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

This study is currently recruiting participants.
Verified October 2017 by Sabrina Anjara, University of Cambridge
Sponsor:
ClinicalTrials.gov Identifier:
NCT02700490
First Posted: March 7, 2016
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Universita di Verona
Gadjah Mada University
Information provided by (Responsible Party):
Sabrina Anjara, University of Cambridge
  Purpose
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.

Condition Intervention
Mental Disorders Behavioral: Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia

Resource links provided by NLM:


Further study details as provided by Sabrina Anjara, University of Cambridge:

Primary Outcome Measures:
  • 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

  • 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 Outcome Measures:
  • 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

  • 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

  • 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


Estimated Enrollment: 400
Actual Study Start Date: December 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700490


Contacts
Contact: Sabrina Anjara 447475494866 sga29@medschl.cam.ac.uk

Locations
Indonesia
Centre for Public Mental Health Recruiting
Yogyakarta, D.I Yogyakarta, Indonesia
Contact: Diana Setiyawati, PhD    62274550435    diana@ugm.ac.id   
Sponsors and Collaborators
University of Cambridge
Universita di Verona
Gadjah Mada University
Investigators
Study Director: Tine Van Bortel University of Cambridge
Study Chair: Carol Brayne University of Cambridge
  More Information

Responsible Party: Sabrina Anjara, PhD Candidate, University of Cambridge
ClinicalTrials.gov Identifier: NCT02700490     History of Changes
Other Study ID Numbers: PRE.2015.108
First Submitted: February 25, 2016
First Posted: March 7, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders