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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders
• Intervention / Treatment: Behavioral: Psychotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • D.I Yogyakarta
    • Yogyakarta, D.I Yogyakarta, Indonesia
      • Centre for Public Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Specialist; Assessment and treatment of common mental disorders by a clinical psychologist in primary care facilities.	Behavioral: Psychotherapy; Behaviour Therapy or Cognitive Behaviour Therapy which forms "service as usual" in primary care centres in Indonesia.
Experimental: Enhanced Usual Care; 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; Behaviour Therapy or Cognitive Behaviour Therapy which forms "service as usual" in primary care centres in Indonesia.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cambridge
• Collaborators: Universita di Verona; Gadjah Mada University
• Investigators: Study Director: Tine Van Bortel, University of Cambridge; Study Chair: Carol Brayne, University of Cambridge

Publications and helpful links

General Publications

• Anjara SG, Bonetto C, Ganguli P, Setiyawati D, Mahendradhata Y, Yoga BH, Trisnantoro L, Brayne C, Van Bortel T. Can General Practitioners manage mental disorders in primary care? A partially randomised, pragmatic, cluster trial. PLoS One. 2019 Nov 7;14(11):e0224724. doi: 10.1371/journal.pone.0224724. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: PRE.2015.108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available through the University of Cambridge data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Study Data/Documents

1. Complete Data Set
   Information identifier: 10.17863/CAM.43399