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Schizophrenia Spectrum DisorderRISENCT02160249

RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

A study testing Community-based rehabilitation and Facility based care in people with Schizophrenia Spectrum Disorder and Schizophrenia, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Community-based rehabilitation and Facility based care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
1 siteEthiopia
Study dates
Sep 2015to 8 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • No specific criteria

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

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

    Addis Ababa

Other trials in Ethiopia

About this study

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

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.

Read the 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.

Being tested
Community-based rehabilitation, Facility based care
Keywords
Schizophrenia, Psychotic disorders, Schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using DSM-IV criteria
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-based rehabilitationBehavioural

  • Facility based careOther

Study groups in NCT02160249
Study groupRoleWhat they receive
Community-based rehabilitation and facility based careExperimentalCommunity-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.
Receives: Behavioral: Community-based rehabilitation; Other: Facility based care
Facility-based careActive comparatorFacility based care (usual care) consists of anti-psychotic medication prescribed by a nurse or clinical officer in a health centre and basic psycho-education.
Receives: Other: Facility based care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Secondary outcomes (16)

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

    Measured: 6 and 12 months

  2. Clinical Global Impression (CGI)

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

  4. Disability (36-item WHODAS 2.0)

    Measured: 6 months

  5. 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.

    Measured: 6 and 12 months

  6. 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)

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

  8. Engagement with facility based care

    Potential mediator

    Measured: 6 and 12 months

  9. 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.

    Measured: 6 and 12 months

  10. Nutritional status (BMI)

    Measured: 6 and 12 months

  11. Serious adverse events

    Measured: 6 and 12 months

  12. 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).

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

  14. Caregiver depression (PHQ9 +1)

    Measured: 6 and 12 months

  15. Patient medication adherence

    Measured: 6 and 12 months

  16. 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.

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2014 (estimated)
  2. Study startSep 2015
  3. Primary completion26 Mar 2017
  4. Study completion8 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160249
Sponsor's protocol ID
7035
Other IDs
100142/Z/12/Z
Acronym
RISE
Status last verified
May 2017
First submitted
3 Jun 2014
Last updated
10 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40069613

  • 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.

    PubMed 35303462

  • 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.

    PubMed 28693614

  • 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.

    PubMed 27342215

  • 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.

    PubMed 24996765

Questions about this trial

What is this clinical trial studying?

A study testing Community-based rehabilitation and Facility based care in people with Schizophrenia Spectrum Disorder and Schizophrenia, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02160249, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.

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