Task Sharing for the Care of Severe Mental Disorders in a Low-income Country: a Randomised, Controlled Non-inferiority Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Cape Town
- Enrollment
- 324
- Locations
- 2
- Primary Endpoint
- Brief Psychiatric Rating Scale, Expanded Version (BPRS-E)
Study Overview
Brief Summary
Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.
Detailed Description
Background and rationale Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.
Methods Setting Meskan and Mareko districts, Gurage Zone, and Silti Zone, Southern Nations, Nationalities and People's Region, Ethiopia.
Design A parallel group, randomized, single-blinded, controlled non-inferiority trial.
Participants Adults (aged between 25 and 65 years) with severe mental disorders (DSM-IV diagnoses of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder) of a severity requiring continuing care who were (1) identified during a population-based survey carried out between 1998 and 2001, and are still under active follow-up, or (2) recruited from Butajira hospital psychiatric outpatient clinic.
Participants will be recruited and randomised in two phases. Phase 1 will include participants who are clinically stable, not pregnant or breastfeeding, not on depot medication and who have no co-morbid substance use or complex medical conditions. After a three month evaluation period, and if no safety or quality issues arise, the study will proceed to Phase 2. Phase 2 will include participants who have more complex needs or are less clinically stable.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Brief Psychiatric Rating Scale, Expanded Version (BPRS-E)
Time Frame: 12 months post-randomisation (18 months for secondary outcome)
Symptom severity scale. Non-inferiority of the experimental intervention is defined as less than six point difference in BPRS-E score between the two arms.
Secondary Outcomes
- Restraint (Proportion chained, restrained of confined in the past month.)(12 and 18 months post-randomisation)
- Quality of clinical care (WHO's mental health gap intervention guide)(12 and 18 months post-randomisation)
- Local functioning scale (disability scale for people with severe mental disorders developed specifically for this trial)(12 and 18 months post-randomisation)
- Relapse of mental disorder (Measured using the Life Chart Schedule)(12 and 18 months post-randomisation)
- Patient service satisfaction (Newly developed 'mental health service satisfaction scale' and qualitative interviews.)(12 and 18 months post-randomisation)
- Medication side effects (Antipsychotic Side effect Checklist)(12 and 18 months post-randomisation)
- Stigma (Family Interview Schedule (caregivers)(12 and 18 months post-randomisation)
- WHO Disability Assessment Scale, version 2.0 (WHODAS 2.0)(12 and 18 months post-randomisation)
- Nutritional status (Body mass index.)(12 and 18 months post-randomisation)
- Service use for physical health care (Client Service Receipt Inventory)(12 and 18 months post-randomisation)
- Adverse event(12 and 18 months post-randomisation)
- Patient adherence and engagement (Medication Adherence Measure and tracking of appointment attendance.)(12 and 18 months post-randomisation)
- Acceptability and feasibility (in-depth interviews with patients, caregivers and health care providers.)(6 months post-randomisation onwards)
Investigators
Charlotte Hanlon
Principal Investigator
Addis Ababa University