Neuner 2008a.
Methods | RCT | |
Participants | Rwandan and Somalian refugees living in the Navikale refugee settlement in Uganda. Participants who fulfilled DSM–IV criteria of PTSD (assessed with the PDS) and lived in 2 villages closest to the research base in the settlement were included | |
Interventions | Narrative exposure therapy (NET): 111 participants Monitoring group: 55 participants |
|
Outcomes | PTSD symptoms | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The list of participants was ordered randomly; the first 4 were consecutively assigned to the NET, TC, NET, and TC groups; and the fifth was assigned to the MG (monitoring) group. This procedure was repeated until all 277 participants were assigned" |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were aware of their treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Interviewers were blind with respect to the particular treatment condition |
Incomplete outcome data (attrition bias) All outcomes | High risk | More than 20% of participants abandoned the study prematurely Study endpoint: 50/111 missing from NET group; 52/111 missing from TC group |
Selective reporting (reporting bias) | Low risk | Only 1 outcome measure tested |
Therapist qualification | Unclear risk | Quote: "Nine refugees were trained as counsellors" |
Treatment fidelity | Low risk | Quote: "Treatment adherence was monitored by case discussions in supervision meetings, by the direct observation of treatment sessions, and by a review of the testimonies and treatment protocols. No major deviation from the study protocol was noticed" |
Therapist/investigator allegiance | High risk | Study authors were involved in treatment development |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out |