RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

London School of Hygiene and Tropical Medicine

Status: Completed

Conditions: Schizophreniform Disorder; Schizophrenia Spectrum Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Other: Facility based care; Behavioral: Community-based rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02160249

100142/Z/12/Z (Other Grant/Funding Number)

7035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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166 participants in 2 patient groups

Community-based rehabilitation and facility based care

Experimental group

Description:

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.

Treatment:

Other: Facility based care

Behavioral: Community-based rehabilitation

Facility-based care

Active Comparator group

Description:

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.

Treatment:

Other: Facility based care