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临床试验/NCT01006694
NCT01006694已完成不适用

Paraprofessional Treatment of Depression in Vietnam

Vietnam Veterans of America Foundation2 个研究点 分布在 1 个国家目标入组 473 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
473
试验地点
2
主要终点
Change across time (random effects slope) in depressive symptoms, as assessed by the PHQ-9 questionnaire

研究概览

简要总结

Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.

详细描述

This project focuses on evaluation of a collaborative care system for treatment of depression in Vietnam. This system involves training para-professional health care workers in a stepped-care model system of depression care to be implemented in commune health stations in Vietnam.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Depression Diagnosis

排除标准

  • active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.

研究组 & 干预措施

Guideline Antidepressant Medication

Active Comparator

Guideline Antidepressant Medication, following the VN National Mental Health plan.

干预措施: Guideline Antidepressant Medication (Drug)

Behavioral Activation + Medication

Experimental

Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.

干预措施: Behavioral Activation + Medication (Other)

结局指标

主要结局

Change across time (random effects slope) in depressive symptoms, as assessed by the PHQ-9 questionnaire

时间窗: 0, 6, 12, 24 weeks

The PHQ-9 (Patient Health Questionnaire-9) assesses depressive symptoms, over the last two weeks. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points.

次要结局

  • "Depression remission", as assessed by the PHQ-9(6, 12, 24 weeks)
  • "Substantial improvement" in depressive symptoms, as assessed by the PHQ-9(6, 12, 24 weeks)
  • Change across time (random effects slope) in anxiety symptoms, as assessed by the GAD-7 questionnaire(0, 6, 12, 24 weeks)
  • Change across time (random effects slope) in physical health, as assessed by the SF-12 questionnaire, Physical Health subscale(0, 6, 12, 24 weeks)
  • Change across time (random effects slope) in behavioral activation skills and behaviors, as assessed by the BADS questionnaire.(0, 6, 12, 24 weeks)
  • Change across time (random effects slope) in mental health, as assessed by the SF-12 questionnaire, Mental Health subscale(0, 6, 12, 24 weeks)

研究者

发起方
Vietnam Veterans of America Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahr Weiss

Associate Professor

Vanderbilt University

研究点 (2)

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