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

NCT ID: NCT02700490

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

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.

Conditions

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Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Specialist

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

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type BEHAVIORAL

Behaviour Therapy or Cognitive Behaviour Therapy which forms "service as usual" in primary care centres in Indonesia.

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.

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type BEHAVIORAL

Behaviour Therapy or Cognitive Behaviour Therapy which forms "service as usual" in primary care centres in Indonesia.

Interventions

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Psychotherapy

Behaviour Therapy or Cognitive Behaviour Therapy which forms "service as usual" in primary care centres in Indonesia.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role collaborator

Gadjah Mada University

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Sabrina Anjara

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tine Van Bortel

Role: STUDY_DIRECTOR

University of Cambridge

Carol Brayne

Role: STUDY_CHAIR

University of Cambridge

Locations

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Centre for Public Mental Health

Yogyakarta, D.I Yogyakarta, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type DERIVED
PMID: 31697724 (View on PubMed)

Study Documents

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Document Type: Complete Data Set

View Document

Other Identifiers

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PRE.2015.108

Identifier Type: -

Identifier Source: org_study_id

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