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. 2018 Jul 5;2018(7):CD011849. doi: 10.1002/14651858.CD011849.pub2

Rahman 2016a.

Methods Single‐blind, individual RCT
Participants Adults from Peshawar (a conflict‐affected area of Pakistan) currently experiencing emotional distress. The study was conducted between November 2014 and Juanuary 2016
To be included, participants need to score both 3 or higher on a screening questionnaire for common mental disorders (12‐item General Health Questionnaire (GHQ‐12)) and 17 or higher on a questionnaire for functional impairments (WHO Disability Assessment Schedule 2.0 (WHODAS 2.0))
Age range: 18‐65 years
Interventions Problem management plus (based on problem‐solving and behavioural techniques): 172 participants
Enhanced usual care: 174 participants
Outcomes Primary outcomes: anxiety and depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS‐A; HADS‐D; HADS total score)
 Secondary outcomes: Post‐traumatic stress disorder symptoms were measured by the 20‐item Posttraumatic Stress Disorder Checklist for DSM‐5 (PCL‐5). Functional impairment was measured by the WHODAS 2.0. The Psychological Outcome Profiles (PSYCHLOPS) instrument was used to measure progress on problems for which the person sought help. Participants were also assessed for symptoms of depressive disorder with the 9‐item Patient Health Questionnaire (PHQ‐9)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed using computerized software on 1:1 basis"
Allocation concealment (selection bias) Low risk Quote: "Randomization was conducted after baseline assessment by an independent research assistant located off site and not involved in any other aspect of the study (...). Allocation concealment was ensured by keeping the random assignments in sequentially numbered, opaque, sealed envelopes at the off‐site center"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk The trial was single blind
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "All assessments were performed by trained research assistants blind to allocation status of participants who received 2‐day training covering administration"
Incomplete outcome data (attrition bias) 
 All outcomes High risk More than 20% of participants abandoned the study prematurely
Study endpoint: 112/172 missing from intervention group; 97/174 missing from enhanced usual care group
Selective reporting (reporting bias) Low risk All outcomes stated in the "Methods" section were correctly reported. The study protocol was publicly accessible
Therapist qualification Unclear risk Intervention was delivered by lay health workers
Treatment fidelity Low risk Quote: "One in‐country supervisor directly observed a randomly selected sample of 10% of health workers' sessions (...) and used a checklist to systematically assess fidelity to the intervention. The session‐wise checklist consisted of items capturing key intervention strategies for each session. The responses were recorded as yes or no for each given strategy for the particular session. Based on this evaluation, the supervisor rated each session overall as satisfactory or unsatisfactory in terms of fidelity achieved. Identified weak areas were reinforced during supervision"
Therapist/investigator allegiance High risk Study authors were involved in treatment development
Other bias Unclear risk The study appears to be free of other sources of bias