RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

London School of Hygiene and Tropical Medicine166 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

166

Conditions

Schizophrenia Spectrum Disorder Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Interventions

Community-based rehabilitationBEHAVIORAL

Facility based careOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Addis Ababa, Ethiopia

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 6 and 12 months

Clinical Global Impression (CGI)

Time frame: 6 and 12 months

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

Time frame: 6 and 12 months

Disability (36-item WHODAS 2.0)

Time frame: 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.

Time frame: 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)

Time frame: 6 and 12 months

Medication adherence (4 item Morisky Medication Adherence Scale)

Time frame: 6 and 12 months

Engagement with facility based care

Potential mediator

Data from ClinicalTrials.gov

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