Hensel‐Dittmann 2011.
Methods | Study design: randomised controlled trial | |
Participants | 28 clinic outpatients, refugees from various countries—most still seeking asylum Diagnosis: PTSD Method of diagnosis:DSM‐IV Age: not given, but no differences between groups Sex: not given, but no differences between groups Location: Germany |
|
Interventions | Participants were randomly assigned to: 1. Experimental arm Duration: 10 individual sessions of mean 90 minutes Treatment protocol: Narrative exposure (NET) manualised (Schauer) Therapist: trained, with interpreter when necessary (17/28) 2. Comparator arm Duration: 10 individual sessions of mean 90 minutes Treatment protocol: stress inoculation training (SIT), avoiding any element of exposure Therapist: trained, with interpreter when necessary (17/28) Same therapists for both arms |
|
Outcomes |
Time points for assessment: pretreatment and at 6‐month and 1‐year follow‐up Assessment language: measures in German; no information on cross‐cultural use Primary outcome PTSD severity score (clinician‐administered scale: CAPS) Secondary outcome PTSD diagnosis: DSM‐IV Depression: Hamilton Depression Scale |
|
baseline characteristics | 76% had been tortured; remainder had experienced war No differences between groups in length of time in Germany, area of origin, education or co‐morbid psychiatric disorders, but no baseline data given |
|
adherence and completion | 5 dropouts NET, 2 dropouts SIT (1 SIT participant deported) | |
Notes |
Date of study: 2004 to 2007 Funding source: European Refugee Fund and Deutsche Forschungsgemeinschaft Declarations of interest among primary researchers: no conflicting interests |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants matched pairwise by gender, age and region of origin, then allocated by flipping coin |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to render participants nor practitioners blind to allocation. Expectations of benefit not assessed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Assessors blind (unless accidentally unblinded) to allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data provided different N at each time point; analysis by intention‐to‐treat, so mixed‐effect models with neither imputation nor LOCF |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported in trial methods; no protocol available |
Therapist allegiance | High risk | NET: active treatment |
Treatment fidelity | Low risk | Manual by Schauer |
Therapist qualifications | Low risk | Trained therapists |
Other bias | Unclear risk | Most refugees still had asylum undecided, so may have had an incentive to underreport improvement |