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. 2014 Nov 11;2014(11):CD009317. doi: 10.1002/14651858.CD009317.pub2

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