SUCCEED Africa: Support, Comprehensive Care and Empowerment of People With Psychosocial Disabilities
NCT ID: NCT06007105
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-07-18
2024-01-31
Brief Summary
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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.
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Detailed Description
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As part of SUCCEED Africa's formative research, a systematic review of the grey literature on CBR for psychosocial disabilities in LMICs was undertaken, in case there was in fact evidence available that had been excluded as a result of the previous review's strict eligibility criteria. The grey literature review identified 33 different CBR programmes, 11 of which were based in sub-Saharan Africa, but the quality of the evidence was generally very poor and too heterogeneous for any sort of meta-analysis. In contrast to previous reviews, the grey literature review found that the majority of programmes were not focused primarily on health, covering more domains of the CBR Matrix (e.g. livelihoods, empowerment, education, etc.). This suggests a disconnect between how CBR programmes are designed and evaluated to optimise clinical outcomes for research purposes, versus how they are designed to meet pragmatic needs in real-world practice.
The SUCCEED pilot will use a before-and-after study design looking at changes in subjective quality of life (WHOQOL-BREF) among participants with lived experience of psychosis who are offered the SUCCEED intervention over a four-month follow-up period. Key components of the SUCCEED intervention are peer support, case management and livelihoods activities, which are delivered by a gender-mixed team including one peer support worker and one community support worker embedded in a local organisation for persons with disabilities (OPD) in each SUCCEED country.
Nested within this pilot are three other components, described further in the full research protocol (available upon request) :
* A baseline assessment of the feasibility and acceptability of WHOQOL-BREF as a measurement tool (time taken to administer, proportion of participants who complete the tool, perspectives of data collectors assessed through interviews), face validity (assessed through cognitive interviewing) of WHOQOL-BREF, and the validity of proxy (completed by a close family member) versus self-completion.
* A qualitative study using a combination of focus groups (participants with psychosis, family members) and interviews (peer support workers, community support workers, supervisors, data collectors) to further examine the acceptability and feasibility of the SUCCEED's research and M\&E tools (including WHOQOL-BREF) and processes.
* A process evaluation drawing on semi-structured observations and routine monitoring and evaluation (M\&E) of intervention delivery, competency assessment of the two frontline providers (peer support workers and community support workers, via ENACT) research administrative data (adverse events, drop-outs), and end-line qualitative data (see above) to assess key process indicators and implementation outcomes (e.g. acceptability, appropriateness, feasibility, fidelity, safety, etc.).
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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SUCCEED Community-Based Intervention
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.
SUCCEED Community-Based Intervention
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.
Interventions
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SUCCEED Community-Based Intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
The following diagnoses are eligible for inclusion:
* 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)
* Recurrent depressive disorder with psychotic symptoms (6A71.2, 6A71.4)
* Mental or behavioural disorder associated with pregnancy, childbirth or the puerperium, with psychotic symptoms (6E21)
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Ibadan
OTHER
University of Malawi
OTHER
University of Makeni
UNKNOWN
University of Zimbabwe
OTHER
Zimbabwe National Association for Mental Health (ZIMNAMH)
UNKNOWN
Mental Health Users and Carers Association (MeHUCA) Malawi
UNKNOWN
The Asido Foundation
UNKNOWN
Mental Health Coalition Sierra Leone
UNKNOWN
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Professor Thomas Shakespeare
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Locations
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Kamuzu University of Health Sciences
Blantyre, Southern Region, Malawi
University of Ibadan
Ibadan, Oyo State, Nigeria
University of Makeni
Makeni, Northen Province, Sierra Leone
University of Zimbabwe
Harare, North East, Zimbabwe
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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EPPHZT74
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
28346
Identifier Type: -
Identifier Source: org_study_id
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