RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)
- Conditions
- SchizophreniaSchizoaffective DisorderSchizophreniform DisorderSchizophrenia Spectrum Disorder
- Interventions
- Behavioral: Community-based rehabilitationOther: Facility based care
- Registration Number
- NCT02160249
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- 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
- No specific criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Community-based rehabilitation and facility based care 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 and facility based care Community-based rehabilitation 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. 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.
- Primary Outcome Measures
Name Time Method Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0) 12 months
- Secondary Outcome Measures
Name Time Method Caregiver depression (PHQ9 +1) 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 Scale is currently under development. It is being designed and validated to measure functioning in people with severe mental illness in rural Ethiopia.
Medication adherence (4 item Morisky Medication Adherence Scale) 6 and 12 months Serious adverse events 6 and 12 months Economic activity of caregiver 6 and 12 months 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).
Economic activity of patient (employment, income and household work) 6 and 12 months 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)
Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E)) 6 and 12 months Proportion with human rights problems (chaining or restraint)- Caregiver-reported 6 and 12 months 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.
Engagement with facility based care 6 and 12 months Potential mediator
Proportion with human rights problems (chaining or restraint)- self-reported 6 and 12 months 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.
Nutritional status (BMI) 6 and 12 months Caregiver burden (WHO Family Interview Schedule Impact section) 6 and 12 months Patient medication adherence 6 and 12 months
Trial Locations
- Locations (1)
Department of Psychiatry, College of Health Sciences, Addis Ababa University
🇪🇹Addis Ababa, Ethiopia