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Completed

NCT Number: NCT02160249

RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

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.

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Key information

Conditions

Schizophrenia Spectrum Disorder Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, College of Health Sciences, Addis Ababa University

Addis Ababa, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-based rehabilitation

Behavioral

Facility based care

Other

Primary outcomes

  1. Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)

    Time frame: 12 months

Secondary outcomes

  1. Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))

    Time frame: 6 and 12 months

  2. Clinical Global Impression (CGI)

    Time frame: 6 and 12 months

  3. Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))

    Time frame: 6 and 12 months

  4. Disability (36-item WHODAS 2.0)

    Time frame: 6 months

  5. Functioning (indigenous functioning scale)

    Time frame: 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.

  6. Economic activity of patient (employment, income and household work)

    Time frame: 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)

  7. Medication adherence (4 item Morisky Medication Adherence Scale)

    Time frame: 6 and 12 months

  8. Engagement with facility based care

    Time frame: 6 and 12 months

    Potential mediator

  9. Proportion with human rights problems (chaining or restraint)- self-reported

    Time frame: 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.

  10. Nutritional status (BMI)

    Time frame: 6 and 12 months

  11. Serious adverse events

    Time frame: 6 and 12 months

  12. Economic activity of caregiver

    Time frame: 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).

  13. Caregiver burden (WHO Family Interview Schedule Impact section)

    Time frame: 6 and 12 months

  14. Caregiver depression (PHQ9 +1)

    Time frame: 6 and 12 months

  15. Patient medication adherence

    Time frame: 6 and 12 months

  16. Proportion with human rights problems (chaining or restraint)- Caregiver-reported

    Time frame: 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 outcomes

  1. Discrimination (DISC-12)

    Time frame: 6 and 12 months

    Potential mediator

  2. Health service use and costs

    Time frame: 6 and 12 months

    Potential mediator

  3. Depression (PHQ-9+1)

    Time frame: 6 and 12 months

    Potential confounder

  4. Access/ adherence to CBR and reasons for non-adherence

    Time frame: 6 and 12 months

    Potential mediator

  5. Social support (OSLO-3)

    Time frame: 6 and 12 months

    Potential mediator

  6. Stigma and discrimination (WHO Family Interview Schedule Stigma section)

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Addis Ababa University

Registry information

Official study title

RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial

Acronym: RISE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2014
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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