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Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): results of a 12-month cluster-randomized controlled trial

Asher, Laura; Birhane, Rahel; Weiss, Helen A; Medhin, Girmay; Selamu, Medhin; Patel, Vikram; De Silva, Mary; Hanlon, Charlotte; Fekadu, Abebaw

Authors

LAURA ASHER LAURA.ASHER@NOTTINGHAM.AC.UK
Clinical Associate Professor

Rahel Birhane

Helen A Weiss

Girmay Medhin

Medhin Selamu

Vikram Patel

Mary De Silva

Charlotte Hanlon

Abebaw Fekadu



Abstract

Background:
Community-based rehabilitation (CBR) is recommended to address the social and clinical needs of people with schizophrenia in resource-poor settings. We evaluated the effectiveness of CBR in reducing disability at 12 months in persons with schizophrenia who had disabling illness after six months access to standard care.

Methods:
This cluster-randomized controlled trial was conducted in a rural district of Ethiopia. We recruited adults with schizophrenia with disabling illness. 54 sub-districts were allocated in a 1:1 ratio to the intervention arm (facility-based care (FBC) plus CBR) or the control arm (FBC alone). FBC was a task-shared model of mental healthcare integrated within primary care. CBR was delivered by lay workers over 12 months and comprised home visits (psychoeducation, adherence support, family intervention, crisis management) and community mobilization. The primary outcome was disability, measured with the proxy-rated 36-item WHO Disability Assessment Schedule (WHODAS) at 12 months. The analyses used intention-to-treat principles. Trial registration: ClinicalTrials.gov, NCT02160249.

Findings:
Participants were enrolled between Sept 16, 2015 and Mar 11, 2016. Sub-districts without eligible participants were excluded. 79 participants in 24 sub-districts were assigned to CBR plus FBC and 87 participants in 24 sub-districts were assigned to FBC only. The primary analysis included 149 (89.8%) participants in 46 sub-districts. At 12 months, the mean WHODAS scores were 46.1 (SD 23.3) in the control arm and 40.6 (SD 22.5) in the intervention arm, indicating a favourable intervention effect (adjusted mean difference -8·13, 95%CI -15·85 to -0·40; p=0·039; effect size 0·35). Four (5·1%) intervention arm participants and nine (10·3%) control arm participants had at ≥1 serious adverse event (death, suicide attempt and hospitalization).

Citation

Asher, L., Birhane, R., Weiss, H. A., Medhin, G., Selamu, M., Patel, V., …Fekadu, A. (in press). Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): results of a 12-month cluster-randomized controlled trial. Lancet Global Health,

Journal Article Type Article
Acceptance Date Jan 7, 2022
Deposit Date Jan 14, 2022
Publicly Available Date Jan 14, 2022
Journal Lancet Global Health
Publisher Elsevier
Peer Reviewed Peer Reviewed
Public URL https://nottingham-repository.worktribe.com/output/7230283

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