About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (aged 18 years and above);
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
Disqualifiers
Under 18 years of age
Active suicidal ideation
Substance abuse or dependence as primary diagnosed psychiatric condition
Personality disorders
Trial design
Parallel
Treatments tested in this trial
Multilevel psychosocial support for people living with severe mental illness and their caregivers
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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
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.
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
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.
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.
Sponsors and contacts
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University of KwaZulu
Lead sponsor
Columbia University
Collaborator
Universiteit Antwerpen
Collaborator
Medical Research Council, South Africa
Collaborator