Clinical trial NCT02700490: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Universita di Verona
name: Gadjah Mada University
First posted: 2016-03-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in Health of Nations Outcomes Scale (HoNOS) score from baseline
timeFrame: Baseline, 6 months and 12 months
measure: Change in Clinical Interview Schedule Revised (CIS-R) score from baseline
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) score from baseline
timeFrame: Baseline, 6 months and 12 months
measure: Change in European Quality of Life Scale (EQ-5D) score from baseline
timeFrame: Baseline, 6 months and 12 months
measure: Utility of service as measured by Client Service Receipt Inventory (CSRI)
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Centre for Public Mental Health
state: D.I Yogyakarta
Study officials:
affiliation: University of Cambridge
name: Tine Van Bortel
role: STUDY_DIRECTOR
affiliation: University of Cambridge
name: Carol Brayne
role: STUDY_CHAIR
References:
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.