RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)
NCT ID: NCT02160249
Last Updated: 2017-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2015-09-30
2017-05-08
Brief Summary
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Detailed Description
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The aim is to determine whether CBR + FBC is superior to FBC alone in reducing disability related to schizophrenia, measured by the WHO Disability Assessment Schedule version 2.0 (WHODAS 2.0) at 6 and 12 months.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
SINGLE
Study Groups
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Community-based rehabilitation and facility based care
Community-based rehabilitation is delivered to participants and their caregivers at their home by a specialist CBR worker. It comprises psychoeducation, adherence support, rehabilitation (including self-care and social skills), family support groups and accessing existing community organisations. It also involves community awareness raising and education and mobilisation of community leaders.
Facility based care (usual care) consists of anti-psychotic medication prescribed by a nurse or clinical officer in a health centre and basic psycho-education.
Community-based rehabilitation
Facility based care
Facility-based care
Facility based care (usual care) consists of anti-psychotic medication prescribed by a nurse or clinical officer in a health centre and basic psycho-education.
Facility based care
Interventions
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Community-based rehabilitation
Facility based care
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using (DSM-IV) criteria
* Evidence of severe, enduring or disabling illness
* Resident in kebele for \>6 months and no immediate plans to leave the kebele
* Has a primary caregiver who is willing to participate in the study
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Addis Ababa University
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Mary De Silva, PhD MSc
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Abebaw Fekadu
Role: PRINCIPAL_INVESTIGATOR
Addis Ababa University Department of Psychiatry
Locations
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Department of Psychiatry, College of Health Sciences, Addis Ababa University
Addis Ababa, , Ethiopia
Countries
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References
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Dijkstra LG, Weiss HA, Birhane R, Medhin G, de Silva M, Hanlon C, Fekadu A, Asher L. Effects of community-based rehabilitation on caregivers of people with schizophrenia in Ethiopia in the RISE trial. BMC Psychiatry. 2025 Mar 11;25(1):231. doi: 10.1186/s12888-025-06651-4.
Asher L, De Silva M, Hanlon C, Weiss HA, Birhane R, Ejigu DA, Medhin G, Patel V, Fekadu A. Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial. Trials. 2016 Jun 24;17(1):299. doi: 10.1186/s13063-016-1427-9.
Asher L, Birhane R, Weiss HA, Medhin G, Selamu M, Patel V, De Silva M, Hanlon C, Fekadu A. Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE): results of a 12-month cluster-randomised controlled trial. Lancet Glob Health. 2022 Apr;10(4):e530-e542. doi: 10.1016/S2214-109X(22)00027-4.
Asher L, Fekadu A, Teferra S, De Silva M, Pathare S, Hanlon C. "I cry every day and night, I have my son tied in chains": physical restraint of people with schizophrenia in community settings in Ethiopia. Global Health. 2017 Jul 11;13(1):47. doi: 10.1186/s12992-017-0273-1.
De Silva MJ, Breuer E, Lee L, Asher L, Chowdhary N, Lund C, Patel V. Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. Trials. 2014 Jul 5;15:267. doi: 10.1186/1745-6215-15-267.
Other Identifiers
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100142/Z/12/Z
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
7035
Identifier Type: -
Identifier Source: org_study_id
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