Skip to main content
. 2020 May 11;2020(5):CD003689. doi: 10.1002/14651858.CD003689.pub4

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 For unpublished analysis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
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
Outcomes Primary outcomes
  • Depression measured using the MADRS and the HADS

  • Anxiety measured using the MADRS and the HADS


Secondary outcomes
  • Activities of daily living measured using the MBI

  • Stress coping measured using the Stress Appraisal Coping Measure

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