Weiss 2015a.
| Methods | RCT | |
| Participants | The study was conducted in Southern Iraq (recruitment was active between April 2011 and January 2012). Participants were survivors of systematic violence referred to the CMHWs by physicians in the health center where they worked, from local prisoners’ associations, and through self‐referral after learning of services through public service announcements or by word of mouth. Survivors were defined as persons having experienced or witnessed physical torture or militant attacks. A survivor who was 18 years of age or older and who met the symptom criterion was eligible for the trial | |
| Interventions | Common Elements Treatment Approach (CETA): 99 participants Wait list: 50 participants |
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| Outcomes | Primary outcome was trauma symptoms (locally validated Harvard Trauma Questionnaire ‐ HTQ) Secondary outcomes were dysfunction (assessed by mean item scores for gender‐specific items on the locally developed dysfunction scale), anxiety, and depression (assessed by the mean item score on the locally validated HSCL‐25) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The assignment was generated using a random number generator" |
| Allocation concealment (selection bias) | Low risk | Quote: "A piece of paper indicating the treatment assignment (intervention or wait list) was stapled directly to the back of the study consent forms that were pre‐numbered with the participant identification number. This paper could only be read if removed from the consent form" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were aware of their allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote. "To maintain blinding, follow‐up interviews were done by a different community mental health worker than the one who recruited the participant so they were unaware of the participant’s assignment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Study endpoint: 2/99 missing from CETA group; 2/50 missing from WL group |
| Selective reporting (reporting bias) | Low risk | The study protocol is not available, but it is clear that published reports include all expected outcomes |
| Therapist qualification | Unclear risk | Intervention was delivered by trained community mental health workers (CMHWs) |
| Treatment fidelity | Low risk | Quote: "Fidelity was tracked by CMHW self report of elements delivered, supervisor review of notes and CMHW reports, and finally by trainer review" |
| Therapist/investigator allegiance | High risk | Study authors developed the intervention |
| Other bias | Low risk | The research and the services programme provided by Heartland Alliance were solely funded by the USAID Victims of Torture fund (VOT) Award DFD‐A‐00‐08‐00308‐00. USAID/VOT was not involved in the research or programme design or implementation, nor in the management or analysis of data. The study appears to be free of other sources of bias |