- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05777044
The Effect of Hatha Yoga on Mental Health
A Comparison of Hatha Yoga and Mediation on Mental Health Outcomes.
The goal of this clinical trial is to determine the effects of a 10-week (2x a week; 45-minute per session) Hatha yoga intervention in adults ages 18-25 (n = 45) on mental health outcomes. The main questions it aims to answer are:
What is the effect of a hatha yoga intervention on depression and anxiety symptoms?
What is the effect of a hatha yoga intervention on electroencephalogram (EEG) alpha and theta band power?
What is the effect of hatha yoga intervention on heart rate variability?
Participants will be randomized to three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group). Participants in the Hatha yoga experimental group will attend 10 weeks of twice-weekly 45-minute yoga sessions.
The active comparison meditation group will participate in 10 weeks of twice-weekly 45-minute meditation sessions. The control group will continue with their usual routine.
Researchers will compare changes in depression and anxiety symptoms, EEG alpha and theta band power, and heart rate variability between the three groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Auburn, Alabama, United States, 36849
- Auburn University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages 18-35
- Medically healthy to participate in physical activity as determined by the Physical Activity Reading Questionnaire (PAR-Q)
- Concerned about or experiencing heightened anxiety, depression, and/or stress symptoms
Exclusion Criteria:
- Those with diagnosed with an intellectual or developmental disability, currently diagnosed with a concussion, physically unhealthy to participate in physical activity
- Anyone currently taking beta-blockers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control- No Intervention/treatment
Participants in the control group will maintain their usual daily routine.
The participants will complete the pre-test, 10 weeks of normal daily activities, and post-test.
No changes to their daily schedule will be made by the researcher.
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Active Comparator: Active Comparator- 10-week, 2x/week, 45-minute sessions of guided meditation
The active comparator meditation group will complete a 10-week meditation yoga intervention (2x/week, 45 minutes per session).
Each session will consist of yogic breathing, imagery, and meditation, specifically with a focus on each of the yogic limbs.
The yogic limbs that will be incorporated during the meditation intervention are yamas, niyamas, pranayamas, and sense withdrawal/meditative techniques.
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Participation in Hatha Yoga twice a week for 45 minutes for 10 weeks.
The total potential dose is 900 minutes over the course of the intervention.
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Experimental: Experimental- 10-week, 2x/week, 45-minute Hatha yoga sessions
The experimental hatha yoga group will complete a 10-week yoga intervention (2x/week, 45 minutes per session).
Each session will consist of a centering, integration, awakening, vitality, equanimity, grounding, igniting, opening, release, and deep rest; all of which are specific hatha yoga practice sections.
This group will complete the pre-test and post-test measures.
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Participation in Hatha Yoga twice a week for 45 minutes for 10 weeks.
The total potential dose is 900 minutes over the course of the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG
Time Frame: 10 weeks
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Frontal (F7/F8) and Temporoparietal (TP9/TP10) Alpha and Theta EEG power.
5-minute recording at rest; measured using the MUSE-2 system and Mind Monitor application.
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10 weeks
|
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Heart rate variability
Time Frame: 10 weeks
|
Root mean square of successive differences (RMSSD) and low-frequency/high-frequency ratio (LF/HF) indices of heart rate variability (HRV), 5-minute recording at rest; measured using the Polar H8/H9 HR monitors and HRVLogger application.
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10 weeks
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Depression
Time Frame: 10 weeks
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Beck's Depression Inventory (BDI) scores as measured by the Beck's Depression Inventory
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10 weeks
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Anxiety
Time Frame: 10 weeks
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Beck's Anxiety Inventory (BAI) scores as measured by the Beck's Anxiety Inventory
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10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure
Time Frame: 10 weeks
|
Resting blood pressure will be assessed with a automatic blood pressure cuff.
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10 weeks
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Body Fat Percentage
Time Frame: 10 weeks
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• Body Composition as measured by changes in body fat percentage (ratio of lean mass to fat mass)
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10 weeks
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Flexbility
Time Frame: 10 weeks
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Changes in shoulder and hamstring flexibility assessed with the Fitnessgram.
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10 weeks
|
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Muscular Endurance
Time Frame: 10 weeks
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Changes in push-up fitnessgram tests
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10 weeks
|
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Aerobic capacity
Time Frame: 10 weeks
|
3-minute YMCA step-test which will be an index of aerobic capacity
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10 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yoga RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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