Bass 2016.
| Methods | RCT | |
| Participants | The study was undertaken in the Dohuk region, which was characterised by violence since 1980 (Saddam Hussein violent campaigns). Recently, the brutal advance of ISIS (the Islamic State of Iraq and Syria) exacerbated this situation and made Dohuk a major site for refuge for displaced Iraquis and refugees. Trial eligibility criteria comprised being age 18 or older; residing in the Dohuk governorate (Northern Iraq); reporting experiences of torture; presenting with significant depressive symptoms; not currently being psychotic or actively suicidal; and being mentally competent to give consent Trial recruitment ran from June 2009 through June 2010 |
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| Interventions | Counselling sessions (mean number of sessions attended was 11.29): 159 participants Wait list control: 50 participants |
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| Outcomes | Study aimed to assess the impact of the intervention on primary outcomes of depressive symptoms and dysfunction (using Hopkins Symptoms Checklist ‐ HSCL‐25) and on secondary outcomes of post‐traumatic stress (using Harvard Trauma Questionnaire ‐ HTQ), traumatic grief, and anxiety symptoms (using HSCL‐25) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Study CMHWs were provided with a set of pre‐numbered consent forms with the designation of intervention or wait list control status on a piece of paper that was folded and stapled to the back. ID numbers were randomly allocated to study condition by study author using Stata’s randomisation function" |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were aware of their treatment allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The majority (82%, n = 154) of the follow‐up interviews were implemented by CMHWs who were blinded to the participant’s treatment status, whereas 18% (n = 34) were implemented by CMHWs or study supervisors who were unblinded. [...] Analyses were done with and without the 34 participants who were assessed unblinded to evaluate the impact of the unblinded subjects" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rate below 20% |
| Selective reporting (reporting bias) | Low risk | All outcomes are reported |
| Therapist qualification | Unclear risk | The intervention was delivered by trained community mental health workers (CMHWs included pharmacists, nurses, and physician assistants) |
| Treatment fidelity | Low risk | Quote: "Fidelity to the treatment model was promoted by monthly on‐site group supervision by a psychiatrist as well as weekly check‐ins via mobile phone. (...) To monitor adherence to the counselling protocol during the on‐site meetings, the psychiatrist reviewed clinical notes, which included how CMHWs responded to the client's needs and checklists of the different activities the CMHW could have provided. The client monitoring form also included a brief checklist of common mental health symptoms that was used to review client progress and help CMHW and supervisor decide, together with the client, when treatment would be completed" |
| Therapist/investigator allegiance | High risk | A study coauthor was part of the NGO that developed the intervention programme |
| Other bias | Low risk | The study appears to be free of other sources of bias |