Feasibility and Acceptability of an Intervention to Support People With Severe Mental Illness in South Africa

NCT ID: NCT07339462

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-08-31

Brief Summary

Despite commendable progress in developing mental health systems in low-and-middle income countries, critical gaps remain, particularly the development of community-based systems of support for people living with severe mental illness (SMIs). This application will pilot a co-developed health system strengthening intervention programme in a South African district in order to determine its feasibility, appropriateness and limited efficacy in reducing readmission following discharge from acute psychiatric hospitalization. By generating preliminary data on the real-world implementation of a co-developed programme in low-resource contexts in South Africa, this application seeks to build on an existing foundation of research partnerships and local government collaboration to develop a transitional support intervention that could yield significant and tangible impacts on people living with SMIs in low-resource communities.

Detailed Description

The development of appropriate and effective community-based care for people living with severe mental illness (SMIs) continues to be a global challenge, especially in low-and-middle income countries (LMICs). A particularly damaging cycle emerges when people with SMIs are admitted to hospital for acute psychiatric treatment, discharged back into community settings without appropriate support, only to be readmitted again due to psychiatric relapse. This "revolving door" phenomenon is a multilevel challenge to mental health systems, including in countries such as South Africa, with little to no formal community-based support systems for people living with SMIs. Several innovative strategies have been developed to address hospital re-admission, while co-development approaches such as human-centred intervention development have shown much promise in generating improved outcomes. The proposed research project aims to explore the feasibility and limited efficacy of a co-developed health system strengthening intervention programme in a South African district in order to determine its feasibility, appropriateness and limited efficacy in reducing readmission following discharge from acute psychiatric hospitalization.

Specifically, a multi-level helath system strengthening intervention programme has been co-developed, which include 1) the improvement of referral processes across healthcare facilties; 2) the implementation of a psychosocial rehabilitation programme across tertiary, secondary and primary healthcare facilities; 3) the implementation of clinical guidelines refresher training for clinicials on primary healthcare level; 4) the implementation of a structured outreach programme by community health workers following discharge; and 5) the implementation of a Household Champion programme to empower households for better support at home. This package will be piloted in a parallel arm feasibility trial in the uMgungundlovu District Municipality in KwaZulu-Natal, South Africa. We will train registered councellors to deliver psychosocial rehabilitation on primary healthcare level in tandem with nursing staff, train community health workers to work with existing outreach teams to implement the Community Mental Health Education and Detection programme during routine household visits, and will recruit a training and quality improvement team to coordinate, support and mentor training and improvement for the referral pathway and clinician refresher training. Fourty-three people who have been admitted for acute psychiatric reasons will be recruited for each of the two arms. The intervention arm will receive the full intervention package, while the control arm will receive care as usual as well as improved referral and discharge readiness on hospital level. The primary aim is to determine whether enrollment to the full intervention package will reduce the likelihood of people discharged from acute psychiatric hospitalization after 4 months, compared to those in the control group. Secondary measures include the effects of the intervention on service users (in terms of stigma, medication adherence, and recovery) after 4 months; and qualitative measures of feasibility in terms of the acceptability, demand, implementation, practicality, adaptation, integration, and potential for expansion of the intervention. Taken together, the quantitative and qualitative data will provide an indication of the feasibility and limited efficacy of the co-developed intervention package.

Conditions

Mental Disorders, Severe

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Participants in the intervention arm will be exposed to the following interventions:

1. A revised referral pathway across tertiary, secondary and primary levels of care, integrated with existing policies;

2. A psychosocial rehabilitation programme, including a manual and training and mentorship package, introduced to multidisciplinary teams and nursing staff in specialist, regional and district hospitals

3. A psychosocial rehabilitation programme, including a manual and training and mentorship package, introduced to registered counsellors in PHC facilities

4. Refresher training on management of severe mental health conditions for physicians and nurses in PHC facilities

5. A community mental health education and detection toolkit and associated training package for community health worker outreach teams

6. The Household Champion programme, a psychoeducation, empowerment and support programme to improve caregiver capacity and improve community resource linkages.

Group Type: EXPERIMENTAL

Multilevel psychosocial support for people living with severe mental illness and their caregivers

Intervention Type: BEHAVIORAL

The intervention is the product of a human-centred design process, involving a range of health system actors. The intervention entails 1) A revised, integrated referral pathway across tertiary, secondary and primary levels of care; 2) A psychosocial rehabilitation programme, introduced to multidisciplinary teams and nursing staff in specialist, regional and district hospitals; 3) A psychosocial rehabilitation programme, introduced to registered counsellors in PHC facilities; 4) Refresher training on management of severe mental health conditions for physicians and nurses in PHC facilities; 5) A community mental health education and detection toolkit and associated training package for community health worker outreach teams; 6) The Household Champion programme, a psychoeducation, empowerment and support programme to improve caregiver capacity for care.

Control Arm

Service users discharged from acute psychiatric hospitalization to households in the community receiving standard care (i.e. monthly procurement of medicines at the primary healthcare clinic), as well as exposure to improved referral pathways as well as psychosocial rehabilitation on hospital level.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multilevel psychosocial support for people living with severe mental illness and their caregivers

The intervention is the product of a human-centred design process, involving a range of health system actors. The intervention entails 1) A revised, integrated referral pathway across tertiary, secondary and primary levels of care; 2) A psychosocial rehabilitation programme, introduced to multidisciplinary teams and nursing staff in specialist, regional and district hospitals; 3) A psychosocial rehabilitation programme, introduced to registered counsellors in PHC facilities; 4) Refresher training on management of severe mental health conditions for physicians and nurses in PHC facilities; 5) A community mental health education and detection toolkit and associated training package for community health worker outreach teams; 6) The Household Champion programme, a psychoeducation, empowerment and support programme to improve caregiver capacity for care.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults (aged 18 years and above);
• Being admitted to the psychiatric ward of a hospital for observation and treatment due to an acute psychiatric event, based on ICD diagnosis on patient charts according to the following criteria:

• F20-29 including schizophrenia, delusional disorders, schizotypal disorders, acute polymorph psychotic disorders, schizoaffective disorders
• F30-39 Mood [affective] disorders with psychoses
• F30.2 Mania with psychotic symptoms
• F31.2 Bipolar affective disorder, current episode manic with psychotic symptoms
• F31.5 Bipolar affective disorder, current episode severe depression with psychotic symptoms
• F32.3 Severe depressive episode with psychotic symptoms
• F33.3 Recurrent depressive disorder, current episode severe with psychotic symptoms
• Determined by the attending psychiatrist to be discharged into community settings following appropriate recovery from the psychiatric event;
• Willing and able to participate in the intervention programme
• Resides with a caregiver (which could be a family member or member of the household).
• Resides within the geographic boundaries of uMgungundlovu

• Adults (aged 18 years and above)
• Willing and able to participate in the intervention programme
• Resides with a caregiver (which could be a family member or member of the household).
• Resides within the geographic boundaries of uMgungundlovu

Exclusion Criteria

• Under 18 years of age
• Are indicated by their chart history to have the following conditions:

• Active suicidal ideation
• Substance abuse or dependence as primary diagnosed psychiatric condition
• Personality disorders
• Serious cognitive or other sensorial impairment likely to preclude informed consent and reliable assessment
• Does not reside with a caregiver
• Does not reside within the geographic boundaries of uMgungundlovu

• Adults (aged 18 years and above)
• Willing and able to participate in the intervention programme
• Resides with a caregiver (which could be a family member or member of the household).
• Resides within the geographic boundaries of uMgungundlovu

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role: collaborator

University of KwaZulu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Msunduzi Local Municipality

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

André Janse van Rensburg, PhD

Role: CONTACT

jansevanrensburga@ukzn.ac.za

+27312601569

Tasneem Kathree, PhD

Role: CONTACT

Kathree@ukzn.ac.za

+27312601569

Facility Contacts

Tasneem Kathree, PhD

Role: primary

kathree@ukzn.ac.za

+27827869330

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1R34MH131233-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link