RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

NCT02160249 | Completed DMC

• 2 other identifiers: 7035100142/Z/12/Z
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether community-based rehabilitation plus facility-based care is superior to facility-based care alone in reducing disability related to schizophrenia in rural Ethiopia.

Conditions

Schizophrenia Spectrum Disorder; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

Schizophrenia; Psychotic disorders; Schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using DSM-IV criteria

Outcome Measures

Primary Outcomes (1)

• Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)

  12 months

Secondary Outcomes (16)

• Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))

  6 and 12 months

• Clinical Global Impression (CGI)

  6 and 12 months

• Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))

  6 and 12 months

• Disability (36-item WHODAS 2.0)

  6 months

• Functioning (indigenous functioning scale)

  6 and 12 months

Other Outcomes (6)

• Discrimination (DISC-12)

  6 and 12 months

• Health service use and costs

  6 and 12 months

• Depression (PHQ-9+1)

  6 and 12 months

Study Arms (2)

Community-based rehabilitation and facility based care

EXPERIMENTAL

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.

Behavioral: Community-based rehabilitation; Other: Facility based care

Facility-based care

ACTIVE COMPARATOR

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.

Other: Facility based care

Interventions

Community-based rehabilitation BEHAVIORAL

Community-based rehabilitation and facility based care

Facility based care OTHER

Community-based rehabilitation and facility based care; Facility-based care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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

You may not qualify if:

• No specific criteria

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Addis Ababa University: collaborator

Study Sites (1)

Department of Psychiatry, College of Health Sciences, Addis Ababa University

Addis Ababa, Ethiopia

Location

Related Publications (5)

• 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.

  PMID: 40069613 DERIVED

• 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.

  PMID: 35303462 DERIVED

• 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.

  PMID: 28693614 DERIVED

• 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.

  PMID: 27342215 DERIVED

• 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.

  PMID: 24996765 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Mary De Silva, PhD MSc

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Abebaw Fekadu

  Addis Ababa University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 10, 2014
• Study Start: September 1, 2015
• Primary Completion: March 26, 2017
• Study Completion: May 8, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

ET (1)