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临床试验/NCT03751696
NCT03751696Unknown不适用

Coaching Intervention to Improve Mental Well-being of Community Women Who Are At-risk of Common Mental Disorders in Hong Kong: A Pilot Randomized Controlled Trials

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Depressive symptoms

研究概览

简要总结

This study aims to provide preventative intervention to 60 women who are at risk of common mental disorders in Hong Kong.

详细描述

Participants will be recruited through the following routes: 1) by our partner non-governmental organizations, 2) by our research team through community outreach or training activities, 3) online screening tool, and 4) referral from organizations that provide service to women (e.g., Maternal and Child Health Clinics of Department of Health). Eligible subjects with informed consent provided will be randomly assigned to coaching group or SMS self-help tips. To test the effectiveness of the provided intervention programs, symptoms assessments and data collection on demographics and psychosocial data will be carried out during baseline, immediately, and 3 months post-intervention.

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 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Willing to provide written informed consent
  • Able to understand Cantonese and read/write Chinese
  • With subsyndromal or minor depressive symptoms indicated by
  • Depression subscale of Depression, Anxiety and Stress Scale (DASS) score 10-20 or
  • Edinburgh Postnatal Depression Scale (EPDS) scores 10-13

排除标准

  • A positive response in items about suicidal thoughts if applicable ("Yes, quite often" and "sometimes" in EPDS) (These participants will be referred to suicidal management)
  • Those mental conditions that require other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
  • Those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness)
  • Those who are receiving structured psychotherapy or counseling

结局指标

主要结局

Depressive symptoms

时间窗: immediate post-intervention

Measured by the depression subscale of the Depression, Anxiety and Stress Scale

Anxiety symptoms

时间窗: immediate post-intervention

Measured by the anxiety subscale of the Depression, Anxiety and Stress Scale

次要结局

  • Anxiety symptoms(3-month post intervention)
  • Depressive symptoms(3-month post intervention)

研究者

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

Professor Eric Y.H. Chen

Chair Professor

The University of Hong Kong

研究点 (2)

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