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

NCT07339462 | Recruiting DMC

• 1 other identifier: 1R34MH131233-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders, Severe

Keywords

Severe mental illness; Community-based care; Family empowerment; Recovery; Hospital readmission; Deinstitutionalization; Integrated care

Outcome Measures

Primary Outcomes (1)

• Change in rate of hospital psychiatric re-admission among people living with severe mental illness, as assessed by medical records, at 4 months.

  The proportion of intervention arm participants who have not relapsed and re-hospitalised for an acute psychiatric event within a period of four months since enrolment, compared to control arm participants, as measured by trial monitoring data.

  From enrollment to 4 months

Secondary Outcomes (10)

• Change in recovery score among people living with severe mental illness, as assessed by the total score on the Recovery Assessment Scale - Domains and Stages (RAS-DS), at 4 months

  Baseline, 4-month follow-up fieldworker-administered questionnaire

• Change in internalized stigma score among people living with severe mental illness, as assessed by the total score on the Brief version of the Internalized Stigma of Mental Illness (ISMI) scale, at 4 months

  Baseline, 4-month follow-up fieldworker-administered questionnaire

• Change in treatment adherence score among people living with severe mental illness, as assessed by the total score on a tailored scale, at 4 months

  Baseline, 4-month follow-up fieldworker-administered questionnaire

• Description of stakeholder views regarding the acceptability of the MhINT Recovery intervention after 4 months of implementation

  From enrollment to the end of the intervention at 4 months

• Description of perceptions of stakeholders regarding the demand of the MhINT Recovery intervention after 4 months of implementation

  From enrollment to the end of the intervention at 4 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

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

Control Arm

NO INTERVENTION

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.

Interventions

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• University of KwaZulu: lead
• Universiteit Antwerpen: collaborator
• Medical Research Council, South Africa: collaborator
• Columbia University: collaborator

Study Sites (1)

Msunduzi Local Municipality

Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

André Janse van Rensburg, PhD

CONTACT

+27312601569; jansevanrensburga@ukzn.ac.za

Tasneem Kathree, PhD

CONTACT

+27312601569; Kathree@ukzn.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Co-developed health system strengthening intervention (MhINT Recovery)

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: January 14, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)