DepressionNCT05777044
The Effect of Hatha Yoga on Mental Health
A study testing Yoga in people with Depression and Anxiety, run by Auburn University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Mental Health Issue
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Depression, Anxiety, Mental Health Issue
- Being tested
- Yoga
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Depression
Beck's Depression Inventory (BDI) scores as measured by the Beck's Depression Inventory
Measured: 10 weeks
Anxiety
Beck's Anxiety Inventory (BAI) scores as measured by the Beck's Anxiety Inventory
Measured: 10 weeks
Secondary outcomes (5)
Blood Pressure
Resting blood pressure will be assessed with a automatic blood pressure cuff.
Measured: 10 weeks
Body Fat Percentage
- Body Composition as measured by changes in body fat percentage (ratio of lean mass to fat mass)
Measured: 10 weeks
Flexbility
Changes in shoulder and hamstring flexibility assessed with the Fitnessgram.
Measured: 10 weeks
Muscular Endurance
Changes in push-up fitnessgram tests
Measured: 10 weeks
Aerobic capacity
3-minute YMCA step-test which will be an index of aerobic capacity
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start9 Sep 2022
- Primary completion12 Nov 2022
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle D Wadsworth, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777044
- Sponsor's protocol ID
- Yoga RCT
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Hatha Yoga and Mediation on Mental Health Outcomes.
- ClinicalTrials.gov ID
- NCT05777044
- Acronym / sponsor ID
- Yoga RCT
- Conditions
- Depression, Anxiety, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized to one of three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: YogaThe 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. |
| Experimental- 10-week, 2x/week, 45-minute Hatha yoga sessions | Experimental | Behavioral: YogaThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaParticipation 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. | Behavioural | Active Comparator- 10-week, 2x/week, 45-minute sessions of guided meditation, Experimental- 10-week, 2x/week, 45-minute Hatha yoga sessions |
Primary outcome
EEG
Time frame: 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.
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.
Depression
Time frame: 10 weeks
Beck's Depression Inventory (BDI) scores as measured by the Beck's Depression Inventory
Anxiety
Time frame: 10 weeks
Beck's Anxiety Inventory (BAI) scores as measured by the Beck's Anxiety Inventory
5 secondary outcomes
Blood Pressure
Time frame: 10 weeks
Body Fat Percentage
Time frame: 10 weeks
Flexbility
Time frame: 10 weeks
Muscular Endurance
Time frame: 10 weeks
Aerobic capacity
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Depression and Anxiety, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.