Bryant 2017.

Study characteristics
Methods	Study design: single‐blind parallel randomised controlled trial  Duration of study: between 15 April 2015 and 20 August 2015 (with final follow‐up assessments completed on 16 January 2016)
Participants	Country: Kenya  Income classification: lower‐middle income from 2015 to 2016  Geographical scope: peri‐urban; Nairobi, Kenya  Healthcare setting: home  Mental health condition: common mental disorders  Population: women exposed to gender‐based violence and indicating significant distress as reflected in scores on GHQ > 2 and impaired functioning reflected in scores on WHODAS > 16  1. Age ≥ 18 years  2. Gender: female  3. Socioeconomic background: intervention 49.8% working; control 50.9% working  4. Inclusion criteria  a. History of GBV ‐ any (prior or current) experience of interpersonal violence on the Life Events Checklist (LEC) or the WHO Violence Against Women Instrument (WHO‐VAW)  b. Distress as reflected in scores on GHQ > 2  c. Impaired functioning as reflected in scores on WHODAS > 16  5. Exclusion criteria    a. Imminent suicidal intent  b. Severe mental disorder  c. Severe cognitive impairment  d. Acute protection risks  e. Exposure to trauma in last month  f. Male gender
Interventions	Stated purpose: to assess the effectiveness of Problem Management Plus (PM+) for alleviating distress in women who had experienced gender‐based violence (GBV) in peri‐urban slums in Nairobi, Kenya, compared to enhanced usual care (EUC) delivered by qualified community nurses INTERVENTION (n = 209) Name: Problem Management Plus (PM+)  Delivered by: LHWs Title/name of PW and number: community health workers ‐ 23  1. Selection: no prior training or experience in mental health care. Social collaborators may be recruited to their role due to existing community involvement and leadership (e.g. as village care workers, Red Cross volunteers, Women’s Union staff). Passed competency assessments conducted in the form of mock interviews after training  2. Educational background: 10 years' school education  3. Training: 64‐hour training programme over 8 days.  covered knowledge of common mental health conditions, basic counselling delivery, PM+, and self‐care strategies. CHWs also received a 1‐day training in psychological first aid (PFA) to prepare them for managing people in crisis (e.g. ongoing violence) who required immediate attention and possible referral. Training also addressed issues related to GBV, as well as ethical and confidentiality matters. Provided by the Research Team  4. Supervision: 2 hours of weekly supervision by the local supervisor, who provided supervision in 4 separate groups to CHWs (5 CHWs per group). Local supervisors received 1.5 hours of weekly training and mentoring in supervision by the research team via Skype  5. Incentives/remuneration: not mentioned  Intervention details  1. Duration/frequency: 5 weekly 90‐minute individual sessions  2. Content of intervention: PM+ commenced with an introduction to the programme, motivational interviewing, psychoeducation, and stress management (Session 1); problem‐solving strategies focused on specific problems nominated by the participant and review of stress management strategies (Session 2); behavioural activation and review of problem‐solving and stress management (Session 3); strengthening of social supports and review of stress management, problem‐solving, behavioural activation, and social supports (Session 4); and reinforcement of all strategies and relapse prevention education (Session 5)  CONTROL: enhanced usual care (n = 212) EUC was provided by 6 community nurses at primary healthcare centres in the area, where nurses provided non‐specific counselling, using strategies and numbers of sessions they deemed appropriate
Outcomes	Patients    1. GHQ‐12  2. WHO‐DAS 2.0  3. PCL‐5  4. Psychological outcomes profile (PSYCHLOPS)  Carers  None  Process/health workers None  Economic outcomes  None  Time points: baseline, post‐treatment, 3 months post‐intervention
Notes	Source of funding: Grand Challenges Canada #0368‐04 (www. grandchallenges.ca/), World Vision Canada (http://www.worldvision.ca/), and World Vision Australia (www.worldvision.com.au/ home‐east‐africa)   Notes on validation of instruments (screening and outcomes): all validated  Additional information: trial protocol; declaration of interests ‐ study authors declared no competing interests Handling the data: as per footnotes in data and analysis  Prospective trial registration number: Australian New Zealand Clinical Trials Registry ACTRN12614001291673
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomization was performed using computerized software by an independent colleague (i.e. off‐site in Sydney and not involved in the trial)"
Allocation concealment (selection bias)	Low risk	Judgement comment: participants randomly allocated to intervention or control group using computer programme conducted by an independent researcher; therefore allocation concealment could be ensured
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and interventionists were not blinded, but this is unlikely to have affected outcomes
Blinding of outcome assessment (detection bias) all outcomes	Low risk	Post‐treatment assessments were completed by independent assessors who were unaware of the treatment condition of participants. Blindness was maintained; therefore considered low risk
Baseline outcome measurements similar	Low risk	"There were no differences detected between participants in the PM+ and ETAU conditions on any of the pre‐treatment outcome measures, demographics, or trauma exposure"; therefore, considered low risk
Baseline characteristics similar?	Low risk	Table 1: baseline characteristics are reported and are similar
Incomplete outcome data (attrition bias) Efficacy data	High risk	Higher level of dropout in control group (10 vs 5); likely to impact results as the groups are small
Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)	Low risk	No adverse or serious adverse events were reported by women receiving the intervention, suggesting that PM+ did not cause harm nor exacerbate distress beyond one's capacity to cope with it. PM+ did not appear to result in increased risk to safety, and no instances of stigma associated with receiving the intervention were reported
Protection against contamination	Unclear risk	Quote: "careful attention was paid to ensure assessors had no contact with CHWs or ETAU nurses by having them work in different locations. Any adverse reactions reported spontaneously" Judgement comment: allocated by patient; unclear risk of contamination
Selective reporting (reporting bias)	High risk	Three outcomes from trial registry not reported. Personalised outcomes as measured by the Psychological Outcomes Profile (PSYCHLOPS) scale; health service use as measured by reported access of Nairobi Health Services; stressful life events as measured by the Life Events Checklist. Also, follow‐up after post‐treatment assessment is not included in this feasibility trial, but all this is included in the full trial
Other bias	Low risk	No other sources of bias were found