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The Effect of Hatha Yoga on Mental Health

Primary Purpose

Depression, Anxiety, Mental Health Issue

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Auburn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Auburn University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control- No Intervention/treatment

Active Comparator- 10-week, 2x/week, 45-minute sessions of guided meditation

Experimental- 10-week, 2x/week, 45-minute Hatha yoga sessions

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

EEG
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.
Heart rate variability
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.
Depression
Beck's Depression Inventory (BDI) scores as measured by the Beck's Depression Inventory
Anxiety
Beck's Anxiety Inventory (BAI) scores as measured by the Beck's Anxiety Inventory

Secondary Outcome Measures

Blood Pressure
Resting blood pressure will be assessed with a automatic blood pressure cuff.
Body Fat Percentage
• Body Composition as measured by changes in body fat percentage (ratio of lean mass to fat mass)
Flexbility
Changes in shoulder and hamstring flexibility assessed with the Fitnessgram.
Muscular Endurance
Changes in push-up fitnessgram tests
Aerobic capacity
3-minute YMCA step-test which will be an index of aerobic capacity

Full Information

First Posted
March 9, 2023
Last Updated
March 9, 2023
Sponsor
Auburn University
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1. Study Identification

Unique Protocol Identification Number
NCT05777044
Brief Title
The Effect of Hatha Yoga on Mental Health
Official Title
A Comparison of Hatha Yoga and Mediation on Mental Health Outcomes.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
November 12, 2022 (Actual)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Mental Health Issue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to one of three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group).
Masking
Outcomes Assessor
Masking Description
Research personnel who administer heart rate variability and EEG were blinded to group assignment.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control- No Intervention/treatment
Arm Type
No Intervention
Arm Description
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.
Arm Title
Active Comparator- 10-week, 2x/week, 45-minute sessions of guided meditation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental- 10-week, 2x/week, 45-minute Hatha yoga sessions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG
Description
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.
Time Frame
10 weeks
Title
Heart rate variability
Description
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.
Time Frame
10 weeks
Title
Depression
Description
Beck's Depression Inventory (BDI) scores as measured by the Beck's Depression Inventory
Time Frame
10 weeks
Title
Anxiety
Description
Beck's Anxiety Inventory (BAI) scores as measured by the Beck's Anxiety Inventory
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Resting blood pressure will be assessed with a automatic blood pressure cuff.
Time Frame
10 weeks
Title
Body Fat Percentage
Description
• Body Composition as measured by changes in body fat percentage (ratio of lean mass to fat mass)
Time Frame
10 weeks
Title
Flexbility
Description
Changes in shoulder and hamstring flexibility assessed with the Fitnessgram.
Time Frame
10 weeks
Title
Muscular Endurance
Description
Changes in push-up fitnessgram tests
Time Frame
10 weeks
Title
Aerobic capacity
Description
3-minute YMCA step-test which will be an index of aerobic capacity
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.

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The Effect of Hatha Yoga on Mental Health

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