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| ID | Type | Description | Link |
|---|---|---|---|
| 100142/Z/12/Z | Other Grant/Funding Number | Wellcome Trust |
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| Name | Class |
|---|---|
| Addis Ababa University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-based rehabilitation | Behavioral |
| ||
| Facility based care |
| Measure | Description | Time Frame |
|---|---|---|
| Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0) | 12 months |
| 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)) |
| Measure | Description | Time Frame |
|---|---|---|
| Discrimination (DISC-12) | Potential mediator | 6 and 12 months |
| Health service use and costs | Potential mediator | 6 and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary De Silva, PhD MSc | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Abebaw Fekadu | Addis Ababa University Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, College of Health Sciences, Addis Ababa University | Addis Ababa | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40069613 | Derived | 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. | |
| 35303462 | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Other |
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| 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 |
| 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 |
| 28693614 | 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. |
| 27342215 | 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. |
| 24996765 | 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. |