Clinical trial NCT06620783: The Efficacy of an Exercise Program and a Yoga Program in Mitigating Stress and Improving Mental Health Among Employees
Official title: The Efficacy of an Exercise Program and a Yoga Program in Mitigating Stress and Improving Mental Health Among Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
PTSD
Work Related Stress
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Boramae Hospital
First posted: 2024-10-01
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Adults under the age of 19 or over the age of 49.
* 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.

Primary outcomes:
measure: Stress level
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
measure: Depression level
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Secondary outcomes:
measure: Insomnia level
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
measure: PTSD symptoms
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
measure: Work-related stress levels
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
measure: Burnout symptoms
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
measure: Emotional states
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
measure: Basic physical level
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
measure: 2-lead EEG
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
measure: Heart rate variability
timeFrame: Pre-intervention, Post-intervention (right after the 4 weeks of intervention, within at most a week timeframe), 1 month follow-up
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Study officials:
References: