RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia) (RISE)

RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Schizophrenia Spectrum Disorder
• Intervention / Treatment: Behavioral: Community-based rehabilitation; Other: Facility based care

Detailed Description

This is a cluster randomised trial set in rural Ethiopia with kebeles (villages) as the unit of randomisation. 54 kebeles will be included. 27 will be randomly allocated to the intervention arm (Facility based care (FBC) + Community-based Rehabilitation (CBR)) and 27 randomly allocated to the control arm (FBC alone).

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.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• No specific criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Community-based rehabilitation; Other: Facility based care
Active Comparator: 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.	Other: Facility based care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Scale is currently under development. It is being designed and validated to measure functioning in people with severe mental illness in rural Ethiopia.	6 and 12 months
Economic activity of patient (employment, income and household work)	Section includes current occupation (categories), employment status (categories), typical income (specific amount). Section also includes questions adapted from the WHO-DAS 12 and 36 relating to problems doing usual work task both generally and as a result of their mental illness (likert scale)	6 and 12 months
Medication adherence (4 item Morisky Medication Adherence Scale)		6 and 12 months
Engagement with facility based care	Potential mediator	6 and 12 months
Proportion with human rights problems (chaining or restraint)- self-reported	The outcome is the proportion chained, restrained or confined within last one month. Additional data on who perpetrated the chaining i.e. traditional healer/ family member will be collected.	6 and 12 months
Nutritional status (BMI)		6 and 12 months
Serious adverse events		6 and 12 months
Economic activity of caregiver	Section includes current occupation (categories), employment status (categories), typical income (specific amount). Section also includes questions adapted from the WHO-DAS 12 and 36 relating to problems doing usual work tasks (likert scale).	6 and 12 months
Caregiver burden (WHO Family Interview Schedule Impact section)		6 and 12 months
Caregiver depression (PHQ9 +1)		6 and 12 months
Patient medication adherence		6 and 12 months
Proportion with human rights problems (chaining or restraint)- Caregiver-reported	Caregiver to report presence of human rights problems relating to patient. The outcome is the proportion chained, restrained or confined within last one month. Additional data on who perpetrated the chaining i.e. traditional healer/ family member will be collected.	6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discrimination (DISC-12)	Potential mediator	6 and 12 months
Health service use and costs	Potential mediator	6 and 12 months
Depression (PHQ-9+1)	Potential confounder	6 and 12 months
Access/ adherence to CBR and reasons for non-adherence	Potential mediator	6 and 12 months
Social support (OSLO-3)	Potential mediator	6 and 12 months
Stigma and discrimination (WHO Family Interview Schedule Stigma section)		6 and 12 months

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Addis Ababa University
• Investigators: Principal Investigator: Mary De Silva, PhD MSc, London School of Hygiene and Tropical Medicine; Principal Investigator: Abebaw Fekadu, Addis Ababa University Department of Psychiatry

Publications and helpful links

General Publications

• 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. Erratum In: Lancet Glob Health. 2022 Jun;10(6):e797.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 26, 2017
• Study Completion (Actual): May 8, 2017

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: June 9, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychotic disorders; Schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using DSM-IV criteria
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders
• Other Study ID Numbers: 7035; 100142/Z/12/Z (Other Grant/Funding Number: Wellcome Trust)