NCT06007105

Brief Summary

Although psychotic disorders typically affect less than 1% of the population, they are a significant cause of disability worldwide. Psychotic symptoms such as hallucinations, delusions and suicidal ideation can be profoundly disturbing, and negatively impact daily living. However, the social consequences of psychosis are often even more troubling than the symptoms. For example, people with psychosis have a high risk of experiencing violence, poverty, homelessness, incarceration, and unemployment, among other adverse outcomes. There is a need for a range of accessible, appropriate interventions for people with psychosis to be delivered to those in the most vulnerable situations, including in low-resource settings in sub-Saharan Africa. A systematic review recently carried out as part of the formative research for SUCCEED identified 10 studies evaluating the impact of interventions for people with psychosis in Africa, most of which had a strongly clinical focus. The review concluded that there was a need for further research involving people with lived experience of psychosis in designing and evaluating holistic interventions that meet their diverse needs, within and beyond the health sector. SUCCEED Africa is a six-year Health Research Programme Consortium (RPC) that has brought together people with lived experience of psychosis and people with professional experience (researchers, clinicians) from four African countries (Malawi, Nigeria, Sierra Leone, Zimbabwe) to co-produce a community-based intervention for psychosis, using a Theory of Change-driven approach. The SUCCEED intervention takes the World Health Organisation's (WHO's) CBR Matrix as a point of departure to consider the multifaceted needs of people living with psychosis and other psychosocial disabilities, and how best to meet these needs by mobilising the resources of individuals and families affected, as well as their broader communities. This protocol describes a pilot study in which the SUCCEED intervention will be delivered and evaluated on a small scale, in preparation for a larger multi-country research evaluation using more rigorous methods, including randomised controlled trials in Nigeria and Zimbabwe and observational studies in Malawi and Sierra Leone, respectively. The main outcome of interest is change in subjective quality of life among participants with lived experience of psychosis who are offered the intervention over a four-month follow up period.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

August 23, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

July 20, 2023

Last Update Submit

August 17, 2023

Conditions

Keywords

Sub-Saharan AfricaPsychosisCo-ProductionPeer supportHuman rightsNigeriaMalawiZimbabweSierra LeonePilot trialSchizophreniaCommunity-based rehabilitationLivelihoods

Outcome Measures

Primary Outcomes (1)

  • Change in self-reported Quality of Life (World Health Organisation Quality of Life Questionnaire Brief Version)

    WHOQOL-BREF has 26 items assessing individual's perception of their well-being over previous 2 weeks, across four domains (physical, psychological, social relationships and environment). Response to each item is rated against a 5-point Likert scale (1=not at all and 5=large amount). Scores are linearly transformed to total out of 100 where higher scores indicate better quality of life. WHOQOL-BREF may be administered by a data collector in an interview format or self-completed (with data collector available for any assistance needed). We will also invite a close family member to complete the WHOQOL-BREF independently at baseline to investigate reliability of self- versus proxy-reported quality of life. Both participants with lived experience of psychosis and family members will be asked to complete a cognitive interview checking understanding of the questionnaire following completion of the WHOQOL-BREF at baseline.

    Baseline and at 4 months follow up (endpoint)

Study Arms (1)

SUCCEED Community-Based Intervention

EXPERIMENTAL

The SUCCEED community-based intervention (offering a combination of peer support, case management and livelihoods activities) will be delivered to 10 participants with lived experience of psychosis at each of the 4 pilot sites.

Behavioral: SUCCEED Community-Based Intervention

Interventions

The main components of the intervention are peer support, case management and livelihoods activities, delivered by a peer support worker and a community support worker. The peer support worker has lived experience of psychosis and draws on a variety of manualised tools and techniques adapted from previous studies. The community support worker mobilises families and communities to activate resources in support of participants (e.g., education and employment, social and recreational activities), drawing on established models of mental health case management and community-based inclusive development. The peer support worker and community support worker also run self-help groups for people with lived experience and their family members, respectively. Self-help group meetings are also used as an opportunity for group livelihoods activities taking an "ABCD" (asset-based community development" approach.

SUCCEED Community-Based Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with lived experience of psychosis must:
  • Be consenting/assenting adults (age 18+)
  • Be able to speak one of the main study languages: English, Chichewa, Krio, Shona, Yoruba
  • Live within the pilot study area
  • Have a current or past diagnosis of schizophrenia or other primary psychotic disorder, bipolar or depressive disorder with psychotic symptoms, or a maternal mental health or behavioural disorder with psychotic symptoms, as per the World Health Organisation's International Classification of Diseases Version 11 (see full list of eligible diagnoses, below).
  • For participants recruited from within the health care system, diagnosis will be confirmed from health records. For those identified in the community, a research worker will administer the World Health Organisation's Composite International Diagnostic Interview (WHO CIDI) screening tool for psychosis.
  • Schizophrenia (6A20)
  • Schizoaffective disorder (6A21)
  • Schizotypal disorder (6A22)
  • Acute and transient psychotic disorder (6A23)
  • Delusional disorder (6A24)
  • Other specified (6A2Y) or unspecified (6A2Z) primary psychotic disorder
  • Bipolar type I disorder with psychotic symptoms (6A60.1, 6A60.5, 6A60.7, 6A60.A)
  • Bipolar type II disorder with psychotic symptoms (6A61.3, 6A61.5)
  • Single episode depressive disorder with psychotic symptoms (6A70.2, 6A70.4)
  • +2 more criteria

You may not qualify if:

  • People who are currently homeless, for logistical reasons; the SUCCEED intervention relies on PSWs and CSWs being able to regularly contact participants, including for home visits.
  • People with secondary psychotic syndromes (6E61), as these are considered to be the direct consequences of physical health conditions as opposed to mental health conditions.
  • People diagnosed with a substance-induced psychotic disorder (6C40.6-6C47.6), as recovery from substance use conditions is a specialist area outside the scope of the SUCCEED intervention under development.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kamuzu University of Health Sciences

Blantyre, Southern Region, 0000, Malawi

NOT YET RECRUITING

University of Ibadan

Ibadan, Oyo State, 0000, Nigeria

NOT YET RECRUITING

University of Makeni

Makeni, Northen Province, 0000, Sierra Leone

RECRUITING

University of Zimbabwe

Harare, North East, 0000, Zimbabwe

RECRUITING

Related Publications (4)

  • Hunt X, Abdurahman H, Omobowale O, Afolayan A, Munetsi E, Dzapasi L, Mokaya N, Koroma A, Barrie I, Ogunmola O, Koroma A, Shakespeare T, Eaton J, Ryan G. Interventions for adolescents and adults with psychosis in Africa: a systematic review and narrative synthesis. Glob Ment Health (Camb). 2022 May 27;9:223-240. doi: 10.1017/gmh.2022.25. eCollection 2022.

    PMID: 36618745BACKGROUND
  • Omigbodun OO, Ryan GK, Fasoranti B, Chibanda D, Esliker R, Sefasi A, Kakuma R, Shakespeare T, Eaton J. Reprioritising global mental health: psychoses in sub-Saharan Africa. Int J Ment Health Syst. 2023 Mar 28;17(1):6. doi: 10.1186/s13033-023-00574-x.

    PMID: 36978186BACKGROUND
  • Bella-Awusah T, Abdurahman H, Omobowale O, Aturu O, Afolayan A, Ogunmola O, Fasoranti B, Olusanmi M, Tamambang R, Bamidele O, Ryan G, Shakespeare T, Eaton J, Omigbodun O. Lessons of Hope and Resilience: A Co-Produced Qualitative Study of the Experiences of Youth Living with Psychosis During the COVID-19 Pandemic in Nigeria. Community Ment Health J. 2024 Jan;60(1):47-59. doi: 10.1007/s10597-023-01128-8. Epub 2023 Jun 12.

    PMID: 37306804BACKGROUND
  • Lee YY, Buyanga M, Mehta A, Omowunmi OA, Ryan G, Sunkel C, Vasquez A, Jones N. Cracks that Let the Light in: Collective Reflections on Integrating Lived Experience of Psychosis in Research and Policy in the Context of a Global Commission. Community Ment Health J. 2023 Jul;59(5):819-825. doi: 10.1007/s10597-023-01118-w. Epub 2023 Mar 20.

    PMID: 36939989BACKGROUND

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSchizotypal Personality DisorderSchizophrenia, Paranoid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonality Disorders

Study Officials

  • Professor Thomas Shakespeare

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a four-country pilot using a before-and-after study design to measure change in quality of life using the 26-item WHOQOL-BREF in participants with lived experience of psychosis who are offered the SUCCEED intervention (including case management, peer support and livelihoods activities) over a four-month follow-up period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 23, 2023

Study Start

July 18, 2023

Primary Completion

December 15, 2023

Study Completion

January 31, 2024

Last Updated

August 23, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Only anonymised data will be uploaded for archiving and data sharing. SUCCEED Data Access and Publication Policy stipulates that data are jointly owned by all SUCCEED partners; thus all partners are free to access anonymised SUCCEED data. Access is facilitated by the Data Management Team, which is comprised of nominated researchers at each site.

Shared Documents
STUDY PROTOCOL
Time Frame
After an 18-month embargo period, data are prepared for upload to LSHTM Data Compass site, in line with FCDO UK guidance on data sharing.
Access Criteria
Any individual internal or external to SUCCEED may submit an expression of interest using a standardised online form outlining their intention to access and/or publish SUCCEED data; expressions of interest are reviewed on a regular basis by SUCCEED's five-country leadership team for approval. This is the main avenue by which SUCCEED ensures the use of data is for valid research. Once approved, those accessing the project data are required to sign a data access/confidentiality form.
More information

Locations