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

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700490
• Other study ID #: PRE.2015.108
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2019
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders

Intervention

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

Locations

Country	Name	City	State
Indonesia	Centre for Public Mental Health	Yogyakarta	D.I Yogyakarta

Sponsors (3)

Lead Sponsor	Collaborator
University of Cambridge	Gadjah Mada University, Universita di Verona

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health of Nations Outcomes Scale (HoNOS) score from baseline	Measures health and social functioning of participants	Baseline, 6 months and 12 months
Primary	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	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
Secondary	Change in European Quality of Life Scale (EQ-5D) score from baseline	Measures quality of life of participants	Baseline, 6 months and 12 months
Secondary	Utility of service as measured by Client Service Receipt Inventory (CSRI)	Measures service utility within the time frame	Baseline, 6 months and 12 months