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临床试验/NCT02700490
NCT02700490已完成不适用

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

University of Cambridge1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Change in Clinical Interview Schedule Revised (CIS-R) score from baseline

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants are adults who meet the screening criteria for depression and anxiety on the self-report General Health Questionnaire (GHQ-12)

排除标准

  • Potential participants who are currently receiving treatment for any mental health disorders will not be invited to participate in the study.

研究组 & 干预措施

Specialist

Active Comparator

Assessment and treatment of common mental disorders by a clinical psychologist in primary care facilities.

干预措施: Psychotherapy (Behavioral)

Enhanced Usual Care

Experimental

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.

干预措施: Psychotherapy (Behavioral)

结局指标

主要结局

Change in Clinical Interview Schedule Revised (CIS-R) score from baseline

时间窗: Baseline, 6 months and 12 months

Measures the presence and severity of psychiatric symptoms

Change in Health of Nations Outcomes Scale (HoNOS) score from baseline

时间窗: Baseline, 6 months and 12 months

Measures health and social functioning of participants

次要结局

  • Utility of service as measured by Client Service Receipt Inventory (CSRI)(Baseline, 6 months and 12 months)
  • Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) score from baseline(Baseline, 6 months and 12 months)
  • Change in European Quality of Life Scale (EQ-5D) score from baseline(Baseline, 6 months and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabrina Anjara

PhD

University of Cambridge

研究点 (1)

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