StressNCT06260098
StressLess Yoga Study
A study testing Yoga with High Breath work & meditation; Low movement/postures and Yoga with Low Breath work & meditation; High movement/postures in people with Stress, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress
- What is being tested?
- Yoga with High Breath work & meditation; Low movement/postures and Yoga with Low Breath work & meditation; High movement/postures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2024to 5 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Self-identification as "stressed"
- Scoring 8 or higher on the Perceived Stress Scale (PSS) indicating moderate-to-high stress
- Willingness to complete the 8-week yoga intervention
- Willingness to attend baseline and follow-up visits
- Ability to read and write in English
- Having practiced yoga ≤ 2x in the last 6 months
Who cannot join
- Serious or unstable psychiatric illness (e.g., psychosis, mania)
- Major coexisting medical illness (e.g., cancer, COPD, obesity)
Trial locations and contacts
1 site in 1 country.
United States1 site
Bousfield Psychology Building, 406 Babbidge Road
Storrs, Connecticut, 06269
About this study
Official title: StressLess Yoga Study: A Scientific Exploration of Yoga for Stress Reduction
The purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. low breath work and meditation; high movement/postures). In addition to self-report stress, measures include sleep, heart rate variability, mindfulness, Essential Properties of Yoga, and acceptability questions.
- Conditions
- Stress
- Being tested
- Yoga with High Breath work & meditation; Low movement/postures, Yoga with Low Breath work & meditation; High movement/postures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga with High Breath work & meditation; Low movement/posturesBehavioural
Participants will engage in an 8 week asynchronous yoga class focused on the internal and cognitive experience within the practice using breathing and meditation focused techniques.
Yoga with Low Breath work & meditation; High movement/posturesBehavioural
Participants will engage in an 8 week asynchronous yoga class with a emphasis on the physicality and movements of the practice.
| Study group | Role | What they receive |
|---|---|---|
| Yoga with High Breath work & meditation; Low movement/postures | Experimental | Not described Receives: Behavioral: Yoga with High Breath work & meditation; Low movement/postures |
| Yoga with Low Breath work & meditation; High movement/postures | Experimental | Not described Receives: Behavioral: Yoga with Low Breath work & meditation; High movement/postures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number (percentage)of people completing the whole protocol (6/8 yoga classes & 2 in-person visits)
The number (percentage)of people completing the whole protocol (6/8 yoga classes \& 2 in-person visits)
Measured: 8 weeks
The combined score (out of 35) on the 5-item Treatment Acceptability Questionnaire (TAQ)
The combined score (out of 35) on the 5-item Treatment Acceptability Questionnaire (TAQ). The measure is scored on a 1-7 Likert scale. Higher scores indicate highly acceptable, ethical, knowledgeable, and trustworthy study treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start3 Apr 2024
- Primary completion5 May 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Park, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260098
- Sponsor's protocol ID
- H23-0617
- Status last verified
- May 2024
- First submitted
- 25 Jan 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StressLess Yoga Study: A Scientific Exploration of Yoga for Stress Reduction
- ClinicalTrials.gov ID
- NCT06260098
- Acronym / sponsor ID
- H23-0617
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 15 Feb 2024 (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 purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. low breath work and meditation; high movement/postures). In addition to self-report stress, measures include sleep, heart rate variability, mindfulness, Essential Properties of Yoga, and acceptability questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga with High Breath work & meditation; Low movement/postures | Experimental | Behavioral: Yoga with High Breath work & meditation; Low movement/postures |
| Yoga with Low Breath work & meditation; High movement/postures | Experimental | Behavioral: Yoga with Low Breath work & meditation; High movement/postures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Self-identification as "stressed"
- Scoring 8 or higher on the Perceived Stress Scale (PSS) indicating moderate-to-high stress
- Willingness to complete the 8-week yoga intervention
- Willingness to attend baseline and follow-up visits
Key exclusion criteria (2 listed)
- Serious or unstable psychiatric illness (e.g., psychosis, mania)
- Major coexisting medical illness (e.g., cancer, COPD, obesity)
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 |
|---|---|---|
| Yoga with High Breath work & meditation; Low movement/posturesParticipants will engage in an 8 week asynchronous yoga class focused on the internal and cognitive experience within the practice using breathing and meditation focused techniques. | Behavioural | Yoga with High Breath work & meditation; Low movement/postures |
| Yoga with Low Breath work & meditation; High movement/posturesParticipants will engage in an 8 week asynchronous yoga class with a emphasis on the physicality and movements of the practice. | Behavioural | Yoga with Low Breath work & meditation; High movement/postures |
Primary outcome
The number (percentage)of people completing the whole protocol (6/8 yoga classes & 2 in-person visits)
Time frame: 8 weeks
The number (percentage)of people completing the whole protocol (6/8 yoga classes \& 2 in-person visits)
The combined score (out of 35) on the 5-item Treatment Acceptability Questionnaire (TAQ)
Time frame: 8 weeks
The combined score (out of 35) on the 5-item Treatment Acceptability Questionnaire (TAQ). The measure is scored on a 1-7 Likert scale. Higher scores indicate highly acceptable, ethical, knowledgeable, and trustworthy study treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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 with High Breath work & meditation; Low movement/postures and Yoga with Low Breath work & meditation; High movement/postures in people with Stress, run by University of Connecticut 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 7 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: finished, as of the sponsor's last update on 8 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number (percentage)of people completing the whole protocol (6/8 yoga classes & 2 in-person visits) (time frame: 8 weeks). The study lists 2 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 8 May 2024.