| Methods |
Design: three group parallel trial
Purpose: study the effect of cognitive behavioral psychotherapy for post‐stroke depression |
| Participants |
Patients: out‐patients with a recent stroke and depression
Baseline comparability: yes |
| Interventions |
Placebo: sessions with conversations focusing on daily events and physical effects of stroke and life changes
Untreated: no sessions
Experimental: sessions with cognitive behavioural psychotherapy
(Co‐intervention: NS) |
| Outcomes |
Beck depression inventory
Wakefield self‐assessment of depression inventory
Extended activities of daily living scale
London handicap scale
Satisfaction with care rating |
| Notes |
Standard deviation for the mean scores on the Beck depression inventory were not reported. We took the standard deviation from another trial (Verduyn C 2003). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
'computer generated' |
| Allocation concealment? |
Low risk |
'sealed in opaque, consecutively numbered envelopes' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/cognitive behavioral psychotherapy) |
| Blinding?
Outcome assessor |
Low risk |
'Outcome assessments were administered by an assistant psychologist, who was blind to the group allocation...' |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
High risk |
No protocol available. Standard deviation for the mean scores on the Beck depression inventory were not reported. We took the standard deviation from another trial (Verduyn C 2003). |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 80 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |
