Bolton 2014a.
| Methods | RCT | |
| Participants | Kurdistan, Iraq. The region was exposed to conflict and violence. At the time of the study, Kurdistan was experiencing relatively little violence, and this period was alternated with substantial conflict in nearby areas under control of the ISIL (Islamic State of Iraq and the Levant) Inclusion criteria: survivors of systematic violence living in the governor rates of Erbil or Sulaimaniyah, 18 years of age or over, fluent in Sorani Kurdish, reported significant depression symptoms on the adapted HSCL‐25, had no current psychotic symptoms or active suicidality, and appeared mentally competent to consent. Recruitment occurred between May 2009 and June 2010 Exclusion criteria: inability to be interviewed due to a cognitive or physical disability, severe suicidal ideation or behaviour |
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| Interventions | Intervention status: behavioural activation (BA) treatment for depression: 114 participants; cognitive processing therapy: (CPT) 101 participants Wait list control status: 66 participants |
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| Outcomes | Primary outcomes: depression and dysfunction severity scores on scales adapted and validated for local use Secondary outcomes: post‐traumatic stress; anxiety; traumatic grief |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "We used a two‐tier randomisation process. First, 20 CMHWs who worked at primary clinics throughout rural Erbil and Sulaimaniyag governorates were randomised to receive training either BA (N=11) or CPT (N=9) (...). The second‐tier randomisation happened at the level of the study participant. Study participants were randomised to study condition (treatment or wait list control) by the CMHW they saw at their local primary care center where they went for treatment. The CMHWs received 20 participant IDs randomly assigned to intervention or control in the ratio of 3:1 of treatment to wait controls. Randomisation of CMHWs and participant IDs was done by JB using Stata's randomisation function" |
| Allocation concealment (selection bias) | Low risk | Quote: "if a person consented, the CMHW opened a sealed envelope attached to the consent form containing the participant's assignment" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided on blinding of participants |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "CMHWs or supervisors blind to participants' treatment status did 197 (85%) of the interviews; 35 (15%) were implemented by unblinded CMHWs. The latter group included participants who terminated treatment and refused further contact. Rather than forgo assessment, the treating CMHW did the interview" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts were reported: 32/114 BA group; 34/101 CPT group; 13/66 wait list group |
| Selective reporting (reporting bias) | Low risk | Outcomes listed in the "Methods" were also reported in the "Results" |
| Therapist qualification | Unclear risk | Interventions were delivered by community mental health workers (CMHWs) |
| Treatment fidelity | Unclear risk | No information provided |
| Therapist/investigator allegiance | Unclear risk | No information provided |
| Other bias | Low risk | The study seems to be free of other bias |