Clinical trial NCT06007105: SUCCEED Africa: Support, Comprehensive Care and Empowerment of People With Psychosocial Disabilities
Official title: SUCCEED Africa: Protocol for a Multi-method Pilot Study of a Community-based Intervention for People With Psychosis in West and Southeast Africa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Schizotypal Disorder
Acute and Transient Psychotic Disorder
Delusional Disorder
Other Specified or Unspecified Primary Psychotic Disorder
Bipolar Type I Disorder With Psychotic Symptoms
Bipolar Type II Disorder With Psychotic Symptoms
Single Episode Depressive Disorder With Psychotic Symptoms
Recurrent Depressive Disorder With Psychotic Symptoms
Perinatal Mental or Behavioural Disorder With Psychotic Symptoms
Keywords: Sub-Saharan Africa
Psychosis
Co-Production
Peer support
Human rights
Nigeria
Malawi
Zimbabwe
Sierra Leone
Pilot trial
Schizophrenia
Community-based rehabilitation
Livelihoods
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: University of Ibadan
name: University of Malawi
name: University of Makeni
name: University of Zimbabwe
name: Zimbabwe National Association for Mental Health (ZIMNAMH)
name: Mental Health Users and Carers Association (MeHUCA) Malawi
name: The Asido Foundation
name: Mental Health Coalition Sierra Leone
First posted: 2023-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Recognising the need for a framework for interventions to support people with psychosocial disabilities in LMICs, the WHO's 2010 CBR Guidelines included a special supplement on mental health, which drew mainly from expert opinion, evidence in community mental health, and basic development principles, to make recommendations for best practice. However, a 2016 review examining CBR for disabilities in LMICs identified only one example of CBR for psychosocial disabilities in Sub-Saharan Africa. The authors concluded that there was a need for more evidence from this region, in particular.

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.).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in self-reported Quality of Life (World Health Organisation Quality of Life Questionnaire Brief Version)
timeFrame: Baseline and at 4 months follow up (endpoint)
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Kamuzu University of Health Sciences
state: Southern
city: Ibadan
country: Nigeria
facility: University of Ibadan
state: Oyo State
city: Makeni
country: Sierra Leone
facility: University of Makeni
state: Northen Province
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
state: North East
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Professor Thomas Shakespeare
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.