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

NCT ID: NCT06620783

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2024-03-31

Brief Summary

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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

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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.

Conditions

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Depression PTSD Work Related Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exercise program group

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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

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.

yoga program group

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.

Group Type ACTIVE_COMPARATOR

yoga

Intervention Type BEHAVIORAL

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.

self-care group

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.

Group Type SHAM_COMPARATOR

active self-care

Intervention Type BEHAVIORAL

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.

Interventions

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exercise

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.

Intervention Type BEHAVIORAL

yoga

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.

Intervention Type BEHAVIORAL

active self-care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Boramae Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-2309-855-301

Identifier Type: -

Identifier Source: org_study_id

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