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临床试验/NCT05313542
NCT05313542Unknown不适用

Effect of Physical Activity in the Format of Self-defence Training for Depressive Symptoms - A Pilot Randomised Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Change in the Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

Inadequate mental health care capacity is a long-standing issue in Hong Kong (Yang & Mak, 2020). For example, a recent study predicts an additional 12% service need for specialist psychiatric care (Ni et al., 2020). It would be helpful to develop interventions that would ease the high demand of the health care system. Physical activity has been shown to reduce depressive symptoms in a number of studies (Bellón et al., 2021; Josefsson et al., 2014; Kvam et al., 2018; Schuch et al., 2016). Its flexibility and low-cost nature make physical activity a good intervention option for depressed individuals to do it anytime and anywhere.

This study aims to investigate the effect of physical activity intervention in the format of self-defence training on depressive symptoms. Around 40 eligible participants with at least moderate level of depressive symptoms will be randomly assigned to the physical activity (PA) group and waitlist (WL) control group. The PA group will receive a 6-week home-based self-defence training programme consisting of 120 min video training (including daily practice time) per week. Self-report questionnaires will be collected at baseline, immediate post-intervention, and 4-week follow up assessments. The primary outcome measure will be the Patient Health Questionnaire-9 to evaluate depression severity. Secondary outcomes will include psychological health symptoms, sleep quality, lifestyle, and quality of life. This research will provide new perspectives on the application of physical activity in the form of self-defence training as an intervention for depressive individuals.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 65 years old
  • Hong Kong Residents
  • Patient Health Questionnaire (PHQ-9) score ≥ 10; and
  • Willingness to provide informed consent and comply with the trial protocol.

排除标准

  • Patients with any cardiovascular diseases
  • Receiving psychological treatment or medication for psychiatric disorders
  • Participated in self defence training in the past 6 months

结局指标

主要结局

Change in the Patient Health Questionnaire (PHQ-9)

时间窗: Baseline, immediately post-intervention, 4-week follow-up

The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

次要结局

  • Change in the Short Form (Six-Dimension) Health Survey (SF-6D)(Baseline, immediately post-intervention, 4-week follow-up)
  • Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)(Baseline, immediately post-intervention, 4-week follow-up)
  • Change in Treatment Adherence Survey (TAS)(Baseline, immediately post-intervention)
  • Change in Hospital Anxiety and Depression Scale (HADS-14)(Baseline, immediately post-intervention, 4-week follow-up)
  • Change in Credibility-Expectancy Questionnaire (CEQ)(Baseline, immediately post-intervention, 4-week follow-up)
  • Change in the Insomnia Severity Index (ISI)(Baseline, immediately post-intervention, 4-week follow-up)
  • Change in Multidimensional Fatigue Inventory (MFI-20)(Baseline, immediately post-intervention, 4-week follow-up)

研究者

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

Fiona YY Ho

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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