The Effect of Hatha Yoga on Mental Health

Sponsor
Auburn University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05777044
Collaborator
(none)
45
1
3
10.7
4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga
N/A

Detailed Description

There are knowledge gaps that need to be addressed in understanding the effects of yoga, specifically long-term interventions, on physiological markers, electroencephalography (EEG) and heart rate variability (HRV) and elevated mental health symptoms in young adults. The present study will address the knowledge gaps by evaluating the effect of a 10-week (2x a week; 45-minute per session) Hatha yoga intervention in adults ages 18-25 (n = 45). Participants will be truly randomized to three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group). This design will allow the investigators to determine the effects of Hatha yoga on relevant outcome measures. Changes in depression symptoms (BDI), anxiety symptoms (BAI), EEG alpha and theta band power, heart rate variability indices (RMSSD, LF/HF) will be assessed. Compared to the control group, investigators hypothesize that both the Hatha yoga and meditation groups will exhibit an improvement in depression and anxiety symptoms, an increased alpha and theta band power at rest, and an increased RMSSD and decreased LF/HF at rest. Moreover, the investigators hypothesize that the Hatha yoga group will improve body composition, flexibility, muscular endurance and strength, and cardiovascular recovery more than the meditation group.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to one of three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group).Participants will be randomized to one of three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group).
Masking:
Single (Outcomes Assessor)
Masking Description:
Research personnel who administer heart rate variability and EEG were blinded to group assignment.
Primary Purpose:
Treatment
Official Title:
A Comparison of Hatha Yoga and Mediation on Mental Health Outcomes.
Actual Study Start Date :
Sep 9, 2022
Actual Primary Completion Date :
Nov 12, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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.

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.

Behavioral: Yoga
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.

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.

Behavioral: Yoga
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.

Outcome Measures

Primary Outcome Measures

  1. EEG [10 weeks]

    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.

  2. Heart rate variability [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.

  3. Depression [10 weeks]

    Beck's Depression Inventory (BDI) scores as measured by the Beck's Depression Inventory

  4. Anxiety [10 weeks]

    Beck's Anxiety Inventory (BAI) scores as measured by the Beck's Anxiety Inventory

Secondary Outcome Measures

  1. Blood Pressure [10 weeks]

    Resting blood pressure will be assessed with a automatic blood pressure cuff.

  2. Body Fat Percentage [10 weeks]

    • Body Composition as measured by changes in body fat percentage (ratio of lean mass to fat mass)

  3. Flexbility [10 weeks]

    Changes in shoulder and hamstring flexibility assessed with the Fitnessgram.

  4. Muscular Endurance [10 weeks]

    Changes in push-up fitnessgram tests

  5. Aerobic capacity [10 weeks]

    3-minute YMCA step-test which will be an index of aerobic capacity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Auburn University Auburn Alabama United States 36849

Sponsors and Collaborators

  • Auburn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Danielle D Wadsworth, Professor, Auburn University
ClinicalTrials.gov Identifier:
NCT05777044
Other Study ID Numbers:
  • Yoga RCT
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2023