Pokhariyal 2012.
Methods | Study design: randomised controlled trial | |
Participants | 96 survivors of torture: 43 Kenyan torture survivors recruited from People Against Torture or released Kenyan political prisoners and 53 refugees in Kenya under UNHCR refugee programme Diagnosis: none Age: Kenyans mean 36.9 years (SD 11.5); refugees mean 26.7 years (SD 6.5) Sex: Kenyans 81% men, 19% women; refugees 51% men, 49% women Location: Kenya |
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Interventions | Participants were randomly assigned to: 1. Experimental arm Duration: mean 5 individual sessions MTP + 5 participants had 1 to 3 sessions CT Treatment protocol: Multi‐sensory trauma processing (MTP) +/‐ conventional treatment (CT) Therapists: members of research team, all experienced and qualified in counselling psychology 2. Comparator arm Duration: mean 9 individual sessions Treatment protocol: conventional treatment (CT) = "eclectic methods of psychotherapy": an assortment of therapeutic techniques with varied or no evidence of efficacy Therapists: members of research team, all experienced and qualified in counselling psychology Interpreted into Kiswahili or Kikuyu for Kenyan participants when necessary |
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Outcomes |
Time points for assessment: pretreatment, post treatment Assessment language: in Kiswahili or Kikuyu for Kenyan participants; some used interpreters Primary outcome Stress State Inventory (SSI) (self‐report) (items on PTSD symptoms) Secondary outcome: none SSI developed for US veterans: no comment on cross‐cultural validity |
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baseline characteristics | Partial data only Kenyans (N = 26): 18 educated up to secondary level, 7 beyond; 17 married, 6 single, 3 divorced/widowed; 16 Christian, 5 Muslim, 5 other Refugees (N = 30): educated up to secondary level, 10 beyond; 30 married, 17 single, 2 divorced/widowed; 20 Christian, 26 Muslim, 3 other |
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adherence and completion | 27 "excluded for various reasons": 35 Kenyans and 34 refugees completed | |
Notes |
Date of study: not given Funding source: USAID, USIU Declarations of interest among primary researchers: none Kenyan and refugee participants had somewhat different baseline scores and received different doses of treatment, but we combined them for analysis Data were provided individually per subject in tables, so means and standard deviations were calculated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Names of recruits converted to numbers and then "randomly assigned" Kenyans and refugees separately. No further detail |
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 | Self‐report measure but described as "administered," so unclear |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only completers analysed |
Selective reporting (reporting bias) | Unclear risk | Single outcome measure in trial reported; no protocol available |
Therapist allegiance | Unclear risk | No information provided |
Treatment fidelity | Unclear risk | No information provided |
Therapist qualifications | Low risk | Qualified therapists |
Other bias | Unclear risk | Real‐time translation of assessment measures, so not standardised |