Interventions for treating anxiety after stroke
Referencias
References to studies included in this review
References to studies excluded from this review
References to studies awaiting assessment
Additional references
References to other published versions of this review
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Methods | RCT, feasibility study | |
| Participants | Location: UK, community setting 21 stroke survivors experiencing anxiety and living in the community, HADS‐A ≥ 6 Group 1: 60% male, mean age 67.8 years (SD 7.5) Group 2: 50% male, mean age 62.4 years (SD 8.4) | |
| Interventions | Intervention group 1: 10 participants, self‐help autogenic relaxation CD, asked to follow instructions 5 times per week for 1 month, asked to complete a diary sheet Intervention group 2: 10 participants, received CD at end of follow‐up Duration: 3 months Study dates: not stated | |
| Outcomes | HADS‐A at months 1, 2, and 3 Loss to follow‐up: 1 withdrew at 1 week for personal reasons (group 1), not included in analysis; 1 withdrew after 1 month owing to additional health concerns (group1), included in analysis | |
| Notes | Exclusions: inability to complete rating scales via telephone; TICS ≤ 20; significant difficulties with language or non‐English speaking; co‐morbid psychiatric disorder other than an affective disorder; currently receiving other psychological intervention Funding sources/declarations of interest: none | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Use of a random number generator. Researcher unaware of group assignment at this stage |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding (performance bias and detection bias) | High risk | Not possible. Participants may have had a positive bias towards the intervention |
| Incomplete outcome data (attrition bias) | High risk | Evaluated by participant who was not blinded |
| Selective reporting (reporting bias) | Unclear risk | Clinical trial registration not reported; therefore not possible to assess risk of bias |
| Other bias | High risk | Recruitment methods (advertisement circulated at 97 stroke survivor groups and placed in a national stroke survivor publication) may have led to a participant population biased towards the intervention and proactively seeking support for anxiety |
| Methods | RCT | |
| Participants | Location: China 81 CT/MRI confirmed first ever stroke according to CCMD‐3 criteria with co‐morbid anxiety and depression Group 1: 52% male, mean age 62.4 years (SD 6.1) Group 2: 52% male, mean age 64.0 years (SD 5.3) Group 3: 52% male, mean age 63.2 years (SD 5.7) | |
| Interventions | Intervention group 1: 27 participants, paroxetine 20 mg daily + routine treatment Intervention group 2: 27 participants, paroxetine 20 mg daily + routine treatment + psychiatrist‐administered individual supportive psychotherapy (30 to 60 minutes per week) Group 3: 27 participants, control group routine treatment only Duration: 6 weeks Study dates: March 2002 to September 2009 | |
| Outcomes | Anxiety (HAM‐A), depression (HAM‐D), BI at 2, 4, and 6 weeks Loss to follow‐up: none Adverse events: 26
Other outcomes: neurological impairment (SSS), activities of daily living (BI) | |
| Notes | Exclusions: coma, aphasia, severe cognitive dysfunction, other serious diseases, depression or antipsychotic medications within 3 months, allergic to paroxetine, or bipolar disorder Funding sources/declarations of interest: no details | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random number list (details not provided) |
| Allocation concealment (selection bias) | Unclear risk | Unknown |
| Blinding (performance bias and detection bias) | Unclear risk | Unknown |
| Incomplete outcome data (attrition bias) | Low risk | Not applicable; data available from all participants recruited to the study |
| Selective reporting (reporting bias) | Unclear risk | All outcomes measured at start of the trial reported at all time points |
| Other bias | Unclear risk | Unknown |
| Methods | RCT | |
| Participants | Location: China 94 participants (47 each in control and intervention groups) with clinical diagnosis of stroke according to CCMD‐3 criteria and affective disorders (72 included in final analysis) Intervention group: 64% male, 57.8 years (SD 6.4) Control group: 61% male, 59.2 years (SD 5.8) | |
| Interventions | Intervention group: 36 participants, buspirone hydrochloride 20 to 30 mg daily in first week, 40 to 60 mg in second week + routine care Control group: 36 participants, routine care (no description of routine care) Duration: 4 weeks Study dates: May 2001 to June 2002 | |
| Outcomes | Anxiety (HAM‐A) and depression (HAM‐D) at 2 and 4 weeks Loss to follow‐up: 22 (11 in each group)
Adverse effects: 5
Other outcomes: American Heart Stroke Outcome Classification | |
| Notes | Exclusion: patients with unstable conditions Funding sources/declarations of interest: no details | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | Unclear risk | High number of losses but balanced between groups |
| Selective reporting (reporting bias) | Unclear risk | No information provided |
| Other bias | Unclear risk | No information provided |
BI: Barthel Index
CCMD‐3: Chinese Classification of Mental Disorders Version 3
CT: computed tomography
HADS‐A: Hospital Anxiety and Depression Scale ‐ anxiety subscale
HAM‐A: Hamilton Anxiety Scale
HAM‐D: Hamilton Depression Rating Scale
MRI: magnetic resonance imaging
RCT: randomised controlled trial
SD: standard deviation
SSS: Scandinavian Stroke Scale
TICS: Telephone Interview of Cognitive Status
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| RCT, assessing exercise programme on levels of depression and anxiety among stroke survivors. Excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing exercise programme on levels of depression and anxiety among stroke survivors. Excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing rehabilitation programme for stroke survivors to include working memory training. Included secondary outcome assessment of anxiety but excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing rehabilitation programme for stroke survivors. Assessment of HADS, although did not report anxiety scores separately. Excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing yoga for stroke survivors. Includes assessment of anxiety and depression, but excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing self‐management intervention programme specifically designed to target anxiety and depression among stroke survivors. Excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing multi‐disciplinary interventions to target and reduce risks of further vascular incident among stroke survivors. Included secondary outcome assessment of HADS. Excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing yoga for stroke survivors. Included assessment of anxiety, but excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing massage therapy given to stroke survivors. Included assessment of anxiety, but excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing pharmacological agents administered to stroke survivors. Included assessment of anxiety, but excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| Assessing pharmacological agent for stroke survivors with clinical diagnosis of moderate to severe depression but excluded participants with GAD. Cohort study design; therefore excluded from review | |
| RCT, assessing creative therapy combined with conventional rehabilitation programmes for stroke survivors. Included assessment of anxiety, but excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| Assessing transcranial magnetic stimulation for stroke survivors. Information taken from English abstract only. Does not appear to be an RCT. Assessment of anxiety is a secondary outcome and we have assumed that participants were unlikely to be required to have a clinical diagnosis of anxiety; therefore we have excluded this study | |
| Assessing early functional training that included component of supportive treatment without antianxiety or antidepressant prescriptions. Not an RCT, and intervention not compared against placebo or standard care; therefore excluded from review | |
| RCT, assessing the use of pharmacological agents among stroke survivors with anxiety. However, agents were not compared against placebo or standard care; therefore excluded from review | |
| RCT, assessing effectiveness of an antidepressant on GAD, but not all participants were required to have GAD for study inclusion; therefore we excluded this study | |
| RCT, assessing slow stroke back massage for stroke survivors. Included assessment of anxiety using Chinese State Trait Anxiety Inventory, but participants were not required to meet a cut‐off criterion for anxiety; therefore we excluded this study | |
| Assessing use of a self‐help workbook aimed at enhancing non‐avoidant coping and increasing personal control over recovery. Participants were stroke survivors and anxiety was assessed, but participants were not required to have anxiety for eligibility. Study used a quasi‐experimental cohort design; therefore we excluded this study | |
| RCT, assessing a neuro‐linguistic programme (NLP) intervention for stroke survivors. Included assessment of anxiety and depression, but we excluded it from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing electroacupuncture and transcutaneous electrical nerve stimulation among stroke survivors. Included assessment of anxiety, but excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, comparing alprazolam with acupuncture for stroke survivors with neurosis. Does not include comparison against placebo or standard care; therefore excluded from this review | |
| RCT, assessing early psychological and physical rehabilitation programme. Included assessment of anxiety, but excluded from review as participants were not required to have a clinical diagnosis of anxiety to be eligible | |
| RCT, assessing use of mecobalamine among stroke survivors. Currently published only as an abstract. Included assessment of anxiety but not as a primary outcome. We have assumed therefore that participants were not required to have a clinical diagnosis of anxiety to be eligible and have excluded this study | |
| RCT, comparison of pharmacological agents and rehabilitative training for stroke survivors with anxiety and depression. Did not include comparison against placebo or standard care; therefore excluded from this review |
GAD: generalised anxiety disorder
HADS: Hospital Anxiety and Depression Scale
RCT: randomised controlled trial
Characteristics of studies awaiting assessment [ordered by study ID]
| Methods | Unclear if study is an RCT |
| Participants | Stroke survivors |
| Interventions | Inpatient rehabilitation programme to include psycho‐education and relaxation |
| Outcomes | Distress, before and after intervention |
| Notes | Study is currently published only as an abstract. Information in abstract is insufficient to establish review eligibility. No study author contact details in abstract. Attempted to source study author contact details through the university, but no response to email enquiries |
| Methods | RCT |
| Participants | Stroke survivors |
| Interventions | Enhanced rehabilitation programme |
| Outcomes | Self‐rating of anxiety and depression as primary outcomes |
| Notes | Study is currently published only as an abstract. No study author contact details in abstract and unable to source any possible contacts for this study author. Information in abstract is insufficient to establish whether participants were required to have a diagnosis of anxiety; therefore unable to assess if study meets review eligibility |
| Methods | RCT, pilot study |
| Participants | Stroke survivors |
| Interventions | In‐hospital intervention of early motivational interviewing |
| Outcomes | HADS, Quality of Life Index |
| Notes | Study is currently published only as an abstract. Information in abstract is insufficient to establish whether participants were required to have a diagnosis of anxiety; therefore unable to assess if study meets review eligibility. No study author contact details in abstract. Sourced possible email address through other publication, but no response to email enquiries |
| Methods | RCT |
| Participants | Stroke survivors |
| Interventions | Guided computerised cognitive‐behavioural therapy |
| Outcomes | Beck Anxiety and Depression Inventories |
| Notes | Study is currently published only as an abstract. Information in abstract is insufficient to establish whether participants were required to have a diagnosis of anxiety; therefore unable to assess if study meets review eligibility |
HADS: Hospital Anxiety and Depression Scale
RCT: randomised controlled trial
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Dizziness Show forest plot | 2 | 153 | Risk Ratio (M‐H, Random, 95% CI) | 7.32 [0.96, 55.95] |
| Analysis 1.1  Comparison 1 Pharmacological agents versus control, Outcome 1 Dizziness. | ||||
Search flow diagram (from searches conducted for the review update, October 2010 to January 2017).
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1 Pharmacological agents versus control, Outcome 1 Dizziness.
| Interventions for treating anxiety after stroke | ||||||
| Patient or population: stroke survivors with anxiety | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No. of Participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Interventions | |||||
| Proportion of stroke patients without clinical diagnosis of an anxiety disorder | See comment | See comment | Not estimable | 19 | ⊕⊝⊝⊝ | Clinical anxiety at 3 months: 4/9 in intervention group no longer had anxiety, 1/10 in control group no longer had anxiety |
| Proportion of stroke patients scoring outside anxiety range; or changes from baseline on an anxiety rating scale | See comment | See comment | Not estimable | 196 | ⊕⊝⊝⊝ | Statistically significant difference in anxiety scores on HADS‐A scale at 3 months, with reduction in anxiety for those using therapeutic CD (P value = 0.001); statistically significant differences in HAM‐A scores at 6 weeks and 4 weeks with reduced anxiety for those taking paroxetine and paroxetine with psychological therapy and those taking buspirone, respectively (P value < 0.01) |
| Co‐morbid depression | See comment | See comment | Not estimable | 175 | See comment | Reduction in depression symptoms according to HAM‐D at 6 weeks and at 4 weeks for those taking paroxetine and paroxetine with psychological therapy and those taking buspirone, respectively |
| Quality of life ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | Outcome not reported in any study |
| Social activities ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | Outcome not reported in any study |
| Activities of daily living | See comment | See comment | Not estimable | 81 | ⊕⊝⊝⊝ | Improvement in activities of daily living in all groups, but greatest improvement in those taking paroxetine with psychological therapy |
| Principal caregiver burden ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | Outcome not reported in any study |
| *The basis for the assumed risk (e.g. 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 | ||||||
| aStudy was unblinded, with further risks of recruitment bias and drop‐outs. Downgraded one level for risk of bias | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Dizziness Show forest plot | 2 | 153 | Risk Ratio (M‐H, Random, 95% CI) | 7.32 [0.96, 55.95] |
