Neuner 2008.

Study characteristics
Methods	Study design: randomised (although partly random and partly alternate sequence), parallel‐group assessor‐blinded 3‐armed controlled clinical trial Duration of study: 2003 to 2004
Participants	Country: Uganda Income classification: low Geographical scope: Nakivale refugee settlements in Uganda for Somali and Rwandan refugees; semi‐rural (2 refugee camps close to base hospital) Healthcare setting: home‐based care Mental health condition: PTSD Population: patients 1. Age: > 18 years; mean age 34 to 36 years (SD 12 to 14 years) in the 3 groups 2. Gender: both 3. Socioeconomic background: refugees from Somalia and Rwanda 4. Inclusion criteria a. Fulfilling DSM‐IV criteria for PTSD (assessed using the PDS) b. Consent to participate 5. Exclusion criteria a. Drug abuse b. Obvious mental retardation c. Psychosis
Interventions	Stated purpose: to evaluate whether trained counsellors from the local afflicted population can effectively deliver a manual‐based approach to counselling victims of civil war trauma, and to compare structured manual‐based approach vs a more flexible approach or no specific intervention INTERVENTION 1 Name: narrative exposure therapy (NET) ‐ 111 people Delivered by: LHW (residents of refugee camps trained in counselling for the study) Title/name of PW and number: counsellors (9 in total; Somali and Rwandan refugees; 5 women, 4 men; mean age 27 years) 1. Selection: literacy in English and in mother tongue; ability to empathise with clients; strong motivation 2. Educational background: secondary school (7); primary school (1); university (1) 3. Training: 6 weeks of general counselling skills; NET and TC given by 5 post‐doc and doctoral university personnel from Germany and Uganda; used the NET manual and case discussions. 5 trainees had PTSD (3 lifetime, 2 current) and were given individual NET by trainees 4. Supervision: weekly case and personal supervision by trainers; treatment adherence monitored by case discussions during supervision, direct observation of treatment sessions, and review of patient testimonies and treatment protocols 5. Incentives/remuneration: not stated in this report Intervention details 1. Duration/frequency: 6 sessions (2 per week for 3 weeks); 1 to 2 hours' duration 2. Content of intervention: manualised, structured reconstruction of chronology of biography incorporating traumatic events into a coherent narrative; emphasis on reliving and describing emotional, physiological, cognitive, and behavioural reactions to traumatic events; habituation of reactions. Final narrative report (psychoeducation about PTSD in initial sessions; written rationale about relationship between PTSD and multiple past trauma; written chronological autobiography of traumatic experiences given to participant) INTERVENTION 2 Name: trauma counselling (TC) ‐ 111 people Delivered by: lay PHW (LHW) ‐ residents of refugee camps trained in counselling for the study; same as those who gave NET Title/name of PHW/CW and number: counsellors (9 in total; Somali and Rwandan refugees; 5 women, 4 men; mean age 27 years) 1. Selection: as above 2. Educational background: as above 3. Training: flexible, less directive approach than NET; developed through discussions with trainees by experienced senior counsellors from Uganda; training sessions focused on psychological and social needs, conflicts, and current life problems of clients; related current problems to past traumatic experiences; counsellors also trained in non‐directive active listening; problem‐solving; exploring coping skills and grief interventions 4. Supervision: weekly supervision assisted by experienced senior Ugandan counsellor 5. Incentives/remuneration: not stated Intervention details 1. Duration/frequency: 6 sessions (2 per week for 3 weeks) of 1 to 2 hours' duration 2. Content of intervention: not manualised but used a flexible approach focusing on current psychological and social needs of clients; NET considered a part of this approach but not mandatory. Psychoeducation about PTSD in initial sessions; written rationale about relationship between PTSD and multiple past trauma developed; final report in mother tongue of participant included current and past problems discussed with the counsellor and possible solutions and coping strategies CONTROL: monitoring group (no treatment) who were told they would be eligible for NET or TC if they proved effective ‐ 55 people CO‐INTERVENTIONS: not stated
Outcomes	Patients 1. PDS (Foa 2005; contains 17 items of DSM‐IV for PTSD; translated and linguistically adapted; standard methods to translate and back‐translate from Afsomali and Kinyaruwanda ‐ methods published separately; used to make DSM‐IV diagnoses of PTSD at baseline, 3 months, and 6 months by 12 trained research assistants blind to allocation 2. Expert evaluation: using PTSD section of Composite International Diagnostic Interview (WHO 1997), by PhD level psychologists or graduate students (number not stated) at 9 months; blind to allocation 3. Physical health checklist: sum of scores of symptoms of common illnesses over last 4 weeks (not validated) Carers Not applicable Process/health workers Not reported Economic outcomes (and where these can be found, e.g. ref or table number) Not reported Time points: baseline for all; 3 and 6 months for intervention groups; 3 and 6 months for monitoring group
Notes	Source of funding: German funding agencies (DFG; BMZ) Notes on validation of instruments (screening and outcomes): psychological outcomes validated; physical symptoms checklist not validated Additional information (e.g. provided by authors, existence of a published study protocol): translation of instruments published. Declaration of interest ‐ none Handling the data: as per footnotes in data and analysis Prospective trial registration number: not prospectively registered
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote from report: "the list of participants was ordered randomly; the first 4 were consecutively assigned to NET (narrative exposure therapy), TC (trauma counselling). NET, TC and the fifth was assigned to the MG (monitoring) group.This procedure was repeated until all 277 participants were assigned" Comment: alternate assignment; prone to prediction of next allocation and to high risk of bias; baseline imbalances in nationalities due to lack of stratification
Allocation concealment (selection bias)	High risk	Comment: allocation not concealed; participants approached at home and allocated to treatments after randomisation; baseline imbalances in prognostic variables evident
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: open‐label trial; group supervision of cases also precludes effective blinding; counsellors used both interventions; risk of contamination present, as well as of differential interventions
Blinding of outcome assessment (detection bias) all outcomes	Low risk	Comment: outcome assessors were blind to allocation
Baseline outcome measurements similar	Unclear risk	Comment: mean (SD) for PTS diagnostic scale in NET and TC groups were similar at baseline (25.9 (13.2) and 26.7 (12.5), respectively); however, it was lower in the control group (21.3 (10.3)). Unclear if this is a significant difference
Baseline characteristics similar?	High risk	Comment: baseline differences in proportions of Somali and Rwandan refugees in intervention groups, with highest % of Rwandan nationals in monitoring group (79%), and lowest in NET group (32%) (P < 0.01). Somali participants had more trauma than Rwandan participants; analyses in report were adjusted for this difference, but this is unlikely to have eliminated risk of bias
Incomplete outcome data (attrition bias) Efficacy data	High risk	Comment: dropouts > 65% in all groups; significantly high differential dropout rates
Protection against contamination	High risk	Comment: contamination likely, as same therapists used NET and TC; NET was a manualised treatment and TC is expected to incorporate NET; it is also possible that participants discussed treatments among themselves in the refugee camps, further contaminating the fidelity of the interventions
Selective reporting (reporting bias)	Unclear risk	Comment: trial not prospectively registered; protocol not available; yet we could detect no evidence of selective reporting
Other bias	Low risk	Comment: none detected