Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia

Study Overview
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Brief Summary
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This study is a cluster randomised controlled trial, which aims to examine the short-term strategy of addressing treatment gap through increasing primary mental health service capacity. This study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients.

Detailed Description
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Two primary mental health service frameworks in Yogyakarta are compared: the specialist framework and the enhanced usual care framework. Both frameworks have not been evaluated in the Indonesian context, despite their potential to be the framework of choice for other provincial and district governments to adopt. Extension to existing services has been planned, which provides us with the opportunity to implement in a random manner the enhanced usual care framework in new areas. This study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients. This study receives ground-level support from the Centre for Public Mental Health, Universitas Gadjah Mada, which manages the specialist primary mental health framework in Yogyakarta province, regional and national-level support from the Ministry of Health of Indonesia, and will be hopefully funded by the LPDP, Ministry of Finance of Indonesia.

Official Title
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Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia

Conditions
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Mental Disorders

Intervention / Treatment
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* Behavioral: Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are adults who meet the screening criteria for depression and anxiety on the self-report General Health Questionnaire (GHQ-12) Exclusion Criteria: Potential participants who are currently receiving treatment for any mental health disorders will not be invited to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Specialist<br>Assessment and treatment of common mental disorders by a clinical psychologist in primary care facilities. | Behavioral: Psychotherapy<br>* Behaviour Therapy or Cognitive Behaviour Therapy which forms service as usual in primary care centres in Indonesia.<br>|
| Experimental: Enhanced Usual Care<br>Assessment and treatment of common mental disorders by a general practitioner and nurse practitioner, who have been trained in the WHO mhGap manual, in primary care facilities. | Behavioral: Psychotherapy<br>* Behaviour Therapy or Cognitive Behaviour Therapy which forms service as usual in primary care centres in Indonesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health of Nations Outcomes Scale (HoNOS) score from baseline | Measures health and social functioning of participants | Baseline, 6 months and 12 months | 
| Change in Clinical Interview Schedule Revised (CIS-R) score from baseline | Measures the presence and severity of psychiatric symptoms | Baseline, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) score from baseline | Measures type and extent of disability of participants | Baseline, 6 months and 12 months | 
| Change in European Quality of Life Scale (EQ-5D) score from baseline | Measures quality of life of participants | Baseline, 6 months and 12 months | 
| Utility of service as measured by Client Service Receipt Inventory (CSRI) | Measures service utility within the time frame | Baseline, 6 months and 12 months |