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Clinical Trials/NCT02700490
NCT02700490
Completed
Not Applicable

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

University of Cambridge1 site in 1 country400 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Disorders
Sponsor
University of Cambridge
Enrollment
400
Locations
1
Primary Endpoint
Change in Clinical Interview Schedule Revised (CIS-R) score from baseline
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sabrina Anjara

PhD

University of Cambridge

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Clinical Interview Schedule Revised (CIS-R) score from baseline

Time Frame: Baseline, 6 months and 12 months

Measures the presence and severity of psychiatric symptoms

Change in Health of Nations Outcomes Scale (HoNOS) score from baseline

Time Frame: Baseline, 6 months and 12 months

Measures health and social functioning of participants

Secondary Outcomes

  • Utility of service as measured by Client Service Receipt Inventory (CSRI)(Baseline, 6 months and 12 months)
  • Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) score from baseline(Baseline, 6 months and 12 months)
  • Change in European Quality of Life Scale (EQ-5D) score from baseline(Baseline, 6 months and 12 months)

Study Sites (1)

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