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Referencias

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

de Godoy 2003

Methods

Country: Brazil

Design: a blinded prospective RCT

Multicentre?: no

Funders of the trial: supported by the Universidade de Caxias do Sul (BPC level II grant)

Duration of trial: October 1999‐May 2001

Duration of participation: 12‐week programme

Participants

Population description: people with COPD treated at a pulmonary rehabilitation clinic in Brazil; participant's COPD was stratified according to the Brazilian Society of Pulmonology and Tisiology guidelines into 3 severity levels: mild, moderate and severe

Setting: all participants were referred from the University's Department of Respiratory Diseases to the Pulmonary Rehabilitation Clinic

Inclusion criteria: diagnosis of COPD (corroborated by clinical history, physical examination, spirometry, chest plain films, thoracic computer tomography or both and pulse oximetry

Exclusion criteria: physical incapacity to perform the proposed protocol; refusal to participate in the pulmonary rehabilitation programme; lack of adherence to the pulmonary rehabilitation programme due to illness of more than 2 weeks' duration

Method of participant recruitment: pulmonary rehabilitation clinic patients

Total number randomised: 30 participants

Withdrawals and exclusions: no withdrawals mentioned

Age: mean age 60.33

Sex: 22 men and 8 women

Race/ethnicity: not stated

Interventions

Intervention

Number randomised to group: 14

Details of the interventions:

  • 12 psychotherapy sessions including sessions of psychotherapy which addressed the patient’s psychosocial needs and included his/her social, marital, work, health, and interpersonal philosophy and habits; cognitive therapy and logotherapy techniques were used during these sessions

Intervention intensity: 12‐week treatment programme with 12 psychotherapy sessions in addition to co‐interventions of 24 physiotherapy sessions, 24 physical exercise sessions and 3 educational sessions

Mode of delivery: unclear if intervention was delivered in group settings or to individuals

Co‐interventions:

  • 24 sessions of exercise (arm and leg exercises, aerobic condition with a treadmill, and flexibility training

  • 24 sessions of physiotherapy (diaphragmatic breathing, sputum clearance, bending forward postures, pursed‐lip breathing, postural drainage, chest percussion, vibration, directed cough and forced expiratory technique was used)

  • 3 education sessions (including compliance, coping with illness, stress management, anatomy and physiology of the lungs, relaxation and energy‐saving techniques, drug actions, side effects and technique for administration, good nutrition, use of oxygen, environmental control, intimacy and sexuality, the doctor‐patient relationship, smoking cessation, benefits of exercise

Comparison

Comparison name: reported as 'Group 2' in the paper

Number randomised to group: 16

Details of the interventions:

  • 24 sessions of exercise (arm and leg exercises, aerobic condition with a treadmill, and flexibility training)

  • 24 sessions of physiotherapy (diaphragmatic breathing, sputum clearance, bending forward postures, pursed‐lip breathing, postural drainage, chest percussion, vibration, directed cough and forced expiratory technique was used)

  • 3 education sessions (including compliance, coping with illness, stress management, anatomy and physiology of the lungs, relaxation and energy‐saving techniques, drug actions, side effects and technique for administration, good nutrition, use of oxygen, environmental control, intimacy and sexuality, the doctor‐patient relationship, smoking cessation, benefits of exercise

Intervention intensity: 12‐week treatment programme with 24 physiotherapy sessions, 24 physical exercise sessions and 3 educational sessions

Mode of delivery: unclear if intervention was delivered in group settings or to individuals

Outcomes

Outcomes collected: BAI, BDI and 6MWD

Time points measured: baseline and post‐intervention

Person collecting time point: not specified

Outcome measures validated?: yes for all three

Missing data addressed?: not reported

Notes

Note: no mention of a sample size calculation is made but authors do report the "relatively small sample size" as a limitation of the study.

Funding: Supported by the Universidade de Caxias do Sul (BPC level II grant); No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the authors or upon any organization with which the authors are associated

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method of randomisation not specified "patients were randomised into 2 groups"

Allocation concealment (selection bias)

Unclear risk

Details of allocation concealment not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Group 1 was blinded in relation to the activities of Group 2 and vice versa

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No mention of blinding for outcome assessors

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Reasons for choosing not to participate prior to randomisation (n = 6 participants) and attrition post recruitment (n = 3 intervention participants) were reported for all participants

Selective reporting (reporting bias)

Unclear risk

Insuffient information due to lack of prespecified study protocol

Other bias

Low risk

No other biases identified

Hynninen 2010

Methods

Country: Norway

Design: prospective RCT

Multicentre?: no

Funders of the trial: no funding sources mentioned

Duration of trial: participants were enrolled over a period of 1.5 years; no other information provided

Duration of participation: 8 months from baseline

Participants

Population description: people with COPD who answered positively to at least 2 of the 5 anxiety and depression questions from the PRIME‐MD questionnaire

Setting: participants in both groups attended the pulmonary clinic at baseline and 2 and 8 months later for spirometry, self‐report measures and provision of Actigraph device for sleep registration

Inclusion criteria: COPD diagnosis confirmed with post –bronchodilator spirometry FEV1 < 80% predicted and ratio < 0.7, aged 40 years or over, had BAI scores > 15 and/or BDI‐II > 13, not participating in other psychological interventions e.g. pulmonary rehabilitation, no cognitive impairment (MMSE score > 23) and no severe psychiatric disorders as per DSMIV

Exclusion criteria: as per inclusion criteria

Method of participant recruitment: consecutive eligible patients who were interested in participating in the study were recruited from an outpatient clinic at the Haukeland University Hospital, Bergen, Norway or were recruited via a newspaper advertisement

Total number randomised: 51 participants

Withdrawals and exclusions: intervention arm: 2 discontinued intervention; control arm: 2 could not be contacted and 1 died

Age: intervention group: mean 59.3 years; control group: mean 62.6 years

Sex: intervention group: 11 women, 14 men; control group: 15 women, 11 men

Race/ethnicity: not reported

Interventions

Intervention

Number randomised to group: 25 (23 received allocated intervention)

Details of the interventions:

  • psychoeducation awareness (how COPD may affect psychological well‐being, patterns of anxiety and depression adding to the burden of lung disease)

  • relaxation (using breathing techniques and postural changes for relaxation and coping with physical symptoms)

  • cognitive therapy (identifying unhelpful thoughts and explore more functional patterns of thought)

  • behavioural therapy (identify depressive, passive behaviours and replace them with activities that are pleasant/increase mastery;

  • fear‐based exposure (replace avoidance with graded exposure to increase tolerance)

  • sleep skills management (learn about sleep hygiene and use skills);

CBT was undertaken in the Department of Clinical psychology. The group session was facilitated by two masters‐level psychology students; The sessions were videotaped and a specialist in clinical psychology monitored the students' competence

Intervention intensity: 7 weekly 2‐h sessions

Mode of delivery: group sessions (4‐6 participants, 5 on average)

Co‐interventions

  • Participants were phoned 1 and 3 months after post‐treatment assessments and encouraged to maintain behavioural changes instigated in therapy

Comparison

Comparison name: Enhanced Standard care for COPD

Number randomised to group: 26 (23 received allocated intervention)

Details of the interventions:

  • standard COPD care plus telephone contact every 2 weeks in the intervention period of seven weeks;

  • the same student therapists conducted the phone calls

Intervention intensity: phone calls every 2 weeks for intervention period; Calls lasted 5‐10 min

Mode of delivery: telephone

Co‐interventions

  • participants were phoned 1 and 3 months after post‐treatment assessments and encouraged to maintain behavioural changes instigated in therapy

Outcomes

Outcomes collected: BAI, BDI, SGRQ, PSQI, Actigraphy (objective measure of sleep efficiency) and CSQ

Time points measured: baseline, 2 and 8 months (or baseline, post treatment and six months post treatment)

Person collecting time point: not reported

Outcome measures validated?: yes for all

Missing data addressed?: yes, ITT analysis used and authors report that missing data at one measurement point did not prevent including the individual in the analysis

Notes

Note: the target sample size identified as being necessary in the power analysis (33 in each arm) was not reached by the end of the study period (25 in the intervention arm and 26 in the control arm)

Funding: no mention of funding or financial support for this work

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomisation reported however methods not described

Allocation concealment (selection bias)

Low risk

Allocation concealment was implemented using numbered containers that were identical in appearance for the two groups

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Neither participants nor therapists were blinded to the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No mention of blinding for outcome assessors

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Reasons for attrition reported in participant flow chart. Missing outcome data at one measurement point did not preclude analysis as mixed models with random effect was used for analysis; Intention‐to‐treat analysis occurred

Selective reporting (reporting bias)

Low risk

Prespecified protocol available and no selective reporting identified

Other bias

Low risk

No other biases identified

Kunik 2008

Methods

Country: USA

Design: prospective RCT

Multicentre?: no

Funders of the trial: grant from Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development; Houston Centre for Quality Care and Utilization Studies and South Central Medical Illness Research, Education and Clinic Center, Department of Veterans Affairs

Duration of trial: 11 July 2002‐30 April 2005

Duration of participation: 12 months' follow‐up from baseline

Participants

Population description: people with a chronic breathing disorder (COPD) who had moderate anxiety symptoms and/or depression and were receiving care at the Michael E DeBakey VA Medical Centre (MEDVAMC) within the year before the study

Setting: participants were from the Michael E DeBakey VA Medical Center in Houston, Texas, USA and community members meeting the criteria outside of the medical centre

Inclusion criteria: diagnosis of COPD confirmed with spirometry (ratio < 70 and FEV1 < 70; according to ATS 1991); moderate anxiety (BAI ≥ 16) and/or depression (BDI > 14); and treatment by primary care or provider or pulmonologist

Exclusion criteria: cognitive disorder or evidence of score of 23 or less on MMSE, a psychotic disorder and people with psychotic and non‐nicotine substance use disorders

Method of participant recruitment: people on administrative database from the Michael DeBakey Medical Center (MEDVAMC) were targeted for recruitment and screened, in addition to other methods including flyers and advertisements

Total number randomised: 238

Withdrawals and exclusions: 69 participants dropped out following randomisation(because of the following reasons: medical 2, no time 6,transportation 6,no interest 49, no information 46).

Age: Mean 66.3 + 10.2 years

Sex: 226 men and 9 women in total

Race/ethnicity: white n = 192, Hispanic n = 7 and black n = 38

Interventions

Intervention

Number randomised to group: 118 (89 attended at least one CBT session)

Details of the interventions:

  • education and awareness training focused on anxiety, depression and associated physiological, cognitive and behavioural symptoms (session 1)

  • relaxation training (session 2)

  • increasing pleasurable activity and decreasing anxiety‐related avoidance (session 2‐3)

  • cognitive therapy – alternative thoughts, encouraging self statements and thought stopping (session 4‐5)

  • problem‐solving techniques (session 6)

  • sleep management skills (session 7)

  • skills review and maintenance of gains (session 8)

Intervention intensity: eight 1‐h sessions

Mode of delivery: group CBT (up to 10 participants each session)

Co‐interventions

  • Group discussion

Comparison

Comparison name: COPD Education

Number randomised to group: 120 (92 received the education intervention)

Details of the interventions:

  • COPD education 45 min sessions with similar frequency to CBT group;

  • Topics included: breathing strategies, airways management, physiology of lung disease, use of oxygen, avoidance of environmental irritants, nutrition, exercise, smoking cessation and end‐of‐life planning

Intervention intensity: eight 45‐min lectures and 15‐min discussions (to control for contact time)

Mode of delivery: group sessions

Co‐interventions:

  • Group discussion

Outcomes

Outcomes collected: CRQ, SF36, BAI, BDI, 6MWD and service use determined by number of hospitalisations, outpatient, mental health and emergency room visits

Time points measured: 1 month, 2 months, 4 months, 8 months and 12 months

Person collecting time point: not reported

Outcome measures validated?: yes, with the exception of service use outcomes

Missing data addressed?: Yes, ITT analysis used and authors reported that missing data at one measurement point did not prevent including the individual in the analysis

Notes

Note: of 256 eligible participants, 238 were randomised but only 181 attended their first session. Study authors reported that retention in research studies at that particular facility could often be challenging with patients treated at Veteran Affairs facilities having more physical and mental health problems than the average US citizen. Also, the sample size calculation in the statistical analysis section stated that 120 participants per group would be required yet this n‐value was not met

Funding: study supported by grant No IIR 00‐097 from the Department of Veterans Affairs, Veteran Health Administration, Health Services Research and Development, Washington DC and in part by Houston Center for Quality of Care and Utilization Studies, Office of Research and Development; and the South Central Mental Illness Research, Education and Clinical Center, Department of Veteran Affairs

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation list occurred via computer program (SAS) with blocks to provide appropriately equal numbers per class of COPD; instructor assigned treatment to the code initially by flip of coin

Allocation concealment (selection bias)

Low risk

The statistician provided randomisation numbers and treatment codes to the study co‐ordinator when sufficient participants for two classes had completed the baseline assessment and consented to participate; the instructor assigned the treatment to the code initially by flipping a coin

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and staff performing the intervention were not blinded to treatment allocation

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Study personnel performing assessments were blinded to treatment condition

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing data accounted for in regression analyses; reasons for participants' exclusion (pre‐enrolment) and attrition of participants post recruitment are reported in detail within the subject flowchart; reasons for exclusion reported

Selective reporting (reporting bias)

Low risk

Pre‐specified protocol available and no selective reporting identified

Other bias

Low risk

No other biases identified

6MWD: Six Minute Walking Distance
BAI: Beck Anxiety Inventory
BDI: Beck Depression Inventory
COPD: chronic obstructive pulmonary disease
CRQ: Chronic Respiratory Questionnaire
CSQ: client satisfaction questionnaire
DSMIV: Diagnostic and Statistical Manual of Mental Disorders (4th Ed)
FEV1: forced expiratory volume in 1 second
ITT: intention‐to‐treat
MMSE: Mini‐Mental State Examination
PRIME‐MD: Primary Care Evaluation of Mental Disorders
PSQI: Pittsburgh Sleep Quality Index
RCT: randomised controlled trial
SGRQ: Saint George's Respiratory Questionnaire
SF36: Medical Outcomes Survey Short Form 36

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Aubuchon 1990

Participants not diagnosed with anxiety at baseline

Blake 1990

Participants not diagnosed with anxiety at baseline (diagnosed with stress) and not COPD‐specific

Blumenthal 2014

Participants not diagnosed with anxiety at baseline

Cully 2007

Not a RCT as defined for this review

de Godoy 2005

No adequate control group: co‐intervention in groups 1 and 3 was an exercise regimen, which was not a prespecified co‐intervention for this review

Doyle 2013

Participants not diagnosed with anxiety at baseline. No intervention arm

Gift 1992

Participants not diagnosed with anxiety at baseline

Lamers 2010

Anxiety data not reported separately

Livermore 2010a

Participants not diagnosed with anxiety at baseline and mean HADS scores are with normal range

Lolak 2008

Progressive muscle relaxation, not psychological intervention

Pommer 2012

Multi‐component intervention, more than just a psychological intervention

Williams 2011

Participants not diagnosed with anxiety at baseline

Yang 2015

Multi‐component intervention, more than just a psychological intervention

COPD: chronic obstructive pulmonary disease
HADS: Hospital Anxiety and Depression Scale
RCT: randomised controlled trial

Characteristics of studies awaiting assessment [ordered by study ID]

Bove 2015

Methods

Parallel RCT

Participants

N = 66 subjects with severe COPD and associated anxiety randomised

Exclusion criteria: HADS‐A (anxiety) subscale score of < 8, a psychiatric diagnosis, pulmonary cancer or involvement in a different interventional trial

Interventions

Single psycho‐educative session in the participant's home in combination with a telephone booster session; intervention based on a manual, with theoretical foundation in CBT and psychoeducation

Usual care comparator

Outcomes

Primary outcomes: HADS‐A (anxiety) and HADS‐D (depression)

Secondary outcomes: CRQ and SGRQ for quality of life and mastery of dyspnoea

Notes

Part of a PhD project

Cully 2012

Methods

Parallel RCT

Participants

N= 320 participants with patient‐reported functional limitations associated with COPD, and/or heart failure, with clinically significant symptoms of anxiety and/or depression

Exclusion criteria: clinical factors e.g. ongoing psychotherapy, concurrent speciality mental healthcare and patient factors e.g. cognitive, bipolar, psychotic or substance abuse disorders

Interventions

Brief manualised CBT delivered by clinicians in comparison to usual care

Intervention group: 6 weekly treatment sessions and 2 brief (10‐15‐min) telephone booster sessions within a 4‐month time frame of the ACCESS

Intervention: core modules focus on increasing awareness and controlling physical and emotional symptoms and subsequently producing skills aligning with their most pressing needs; therapists used a structured manual yet could also tailor the intervention with the participant based on their needs; participant workbook also provided

Control group: usual care with feedback about their depression and anxiety

Outcomes

Participant outcomes: depression, anxiety and physical health functioning

Implementation outcomes: participant engagement, adherence and clinician brief CBT adoption and fidelity

Notes

Farver‐Vestergaard 2014

Methods

Double‐blind RCT

Participants

Estimated n = 120 participants with severe to very severe COPD, motivated to participate in pulmonary rehabilitation and with sufficient mobility to attend pulmonary rehabilitation

Exclusion criteria: certain co‐morbidities (e.g. unstable coronary complications, psychiatric illness), severe cognitive disability (e.g. dementia) and inability to speak Danish

Interventions

Mindfulness‐based cognitive therapy + pulmonary rehabilitation compared to pulmonary rehabilitation only

Intervention group: 8‐week manual‐based programme developed by Segal, Williams and Teasdale (2013) adjusted to the COPD population; programme delivered as an add‐on to an 8‐week standardised rehabilitation programme consisting of physical exercise and COPD‐specific patient education

Control group: 8‐week standardised rehabilitation programme consisting of physical exercise and COPD‐specific patient education

Outcomes

Primary outcomes: quality of life (CAT), anxiety and depression (HADS), and BODE index

Secondary outcomes: physical activity (measured by accelerometry), inflammation and oxidative stress (measured by gene expression profiling)

Notes

Heslop 2013

Methods

Parallel RCT

Participants

N = 312 participants with a confirmed diagnosis of COPD (FVC/FEV1 ratio < 70%, (NICE 2010); including mild‐moderate (FEV1 > 50% predicted) and severe‐very severe (< 50% predicted)), probable anxiety defined by HADSA > 8, willing to participate and provide informed consent, agreed to attend minimum of 2 and maximum of 6 CBT sessions

Exclusion criteria: people with HADS‐A scores < 8, known psychosis or personality disorders, currently receiving psychological therapy including counselling or psychotherapy, unable to engage in CBT (due to cognitive impairment or dementia) and limited verbal and/or written communication problems

Interventions

Psychological treatment for anxiety and depression through CBT compared to self‐help leaflets

Intervention group: 2‐6 sessions depending on participant need and progress as per HADS (usually involved 1 session of CBT every two weeks); components of CBT included developing a CBT formulation, psychoeducation about COPD with panic/depression, identifying/challenging negative or unhelpful thinking, identifying challenging negative or unhelpful behaviours, distraction, breathing control, relaxation, mindfulness, behavioural experiments and graded exposure

Control group: self‐help leaflets

Outcomes

Primary outcome: HADS (3 months)

Secondary outcomes: HADS (6 and 12 months)

Notes

Livermore 2015

Methods

RCT

Participants

People with moderate to severe COPD

Interventions

CBT (4 sessions) versus usual care

Outcomes

Dyspnea scores

Notes

We have tried to contact the study authors to get more information in regards to the baseline anxiety scores of the individual participants to assess the eligibility of some of the participants for this review. We will continue intermittent attempts at contact and if no response has been received by the time of the next update, this study will be moved to the excluded category.

Phan 2015

Methods

Parallel, multi‐arm RCT

Participants

N = 128 people attending the COPD outpatient community clinics in Perth, Western Australia were included if they had a diagnosis of COPD confirmed from medical records and screened positive for anxiety and depression

Exclusion criteria: life expectancy of less than 6 months, were currently involved in another research study, had an illness exacerbation resulting in hospitalisation within the previous month, were not fluent in English, or were blind, deaf or diagnosed with dementia or Alzheimer’s disease

Interventions

Six weeks of 2 formats of CBT, being group therapy (6‐16 people in each group) versus a self‐paced simulation‐based learning resource (DVD) compared to usual care; group therapy consisted of 2 half‐day sessions a fortnight apart and a 1‐hour telephone booster session 4 weeks later; the sessions were semi‐structured in nature and included both CBT global concepts and those that were specific to people with COPD; a manual was provided to participants for referral to CBT concepts; CBT included information about treatment rationale explaining the link between cognitions, behaviours and breathing, coping skills training, cognitive restructuring and the application and maintenance of learned coping skills; The self‐paced simulation included 6 vignettes (participants were asked to watch one per week) approximately 10 min in length on CBT skills to cope with anxiety disorders and depression, a resource manual to guide participants through the video and a weekly phone call by a researcher to check if each vignette was watched, activities completed and if participants had any questions

Usual care group was under the usual treating physician; telephone follow‐up (or home visits for those with hearing difficulties) occurred at one week post‐intervention completion, 3, 6, 9 and 12 months

Outcomes

Primary outcomes: BAI and BDI

Secondary outcomes: SGRQ, absolute FEV1, FEV1 % predicted, FVC

Notes

Shao 2003

Methods

The aim of the study was to explore the effect of behavioral intervention on the quality of life among people with COPD during the remission period

Participants

54 people with COPD were randomly divided into intervention group and control group

Interventions

The 2 groups were treated with the same clinical therapy. The intervention group was also given a behavioral intervention that included psychological therapy with a somatic function and lifestyle intervention

Outcomes

All participants were evaluated with the Fang Zhong‐Jun quality‐of‐life scale pretreatment, before discharge, 3 months and 1 year after discharge

Notes

Results: at 1 year follow‐up, quality of life (measured as 'ability of daily life' and 'status of social activity'), psychological symptom of depression, and psychological symptom of anxiety in the intervention group (2.03 +/‐ 0.32, 2.29 +/‐ 0.77, 2.36 +/‐ 0.34, 2.07 +/‐ 0.25) were significantly lower than those in the control group (2.29 +/‐ 0.30, 2.39 +/‐ 0.41, 2.41 +/‐ 0.28, 2.16 +/‐ 0.51), (t = 2.801, 2.914, P < 0.01, t = 2.250, 2.340, P < 0.05)

ACCESS: Adjusting to Chronic Conditions Using Eucation, Support, and Skills
BAI: Beck Anxiety Inventory
BDI: Beck Depression Inventory
BODE: Body mass index, airflow Obstruction, Dyspnea and Exercise capacity
CAT: COPD Assessment Text
CBT: cognitive behavioural therapy
COPD: chronic obstructive pulmonary disease
CRQ: Chronic Respiratory Questionnaire
HADS‐A: Hospital Anxiety and Depression Scale ‐ Anxiety Subscale
HADS‐D: Hospital Anxiety and Depression Scale ‐ Depression Subscale
FEV1: forced expiratory volume in 1 second
FVC: forced vital capacity
RCT: randomised controlled trial
SGRQ: Saint George's Respiratory Questionnaire

Characteristics of ongoing studies [ordered by study ID]

ACTRN12612000254897

Trial name or title

Telephone Cognitive Behavioural Therapy for the treatment of depression and anxiety associated with chronic obstructive pulmonary disease: a pragmatic randomised controlled trial

Methods

Parallel RCT

Participants

N = 140 participants over 45 years of age, with a HADS score of > 8 and a PHQ‐9 score > 10, with a diagnosis of COPD, living in the community and able to speak English

Exclusion criteria: people who commenced anti‐depressants and/or anxiolytics in the past 3 months or have had a clinically significant change in this medication in the last 3 months and deafness

Interventions

Telephone administered Cognitive Behavioural Therapy (CBT) plus usual care

Control population not specified

Intervention group: starts with a face‐to‐face 50‐min session at the outpatient clinic or participant's home followed by 8 scheduled weekly telephone calls for up to 30 min in length

Intervention includes behavioural strategies such as behavioural activation, activity scheduling, relaxation training, exposure hierarchies and social skills training, as well as cognitive strategies, such as cognitive restructuring, structured problem solving and behavioural experiments

Outcomes

Primary outcomes: BAI and PHQ‐9 (depression scale)

Secondary outcomes: costs of illness (including medical treatment, equipment and working hours), quality of life (AQoL‐4D), client satisfaction, COPD assessment test, General Self‐Efficacy scale, Working Alliance Inventory, acute hospitalisations, number of pulmonary rehabilitation attendances

Starting date

February 2012

Contact information

Colleen Doyle; +61 3 8387 2169; [email protected]; National Ageing Research Institute 34‐54 Poplar Rd Parkville Victoria 3052, Australia

Notes

ACTRN12614000915651

Trial name or title

Randomised controlled trial of a brief telephone based cognitive behavioural therapy (CBT) for patients with chronic lung disease and anxiety and/or depression undergoing pulmonary rehabilitation to evaluate the effect on quality of life, symptoms of anxiety and depression, and exacerbation rate

Methods

Parallel RCT

Participants

N = 100 participants with chronic lung disease, undergoing pulmonary rehabilitation and clinical or sub‐clinical anxiety or depression defined by GAI score ≥ 4/20, and/or GDS of ≥ 4/15

Exclusion criteria: inability to provide written informed consent, known psychotic disorder, cognitive impairment determined by MOCA score of < 25/30 and current enrolment in other interventional clinical trials that would potentially interfere with this study

Interventions

6 CBT sessions administered by psychology interns compared to usual care

Intervention group: 6 CBT sessions divided into: 2 face‐to‐face individual sessions of 1 h each, within the first 4 weeks of pulmonary rehabilitation; 4 phone sessions of 60 min each undertaken for counselling, each session will be fortnightly within the first 2 months after the face‐to‐face sessions; CBT intervention will be standardised following a manual written by the Prince Charles Hospital psychology department

Control group: usual care comprised of medical treatment and pulmonary rehabilitation

Outcomes

Primary outcomes: symptoms of anxiety using GAI and depression using GDS

Secondary outcomes: 6MWD, SGRQ, Asthma Quality‐of‐Life Questionnaire, Asthma Control Questionnaire, primary care and hospital health service utilisation, pulmonary rehabilitation attendance and participation assessment

Starting date

September 2014

Contact information

A/Prof Ian Yang; +61‐7‐31395050; [email protected]; The Prince Charles Hospital Rode Road Chermside, Postcode 4032 Queensland, Australia; and Dr Marsus I Pumar; +61 04 37739874; [email protected]; The Prince Charles Hospital Rode Road Chermside, Postcode 4032 Queensland, Australia

Notes

6MWD: Six Minute Walking Distance
BAI: Beck Anxiety Inventory
CBT: cognitive behavioural therapy
COPD: chronic obstructive pulmonary disorder
GAI: Geriatric Anxiety Inventory
GDS: Geriatric Depression scale
HADS: Hospital Anxiety and Depression Scale
MOCA: Montreal Cognitive Assessment (MOCA)
PHQ‐9: Patient Health Questionnaire‐9
SGRQ: Saint George's Respiratory Questionnaire

Data and analyses

Open in table viewer
Comparison 1. Psychological therapies versus co‐intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

3

319

Mean Difference (IV, Random, 95% CI)

‐4.41 [‐8.28, ‐0.53]

Analysis 1.1

Comparison 1 Psychological therapies versus co‐intervention, Outcome 1 Anxiety.

Comparison 1 Psychological therapies versus co‐intervention, Outcome 1 Anxiety.

2 Quality of life Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Psychological therapies versus co‐intervention, Outcome 2 Quality of life.

Comparison 1 Psychological therapies versus co‐intervention, Outcome 2 Quality of life.

2.1 SGRQ and SF36 Physical composite

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.40 [‐0.88, 0.08]

2.2 SGRQ and SF36 Emotional composite

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.30 [‐1.03, 0.44]

3 Six minute walking distance Show forest plot

2

268

Mean Difference (IV, Fixed, 95% CI)

‐2.78 [‐58.49, 52.94]

Analysis 1.3

Comparison 1 Psychological therapies versus co‐intervention, Outcome 3 Six minute walking distance.

Comparison 1 Psychological therapies versus co‐intervention, Outcome 3 Six minute walking distance.

Open in table viewer
Comparison 2. Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.1

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 1 Anxiety.

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 1 Anxiety.

1.1 Short‐term (0 to 3 months)

3

319

Mean Difference (IV, Random, 95% CI)

‐3.86 [‐6.63, ‐1.10]

1.2 Long term (6 to 12 months)

2

289

Mean Difference (IV, Random, 95% CI)

‐4.30 [‐10.57, 1.97]

2 Six minute walking distance Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.2

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 2 Six minute walking distance.

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 2 Six minute walking distance.

2.1 Short‐term (0 to 3 months)

2

268

Mean Difference (IV, Random, 95% CI)

29.35 [‐30.13, 88.82]

2.2 Long‐term (6 to 12 months)

2

268

Mean Difference (IV, Random, 95% CI)

‐30.08 [‐170.92, 110.77]

3 Quality of life ‐ SGRQ and SF36 Physical composite Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.3

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 3 Quality of life ‐ SGRQ and SF36 Physical composite.

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 3 Quality of life ‐ SGRQ and SF36 Physical composite.

3.1 Short‐term (0 to 3 months)

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.73, 0.13]

3.2 Long‐term (6 to 12 months)

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.40 [‐0.88, 0.08]

4 Quality of life ‐ SGRQ and SF36 Emotional composite Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 2.4

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 4 Quality of life ‐ SGRQ and SF36 Emotional composite.

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 4 Quality of life ‐ SGRQ and SF36 Emotional composite.

4.1 Short‐term (0 to 3 months)

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.17 [‐0.93, 0.60]

4.2 Long‐term (6 to 12 months)

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.30 [‐1.03, 0.44]

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Forest plot of comparison 1: Psychological therapies versus co‐intervention, outcome: 1.1 Anxiety
Figuras y tablas -
Figure 4

Forest plot of comparison 1: Psychological therapies versus co‐intervention, outcome: 1.1 Anxiety

Comparison 1 Psychological therapies versus co‐intervention, Outcome 1 Anxiety.
Figuras y tablas -
Analysis 1.1

Comparison 1 Psychological therapies versus co‐intervention, Outcome 1 Anxiety.

Comparison 1 Psychological therapies versus co‐intervention, Outcome 2 Quality of life.
Figuras y tablas -
Analysis 1.2

Comparison 1 Psychological therapies versus co‐intervention, Outcome 2 Quality of life.

Comparison 1 Psychological therapies versus co‐intervention, Outcome 3 Six minute walking distance.
Figuras y tablas -
Analysis 1.3

Comparison 1 Psychological therapies versus co‐intervention, Outcome 3 Six minute walking distance.

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 1 Anxiety.
Figuras y tablas -
Analysis 2.1

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 1 Anxiety.

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 2 Six minute walking distance.
Figuras y tablas -
Analysis 2.2

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 2 Six minute walking distance.

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 3 Quality of life ‐ SGRQ and SF36 Physical composite.
Figuras y tablas -
Analysis 2.3

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 3 Quality of life ‐ SGRQ and SF36 Physical composite.

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 4 Quality of life ‐ SGRQ and SF36 Emotional composite.
Figuras y tablas -
Analysis 2.4

Comparison 2 Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention, Outcome 4 Quality of life ‐ SGRQ and SF36 Emotional composite.

Summary of findings for the main comparison. Psychological therapies for anxiety for people with COPD

Psychological therapies for anxiety for people with COPD

Patient or population: people with COPD
Settings: hospital and home
Intervention: psychological therapies plus co‐interventions for anxiety

Comparators: co‐intervention alone

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Psychological therapies for anxiety

Anxiety
Becks Anxiety Inventory. Scale from: 0 to 63.
Follow‐up: 3‐12 months

The mean anxiety in the control groups was
15.51

The mean anxiety in the intervention groups was
4.41 lower
(8.28 to 0.53 lower)

319
(3 studies)

⊕⊕⊝⊝
low1,2

Beneficial findings were observed in favour of the psychological therapy group (p= 0.03), with levels of anxiety half that of the control population by final follow‐up (Gillis 1995)

Adverse events

Study population

Not estimable

0
(0)

See comment

No studies reported on adverse events

See comment

See comment

Moderate

Quality of life ‐ physical composite
SGRQ and SF36
Follow‐up: 6‐12 months

The mean quality of life ‐ physical composite in the control groups was
45.08

The mean quality of life ‐ physical composite in the intervention groups was
0.40 standard deviations lower
(0.88 lower to 0.08 higher)

289
(2 studies)

⊕⊕⊝⊝
low1,3

Two studies reported on quality of life with one study (Kunik 2008) reporting both SF36 and CRQ. Meta‐analysis occurred only for SF36 composite scores with SGRQ, as no totals were available for CRQ. Sub‐group analyses separating short‐term (0 to 3 months; SMD ‐0.22, 95% CI ‐0.45 to 0.01; P = 0.06) and long‐term follow‐up (6 to 12 months; SMD ‐0.30, 95% CI ‐0.53 to ‐0.06; P = 0.01) resulted in better treatment outcomes long‐term.

Quality of life ‐ emotional composite
SGRQ and SF36
Follow‐up: 6‐12 months

The mean quality of life ‐ emotional composite in the control groups was
52.3

The mean quality of life ‐ emotional composite in the intervention groups was
0.30 standard deviations lower
(1.03 lower to 0.44 higher)

289
(2 studies)

⊕⊕⊝⊝
low1,3

Two studies reported on quality of life with one study (Kunik 2008) reporting both SF36 and CRQ. We only meta‐analysed SF36 composite scores with SGRQ as no totals were available for CRQ. Sub‐group analyses separating short‐term (0 to 3 months; (SMD 0.05, 95% CI ‐0.18 to 0.28) and long‐term follow‐up (6 to 12 months; (SMD ‐0.09, 95% CI ‐0.32 to 0.14) resulted in better treatment outcomes long‐term.

Exercise capacity
6MWD
Follow‐up: 3‐12 months

The mean exercise capacity in the control groups was
839

The mean exercise capacity in the intervention groups was
2.78 lower
(58.49 lower to 52.94 higher)

268
(2 studies)

⊕⊕⊝⊝
low1,4

The Kunik 2008 study which examined 6MWD at 8 weeks (post‐intervention) and again at 12 months' follow‐up with a difference in favour of the control arm at 12 months (P = 0.05). However, authors reported that group means at beginning of the follow‐up period were not equal (P < 0.01), contributing to the spurious finding.

*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).
6MWD: six minute walking distance; CI: confidence interval; CRQ: Chronic Respiratory Questionnaire; SF36: Short Form 36; SGRQ: Saint George's Respiratory Questionnaire

GRADE Working Group grades of evidence
High quality: further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: we are very uncertain about the estimate.

1Substantial heterogeneity as identified via the I‐squared statistic and visual inspection of the data.
2Two of the three studies have sample sizes lower than the prespecified optimal sample size, study participants were predominantly men across all three studies and most subjects had comorbid anxiety and depression, therefore imprecision was downgraded by one point.
3Both studies had sample sizes lower than the prespecified optimal sample size.
4Wide confidence intervals around effect estimate.

Figuras y tablas -
Summary of findings for the main comparison. Psychological therapies for anxiety for people with COPD
Comparison 1. Psychological therapies versus co‐intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

3

319

Mean Difference (IV, Random, 95% CI)

‐4.41 [‐8.28, ‐0.53]

2 Quality of life Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 SGRQ and SF36 Physical composite

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.40 [‐0.88, 0.08]

2.2 SGRQ and SF36 Emotional composite

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.30 [‐1.03, 0.44]

3 Six minute walking distance Show forest plot

2

268

Mean Difference (IV, Fixed, 95% CI)

‐2.78 [‐58.49, 52.94]

Figuras y tablas -
Comparison 1. Psychological therapies versus co‐intervention
Comparison 2. Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anxiety Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 Short‐term (0 to 3 months)

3

319

Mean Difference (IV, Random, 95% CI)

‐3.86 [‐6.63, ‐1.10]

1.2 Long term (6 to 12 months)

2

289

Mean Difference (IV, Random, 95% CI)

‐4.30 [‐10.57, 1.97]

2 Six minute walking distance Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 Short‐term (0 to 3 months)

2

268

Mean Difference (IV, Random, 95% CI)

29.35 [‐30.13, 88.82]

2.2 Long‐term (6 to 12 months)

2

268

Mean Difference (IV, Random, 95% CI)

‐30.08 [‐170.92, 110.77]

3 Quality of life ‐ SGRQ and SF36 Physical composite Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Short‐term (0 to 3 months)

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.73, 0.13]

3.2 Long‐term (6 to 12 months)

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.40 [‐0.88, 0.08]

4 Quality of life ‐ SGRQ and SF36 Emotional composite Show forest plot

2

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Short‐term (0 to 3 months)

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.17 [‐0.93, 0.60]

4.2 Long‐term (6 to 12 months)

2

289

Std. Mean Difference (IV, Random, 95% CI)

‐0.30 [‐1.03, 0.44]

Figuras y tablas -
Comparison 2. Duration of intervention sub‐group analyses ‐ psychological therapies versus co‐intervention