RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophrenia Spectrum Disorder, Schizophreniform Disorder

Keywords

Schizophrenia, Psychotic disorders, Schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using DSM-IV criteria

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.

Dijkstra LG, Weiss HA, Birhane R, Medhin G, de Silva M, Hanlon C, Fekadu A, Asher L.

2025-03-11

10.1186/s12888-025-06651-4

Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE): results of a 12-month cluster-randomised controlled trial.

Asher L, Birhane R, Weiss HA, Medhin G, Selamu M, Patel V, De Silva M, Hanlon C, Fekadu A.

2022-04-0135 citations

10.1016/s2214-109x(22)00027-4

"I cry every day and night, I have my son tied in chains": physical restraint of people with schizophrenia in community settings in Ethiopia.

Asher L, Fekadu A, Teferra S, De Silva M, Pathare S, Hanlon C.

2017-07-1142 citations

10.1186/s12992-017-0273-1

Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

Asher L, De Silva M, Hanlon C, Weiss HA, Birhane R, Ejigu DA, Medhin G, Patel V, Fekadu A.

2016-06-2436 citations

10.1186/s13063-016-1427-9

Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions.

De Silva MJ, Breuer E, Lee L, Asher L, Chowdhary N, Lund C, Patel V.

2014-07-05414 citations

10.1186/1745-6215-15-267

Interventions

BEHAVIORALCommunity-based rehabilitation

OTHERFacility based care

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
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	—
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.

Other

Measure	Time frame	Description
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	—
Discrimination (DISC-12)	6 and 12 months	Potential mediator

Countries

Ethiopia

Outcome results

None listed