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OpenTrials
Completed

NCT Number: NCT02700490

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.

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Key information

Conditions

Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Public Mental Health

Yogyakarta, D.I Yogyakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychotherapy

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) score from baseline

    Time frame: Baseline, 6 months and 12 months

    Measures type and extent of disability of participants

  2. Change in European Quality of Life Scale (EQ-5D) score from baseline

    Time frame: Baseline, 6 months and 12 months

    Measures quality of life of participants

  3. Utility of service as measured by Client Service Receipt Inventory (CSRI)

    Time frame: Baseline, 6 months and 12 months

    Measures service utility within the time frame

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • Gadjah Mada University
  • Universita di Verona

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 7, 2016
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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