bias) | Unclear risk | NR. |
| Blinding of outcome assessment (detection bias) | Unclear risk | NR. |
| Incomplete outcome data (attrition bias) | Unclear risk | NR. |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the methods were reported in the results section. |
| Groups balanced at baseline | High risk | "More controls were in the unmarried category (P <0.03), more exercise patients were in the 49 to 58 year old age range (P <0.02) and more group patients were admitted less than four months following MI (P <0.05)." |
| Intention‐to‐treat analysis | Unclear risk | NR. |
| Groups received same cointerventions | High risk | Intervention included education. |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Australia. Dates participants recruited: June 2006 to May 2008. Participants recruited (number of sites): hospital, adverts, research registers (NR). Maximum follow‐up: 12 months. Follow‐up schedule: 2, 6, and 13 months. | |
| Participants | Inclusion criteria: aged ≥ 18 years; cardiac event ≥ 2 months prior (ACS, PCI, CABG) or confirmed diagnosis of a heart condition (CHD, congestive heart failure, cardiomyopathy, chronic atrial fibrillation) (or both); and depressive symptoms (> 13 BDI‐II) at initial screening. Exclusion criteria: history or current psychotic illness or organic brain diseases at initial screening; antidepressant medication for < 1 month' duration, and non‐English speakers. Indication (% participants): past admissions or treatment for ACS, PCI, or CABG (88%); congestive heart failure, chronic atrial fibrillation, or cardiomyopathy (12%). Psychopathology: depressive symptoms, > 13 BDI‐II (100%). Number randomised: total: 57; intervention: 25; comparator: 32. Age (mean ± SD): total: 62.0 ± 10.0 years; intervention: 61.0 ± 11.0 years; comparator: 6.20 ± 9.0 years. Men: total: 72%; intervention: 76%; comparator: 72%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: CBT group intervention following a treatment manual included: emotional distress; activity planning; thought monitoring and challenging; structured problem‐solving; strategies to increase motivation; and a programme review and how to get further assistance. Group discussion around experiences and learning from homework tasks, introduction to various skills, and homework was set for the following week. Treatment targets: reduce depression. Components: psychoeducation including emotional distress, activity planning, thought monitoring and challenging, structured problem‐solving, strategies to increase motivation, and a programme review and how to get further assistance. Treatment setting (number of sites): community‐based programme (NR). Modality (group size): group (≤ 11 participants). Dose:
Delivered by: clinical psychologists. Follow‐up further reinforcement: NR. Cointerventions: NR. COMPARATOR: brief educational intervention feeding back assessment results, providing education, written self‐help materials and guidance on support available for mental health. In initial meeting, participants received individualised verbal feedback regarding assessment results (severity of depression and anxiety symptoms, likely presence of a depressive or anxiety disorder, alcohol consumption) and any other concerns. Recommendations for treatment were provided, including: written self‐help material on depression, anxiety, and stress, in the context of co‐occurring cardiac disease; and relevant mental health and support services information. Individualised letters (and telephone call if symptoms were severe or concerning (or both)) were sent to the participant's selected health professionals (cardiac rehabilitation nurse, general practitioner, specialists) regarding baseline and 2‐month assessment results. Cointerventions: NR. | |
| Outcomes | Anxiety (HADS‐A). Depression (BDI). | |
| Source of funding | Australian Rotary Health. | |
| Conflicts of interest | Authors reported no conflict of interest. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Once a block of participants was recruited, participants in that block were randomly assigned to receive either an additional six weekly group CBT sessions (CBT) or no further intervention (BI [brief intervention]). A block randomisation procedure was utilised, with a computer‐generated random number sequence created by an independent researcher and placed in an opaque envelope. Maximum block size was 11 with smaller size at times of slower recruitment to ensure minimum time between assessment and allocation." |
| Allocation concealment (selection bias) | Low risk | A block randomisation procedure was utilised, with a computer‐generated random number sequence created by an independent researcher and placed in an opaque envelope. Maximum block size was 11 with smaller size at times of slower recruitment to ensure minimum time between assessment and allocation." "Baseline assessors were informed of condition allocation once all participants in that block had completed their assessment." |
| Blinding of outcome assessment (detection bias) | Low risk | "All participants completed follow‐up assessments at 2, 6 and 12 months with an assessor blind to treatment allocation." |
| Incomplete outcome data (attrition bias) | Low risk | Lost to follow‐up at 6 and 12 months (including 3 deaths): 17.5% (intervention: 5; comparator: 5). |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Groups balanced at baseline | Low risk | "No significant differences occurred between the CBT (n = 25) or BI [brief intervention] conditions (n = 32) on any of the baseline characteristics (Table 1)." |
| Intention‐to‐treat analysis | Unclear risk | NR. |
| Groups received same cointerventions | Low risk | "Participants were able to access additional treatments outside the research study and these were monitored during follow‐up assessments." |
| Study characteristics | ||
| Methods | Design: multicentre RCT. Country: Australia. Dates participants recruited: March 2007 to November 2008. Participants recruited (number of sites): hospital (2). Maximum follow‐up: 12 months. Follow‐up schedule: 4 and 12 months. | |
| Participants | Inclusion criteria: post‐AMI, CABG, or PCI; aged ≤ 75 years; residing in metropolitan Melbourne; and understood English. Exclusion criteria: serious physical or psychiatric illness/disability, transport difficulties, non‐availability for follow‐up. Indication (% participants ): post‐AMI, CABG or PCI (100%); AMI or PCI event (vs CABG) (intervention: 48%; comparator: 76%). Psychopathology: significant depression symptoms (100%). Number randomised: total: 42; intervention: 21; comparator: 21. Age (mean ± SD): total: NR; intervention: 55.6 ± 8.8 years; comparator: 57.0 ± 11.2 years. Men: total: 79%; intervention: 86%; comparator: 71%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: Beating Heart Problems group programme included 8 modules: physical activity, diet, medication adherence, smoking cessation, depression, anxiety, anger, and social support. Manualised guidelines utilising motivational interviewing and CBT components were followed. Participants received weekly handouts from a group workbook. The intervention was conducted as a rolling group (maximum 9 participants) with participants joining the group the week after randomisation. Treatment targets: reduce/manage depression, anxiety, anger. Components: motivational interviewing (risk reduction), CBT (depression, anxiety, anger, and social support). Treatment setting (number of sites): hospital (2). Modality (group size): group (up to 9 participants). Dose:
Delivered by: psychologists. Follow‐up further reinforcement: NR. Cointerventions: NR. COMPARATOR: usual medical care. Cointerventions: NR. | |
| Outcomes | Anxiety (HADS‐A). Depression (BDI). | |
| Source of funding | Australian Rotary Health and the Norman H Johns Trust. | |
| Conflicts of interest | Authors declared no conflict of interest. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation not described. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Low risk | "Four‐ and 12‐month follow‐up assessments were conducted with outcome assessors blinded to treatment allocation." |
| Incomplete outcome data (attrition bias) | Unclear risk | "Of the 42 patients, 11 (26.2%) patients were lost to follow‐up by 4 months and 12 (28.6%) by 12 months, with no differences in ICBT [Beating Heart Problems group programme] and control group attrition." |
| Selective reporting (reporting bias) | Low risk | All outcomes described in methods were reported for all outcomes. |
| Groups balanced at baseline | Low risk | "At baseline, patients in the ICBT [Beating Heart Problems group programme] group were more likely to be partnered than those in the control group (Table 1). No other baseline differences were found." |
| Intention‐to‐treat analysis | Low risk | "Intention‐to‐treat analysis was undertaken, with ICBT [Beating Heart Problems group programme] patient retained in their original group, regardless of programme completion." |
| Groups received same cointerventions | Low risk | "Control participants received no intervention beyond usual medical care." |
| Study characteristics | ||
| Methods | Design: single‐centre RCT. Country: Netherlands. Dates participants recruited: 1981‐1983. Participants recruited (number of sites): hospital (1). Maximum follow‐up: 5 years. Follow‐up schedule: post‐test (~ 6 weeks), 2 and 5 years. | |
| Participants | Inclusion criteria: no age limit, diagnosis of recent MI (< 1 month), and the ability to participate in a physical exercise programme. Exclusion criteria: people considered in need of individual (psychosocial) help in addition to exercise training (from van Dixhoorn 1991). Indication (% participants): AMI within 1 month (100%). Psychopathology: none (0%). Age (mean ± SD): total: 55.5 (SD NR) years; intervention: 55.4 ± 8.2 years; comparator: 55.7 ± 8.1 years. Men: total: 94%; intervention: 93%; comparator: 95%. Ethnicity (% white): NR. | |
| Interventions | INTERVENTION: procedure included: electromyography feedback of the frontalis muscle was used as a "mental device" to focus attention for passive relaxation, to give feedback of muscle tension and explain the concept of relaxation, and to monitor excess inspiratory effort. Participants also learned a method of breathing regulation and the therapist chose the appropriate instructions for each participant. Participants were asked to practise at home. Treatment targets: stress. Components: active and passive relaxation, homework. Treatment setting (number of sites): NR (NR). Modality (group size): individual. Dose:
Delivered by: 5 specially trained people including a psychologist, medical doctor, and physiotherapist. Follow‐up further reinforcement: NR. Cointerventions: physical exercise training (as provided to comparator group) and usual medical care. COMPARATOR: physical exercise training and usual medical care. Exercise training was offered as a 5‐week programme, once per day for 30 minutes, within groups of 4 participants supervised by 2 physiotherapists. Cointerventions: NR. | |
| Outcomes | Cardiac mortality. Non‐fatal MI. Revascularisation. Cost‐effectiveness. | |
| Source of funding | NR. | |
| Conflicts of interest | NR. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Reported randomisation, but insufficient detail provided. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Methods stated that clinical data were extracted from medical records, but did not state by whom. |
| Incomplete outcome data (attrition bias) | Low risk | All the randomised 156 participants were included in the 2‐ and 5‐year follow‐up analyses. |
| Selective reporting (reporting bias) | Unclear risk | Not described. |
| Groups balanced at baseline | Low risk | "There were no differences between the two treatments in base‐line clinical data as shown in Table 1." |
| Intention‐to‐treat analysis | Low risk | "Finally, dropouts were included and classified on the basis of the reason for not completing the programme." |
| Groups received same cointerventions | Low risk | Comparator participants received exercise training only, while intervention group participants received exercise training plus relaxation therapy. |
ACS: acute coronary syndrome; AMI: acute myocardial infarction; ANCOVA: analysis of covariance; BDI: Beck Depression Inventory (Beck 1997)|; CABG: coronary artery bypass graft; CAD: coronary artery disease; CBT: cognitive behavioural therapy; CHD: coronary heart disease; CVD: cardiovascular disease; DISH: Depression Interview and Structured Hamilton; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders ‐ 4th edition; ECG: electrocardiograph; HADS‐A: Hospital Anxiety and Depression scale ‐ Anxiety subscale (HADS 1983); HADS‐D: Hospital Anxiety and Depression scale ‐ Depression subscale (HADS 1983); HAM‐D: Hamilton Depression Rating Scale (HAM‐D 1988); HRQoL: health‐related quality of life; LVEF: left ventricular ejection volume; Maastricht Questionnaire: Maastricht Questionnaire for Vital Exhaustion (MIVE 1996; MQ 1987); MacNew Questionnaire: MacNew Heart Disease Heath‐Related Quality of Life Questionnaire (Lim 1993); MI: myocardial infarction; NR: not reported; NYHA: New York Heart Association; PCI: percutaneous coronary intervention; PHQ‐9: Patient Health Questionnaire 9; PSS‐10: Perceived Stress Scale 10; PTCA: percutaneous transluminal coronary angioplasty; RCT: randomised controlled trial; SADS‐C: Schedule of Affective Disorders and Schizophrenia ‐ Change; SCL‐90‐R: Symptoms Checklist List ‐ 90 ‐ Revised (SCL‐90‐R 1983); SD: standard deviation; SF‐12: 12‐item Short Form (Short Form Questionnaires); SF‐36: 36‐item Short Form (Short Form Questionnaires); SSM: supportive stress management; STAI: Spielberger Trait Anxiety Inventory (STAI 1970); STAXI: Spielberger Anger scales (STAXI 1985); STEMI: ST‐elevation myocardial infarction; ZDS: Zung Self‐rated Depression Rating Scale (Zung 1965).
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Comparator group also received psychological intervention. | |
| Intervention targeted risk reduction. | |
| Not a psychological intervention. | |
| Comparator group also received psychological intervention. | |
| Follow‐up too short (5 months). | |
| Participants were not randomised. | |
| Intervention was cardiac rehabilitation including exercise. | |
| Ongoing study identified in second update: intervention was multifactorial. | |
| Intervention was multifactorial. | |
| No primary outcomes of interest were collected. | |
| Exercise‐based programme. | |
| Follow‐up too short and mixed participant group. | |
| No outcomes of interest were collected. | |
| Follow‐up too short (8 weeks). | |
| Intervention was peer led (not delivered by a trained practitioner). | |
| Population was mixed ‐ while data were analysed separately for heart disease, this subpopulation included heart failure and atrial fibrillation. | |
| Population had heart failure. | |
| Cross‐over trial in which comparator participants were offered treatment before the 9‐month follow‐up. | |
| No useful outcomes. | |
| Not an RCT. | |
| Follow‐up too short (6 weeks). | |
| Intervention targeted risk reduction. | |
| Intervention was multifactorial. | |
| Follow‐up too short (12 weeks). | |
| Population had heart failure. | |
| Mixed participant group including heart failure and cardiomyopathy. | |
| Follow‐up < 6 months. | |
| Population had heart failure. | |
| Population had heart failure. | |
| Ongoing study identified in second update: intervention was exercise. | |
| Intervention was educational. | |
| Population was mixed ‐ included people with diabetes. | |
| Population was mixed ‐ people with depression and CHD or diabetes. | |
| Population did not have CHD. | |
| Follow‐up < 6 months. | |
| Comparator group also received psychological intervention. | |
| Not a psychological intervention. | |
| Follow‐up too short (5 days). | |
| Not an RCT. | |
| Review article. | |
| Intervention largely pharmacological. | |
| Comparator group also received psychological intervention. | |
| Not an RCT. | |
| Not a psychological intervention. | |
| Follow‐up too short (8 weeks); unsuitable participant group. | |
| Comparator group also received psychological intervention. | |
| Participants recruited for implantable cardioverter defibrillator. | |
| Ongoing study identified in second update: follow‐up < 6 months. | |
| Not a psychological intervention. | |
| Not a psychological intervention. | |
| Intervention included exercise. | |
| Not an RCT. | |
| Follow‐up too short (3 months). | |
| Comparator group also received psychological intervention. | |
| Intervention was multifactorial. | |
| Intervention was multifactorial. | |
| Not a psychological intervention. | |
| Follow‐up too short (3 months). | |
| Follow‐up too short (4 months). | |
| Follow‐up too short (3 months). | |
| Included exercise. | |
| Not a psychological intervention. | |
| Mixed participant group including heart failure and CHD or 2 risk factors. | |
| Follow‐up too short (4 weeks). | |
| Population had heart failure. | |
| Interventions delivered by non‐psychologically trained clergy. | |
| Intervention was multifactorial. | |
| Intervention was multifactorial. | |
| Population had heart failure. | |
| Intervention was multifactorial. | |
| Follow‐up < 6 months. | |
| Participants were not randomised. | |
| Population did not have CHD. | |
| No useful outcomes. | |
| Not a psychological intervention. | |
| No outcomes of interest. | |
| Intervention included exercise. | |
| Population had heart failure. | |
| Follow‐up too short (12 weeks). | |
| Staff not trained in psychological intervention. | |
| Not a psychological intervention. | |
| Follow‐up too short (6 weeks). | |
| Intervention included exercise. | |
| Population had heart failure. | |
| Not an RCT. | |
| Follow‐up too short (16 weeks). | |
| Population had heart failure. | |
| Intervention was not psychological. | |
| Intervention included many optional components; only 84% of participants selected the stress management component and no separate analyses reported for this group. | |
| Not a psychological intervention. | |
| Participants recruited with hypertension only. Follow‐up too short (4 months). | |
| Not a psychological intervention. | |
| Participants recruited for non‐specific chest pain. | |
| Intervention included exercise. | |
| Population had heart failure. | |
| Intervention was not psychological. | |
| No useful outcomes. | |
| No useful outcomes. | |
| Intervention delivered by nurses, but no mention of psychological training. | |
| Mixed participant group including heart failure and stroke. | |
| Mixed participant group including arrhythmia, heart failure, and valvular disease. | |
| Intervention delivered by cardiac nurses without specific training. | |
| Follow‐up too short (5 months). | |
| Staff not trained in psychological intervention. | |
| Comparator group also received psychological intervention. | |
| Intervention largely pharmacological. | |
| No relevant outcomes. | |
| Intervention was multifactorial. | |
| Not a psychological intervention. | |
| Population had heart failure. | |
| Intervention was multifactorial. | |
| Population had heart failure. | |
| Not a psychological intervention. | |
| Follow‐up too short (4 months). | |
| Comparator group also received psychological intervention. | |
| Intervention included exercise. | |
| Intervention included exercise. | |
| Intervention included exercise. | |
| Intervention included exercise. | |
| Intervention was multifactorial. | |
| Follow‐up too short (16 weeks). | |
| Follow‐up too short (12 weeks). | |
| Follow‐up too short (immediate postintervention). | |
| Not a psychological intervention. | |
| Not an RCT. | |
| Not an RCT (case‐matched historical controls). | |
| Intervention is for smoking cessation. | |
| Not a psychological intervention; treatment included exercise. | |
| Follow‐up too short (10 weeks). | |
| Intervention largely pharmacological. | |
| Comparator group also received psychological intervention. | |
| Did not state whether staff were psychologically trained. | |
| Population did not have CHD. | |
| Intervention targets physical activity. | |
| Not a psychological intervention; treatment included exercise. | |
| Participants were not randomised. | |
| Follow‐up too short (2 months) and no suitable outcomes. | |
| Follow‐up too short (4 months). | |
| Follow‐up less than 6 months. | |
| Not an RCT. | |
| Population had heart failure. | |
| Exercise‐based programme. | |
| Follow‐up too short (1 month). | |
| Participants were not randomised. | |
| Intervention was an audiotape ‐ no therapist input. | |
| No useful outcomes. | |
| Population had heart failure. | |
| Staff not trained in psychological intervention. | |
| Intervention included exercise. | |
| Population was mixed. | |
| Follow‐up period not stated, but seems likely < 6 months. Authors contacted for clarification with no reply. | |
| Not an RCT. | |
| No mention of randomisation. | |
| Population had heart failure. | |
| Intervention included exercise. | |
| Not a psychological intervention; treatment included exercise. | |
| Follow‐up too short (8 weeks). | |
| Intervention targeted risk reduction. | |
| No useful outcomes. | |
| Participants at risk of CHD, but without established disease. | |
| Population had heart failure. | |
| Not a psychological intervention. | |
| Population had heart failure. | |
| Follow‐up too short. | |
| Intervention was multifactorial. | |
| Staff administering psychological intervention did not receive specialist training. | |
| Intervention was multifactorial. |
CHD: coronary heart disease; RCT: randomised controlled trial.
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | Unknown. |
| Participants | People with coronary heart disease after a percutaneous transluminal coronary angioplasty. |
| Interventions | 'Psychological intervention.' |
| Outcomes | Unknown. |
| Notes | Published in Chinese. Only abstract available ‐ awaiting full text for translation. |
Characteristics of ongoing studies [ordered by study ID]
| Study name | A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease (SPIRR‐CAD): Rationale and Design of a Multicenter, Randomised Trial in Depressed Patients with CAD. |
| Methods | RCT. |
| Participants | 450 participants with any manifestation of CAD and depression scores ≥ 8 on HADS‐D. |
| Interventions | Intervention: 3 initial sessions of supportive individual psychotherapy, after re‐evaluation of depression (weeks 4‐8), participants with persisting symptoms receive an additional 25 sessions of combined psychodynamic and group CBT. Comparator: participants receive 1 psychosocial counselling session. |
| Outcomes | Cardiac events. Depression (HADS‐D, HAM‐D). HRQoL (SF‐36). Cost‐effectiveness up to 24 months of follow‐up. |
| Starting date | Participant recruited November 2008‐2011. |
| Contact information | C Albus, Dept of Psychosomatic Medicine, University of Cologne, Kerpener Str 62; D‐50931 Koeln, Cologne, Germany. E‐mail address: christian.albus@uk‐koeln.de. |
| Notes | Conference abstract of initial findings: Deter HC, Orth‐Gomer K, Herrmann‐Lingen CH, Albus CH, Boese A, Juenger J, et al. (2014). Psychosocial gender differences in CAD and effect of a psychosocial intervention on vital exhaustion findings from the SPIRR‐CAD trial. European Heart Journal 35: 225. |
| Study name | The UPBEAT Nurse‐Delivered Personalized Care Intervention for People with CHD who Report Current Chest Pain and Depression: a Randomised Controlled Pilot Study. |
| Methods | RCT. |
| Participants | 81 participants with CHD scoring ≥ 3 PHQ‐2, reported current chest pain and ≥ 8 on HADS‐D subscale. |
| Interventions | Intervention: 6‐month personalised care plan including case management and regular telephone review. Comparator: usual general practice care. |
| Outcomes | Anxiety (HADS‐A). Depression (HADS‐D). HRQoL (Modified Rose Angina Questionnaire, SF‐12). |
| Starting date | Participants recruited October 2010 to June 2011. |
| Contact information | E Barley, Florence Nightingale School of Nursing and Midwifery, James Clerk Maxwell Building, King's College London, London, UK. E‐mail: [email protected]. |
| Notes |
| Study name | Detection and Management of Depression in Patients with Chronic Heart Disease: The Take Heart in Primary Care Cluster Randomised Controlled Trial. |
| Methods | RCT. |
| Participants | 282 participants: 78% CAD; 45% chronic angina pectoris; 37% AMI, 36% AF and 20% HF. At baseline, 24% intervention and 32% comparator were depressed. |
| Interventions | TAKE HEART intervention: screening for depression, academic detailing and tailored psychiatric advice. Comparator: usual primary care management. |
| Outcomes | Depression (CES‐D scale). |
| Starting date | Not reported. |
| Contact information | K Eckert, University of Adelaide, Hanson Institute, Adelaide, Australia. |
| Notes | Data extracted from conference abstract only. |
| Study name | Treatment of Depression and Anxiety with Internet‐Based Cognitive Behavior Therapy in Patients with a Recent Myocardial Infarction (U‐CARE Heart): Study Protocol for a Randomised Controlled Trial. |
| Methods | RCT. |
| Participants | 500 participants with AMI, with depression or anxiety (or both) score of > 7 on HADS‐A or HADS‐D subscales. |
| Interventions | Intervention: 14‐week internet‐based CBT intervention. Participants choose 2 or 3 modules out of 10 modules. Comparator: usual care. |
| Outcomes | Anxiety (HADS‐A, Cardiac Anxiety Questionnaire). Depression (HADS‐D, Montgomery‐Åsberg Depression Rating Scale‐Self rating). HRQoL (EQ‐5D). Cantril Ladder of Life scale. Everyday Life Stress Scale. Vital exhaustion (Maastricht Questionnaire). Posttraumatic Stress Disorder Checklist ‐ Civilian Version. Posttraumatic Growth Inventory ‐ Short Form. |
| Starting date | Participant recruitment commenced September 2013. |
| Contact information | F Norlund, Department of Public Health and Caring Sciences, Uppsala University, Box 564, Uppsala SE‐751 22, Sweden. E‐mail: [email protected]. |
| Notes |
| Study name | Assessing the Effectiveness of Enhanced Psychological Care for Patients with Depressive Symptoms Attending Cardiac Rehabilitation Compared with Treatment as Usual (CADENCE): Study Protocol for a Pilot Cluster Randomised Controlled Trial. |
| Methods | Cluster RCT. |
| Participants | Up to 64 participants (recruited from 8 cardiac rehabilitation teams) admitted for an ACS or following a coronary revascularisation procedure, with or without HF, and with a new‐onset episode of depression (PHQ‐9 ≥ 10 score). |
| Interventions | Enhanced psychological care intervention: embedded into routine cardiac rehabilitation programme lasting approximately 8 weeks. A cardiac nurse specialist will implement within the rehabilitation programme. Enhanced psychological care includes: mental healthcare coordination, behavioural activation programme and self‐help materials, general practitioner referral, referral to local Improving Access to Psychological Therapies services, or referral to specific cardiac patient psychological support services where available, or a combination. Comparator: usual cardiac rehabilitation programme. |
| Outcomes | Total mortality. Cardiac mortality. Cardiac events (ACS and revascularisation procedures). Depression (Becks Depression Inventory). Anxiety (Beck Anxiety Inventory). Behavioral Activation for Depression Scale. HRQoL (EQ‐5D and HeartQoL). |
| Starting date | 1 April 2014. |
| Contact information | S Richards: University of Exeter Medical School, St Luke's Campus, Exeter, EX1 2LU, UK. E‐mail: [email protected]. |
| Notes |
| Study name | The ACTonHEART Study: Rationale and Design of a Randomised Controlled Clinical Trial Comparing a Brief Intervention Based on Acceptance and Commitment Therapy to Usual Secondary Prevention Care of Coronary Heart Disease. |
| Methods | RCT. |
| Participants | 168 participants recently having AMI, ACS, surgical revascularisation (CABG). |
| Interventions | Intervention: 5 × 90‐minute group sessions over 6 weeks based on Acceptance and Commitment Therapy (ACT) with the aim of positively modifying health‐related behaviours and improving psychological health. Comparator: usual outpatient cardiac rehabilitation care. |
| Outcomes | HRQoL (SF‐36). Psychological General Well‐Being Index. |
| Starting date | Not reported. |
| Contact information | C Spatola, Istituto Auxologico Italiano IRCCS, Psychology Research Laboratory, Milan, Italy/Department of Psychology, Catholic University of Milan, Milan, Italy. E‐mail: [email protected]. |
| Notes |
| Study name | Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): Study Protocol for a Randomized Controlled Trial. |
| Methods | RCT. |
| Participants | Aged ≥ 18 years, primary hospital admission for cardiovascular disease, an International Neuropsychiatric Interview diagnosis of major depression, dysthymia, GAD, panic disorder, agoraphobia, social anxiety/phobia, or post‐traumatic stress disorder, PHQ‐9 ≥ 10 score or GAD ≥ 7 score, fluent in English. |
| Interventions | Unified protocol intervention: lasting 12‐18 weeks, aimed at enhancing motivation, readiness for change, and treatment engagement; psychoeducation about emotions; increasing present focused emotion awareness; increasing cognitive flexibility; identifying and preventing patterns of emotion avoidance and maladaptive emotion‐driven behaviours (including tobacco smoking and alcohol use); increasing tolerance of emotion‐related physical sensations; interoceptive and situation‐based emotion‐focused exposure; and relapse prevention strategies. Comparator: enhanced usual care including an education package delivered by the study coordinator consisting of beyondblue™ fact sheet regarding anxiety, depression, and CHD. |
| Outcomes | Major adverse coronary events. Anxiety severity (GAD‐7 and OASIS). Depression (PHQ‐9). HRQoL (SF‐12). General stress (DASS21). |
| Starting date | Not stated but "currently recruiting" ‐ paper accepted December 2015. |
| Contact information | P Tully. Freemasons Foundation Centre for Men's Health, Discipline of Medicine, School of Medicine, The University of Adelaide, Adelaide, Australia. E‐mail: [email protected]. |
| Notes |
ACS: acute coronary syndrome; AF: atrial fibrillation; AMI: acute myocardial infarction; CABG: coronary artery bypass graft; CAD: coronary artery disease; CBT: cognitive behavioural therapy; CES‐D: Center for Epidemiologic Studies Depression Scale; CHD: coronary heart disease; DASS21: Depression Anxiety Stress Scales ‐ 21; GAD: generalised anxiety disorder; HADS‐A: Hospital Anxiety and Depression scale ‐ Anxiety subscale (HADS 1983); HADS‐D: Hospital Anxiety and Depression scale ‐ Depression subscale (HADS 1983); HAM‐D: Hamilton Depression Rating Scale (HAM‐D 1988); HR: heart rate; HRQoL: health‐related quality of life; MI: myocardial infarction; OASIS: Overall Anxiety Severity and Impairment Scale; PHQ‐9: Patient Health Questionnaire 9; RCT: randomised controlled trial; SF‐12: 12‐item Short Form (Short Form Questionnaires); SF‐36: 36‐item Short Form (Short Form Questionnaires).
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Total mortality Show forest plot | 23 | 7776 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.77, 1.05] |
| Analysis 1.1  Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 1: Total mortality | ||||
| 1.2 Cardiac mortality Show forest plot | 11 | 4792 | Risk Ratio (M‐H, Random, 95% CI) | 0.79 [0.63, 0.98] |
| Analysis 1.2  Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 2: Cardiac mortality | ||||
| 1.3 Revascularisation (coronary artery bypass graft surgery and percutaneous coronary intervention combined) Show forest plot | 13 | 6822 | Risk Ratio (M‐H, Random, 95% CI) | 0.94 [0.81, 1.11] |
| Analysis 1.3  Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 3: Revascularisation (coronary artery bypass graft surgery and percutaneous coronary intervention combined) | ||||
| 1.4 Non‐fatal myocardial infarction Show forest plot | 13 | 7845 | Risk Ratio (M‐H, Random, 95% CI) | 0.82 [0.64, 1.05] |
| Analysis 1.4  Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 4: Non‐fatal myocardial infarction | ||||
| 1.5 Depression Show forest plot | 19 | 5825 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.27 [‐0.39, ‐0.15] |
| Analysis 1.5  Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 5: Depression | ||||
| 1.6 Anxiety Show forest plot | 12 | 3161 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.24 [‐0.38, ‐0.09] |
| Analysis 1.6  Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 6: Anxiety | ||||
| 1.7 Stress Show forest plot | 8 | 1251 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.56 [‐0.88, ‐0.24] |
| Analysis 1.7  Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 7: Stress | ||||
Flow diagram summarising study selection. N: number of RCT: randomised controlled trial
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Funnel plot: psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation) for total mortality (Analysis 1.1).
Funnel plot: psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation) for revascularisation (coronary artery bypass graft surgery and percutaneous coronary intervention combined) (Analysis 1.3).
Funnel plot: psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation) for non‐fatal myocardial infarction (Analysis 1.4).
Funnel plot: psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation) for depression (Analysis 1.5).
Funnel plot: psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation) for stress (Analysis 1.7).
Funnel plot: psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation) for cardiac mortality (Analysis 1.2).
Funnel plot: psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation) for anxiety (Analysis 1.6).
Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 1: Total mortality
Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 2: Cardiac mortality
Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 3: Revascularisation (coronary artery bypass graft surgery and percutaneous coronary intervention combined)
Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 4: Non‐fatal myocardial infarction
Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 5: Depression
Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 6: Anxiety
Comparison 1: Psychological intervention (alone or with other rehabilitation) versus comparator (usual care or other rehabilitation), Outcome 7: Stress
| Psychological intervention with or without other rehabilitation compared to control (usual care/other rehabilitation) for coronary heart disease (third update) | ||||||
| Patient or population: people with coronary heart disease (third update) Settings: centre or home based (± telephone support) Intervention: psychological intervention ± other rehabilitation Comparison: control (usual care/other rehabilitation) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Control (usual care/other rehabilitation) | Psychological intervention +/‐ other rehabilitation | |||||
| Total mortality | Study population | RR 0.90 | 7776 | ⊕⊕⊕⊝ | ‐ | |
| 91 per 1000 | 82 per 1000 | |||||
| Moderate population | ||||||
| 36 per 1000 | 32 per 1000 | |||||
| Cardiac mortality | Study population | RR 0.79 | 4792 | ⊕⊕⊝⊝ | ‐ | |
| 72 per 1000 | 57 per 1000 | |||||
| Moderate population | ||||||
| 49 per 1000 | 39 per 1000 | |||||
| Non‐fatal MI | Study population | RR 0.82 | 7845 | ⊕⊕⊝⊝ | ‐ | |
| 95 per 1000 | 78 per 1000 | |||||
| Moderate population | ||||||
| 67 per 1000 | 55 per 1000 | |||||
| Revascularisation (CABG and PCI combined) | Study population | RR 0.94 | 6822 | ⊕⊕⊕⊝ | ‐ | |
| 121 per 1000 | 114 per 1000 | |||||
| Moderate population | ||||||
| 115 per 1000 | 108 per 1000 | |||||
| Anxiety | ‐ | The mean anxiety in the intervention groups was | ‐ | 3165 | ⊕⊕⊝⊝ | ‐ |
| Depression | ‐ | The mean depression in the intervention groups was | ‐ | 5829 | ⊕⊕⊝⊝ | ‐ |
| Stress | ‐ | The mean stress in the intervention groups was | ‐ | 1255 | ⊕⊝⊝⊝ | ‐ |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Random sequence generation, allocation concealment, or blinding of outcome assessors were poorly described in 50% or more of included studies. | ||||||
| Trial | Follow‐up (months) | Measure | Scores at follow‐up: intervention vs comparator, P value | Between‐group difference |
|---|---|---|---|---|
| Depression | ||||
| 18 | Depression (clinical diagnosis, DSM‐IV criteria) | Odds of being depressed, controlling for age, gender, and baseline depression OR 0.50 (95% CI 0.26 to 0.95), P = 0.04 | Intervention > comparator | |
| 9 | Beck Depression Inventory | Mean (SD): CBT 6.7 (8.32); SSM 9.9 (9.07) vs 12.9 (9.29), P < 0.001 | Intervention > comparator | |
| 12 | Hamilton Anxiety and Depression Combined Score | Median (IQR): 6 (2 to 9) vs 7 (4 to 11.5); mean difference ‐2.35 (SD NR), P = NS | Intervention ≈ comparator | |
| 6 | Patient Health Questionnaire ‐ 9 | Mean (SD): 6.1 (5.5) vs 8.1 (5.8), P = NS | Intervention ≈ comparator | |
| 18 | Beck Depression Inventory (diagnosis) | OR 0.31 (95% CI 0.16 to 0.61) vs 1.15 (95% CI 0.60 to 0.22), P = 0.009 | Intervention > comparator | |
| Distress | ||||
| 18 | Symptom Checklist‐25 | OR 0.4 (95% CI 0.21 to 0.84) vs 0.9 (95% CI 0.43 to 1.86), P = NS | Intervention ≈ comparator | |
| Anger | ||||
| 12 | Anger (STAXI): State | Mean (SD): 10.9 (2.3) vs 11.1 (2.6), P = NS | Intervention ≈ comparator | |
| 12 | Anger (STAXI): Trait | Mean (SD): 17.4 (4.2) vs 18 (4.8), P = NS | Intervention ≈ comparator | |
| 12 | Anger (STAXI): In | Mean (SD): 17.1 (4.7) vs 16.8 (4.9), P = NS | Intervention ≈ comparator | |
| 12 | Anger (STAXI): Out | Mean (SD): 11.6 (2.7) vs 11.5 (3.1), P = NS | Intervention ≈ comparator | |
| 12 | Anger (STAXI): Control | Mean (SD): 24.5 (4.2) vs 24.4 (4.5), P = NS | Intervention ≈ comparator | |
| Type A behaviour | ||||
| 54 | Type A: Videotaped Clinical Interview for Type A behaviour | Mean (SD): 15.5 (8.9) vs 22.1 (9.7), P < 0.001 | Intervention > comparator | |
| 9 | Type A: Revised Videotaped Structured Interview (Hostility subscale) | Mean (SD): 53.6 (25.3) vs 58.9 (29.5), P = 0.03 | Intervention > comparator | |
| 9 | Type A: Revised Videotaped Structured Interview (Time Urgency subscale) | Mean (SD): 66.5 (29.6) vs 75 (32.1), P = 0.01 | Intervention > comparator | |
| 9 | Type A: Revised Videotaped Structured Interview (Insecurity subscale) | Mean (SD): 25.8 (20.6) vs 26.3 (22.6), P = NS | Intervention ≈ comparator | |
| Vital exhaustion | ||||
| 9 | Maastricht Questionnaire | Mean (SD): 4.6 (5.7) vs 4.7 (5.5), P = NS | Intervention ≈ comparator | |
| 12 | Mean (SD): 12.2 (17.3) vs 15.8 (19.4), P < 0.05 | Intervention > comparator | ||
| 30 | Mean (SD): 16.5 (11.1) vs 16.9 (11.3), P = 0.005 | Intervention > comparatora | ||
| 23 | Mean (SD): 56.5 (8.1) vs 59.7 (14.5), P = NS | Intervention ≈ comparator | ||
| Hopelessness | ||||
| 9 | Beck Hopelessness Scale | Mean (SD): CBT 3.5 (5.1); SSM 5.5 (5.8) vs 7.5 (6.0), P = NS | Intervention ≈ comparator | |
| a The authors noted in their discussion that "due to regression towards the mean we cannot attribute the decrease in vital exhaustion to the intervention." CBT: cognitive behavioural therapy; CI: confidence interval; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders ‐ 4th edition; IQR: interquartile range; OR: odds ratio; NR: not reported; NS: non‐significant (P >0.10); SD: standard deviation; SSM: supportive stress management; STAXI: Spielberger Anger scales (STAXI 1985). | ||||
| Trial | Follow‐up (months) | Measure | Scores at follow‐up (mean (SD)): intervention vs comparator, P value | Between‐group differencea |
|---|---|---|---|---|
| 18 | MacNew Questionnaire: Global Score | 126.9 (27.4) vs 127.1 (25.8), P = NS | Intervention ≈ comparator | |
| 12 | Swedish Quality of Life Scale | 6.59 (2.95) vs 5.97 (3.15), P = NS | Intervention ≈ comparator | |
| 6 | SF‐12: Physical Component Score | 0.8 (23.0), P = NSb | Intervention ≈ comparator | |
| 6 | SF‐12: Mental Component Score | 2.2 (18.3), P < 0.05b | Intervention > comparator | |
| 6 | Life Satisfaction Scale | 1.0 (9.8), P < 0.05b | Intervention > comparator | |
| 6 | Ladder of Life | 0.3 (4.6), P < 0.05b | Intervention > comparator | |
| 9 | SF‐36: Physical Component Score | CBT 37.6 (9.6); SSM 38.9 (9.7) vs 36.9 (10.6), P = NS | Intervention ≈ comparator | |
| 9 | SF‐36 Mental Component Score | CBT 49.1 (12.2); SSM 47.8 (13.0) vs 42.4 (13.3), P = 0.01 | Intervention > comparator | |
| 6 | SAQ: Physical Limitations | 86.4 (15.6) vs 83.2 (18.7), P = NS | Intervention ≈ comparator | |
| 6 | SAQ: Angina Frequency | 91.7 (16.6) vs 90.8 (18.9), P = NS | Intervention ≈ comparator | |
| 6 | SAQ: Treatment Satisfaction | 89.2 (15.4) vs 88.0 (16.1), P = NS | Intervention ≈ comparator | |
| 6 | SAQ: Disease Perception | 77.8 (20.2) vs 3.9 (24.2), P = NS | Intervention ≈ comparator | |
| 6 | SF‐36: Physical Component Score | 47.4 (9.6) vs 47.0 (10.0), P = NS | Intervention ≈ comparator | |
| 6 | SF‐36: Mental Component Score | 52.1 (10.7) vs 50.5 (10.8), P = NS | Intervention ≈ comparator | |
| 12 | Dartmouth COOP | 14 (IQR 13 to 17) vs 15 (IQR 12.5 to 21), P = NSc | Intervention ≈ comparator | |
| 12 | SF‐36: Physical Component Score | 43.2 (9.2) vs 46.1 (9.3), P = NS | Intervention ≈ comparator | |
| 12 | SF‐36: Mental Component Score | 47.2 (9.2) vs 49.3 (10), P = NS | Intervention ≈ comparator | |
| 12 | SF‐12: Physical Component Score | 36.6 (10.5) vs 36.2 (10.5), P = NR | Intervention ≈ comparator | |
| 12 | SF‐12: Mental Component Score | 45.6 (9.3) vs 42.7 (11.1), P = NR | Intervention ≈ comparator | |
| 30 | SF‐36: Physical Component Score | 64.3 (5.2) vs 61.7 (4.8), P = 0.04 | Intervention > comparator | |
| 30 | SF‐36: Mental Component Score | 58.9 (5.9) vs 53.0 (2.2), P < 0.01 | Intervention > comparator | |
| 12 | MacNew Questionnaire: Global Score | 6.07 (IQR 5.48 to 6.39) vs 5.67 (IQR 4.89 to 6.31), P = 0.07c | Intervention ≈ comparator | |
| 12 | MacNew Questionnaire: Emotional Score | 5.79 (IQR 5.36 to 6.35) vs 5.79 (IQR 5.0 to 6.32), P = NSc | Intervention ≈ comparator | |
| 12 | MacNew Questionnaire: Physical Score | 6.23 (IQR 5.70 to 6.53) vs 5.69 (IQR 4.85 to 6.29), P = 0.03c | Intervention > comparator | |
| 12 | MacNew Questionnaire: Social Score | 6.15 (IQR 5.69 to 6.61) vs 5.86 (IQR 5.0 to 6.46), P = 0.06c | Intervention ≈ comparator | |
| a Intervention ≈ comparator (intervention and comparator equivalent); intervention > comparator (intervention superior to comparator group). b Mean difference (SD). c Median (IQR) and P value from Mann Whitney U test. CBT: cognitive behavioural therapy; NS: non‐significant (P > 0.10); SAQ: Seattle Angina Questionnaire; SD: standard deviation; SF‐12: 12‐item Short Form; SF‐36: 36‐item Short Form; SSM: supportive stress management. | ||||
| Predictor | Total mortality | Explanatory variable codinga |
|---|---|---|
| Population targeted at baseline | ||
| Psychological disorder present | 1.19 (0.18), P = 0.26 | Non‐selected 0, present 1 |
| Characteristics of psychological intervention | ||
| Mode of treatment | 1.21 (0.18), P = 0.21 | Individual 0, group 1, both 2 |
| Family included | 1.11 (0.19), P = 0.55 | No 0, yes 1 |
| CRF education included | 0.92 (0.14), P = 0.58 | No 0, yes 1 |
| Intervention targeted behavioural change of CRFs | 1.06 (0.16), P = 0.72 | No 0, yes 1 |
| Psychological treatment targets | ||
| Depression | 1.28 (0.25), P = 0.22 | No 0, yes 1 |
| Anxiety | 1.22 (0.23), P = 0.31 | No 0, yes 1 |
| Stress | 1.28 (0.39), P = 0.43 | No 0, yes 1 |
| Type A behaviour | 0.98 (0.15), P = 0.89 | No 0, yes 1 |
| Psychological components | ||
| Relaxation training | 1.15 (0.22), P = 0.47 | No 0, yes 1 |
| Stress management techniques | 1.15 (0.25), P = 0.54 | No 0, yes 1 |
| Cognitive challenge/restructuring techniques | 1.10 (0.17), P = 0.53 | No 0, yes 1 |
| Emotional support or client‐led discussion, or both | 1.42 (0.25), P = 0.07 | No 0, yes 1 |
| Adjunct pharmacology | 2.08 (2.53), P = 0.56 | No 0, yes 1 |
| a If relevant information was not reported the study was coded as 0. CRF: cardiac risk factor; SE: standard error. | ||
| Predictor | Cardiac‐mortality | Explanatory variable codinga |
|---|---|---|
| Population targeted at baseline | ||
| Psychological disorder present | 1.17 (0.30), P = 0.58 | Non‐selected 0, present 1 |
| Characteristics of psychological intervention | ||
| Mode of treatment | 1.19 (0.32), P = 0.56 | Individual 0, group 1, both 2 |
| Family includedb | 0.82 (0.09), P = 0.13 | No 0, yes 1 |
| CRF education included | 0.84 (0.24), P = 0.57 | No 0, yes 1 |
| Intervention targeted behavioural change of CRFs | 1.17 (0.49), P = 0.72 | No 0, yes 1 |
| Psychological treatment targets | ||
| Depression | 1.13 (0.31), P = 0.67 | No 0, yes 1 |
| Anxiety | 1.13 (0.31), P = 0.67 | No 0, yes 1 |
| Stress | 1.24 (0.71), P = 0.72 | No 0, yes 1 |
| Type A behaviour | 1.02 (0.46), P = 0.95 | No 0, yes 1 |
| Psychological components | ||
| Relaxation training | 1.27 (0.74), P = 0.70 | No 0, yes 1 |
| Stress management techniques | 1.03 (0.46), P = 0.95 | No 0, yes 1 |
| Cognitive challenge/restructuring techniques | 1.11 (0.40), P = 0.78 | No 0, yes 1 |
| Emotional support or client‐led discussion, or both | 1.16 (0.30), P = 0.58 | No 0, yes 1 |
| Adjunct pharmacologyb | 0.82 (0.9), P = 0.13 | No 0, yes 1 |
| a If relevant information was not reported the variable/study was coded as 0. b 'Yes' category (coded 1) contained no participants. Data reported from a model including 'no' (coded 0) only. CRF: cardiac risk factor; SE: standard error. | ||
| Predictor | Depression | Explanatory variable codinga |
|---|---|---|
| Population targeted at baseline | ||
| Psychological disorder present | ‐0.20 (0.12), P = 0.10 | Non‐selected 0, present 1 |
| Characteristics of psychological intervention | ||
| Mode of treatment | 0.007 (0.09), P = 0.94 | Individual 0, group 1, both 2 |
| Family included | 0.06 (0.14), P = 0.70 | No 0, yes 1 |
| CRF education included | 0.06 (0.13), P = 0.65 | No 0, yes 1 |
| Intervention targeted behavioural change of CRFs | ‐0.16 (0.12), P = 0.20 | No 0, yes 1 |
| Psychological treatment targets | ||
| Depression | 0.15 (0.13), P = 0.26 | No 0, yes 1 |
| Anxiety | 0.18 (0.12), P = 0.17 | No 0, yes 1 |
| Stress | 0.13 (0.13), P = 0.35 | No 0, yes 1 |
| Type A behaviour | ‐0.65 (0.14), P = 0.65 | No 0, yes 1 |
| Psychological components | ||
| Relaxation training | ‐0.09 (0.13), P = 0.50 | No 0, yes 1 |
| Stress management techniques | 0.09 (0.13), P = 0.52 | No 0, yes 1 |
| Cognitive challenge/restructuring techniques | 0.07 (0.14), P = 0.59 | No 0, yes 1 |
| Emotional support or client‐led discussion, or both | 0.14 (0.13), P = 0.28 | No 0, yes 1 |
| Adjunct pharmacology | ‐0.51 (0.15), P = 0.003 | No 0, yes 1 |
| a If relevant information was not reported the variable/study was coded as 0. CRF: cardiac risk factor; SE: standard error. | ||
| Predictor | Anxiety | Explanatory variable codinga |
|---|---|---|
| Population targeted at baseline | ||
| Psychological disorder present | ‐0.28 (0.11), P = 0.03 | Non‐selected 0, present 1 |
| Characteristics of psychological intervention | ||
| Mode of treatment | 0.09 (0.09), P = 0.30 | Individual 0, group 1, both 2 |
| Family included | 0.24 (0.12), P = 0.06 | No 0, yes 1 |
| CRF education included | 0.18 (0.13), P = 0.21 | No 0, yes 1 |
| Intervention targeted behavioural change of CRFs | ‐0.08 (0.17), P = 0.61 | No 0, yes 1 |
| Psychological treatment targets | ||
| Depression | ‐0.04 (0.16), P = 0.83 | No 0, yes 1 |
| Anxiety | 0.05 (0.15), P = 0.78 | No 0, yes 1 |
| Stress | 0.18 (0.13), P = 0.20 | No 0, yes 1 |
| Type A behaviour | ‐01 (0.26), P = 0.97 | No 0, yes 1 |
| Psychological components | ||
| Relaxation training | 0.15 (0.14), P = 0.29 | No 0, yes 1 |
| Stress management techniques | ‐0.03 (0.15), P = 0.87 | No 0, yes 1 |
| Cognitive challenge/restructuring techniques | ‐0.16 (0.14), P = 0.29 | No 0, yes 1 |
| Emotional support or client‐led discussion, or both | 0.12 (0.14), P = 0.44 | No 0, yes 1 |
| Adjunct pharmacology | ‐0.12 (0.24), P = 0.65 | No 0, yes 1 |
| a If relevant information was not reported the variable/study was coded as 0. CRF: cardiac risk factor; SE: standard error. | ||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Total mortality Show forest plot | 23 | 7776 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.77, 1.05] |
| 1.2 Cardiac mortality Show forest plot | 11 | 4792 | Risk Ratio (M‐H, Random, 95% CI) | 0.79 [0.63, 0.98] |
| 1.3 Revascularisation (coronary artery bypass graft surgery and percutaneous coronary intervention combined) Show forest plot | 13 | 6822 | Risk Ratio (M‐H, Random, 95% CI) | 0.94 [0.81, 1.11] |
| 1.4 Non‐fatal myocardial infarction Show forest plot | 13 | 7845 | Risk Ratio (M‐H, Random, 95% CI) | 0.82 [0.64, 1.05] |
| 1.5 Depression Show forest plot | 19 | 5825 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.27 [‐0.39, ‐0.15] |
| 1.6 Anxiety Show forest plot | 12 | 3161 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.24 [‐0.38, ‐0.09] |
| 1.7 Stress Show forest plot | 8 | 1251 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.56 [‐0.88, ‐0.24] |
