| Methods |
Randomised controlled trial |
| Participants |
108 DSM‐IV PTSD individuals with severe mental illness receiving treatment at community health centres (46 men, 62 women) in the USA |
| Interventions |
12 ‐ 16 sessions of TFCBT (n = 54) or TAU (n = 54) |
| Outcomes |
CAPS, PTSD knowledge test, BAI, BDI, BPRS, WAI, SF‐12 |
| Notes |
Experienced therapists delivered therapy and treatment adherence was assessed. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Comment: The method of random sequence generation was not reported. |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Randomization was conducted at a central location in the research centre by a computer‐based randomizations program, with assignments not known in advance by either clinical or research staff." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: ITT analyses were performed. 11 participants dropped out of the treatment group and 11 from TAU. |
| Selective reporting (reporting bias) |
Low risk |
Comment: All specified outcomes were reported. |
| Other bias |
High risk |
Comment: There were no other obvious sources of bias. |
| 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 |
Low risk |
Quote: “All assessments were conducted by master’s or Ph.D. level trained clinical interviewers who were blind to treatment assignment. Clients were instructed at the beginning of interviews to not talk about any treatments for trauma‐related problems they may have received. Interviewers were requested to inform the project coordinator if the client broke the blind during an interview. Interviewers were not asked to guess clients’ treatment assignments, to avoid directly encouraging them to formulate hypotheses about how treatment may have affected clients’ symptoms, which could have influenced subsequent ratings. No specific instances of blind breaking were noted in the study.” |
