- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06260098
StressLess Yoga Study
May 7, 2024 updated by: Crystal Park, University of Connecticut
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Storrs, Connecticut, United States, 06269
- Bousfield Psychology Building, 406 Babbidge Road
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Serious or unstable psychiatric illness (e.g., psychosis, mania)
- Major coexisting medical illness (e.g., cancer, COPD, obesity)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga with High Breath work & meditation; Low movement/postures
|
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.
|
|
Experimental: Yoga with Low Breath work & meditation; High movement/postures
|
Participants will engage in an 8 week asynchronous yoga class with a emphasis on the physicality and movements of the practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
8 weeks
|
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2024
Primary Completion (Actual)
May 5, 2024
Study Completion (Actual)
May 5, 2024
Study Registration Dates
First Submitted
January 25, 2024
First Submitted That Met QC Criteria
February 6, 2024
First Posted (Actual)
February 15, 2024
Study Record Updates
Last Update Posted (Actual)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- H23-0617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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