Mental Disorders Clinical Trial
Official title:
Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia
Verified date | October 2019 |
Source | University of Cambridge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Centre for Public Mental Health | Yogyakarta | D.I Yogyakarta |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge | Gadjah Mada University, Universita di Verona |
Indonesia,
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 |
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