Bass 2013.

Study characteristics
Methods	Study design: cluster‐RCT (8 villages in control arm, 7 villages in therapy arm) Duration of study: intervention period lasted from April through July 2011. Follow‐up data were collected within 1 month after treatment ended and 6 months later
Participants	Country: Democratic Republic of Congo  Income classification: low income from 2011 to 2012  Geographical scope: 14 villages in South Kivu Province and 2 villages on the border in North Kivu Province  Healthcare setting: community groups (?NGO office) Mental health condition: PTSD  Population   1. Age: 18 to 90 years  2. Gender: female  3. Socioeconomic background: despite regional instability, 80% of women were living in their territory of origin. As compared with participants in the therapy group, those in the individual‐support group were younger and were less likely to be married, and they lived with fewer people. Marital status is noted with numbers  4. Inclusion criteria    a. Survivor of sexual violence mental health symptom severity cutoff  b. Functional impairment cutoff  5. Exclusion criteria   a. Active suicidality  b. Not living at study site  c. 1 village was excluded after training because of concerns regarding competency of interventionist
Interventions	Stated purpose: to evaluate an adaptation of group cognitive processing therapy provided by community‐based paraprofessionals (psychosocial assistants), supervised by psychosocial staff at a non‐governmental organisation (NGO) and by clinical experts based in the United States. To evaluate the benefits of adding this therapy to services offered by workers trained only in case management and individual supportive counselling INTERVENTION (n = 157) Name: Cognitive Processing Therapy  Delivered by: PHPs Title/name of PW and number: psychosocial assistants ‐ 15  1. Selection: not specified  2. Educational background: all psychosocial assistants had 1 to 9 years of experience providing case management and individual supportive counselling to survivors of sexual violence and at least 4 years of post–primary school education  3. Training: all underwent a 5‐ to 6‐day training session conducted in case management and specific topics, including counselling, family mediation, stress management, clinical care of survivors, and prevention of human immunodeficiency virus infection and other sexually transmitted diseases. Training provided by the International Rescue Committee (IRC)  4. Supervision: monitoring of services provided by means of monthly visits and reviews of interim monitoring forms. Congolese psychosocial supervisors who were employees of the IRC provided direct supervision to psychosocial assistants through weekly telephone or in‐person meetings; a bilingual clinical social worker trained in the United States provided in‐country supervision and communicated with US trainers through weekly calls for supervision and quality assurance  5. Incentives/remuneration: not specified  Intervention details  1. Duration/frequency: cognitive processing treatment included 1 individual session (1 hour) and 11 sessions with six to eight women per group (2 hours each). Each psychosocial assistant con‐\currently led three groups. Participants in the therapy group had access to the psychosocial assistants as desired outside the therapy.  2. Content of intervention: cognitive processing therapy is a protocol‐based therapy for treating depression, anxiety, and PTSD in sexual‐violence survivors. The group format was chosen to reach large numbers of women. We used the cognitive‐only model (i.e., without a trauma narrative) because its efficacy is similar to that of the full version of the therapy, providing greater ease of administration in groups and greater retention by participants  CONTROL: treatment as usual (n = 248) Support provided by Psychosocial Assistants without training in CPT. When women were informed of their eligibility, psychosocial assistants invited them to receive individual support services as desired, including psychosocial support and economic, medical, and legal referrals  CO‐INTERVENTIONS: nil
Outcomes	Patients   1. Assessments of combined depression and anxiety symptoms (average score on Hopkins Symptom Checklist (range, 0 to 3, with higher scores indicating worse symptoms)) 2. PTSD symptoms (average score on Harvard Trauma Questionnaire (range, 0 to 3, with higher scores indicating worse symptoms)) 3. Functional impairment (average score across 20 tasks (range, 0 to 4, with higher scores indicating greater impairment))    Carers  Nil  Process/health workers Nil  Economic outcomes Nil  Time points: baseline, end of treatment, 6 months after treatment ended
Notes	Source of funding: US Agency for International Development Victims of Torture Fund and the World Bank  Additional information: declarations of interest ‐ Bass J has received travel expenses from the American Red Cross for attending a meeting with the scientific advisory board,  Cetinoglu T received travel expenses for a meeting as advisor to the WHO, was employed by the International Rescue Committee from Feb 2010 to Sept 2012, and was a board member of the Medecins Sans Frontieres (MSF) Greek Section between 2008 (May‐June) and 2011 (June‐July). No other authors reported any potential conflicts of interest Handling the data: as per footnotes in data and analysis  Prospective trial registration number: NCT01385163
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Judgement comment: allocation described as "randomized", but not specified how in protocol or paper
Allocation concealment (selection bias)	Low risk	Judgement comment: randomisation done at interventionist level. From protocol: "randomization will be done at the level of Psychosocial Assistant (PSA). The 19 PSA will be randomly assigned to either receive training in CPT at the beginning of the study, and subsequently provide CPT to their study participants, or to wait until year 2 to receive the CPT training, and therefore continue to provide the treatment as usual"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "there will be no blinding in this study"  Judgement: participants and personnel were not blinded; however, cluster‐randomisation would ensure minimal risk of performance bias because villages where intervention was given were separate from villages randomised to usual care
Blinding of outcome assessment (detection bias) all outcomes	High risk	Interviewers were not blinded. They were included as part of the screening interviews and helped with selection; the same interviewers then collected data in villages
Baseline outcome measurements similar	Low risk	Baseline outcomes differed, but effects were adjusted "To assess whether higher baseline scores in the individual‐support group biased the results, we performed sensitivity analyses restrict‐ ed to women with baseline HSCL‐25 scores higher than 2.0 (84 women in the therapy group and 171 in the individual‐support group) and found that effect sizes remained greater than 1.0"
Baseline characteristics similar?	Low risk	Small differences in baseline characteristics
Incomplete outcome data (attrition bias) Efficacy data	Low risk	Around 30% completed baseline assessment and 1 follow‐up assessment in both groups, but only 52% completed baseline and both follow‐up assessments in the individual support group compared to 65% in the therapy group. Difference is unlikely to have changed the outcome significantly
Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)	Unclear risk	Safety data not mentioned in the paper. However, it is mentioned in the protocol that "any significant worsening of symptoms among any of the participants will be reported to the IRB [institutional review board], along with the measures taken and the results". This features as incomplete reporting, and for the purpose of this heading, it is unclear, as they may have been measured or not in the actual study
Protection against contamination	Unclear risk	Judgement comment: professionals were allocated within a clinic or practice, and it is possible that communication between intervention and control professionals could have occurred
Selective reporting (reporting bias)	Unclear risk	All relevant outcomes in the methods section are reported in the results section. Published trial protocol planned for severity of mental health symptoms as primary outcomes, which were reported, and economic indicators (non‐clinical outcome) as secondary outcomes, which were not reported. Instead, functional impairment was reported. Also safety data are not mentioned in the paper. However, it is mentioned in the protocol that "any significant worsening of symptoms among any of the participants will be reported to the IRB [institutional review board], along with the measures taken and the results". We are unsure how much these unreported data would affect the results
Other bias	Low risk	No other sources of bias were found