An interventional study of Multilevel psychosocial support for people living with severe mental illness and their caregivers in Mental Disorders, Severe, sponsored by University of KwaZulu. Recruiting at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by University of KwaZulu · Not applicable, Interventional, and Health services research
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.
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.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 86 is below the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →University of KwaZulu is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Service user inclusion criteria:
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:
Service user exclusion criteria:
Are indicated by their chart history to have the following conditions:
Caregiver inclusion criteria
Caregiver exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: From enrollment to 4 months
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
The proportion of intervention arm participants who have shown changes in recovery scores, as measured by the Recovery Assessment Scale - Domains and Stages (RAS-DS), following an acute psychiatric event within a period of four months since enrolment, compared to control arm participants. 4-point Likert-type scale: Untrue, A bit untrue, A bit true, Completely true Hancock N, Scanlan JN, Honey A, Bundy AC, O'Shea K. Recovery Assessment Scale - Domains and Stages (RAS-DS): Its feasibility and outcome measurement capacity. Aust N Z J Psychiatry. 2015 Jul;49(7):624-33. doi: 10.1177/0004867414564084. Epub 2014 Dec 19. PMID: 25526940; PMCID: PMC4941096.
Time frame: 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
The proportion of intervention arm participants who have shown changes in internalized stigma as measured by the Brief version of the Internalized Stigma of Mental Illness (ISMI) scale, following an acute psychiatric event within a period of four months since enrolment, compared to control arm participants. 4-point Likert-type scale: Strongly disagree, Disagree, Agree, Strongly agree Matshabane OP, Appelbaum PS, Faure MC, et al. Lessons learned from the translation of the Internalised Stigma of Mental Illness (ISMI) scale into isiXhosa for use with South African Xhosa people with schizophrenia. Transcultural Psychiatry. 2023;0(0). doi:10.1177/13634615231168461
Time frame: 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
The proportion of intervention arm participants who have shown changes in treatment adherence scores as measures by a tailored measure, following an acute psychiatric event within a period of four months since enrolment, compared to control arm participants.
Time frame: 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
A qualitative measure of the degree to which the MhINT Recovery intervention is deemed acceptable to people receiving the intervention, their caregivers, healthcare workers, managers, and policymakers, after four months of implementation.
Time frame: 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
A qualitative measure of the degree to which the MhINT Recovery intervention meets the demands of people receiving the intervention, their caregivers, healthcare workers, managers, and policymakers, after four months of implementation.
Time frame: From enrollment to the end of the intervention at 4 months
Description of perceptions of stakeholders regarding the barriers and facilitators of the implementation of MhINT Recovery, in terms of the Consolidated Framework for Implementation Research (CFIR) domains, after 4 months of implementation
A qualitative measure describing barriers and facilitators in implementation of the MhINT Recovery intervention, in terms of the Consolidated Framework for Implementation Research (CFIR) domains (Inner, Outer, Implementation, Innovation, Individual and Implementation), after four months of implementation.
Time frame: From enrollment to the end of the intervention at 4 months
Description of perceptions of stakeholders regarding the practicality of the MhINT Recovery intervention, after 4 months of implementation
A qualitative measure of the degree to which the MhINT Recovery intervention is deemed to be practical by people receiving the intervention, their caregivers, healthcare workers, managers, and policymakers, after four months of implementation.
Time frame: From enrollment to the end of the intervention at 4 months
Description of perceptions of stakeholders regarding the degree to which the MhINT Recovery intervention can be adapted for specific subgroups after 4 months of implementation
A qualitative measure of the degree to which the MhINT Recovery intervention can be adapted to the needs of different subgroups of people receiving the intervention, after four months of implementation.
Time frame: From enrollment to the end of the intervention at 4 months
Description of perceptions of stakeholders regarding the degree to which the MhINT Recovery intervention can be integrated into the local health system after 4 months of implementation
A qualitative measure of the degree to which the MhINT Recovery intervention is perceived to be integrated with the local health system, after four months of implementation.
Time frame: From enrollment to the end of the intervention at 4 months
Description of perceptions of stakeholders regarding the potential of scaling the MhINT Recovery intervention in future, after 4 months of implementation
A qualitative measure of the perceived potential of the MhINT Recovery intervention to be scaled from trial to routine and sustained service changes for people living with severe mental illness, after four months of implementation.
Time frame: From enrollment to the end of the intervention at 4 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Aug 2025 (actual). Primary completion is estimated for Jun 2026, 10 months after the start.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 10 months is below that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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University of KwaZulu