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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of KwaZulu

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

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.

Time frame
From enrollment to 4 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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University of KwaZulu

Lead sponsor

Columbia University

Collaborator

Universiteit Antwerpen

Collaborator

Medical Research Council, South Africa

Collaborator