Mental Disorders, SevereMhINT RecoveryNCT07339462
Feasibility and Acceptability of an Intervention to Support People With Severe Mental Illness in South Africa
A study testing Multilevel psychosocial support for people living with severe mental illness and their caregivers in people with Mental Disorders, Severe, run by University of KwaZulu at 1 site in South Africa.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders, Severe
- What is being tested?
- Multilevel psychosocial support for people living with severe mental illness and their caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Aug 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Service user 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
Service user 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
Caregiver inclusion criteria
- 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
Caregiver exclusion criteria
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Msunduzi Local Municipality
Pietermaritzburg, KwaZulu-Natal, 3201
Tasneem Kathree, PhD, +27827869330, kathree@ukzn.ac.za
Andre Van Rensburg, PhD
About this study
Official title: Feasibility and Acceptability of Critical Time Intervention to Support People With Severe Mental Illness Following Post-acute Hospital Discharge in South Africa
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.
Read the 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
- Being tested
- Multilevel psychosocial support for people living with severe mental illness and their caregivers
- Keywords
- Severe mental illness, Community-based care, Family empowerment, Recovery, Hospital readmission, Deinstitutionalization, Integrated care
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel psychosocial support for people living with severe mental illness and their caregiversBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorders, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Co-developed health system strengthening intervention (MhINT Recovery)
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Universiteit Antwerpen, Medical Research Council, South Africa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339462
- Sponsor's protocol ID
- 1R34MH131233-01
- Acronym
- MhINT Recovery
- Status last verified
- Oct 2025
- First submitted
- 17 Mar 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Critical Time Intervention to Support People With Severe Mental Illness Following Post-acute Hospital Discharge in South Africa
- ClinicalTrials.gov ID
- NCT07339462
- Acronym / sponsor ID
- MhINT Recovery / 1R34MH131233-01
- Conditions
- Mental Disorders, Severe
- Keywords
- Severe mental illness, Community-based care, Family empowerment, Recovery, Hospital readmission, Deinstitutionalization, Integrated care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- Columbia University, Universiteit Antwerpen, Medical Research Council, South Africa
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Co-developed health system strengthening intervention (MhINT Recovery)
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Multilevel psychosocial support for people living with severe mental illness and their caregiversParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilevel psychosocial support for people living with severe mental illness and their caregiversThe 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. | Behavioural | Intervention Arm |
Primary outcome
Change in rate of hospital psychiatric re-admission among people living with severe mental illness, as assessed by medical records, at 4 months.
Time frame: From enrollment to 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.
10 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Time frame: From enrollment to the end of the intervention at 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel psychosocial support for people living with severe mental illness and their caregivers in people with Mental Disorders, Severe, run by University of KwaZulu at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact André Janse van Rensburg, PhD (+27312601569, jansevanrensburga@ukzn.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of hospital psychiatric re-admission among people living with severe mental illness, as assessed by medical records, at 4 months. (time frame: From enrollment to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026.