Hoffman 2015.
Study characteristics | ||
Methods | Study design: parallel design Number of arms: 2 Experimental arm: cognitive behavioural coping skills therapy Control arm: usual care | |
Participants | Geographical location: Australia
Setting: inpatient
Stroke criteria: unclear. Method of stroke diagnosis: confirmed by chart review Time since stroke: not reported Inclusion criteria: 1) > 18 years old; 2) adequate cognitive capacity to provide informed consent; 3) adequate English and expressive and receptive communication skills Exclusion criteria: 1) neurodegenerative disorder e.g. dementia; 2) living > 50 km away from hospital Depression criteria: depression score not an entry criteria. For unpublished analysis HADS ≥ 8 used for depression criteria Total number randomised in this trial: 16 Number randomised to treatment group: 11 (63.6% men, mean age 63.6, SD 13.0) Number randomised to control group: 5 (60% men, mean age 57.0, SD 14.2) Total number included in final analysis: 14 Number included in treatment group for final analysis: 9 Number included in control group for final analysis: 5 |
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Interventions | Treatment: 8 x 1‐hour cognitive‐behavioural coping skills sessions delivered by a clinical psychologist with the first 2 in hospital and 6 delivered at home. The sessions included cognitive and behavioural exercises to prepare individuals for discharge and to adjust post‐discharge (e.g. psychoeducation, self‐monitoring, graduated activity participation, and cognitive restructuring)
Treatment duration: 8 weeks Administered by: clinical psychologist Supervision: clinical psychologist Intervention fidelity: 10/11 (90%) in the treatment group (1 discontinued after 1 session) completed the sessions and 5/5 (100%) in the control group Control: usual care Follow‐up: 3 months |
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Outcomes | Primary outcomes
Secondary outcomes
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Notes | This trial had 3 arms (self‐management therapy, cognitive behavioural therapy and usual care) but only the data from the cognitive behavioural therapy compared with usual care (n = 14 participants) are presented here | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "... randomly allocated using a predetermined computer generated randomization sequence ..." pp. 118 |
Allocation concealment (selection bias) | Unclear risk | Comments: method of allocation concealment was not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comments: due to the nature of the intervention blinding will not be achievable for participants or staff delivering care |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Outcomes were assessed in a face‐to‐face interview conducted by a research assistant (a registered psychologist) who was blind to group allocation." pp. 118 |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Analysis was completed using ... and on an intention to treat basis and missing data were addressed using the last observation carried forward procedure." pp. 120 |
Selective reporting (reporting bias) | Unclear risk | Comments: no trial protocol available to compare with the publication |
Other bias | Low risk | Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics |