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临床试验/NCT06620783
NCT06620783已完成不适用

The Efficacy of an Exercise Program and a Yoga Program in Mitigating Stress and Improving Mental Health Among Employees

Seoul National University Hospital3 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年10月4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
75
试验地点
3
主要终点
Stress level

研究概览

简要总结

To reduce workplace stress and promote mental health, participants were divided into three groups: exercise program, yoga program, and self-care. The effectiveness of the exercise and yoga programs was evaluated using pre- and post-program self-reported questionnaires, HRV (Heart Rate Variability), and 2-lead EEG.

详细描述

After screening, a preliminary assessment is conducted on the study participants who have agreed to participate. The preliminary assessment includes medical history review, questionnaires related to current physical activity levels, mental health-related questionnaires concerning stress, depression, insomnia, job stress, and job burnout. It also includes tests for heart rate variability (HRV), physiological stress-related indicators via a 2-lead EEG, and a basic physical ability assessment. After the preliminary evaluation:

Those in the exercise program group will access and undertake the exercise program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks.

The yoga program group will access and perform the yoga program on a web or mobile platform for approximately 50 minutes per session, three times a week, for a total of 12 sessions over 4 weeks.

The self-care group will access materials helpful for stress management via a web or mobile platform and engage in self-study three times a week, for a total of 12 sessions over 4 weeks.

After completing their respective programs, participants from the exercise group, yoga group, and the self-care control group will revisit the hospital within a week to undergo the same tests as in the preliminary evaluation, excluding medical history and physical activity information. Moreover, to determine whether the effects of the exercise and yoga programs persist after the program ends, participants will return for the same tests one month after the 4-week program concludes. Using the data obtained, the study will measure the changes induced by the self-directed exercise and yoga programs on the participants' clinical scales like stress, symptoms of depression, HRV, EEG, and basic physical abilities. The effects on the improvement of psychological and physiological stress indicators of the self-care group, using stress data, will then be compared and analyzed.

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
19 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Employed individuals aged 19 to 49 years.
  • Participants with moderate stress levels, scoring 14 or higher on the Perceived Stress Scale.
  • Individuals currently undergoing pharmacological treatment for psychiatric conditions such as depression, anxiety disorders, or insomnia, provided they are in a stable phase with no expected changes in medication dosage during the clinical trial period.
  • Participants who fully understand the clinical trial protocol and have voluntarily consented to participate.

排除标准

  • Adults under the age of 19 or over the age of
  • Individuals with dementia, intellectual disabilities, or other cognitive impairments.
  • Those with neurological disorders such as epileptic conditions, stroke, or other neurological diseases.
  • Individuals with a history of, or currently diagnosed with, psychiatric disorders like schizophrenia or bipolar disorder.
  • Individuals with a history of suicidal ideation or attempts.
  • Those taking medications or having conditions determined by the research team to potentially affect the reliability of the HRV (Heart Rate Variability) test (e.g., heart disease, pulmonary disease, etc.).
  • Those who have received non-pharmacological psychiatric treatment or counseling in the current or past 6 months.
  • Individuals deemed by the research team to have physical limitations that make it difficult to participate in exercise or yoga programs.

结局指标

主要结局

Stress level

时间窗: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up

Stress level by the Perceived Stress Scale. We will use the Korean version of the Perceived Stress Scale, originally developed by Cohen et al. (1983) and revised by Cohen et al. in 1988. This version has been adapted into Korean and validated to measure participants\' perceived stress experiences. The total score ranges from 0 to 40, with each item rated on a 5-point Likert scale from 0 (never) to 4 (very often). A higher score indicates a greater perception of unpredictability, lack of control, and overwhelming stress-related experiences over the past month.

Depression level

时间窗: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up

Depression level by the Patient Health Questionnaire 9. This is a self-report assessment tool designed to briefly screen for depressive disorders and evaluate the severity of depressive symptoms (Kroenke et al., 2001). It comprises items corresponding to the nine diagnostic criteria for major depressive disorder according to the DSM-IV, based on depressive symptoms experienced over the past two weeks. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Scores of 5 or above, 10 or above, 15 or above, and 20 or above suggest mild, moderate, moderately severe, and severe depression, respectively.

次要结局

  • Insomnia level(Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up)
  • PTSD symptoms(Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up)
  • Work-related stress levels(Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up)
  • Burnout symptoms(Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up)
  • Emotional states(Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up)
  • Basic physical level(Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up)
  • 2-lead EEG(Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up)
  • Heart rate variability(Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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