Schizophrenia Clinical Trial
— SUCCEEDOfficial title:
SUCCEED Africa: Protocol for a Multi-method Pilot Study of a Community-based Intervention for People With Psychosis in West and Southeast Africa
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 31, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: 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. 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 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. |
Country | Name | City | State |
---|---|---|---|
Malawi | Kamuzu University of Health Sciences | Blantyre | Southern |
Nigeria | University of Ibadan | Ibadan | Oyo State |
Sierra Leone | University of Makeni | Makeni | Northen Province |
Zimbabwe | University of Zimbabwe | Harare | North East |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Mental Health Coalition Sierra Leone, Mental Health Users and Carers Association (MeHUCA) Malawi, The Asido Foundation, University of Ibadan, University of Makeni, University of Malawi, University of Zimbabwe, Zimbabwe National Association for Mental Health (ZIMNAMH) |
Malawi, Nigeria, Sierra Leone, Zimbabwe,
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. 2023 Jun 12:1-13. doi: 10.1007/s10597-023-01128-8. Online ahead of print. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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