Bichescu 2007.
Methods | Study design: randomised controlled trial | |
Participants | 18 former political detainees under communist Romania, living at home Diagnosis: PTSD on 2 occasions 1 year apart; no signs of disability on MINI Method of diagnosis: CIDI (Composite International Diagnostic Interview, WHO 1997) Age: mean 69 years Sex: 94% men, 6% women Location: Romania |
|
Interventions | Participants were randomly assigned to: 1. Experimental arm Duration: 5 2‐hour sessions Treatment protocol: narrative exposure (NET) Therapist: Romanian‐speaking female PhD psychology student; therapy in own language 2. Comparator arm Duration: 1 session Treatment protocol: psychoeducation (PED); "standardized treatment" Therapist: Romanian‐speaking female PhD psychology student; therapy in own language |
|
Outcomes |
Time points for assessment: pretreatment and at 6‐month follow‐up Assessment language: Romanian; measures translated as necessary Primary outcome Symptoms of PTSD (CIDI) for diagnosis and symptom count, no information about validation Secondary outcome Depression (BDI) through interview with translation from English |
|
baseline characteristics | Mean number of mistreatments 13; no detail Mean of 42 years since release from imprisonment; mean duration of imprisonment 6 years Education, occupational status and marital status recorded |
|
adherence and completion | All 18 completed treatment and follow‐up | |
Notes |
Date of study: 2003 Funding source: Hans‐Böckler Foundation and Deutsche Forschungsgemeinschaft Declarations of interest among primary researchers: no declaration Assessment by clinical psychology and MA psychology students who were intended to be blind to treatment, which was not entirely successfull |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | By "random selection procedure of participants' name‐cards": unclear who performed selection |
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 | Most blind assessors were arranged, but "it was not possible for us to achieve complete blindness in all cases," as participants revealed details of treatment that identified the condition |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included: no attrition |
Selective reporting (reporting bias) | Unclear risk | 2 measures used and reported; no protocol available |
Therapist allegiance | High risk | Allegiance to NET |
Treatment fidelity | Unclear risk | No information |
Therapist qualifications | Unclear risk | In training |
Other bias | Unclear risk | Real‐time translation of assessment measures, so not standardised |