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

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
University of Cambridge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Public Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Specialist

Enhanced Usual Care

Arm Description

Assessment and treatment of common mental disorders by a clinical psychologist in primary care facilities.

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.

Outcomes

Primary Outcome Measures

Change in Health of Nations Outcomes Scale (HoNOS) score from baseline
Measures health and social functioning of participants
Change in Clinical Interview Schedule Revised (CIS-R) score from baseline
Measures the presence and severity of psychiatric symptoms

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2016
Last Updated
October 25, 2019
Sponsor
University of Cambridge
Collaborators
Universita di Verona, Gadjah Mada University
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1. Study Identification

Unique Protocol Identification Number
NCT02700490
Brief Title
Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia
Official Title
Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cambridge
Collaborators
Universita di Verona, Gadjah Mada University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specialist
Arm Type
Active Comparator
Arm Description
Assessment and treatment of common mental disorders by a clinical psychologist in primary care facilities.
Arm Title
Enhanced Usual Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Behaviour Therapy or Cognitive Behaviour Therapy which forms "service as usual" in primary care centres in Indonesia.
Primary Outcome Measure Information:
Title
Change in Health of Nations Outcomes Scale (HoNOS) score from baseline
Description
Measures health and social functioning of participants
Time Frame
Baseline, 6 months and 12 months
Title
Change in Clinical Interview Schedule Revised (CIS-R) score from baseline
Description
Measures the presence and severity of psychiatric symptoms
Time Frame
Baseline, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) score from baseline
Description
Measures type and extent of disability of participants
Time Frame
Baseline, 6 months and 12 months
Title
Change in European Quality of Life Scale (EQ-5D) score from baseline
Description
Measures quality of life of participants
Time Frame
Baseline, 6 months and 12 months
Title
Utility of service as measured by Client Service Receipt Inventory (CSRI)
Description
Measures service utility within the time frame
Time Frame
Baseline, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tine Van Bortel
Organizational Affiliation
University of Cambridge
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carol Brayne
Organizational Affiliation
University of Cambridge
Official's Role
Study Chair
Facility Information:
Facility Name
Centre for Public Mental Health
City
Yogyakarta
State/Province
D.I Yogyakarta
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available through the University of Cambridge data repository.
IPD Sharing URL
https://www.protocols.io/view/evaluating-the-clinical-cost-effectiveness-of-two-6ythfwn
Citations:
PubMed Identifier
31697724
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Complete Data Set
Available IPD/Information URL
https://doi.org/10.17863/CAM.43399
Available IPD/Information Identifier
10.17863/CAM.43399

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

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