SUCCEED Africa: Support, Comprehensive Care and Empowerment of People With Psychosocial Disabilities — SUCCEED  

Schizophrenia Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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.). ;

Related Conditions & MeSH terms

• Delusional Disorder
• Depression
• Depressive Disorder
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophrenia, Paranoid
• Schizotypal Disorder

• NCT number: NCT06007105
• Study type: Interventional
• Source: London School of Hygiene and Tropical Medicine
• Contact: Dr Julian Eaton
• Phone: +44 77 11140365
• Email: julian.eaton@lshtm.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2023
• Completion date: January 31, 2024