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

NCT06620783 | Completed

• 1 other identifier: B-2309-855-301
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; PTSD; Work Related Stress

Outcome Measures

Primary Outcomes (2)

• Stress level

  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.

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

• Depression level

  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.

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

Secondary Outcomes (8)

• 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

Study Arms (3)

exercise program group

ACTIVE COMPARATOR

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.

Behavioral: exercise

yoga program group

ACTIVE COMPARATOR

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.

Behavioral: yoga

self-care group

SHAM COMPARATOR

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.

Behavioral: active self-care

Interventions

exercise 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.

exercise program group

yoga 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.

yoga program group

active self-care 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.

self-care group

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Boramae Hospital: collaborator

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13605, South Korea

Location

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Occupational Stress

Interventions

Exercise; Yoga

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Occupational Diseases; Stress, Psychological

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 1, 2024
• Study Start: October 4, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 31, 2024
• Last Updated: October 1, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)