Igreja 2004.
Methods | Study design: randomised controlled trial | |
Participants | 137 people, post civil war, mostly rural population seen in their homes Diagnosis: PTSD caseness Method of diagnosis: self‐Inventory for PTSD (Hovens et al, 2001) Age: mean 40 years (SD 14) Sex: 56% men, 44% women Location: Mozambique |
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Interventions | Participants were randomly assigned to: 1. Experimental arm Duration: 1 occasionally 2 individual sessions, about 60 minutes Treatment protocol: testimony writing: references to 'testimony method' but no mention of protocol Therapist/interviewer: first study author interpreted into Chi‐Gorongese by native speakers (same sex as participant) 2. Comparator arm Duration: none Treatment protocol: no intervention Therapist: none |
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Outcomes |
Time points for assessment: pretreatment and at 11‐month follow‐up Assessment language: all via structured interview, as participants illliterate, interpreted into Chi‐Gorongese Outcomes (not specified as primary or secondary) Post‐traumatic stress symptoms: self‐Inventory for PTSD; only Western data available on performance of scale Psychiatric symptoms: Self‐Report Questionnaire, validated in non‐Western populations Nightmares: Nocturnal Intrusions after Traumatic Experiences Questionnaire; only Western data available on performance of scale |
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baseline characteristics | 58% intervention group and 55% control group tortured; many other relevant events of organised violence on Harvard Trauma Questionnaire, validated in non‐Western populations Mean 15 years in war zone Mean 4 living children and 3 dead |
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adherence and completion | 6 dropouts | |
Notes |
Date of study: not given Funding source: part by Associação Esperança Para Todos, Mozambique Declarations of interest among primary researchers: none Third arm (not included here) of non‐case participants |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants given consecutive numbers, divided according to caseness, then allocated to treatment or control according to odd or even number |
Allocation concealment (selection bias) | High risk | None |
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 | Unclear who conducted assessments—all by interview |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Several dropouts (death, moving away) |
Selective reporting (reporting bias) | Unclear risk | All outcomes listed in trial reported; no protocol available |
Therapist allegiance | Unclear risk | No information provided |
Treatment fidelity | Unclear risk | No information provided |
Therapist qualifications | Unclear risk | No information provided |
Other bias | Unclear risk | Real‐time translation of assessment measures, so not standardised |