Weiss 2015.

Study characteristics
Methods	Study design: RCT (parallel 2‐site 2‐arm (1:1 allocation) single‐blinded wait‐list randomised controlled trial)  Duration of study: March 2011 to July 2012
Participants	Country: Iraq  Income classification: lower‐middle income in 2011; upper‐middle income in 2012  Geographical scope: areas surrounding the cities of Karbala, Najaf, and Hilla (CETA), and around Basra/Nassariyah (CPT), in Southern Iraq  Healthcare setting: treatment was provided at Ministry of Health primary health care centres unless there was insufficient privacy; if the client found it difficult to travel. In these situations, another mutually convenient and private place was chosen (e.g. client’s home)  Mental health condition: PTSD, depression, anxiety  Population   1. Age: ≥ 18 years  2. Gender: both  3. Socioeconomic background: 30% to 40% not working; 15% to 25% irregular or daily working; 30% to 40% regular stable employment  4. Inclusion criteria    a. Exposure to torture (1) Referred to CMHWs by physicians at the health centre 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 who had experienced or witnessed physical torture or militant attacks b. PTSD   (1) Based on item analysis, trauma symptoms on the locally validated HTQ, along with several additional local trauma symptoms, were used to create a trauma scale. This screening instrument was used by the CMHW both to determine a client’s eligibility for the trial and, if recruited, as their baseline assessment. The instrument had a section on dysfunction, a section on depression and anxiety symptoms, a section on trauma symptoms, a section on problems of torture survivors, and a section with demographic questions. A score of 36 or higher on the 29‐question trauma section was the cutoff used for study eligibility. An earlier validity study found that this cutoff was optimal for discriminating those individuals diagnosed with PTSD from those without PTSD  c. ≥ 18 years old 5. Exclusion criteria   a. Children  b. Mentally incompetent to understand therapy  c. Currently psychotic d. Those who were a danger to themselves or to others
Interventions	Stated purpose: to test the effectiveness of 1 counselling therapies in Southern Iraq in addressing multiple mental health problems among survivors of systematic violence: (1) a transdiagnostic intervention (Common Elements Treatment Approach, or CETA); and (2) cognitive processing therapy (CPT)  INTERVENTION 1 (n = 99) Name: Common Elements Treatment Approach (CETA)  Delivered by: PHP Title/name of PW and number: CMHWs ‐ community mental health workers ‐ 12 (8 males, 4 females) 1. Selection: CMHW working in and around the cities of Karbala, Najaf, and Hilla, south of Baghdad. CMHWs are non‐mental health professionals (medics or nurses who worked in rural Ministry of Health) who are trained to provide mental health services locally (i.e. the mental health equivalent of community health workers, or CHWs); must have some background/experience in counselling or mental health  2. Educational background: from Protocol: CMHWs had received training in non‐specific counselling methods some years before from our partner international non‐governmental organisation (Heartland Alliance International) and continued to provide these services part‐time  3. Training: Heartland Alliance (HA) has trained these CHMWs in non‐specific counselling interventions and currently provides ongoing supervision. Training provided by US‐based clinical psychologists  4. Supervision: weekly 1‐hour group supervision meetings  5. Incentives/remuneration: not mentioned  Intervention details  1. Duration/frequency: CETA was designed to include approximately 8 to 12 weekly individual sessions 50 to 60 minutes in length. Expected time between sessions is 1 week. Total time per client is expected to last about 4 to 5 months to complete the 12 therapy sessions  2. Content of intervention: transdiagnostic treatment approach for delivery by lay counsellors in low‐resource settings with few mental health professionals; designed to treat symptoms of common mental health disorders   INTERVENTION 2 (n = 129) Name: Cognitive Processing Therapy (CPT)  Delivered by: PHW Title/name of PW and number: community mental health workers (CMHWs) ‐ 17  1. Selection: community mental health workers (medics or nurses who worked in rural Ministry of Health) working in and around the cities of Basra and Nassariyah in the far south of Iraq, trained to provide mental health services locally, with some background/experience in counselling or mental health  2. Educational background: non‐mental health professionals, trained to provide mental health services locally; some background/experience in counselling or mental health    3. Training: trained by  US‐based clinical psychologists in Heartland Alliance (HA) in non‐specific counselling interventions 4. Supervision: weekly 1‐hour group supervision meetings by Heartland Alliance (HA) supervisors 5. Incentives/remuneration: not mentioned  Intervention details  1. Duration/frequency: therapy was 12 sessions, usually 1 week apart  2. Content of intervention: cognitive‐behavioural psychotherapy originally developed for treatment of PTS or PTS with comorbid depression  CONTROL: wait‐list enhanced care (CETA trial control, n = 50) (CPT trial control, n = 64) Participants received monthly telephone calls from the CMHWs who enrolled them into the study to assess their safety and to find out whether they needed referral to psychiatric care (i.e. were a danger to self or others or presented with psychosis)  CO‐INTERVENTIONS: nil
Outcomes	Patients    Primary outcome 1. Trauma symptoms, assessed by a trauma scale score representing the mean of scores given to responses on the locally validated HTQ (Harvard Trauma Score) Secondary outcomes 1. Dysfunction, assessed by mean item scores for gender‐specific items on the locally developed dysfunction scale (function scale) 2. Anxiety and depression, assessed using mean item score on the locally validated HSCL‐25 (HSCL anxiety score HSCL depression score)   Carers  Nil Process/health workers Nil Economic outcomes  Nil Time points: baseline, 3.5 to 4 months post interventions
Notes	Source of funding: USAID Victims of Torture fund (VOT)  Notes on validation of instruments (screening and outcomes): validated  Additional information: declarations of interest ‐ study authors declare no conflicts of interest Handling the data: as per footnotes in data and analysis  Prospective trial registration number: NCT01177072
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Judgement comment: "the assignment was generated using a random number generator in Excel, with a 2 to 1 probability of assignment to the intervention vs. the waitlist"
Allocation concealment (selection bias)	Low risk	"A piece of paper indicating the treatment assignment (intervention or waitlist) 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	Low risk	No blinding of participants or personnel, but unlikely to affect outcomes
Blinding of outcome assessment (detection bias) all outcomes	Low risk	Quote: "interviewers at baseline and follow‐up did not know to which study arm the interviewees belonged Quote: "baseline assessments were conducted by CMHWs as part of the recruitment process prior to randomization and who were therefore blind to the assignment of study participants to intervention or WLC. These CMHWs treated those persons they had recruited who were randomly assigned to treatment. Therefore, to maintain blinding, follow‐up interviews were done by a different CMHW than the one who recruited the participant so they were unaware of the participant’s assignment. The supervisors and the study participants were not blind to the treatment condition"
Baseline outcome measurements similar	Low risk	No important differences were present across study groups
Baseline characteristics similar?	Low risk	"There were no apparent differences between intervention and control clients in demographic characteristics (Table 2)"
Incomplete outcome data (attrition bias) Efficacy data	Low risk	107/129 completed intervention in CPT arm vs 97/99 in CETA arm, but unlikely to affect results
Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)	Unclear risk	Adverse events reported, but not as outcomes; not reported per intervention
Protection against contamination	High risk	Judgement comment: allocated by patients
Selective reporting (reporting bias)	Low risk	All outcomes planned in clinical trial registry record were reported
Other bias	Low risk	No other risk of bias found. Adverse events were reported but not as outcomes "The research, and the services program provided by Heartland Alliance, was solely funded by the USAID Victims of Torture fund (VOT) Award DFD‐A‐00‐08‐00308‐00. This was the sole source of funding for each author and for manuscript preparation. USAID/VOT was not involved in the research or program design or implementation, or in the management or analysis of the data"