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SchizophreniaSUCCEEDNCT06007105

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

A study testing SUCCEED Community-Based Intervention in people with Schizophrenia and Schizoaffective Disorder, run by London School of Hygiene and Tropical Medicine at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SUCCEED Community-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
425 participants
Where
4 sitesin 4 countries
Study dates
18 Sep 2025to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 18Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Malawi1 site
  • Kamuzu University of Health Sciences

    Blantyre, Southern Region, 0000

Other trials in Malawi

Nigeria1 site
  • University of Ibadan

    Ibadan, Oyo State, 0000

Other trials in Nigeria

Sierra Leone1 site
  • University of Makeni

    Makeni, Northen Province, 0000

Other trials in Sierra Leone

Zimbabwe1 site
  • University of Zimbabwe

    Harare, North East, 0000

Other trials in Zimbabwe

About this study

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

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.

Read more

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.

Read the 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.).
Being tested
SUCCEED Community-Based Intervention
Keywords
Sub-Saharan Africa, Psychosis, Co-Production, Peer support, Human rights, Nigeria, Malawi, Zimbabwe, Sierra Leone, Pilot trial, Schizophrenia, Community-based rehabilitation, Livelihoods
Medical subject headings
Schizophrenia, Psychotic Disorders, Schizotypal Personality Disorder, Schizophrenia, Paranoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUCCEED Community-Based InterventionBehavioural

    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.

Study groups in NCT06007105
Study groupRoleWhat they receive
SUCCEED Community-Based InterventionExperimentalThe 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.
Receives: Behavioral: SUCCEED Community-Based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and at 4 months follow up (endpoint)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start18 Sep 2025
  3. Primary completion17 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
This is a four-country process evaluation across Nigeria, Sierra Leone, Malawi and Zimbabwe and two open-label individually randomized controlled trials of the SUCCEED Africa intervention in Nigeria and Zimbabwe. The purpose is 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 12 month follow up period.
Masking
None (open label)
Enrolment
425 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007105
Sponsor's protocol ID
28346
Other IDs
EPPHZT74
Acronym
SUCCEED
Status last verified
Mar 2026
First submitted
20 Jul 2023
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36618745
  • 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.

    PubMed 36978186
  • 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.

    PubMed 37306804
  • 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.

    PubMed 36939989

Questions about this trial

What is this clinical trial studying?

A study testing SUCCEED Community-Based Intervention in people with Schizophrenia and Schizoaffective Disorder, run by London School of Hygiene and Tropical Medicine at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Malawi, Nigeria, Sierra Leone, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-reported Quality of Life (World Health Organisation Quality of Life Questionnaire Brief Version) (time frame: Baseline and at 4 months follow up (endpoint)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06007105, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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