Methods |
Randomised controlled trial |
Participants |
58 participants mostly resulting from the troubles in Northern Ireland (23 women, 35 men) |
Interventions |
12 weekly sessions of cognitive therapy (n = 29) vs waiting list (n = 29). Cross‐over trial. |
Outcomes |
PDS, BDI, SDS |
Notes |
Experienced therapists (1 social worker, 1 psychiatrist, and 3 nurse therapists). Treatment adherence does not seem to have been assessed. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Comment: The method of sequence generation was not reported. Participants were randomised remotely. |
Allocation concealment (selection bias) |
Low risk |
Quote: "An independent office allocated patients to immediate therapy or to wait followed by therapy on a stratified random basis using the minimisation method of Pocock. Assessors were not aware of the allocation algorithm". |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "We carried out analyses on an intention to treat basis". Reasons for drop‐out were reported (9 from cognitive therapy and 3 from waiting list). |
Selective reporting (reporting bias) |
Low risk |
Comment: All specified outcomes were reported, |
Other bias |
High risk |
Treatment adherence was not measured. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Comment: Participants were aware of their allocation. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: Measures were self‐reported, but it is unclear how these were administered. |