The Effect of Hatha Yoga on Mental Health

NCT05777044 | Unknown

• 1 other identifier: Yoga RCT
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Mental Health Issue

Outcome Measures

Primary Outcomes (4)

• 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.

  10 weeks

• 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.

  10 weeks

• Depression

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

  10 weeks

• Anxiety

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

  10 weeks

Secondary Outcomes (5)

• Blood Pressure

  10 weeks

• Body Fat Percentage

  10 weeks

• Flexbility

  10 weeks

• Muscular Endurance

  10 weeks

• Aerobic capacity

  10 weeks

Study Arms (3)

Control- No Intervention/treatment

NO INTERVENTION

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

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Interventions

Yoga BEHAVIORAL

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.

Active Comparator- 10-week, 2x/week, 45-minute sessions of guided meditation; Experimental- 10-week, 2x/week, 45-minute Hatha yoga sessions

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research personnel who administer heart rate variability and EEG were blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to one of three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group).

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 20, 2023
• Study Start: September 9, 2022
• Primary Completion: November 12, 2022
• Study Completion: August 1, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)