Bass 2016.

Study characteristics
Methods	Study design: RCT  Duration of study: recruitment June 2009 to June 2010. Intervention 3 to 5 months. Follow‐up was performed between 5 and 7 months post baseline
Participants	Country: Iraq  Income classification: lower‐middle income from 2009 to 2011  Geographical scope: Northern Iraq, Dohuk region  Healthcare setting: this randomised controlled trial was conducted through primary health clinics staffed by study CMHWs  Mental health condition: CMDs with post‐traumatic stress Population: Survivors of Torture and Related Trauma, in Kurdistan, Northern Iraq  1. Age: ≥ 18 years  2. Gender: both  3. Socioeconomic background: most of the sample was married; approximately half reported they were unemployed  4. Inclusion criteria    a. ≥ 18 years of age   b. Residing in the Dohuk governorate  c. Reporting experiences of torture (defined as personally experiencing or witnessing physical torture, imprisonment, and/or military attacks)  d. *Presenting with significant depressive symptoms  e. Not currently psychotic or actively suicidal  f. Mentally competent to give consent  g. Significant depression was defined as reporting a total score ≥ 20 on the 20‐symptom, adapted Hopkins Symptom Checklist (HSCL) depression scale and meeting both of the following specific criteria necessary for a DSM‐IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of a major depressive episode: crying or feeling depressed most or all of the time in the last 2 weeks, and loss of interest in sex or loss of interest in things generally (as evidenced by being unable to enjoy festivals and celebrations most or all of the time) in the last 2 weeks  5. Exclusion criteria a. Nil mentioned
Interventions	Stated purpose: to evaluate the impact of a trauma‐informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes), as well as on post‐traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes)  INTERVENTION (n = 159) Name: counselling intervention  Delivered by: PHPs Title/name of PW and number: community mental health worker (CMHWs) ‐ 11  1. Selection: CMHWs were recruited through a joint selection process by the Department of Health in the Dohuk governorate, the Health Staff Association of Kurdistan, and staff of Heartland Alliance International (US based NGO). The main selection criteria were clinical staff from local primary clinics who had time and expressed an interest in gaining skills in mental health and psychosocial support and had experience working in rural areas with people who had experienced torture and trauma. 11 CMHWs were given refresher training on a much‐shortened version of the original HAI program that was specific for survivors of torture and imprisonment. They were presented with 9 counselling techniques and 4 to 6 activities per technique. Training emphasised core clinical skills of empathic reflection, trust building, emotional expression and regulation, and message of hope and meaning  2. Educational background: These staff, who would become CMHWs, included pharmacists, nurses, and physician assistants, and were permanent employees of the Ministry of Health. None of the CMHWs had any formal mental health training prior to the HAI project  3. Training: the project used an iterative, participatory action model for curriculum development, which took several months to complete and included (1) identifying learning needs in collaboration with Iraqi staff and CMHWs; (2) gathering information via interviews with Iraqi staff and CMHWs to map curriculum content; (3) drafting the curriculum; (4) testing the curriculum during pilot train‐the‐trainer sessions; (5) gathering post‐pilot evaluative information to revise training materials; (6) implementing revised training with CMHWs; and (7) providing ongoing evaluation and further refinement. The curriculum development team consisted of US‐based adult learning experts and mental health technical staff, as well as Iraqi programme staff with diverse expertise in curriculum development, trauma‐focused mental health practice, and Iraqi culture and society. US‐educated, licensed clinical social workers facilitated the train‐the‐trainer programme, and HAI programme staff in Iraq, mainly physicians, facilitated CMHW training  4. Supervision: monthly on‐site group supervision by a psychiatrist (TM) and weekly check‐in via mobile phone. TM available on phone anytime for questions. TM also reviewed clinical notes  5. Incentives/remuneration: not mentioned  Intervention details  1. Duration/frequency: 6 to 12 sessions depending on presenting problems and client progress    2. Content of intervention: time‐limited trauma‐informed support, skills, and psychoeducation intervention. CMHWs were trained to organise interactions with clients into (1) a preparatory first session that set the stage for the development of a trusting relationship and engaged the client in the work; (2) a series of 4 to 10 ‘‘response’’ sessions in which difficulties related to the principal concerns of PTSD, depression, anxiety, traumatic grief, and impaired functioning were assessed and strategies were taught to address them; and (3) a concluding session that focused on exploring progress made in treatment, consolidation of work and skills learned, and planning for the future. The counselling process was expected to require 6 to 12 sessions depending on presenting problems and client progress   CONTROL: wait‐list control (n = 50) Brief monthly check by telephone with instructions to contact CMHWs if symptoms worsened, with referral if necessary (including transport to psychiatrist or rehabilitation and training centre)  CO‐INTERVENTIONS: nil
Outcomes	Patients   Adapted and translated versions of  1. Hopkins Symptom Checklist‐25 (HSCL‐25) (a 25‐item version of the HSCL) for symptoms of depression and anxiety  2. Harvard Trauma Questionnaire (HTQ) for symptoms of post‐traumatic stress  3. Inventory of Traumatic Grief for symptoms of traumatic grief  4. Functional impairment questionnaire (self‐developed)  Carers  Nil  Process/health workers Nil Economic outcomes Nil Time points: baseline, 0 to 1 month post intervention, 3 to 5 months after baseline (control group)
Notes	Source of funding: USAID Victims of Torture Fund (VOT)  Notes on validation of instruments (screening and outcomes): instruments adapted, translated, and validated for local use. Functionality was defined based on a series of tasks and activities, identified during a prior qualitative study, regularly done by adults in Dohuk to take care of themselves and their families, and to participate in the community. Separate measures were developed for men and women  Additional information: declarations of interest ‐ none Handling the data: as per footnotes in data and analysis  Prospective trial registration number: not available
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Judgement comment: ID numbers were randomly allocated to study condition by study author using Stata's randomisation function
Allocation concealment (selection bias)	Low risk	Judgement comment: study CMHWs were given a set of pre‐numbered consent forms with the designation of intervention or wait‐list on a piece of paper that was folded and stapled to the back
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No blinding of participants or personnel, but this does not affect measurement and blinding was not possible in this trial
Blinding of outcome assessment (detection bias) all outcomes	High 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" Judgement: analysis conducted by removing the 34 participants who were assessed unblinded to their treatment resulted in smaller effect sizes for depression, dysfunction, and anxiety, and larger effect sizes for trauma and traumatic grief
Baseline outcome measurements similar	Low risk	No important differences in baseline outcomes were noted across study groups
Baseline characteristics similar?	Low risk	"Demographic characteristics of the participants across the 2 arms were comparable, with no differences reaching statistical significance"
Incomplete outcome data (attrition bias) Efficacy data	Unclear risk	Hakan ‐ LOW: proportion of missing data was similar in intervention and control groups Yen ‐ UNCLEAR: 10% attrition rate in total. Individuals lost to follow‐up were significantly more likely to be female, self‐employed, and unmarried. If they had not dropped out of the study, they might have made a difference in the results
Protection against contamination	Unclear risk	Judgement comment Hakan ‐ HIGH: randomisation at participant level Yen ‐ LOW: although wait‐list participants lived in the same community, the intervention was a one‐to‐one intervention provided by CMHWs designated to each intervention participant following a set plan; therefore contamination between groups is unlikely
Selective reporting (reporting bias)	Unclear risk	No published clinical trial is available. All outcomes from methods section were reported on
Other bias	Low risk	No other risk of biases found. "This study was solely funded by the USAID Victims of Torture Fund (VOT) under grant #101978. USAID/VOT was not involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript"