RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0) [12 months]
Secondary Outcome Measures
- 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]
Scale is currently under development. It is being designed and validated to measure functioning in people with severe mental illness in rural Ethiopia.
- 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)
- Medication adherence (4 item Morisky Medication Adherence Scale) [6 and 12 months]
- 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]
- 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).
- 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 [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.
Other Outcome Measures
- Discrimination (DISC-12) [6 and 12 months]
Potential mediator
- Health service use and costs [6 and 12 months]
Potential mediator
- Depression (PHQ-9+1) [6 and 12 months]
Potential confounder
- Access/ adherence to CBR and reasons for non-adherence [6 and 12 months]
Potential mediator
- Social support (OSLO-3) [6 and 12 months]
Potential mediator
- Stigma and discrimination (WHO Family Interview Schedule Stigma section) [6 and 12 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Psychiatry, College of Health Sciences, Addis Ababa University | Addis Ababa | Ethiopia |
Sponsors and Collaborators
- London School of Hygiene and Tropical Medicine
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 7035
- 100142/Z/12/Z