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临床试验/NCT04288622
NCT04288622已完成不适用

A Randomised Controlled Trial Using Experience Sampling Method as a Way to Improve Depressive and Anxiety Symptoms in Women at Risk of Common Mental Disorder in Hong Kong

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
Severity of depressive symptoms

研究概览

简要总结

This study aims to examine the effectiveness of Experience Sampling Method (ESM) derived personalised feedback for women at risk of common mental disorder in Hong Kong, in reducing individuals depressive and anxiety symptoms.

详细描述

Women who are at-risk for common mental disorders and have completed the online screening for Jockey Club Mental Wellness Project for Women (JCWow) will be recruited. This study aims to test the effectiveness of ESM-derived personalized feedback in reducing symptoms of depression and anxiety using a randomised controlled trial. After given written consent, the participants will be required to undergo a 5 days baseline ESM data collection (week 0). Upon completion of baseline data collection, they will be randomly assigned to the intervention (ESM-F), active reference (ESM) or control (CON) group. The participants in the intervention group will participate in an ESM procedure (three days per week over a 6-week period) using through SMS system (week 1 - 6). This group will receive weekly standardised feedback on personalised patterns of positive affect. The active reference group will also participate in the same ESM procedure without a weekly feedback. The control group will not be required to undergo this 6-week data collection procedure. At week 7, all three groups will undergo another 5 days of post-intervention ESM data collection in order to examine the naturalistic and interventional changes on the depressive symptoms. From week 8 onwards, the participants will be contacted 5 times (week 8, 12, 16, 20 and 32) via telephone to follow-up their condition. After 32 weeks, both active reference and control group will receive the report.

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
None

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

  • Women within the age range of 18-64
  • Identified as at-risk for depressive disorders (iDD) using the Depression Subscale (scored 10 or above) in DASS-21
  • Willing to provide written informed consent
  • Understand Cantonese and can read or write Chinese
  • Use a smartphone

排除标准

  • Those mental conditions that require other treatment priorities (e.g., major depression, 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 counselling.

结局指标

主要结局

Severity of depressive symptoms

时间窗: At week 32

Measured by the Depression Subscale in Depression Anxiety Stress Scales (DASS-21). The subscale consists of 7 items, each with 4 options of responses (from 0-3), the total score of the subscale is calculated by summing up the item score of the 7 items and double it. It ranges from 0 to 42. Higher score indicates more severe level of depressive symptoms.

Severity of anxiety symptoms

时间窗: At week 32

Measured by the Anxiety Subscale in Depression Anxiety Stress Scales (DASS-21). The subscale consists of 7 items, each with 4 options of responses (from 0-3), the total score of the subscale is calculated by summing up the item score of the 7 items and double it. It ranges from 0 to 42. Higher score indicates more severe level of anxiety symptoms.

次要结局

未报告次要终点

研究者

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

Dr. Yi-Nam Suen

Research Assistant Professor

The University of Hong Kong

研究点 (1)

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