Neuner 2008b.
Methods | RCT | |
Participants | Refugees who fulfilled DSM–IV criteria for PTSD (assessed with the PDS) who lived in 2 villages closest to the research base in the settlement | |
Interventions | Trauma counselling (TC): 111 participants Monitoring group (MG): 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 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 | Trained counsellors |
Treatment fidelity | Unclear risk | No information provided |
Therapist/investigator allegiance | High risk | Study authors were involved in treatment development |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out |