- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04453514
Feasibility of a Brief Trauma-informed Yoga Intervention for Anxiety During the Coronavirus Disease (COVID-19) Pandemic
July 20, 2021 updated by: Deanne Tibbitts, PhD, National University of Natural Medicine
Cultivating Calm During COVID-19: A Feasibility Study of Video-based Trauma-informed Yoga
This study will help the investigators understand whether it is feasible and acceptable for people to practice trauma-informed yoga using a pre-recorded video.
This study will also explore the immediate effects of trauma-informed yoga on anxiety, mindfulness, and body awareness.
The results of this study will inform future research on remote delivery of trauma-informed yoga for supporting psychological wellbeing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Emerging data shows a high prevalence of anxiety during the first several months of the COVID-19 pandemic in the United States.
Accordingly, there have been calls for supportive interventions for psychological health during the pandemic.
Due to physical distancing requirements, supportive interventions for psychological health will be most accessible if they can be administered remotely.
Trauma-informed yoga may support psychological health during the COVID-19 pandemic, but research on remote delivery of trauma-informed yoga is needed.
The present study will evaluate the feasibility and acceptability of trauma-informed yoga delivered remotely.
In this study, the investigators will create an online delivery platform within REDCap, a secure web application for research, that 1) hosts a 45-minute video of a trauma-informed yoga practice, and 2) collects data on participants' present moment experience of anxiety, mindfulness, and body awareness immediately before and after the yoga practice.
Feasibility and acceptability data will allow the investigators to evaluate recruitment methods and refine the delivery method of trauma-informed yoga in a way that aligns with participant preferences.
The investigators will also evaluate the short-term effects of trauma-informed yoga on state anxiety, state mindfulness, and body awareness.
This study will allow the investigators to pilot the remote delivery of trauma-informed yoga during the ongoing, highly stressful COVID-19 pandemic and further develop trauma-informed yoga as a supportive intervention for psychological health.
Study Type
Interventional
Enrollment (Actual)
212
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
-
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Oregon
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Portland, Oregon, United States, 97201
- National University of Natural Medicine
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- Has an internet connection
- Willing to try a gentle yoga practice
Exclusion Criteria:
- Cannot read or understand English
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trauma-informed yoga video recording
Participants will complete a single trauma-informed yoga practice using a 45-minute guided video recording.
|
Pre-recorded video of a 45-minute trauma-informed yoga practice.
The yoga practice can be done standing or sitting in a chair.
The yoga practice is comprised of slow, gentle movements combined with paying attention to the body and the breath.
The practice uses invitational language and encourages participants to make choices and customize the movements according to their individual needs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants enrolled over 3 months
Time Frame: 3 months
|
Total number of participants
|
3 months
|
Number of participants enrolled per week over 3 months
Time Frame: 3 months
|
Count of participants enrolled each week
|
3 months
|
Proportion of participants who enroll in the study over 3 months
Time Frame: 3 months
|
Proportion of participants who enroll out of the total who access the consent form
|
3 months
|
Proportion of participants who complete the study over 3 months
Time Frame: 3 months
|
Proportion of participants that reach the final page of the study out of the total who provided informed consent
|
3 months
|
Proportion of missing data over 3 months
Time Frame: 3 months
|
Proportion of participants who filled out less than 70% of the items per questionnaire; mean proportion of items skipped per questionnaire
|
3 months
|
Proportion of participants who complete the 45-minute video over 3 months
Time Frame: 3 months
|
Proportion of participants who self-report watching the video in its entirety and for whom time stamps show that the time elapsed on the page where the video is embedded is greater than or equal to 80% of the length of the video
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form
Time Frame: immediately before/after
|
The State Trait Anxiety Inventory (STAI) - Y6 is a 6-item, validated self-report questionnaire that assesses state anxiety when used with instructions that specify: "indicate how you feel right now, in this moment."
Responses to each item are provided on a 4 point Likert Scale ('Not at all' to 'Very much').
The instrument is scored as the mean of 6 items, multiplied by 20 to use the interpretation guide for the full STAI scale.
|
immediately before/after
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Mean change in state mindfulness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Mind subscale)
Time Frame: immediately before/after
|
The State Mindfulness Scale is a 21-item, validated self-report questionnaire that assesses state mindfulness.
The State Mindfulness Scale is comprised of two subscales, State Mindfulness of Mind and State Mindfulness of Body.
Responses to each item are provided on a 5 point Likert Scale ('Not at all' to 'Very much').
The instrument is scored as the sum of scores from each subscale.
For this outcome, the State Mindfulness of Mind subscale will be used.
|
immediately before/after
|
Mean change in body awareness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Body subscale)
Time Frame: immediately before/after
|
The State Mindfulness Scale is a 21-item, validated self-report questionnaire that assesses state mindfulness.
The State Mindfulness Scale is comprised of two subscales, State Mindfulness of Mind and State Mindfulness of Body.
Responses to each item are provided on a 5 point Likert Scale ('Not at all' to 'Very much').
The instrument is scored as the sum of scores from each subscale.
For this outcome, the State Mindfulness of Body subscale will be used.
|
immediately before/after
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Deanne Tibbitts, PhD, National University of Natural Medicine
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)
July 21, 2020
Primary Completion (Actual)
June 19, 2021
Study Completion (Actual)
June 19, 2021
Study Registration Dates
First Submitted
June 30, 2020
First Submitted That Met QC Criteria
June 30, 2020
First Posted (Actual)
July 1, 2020
Study Record Updates
Last Update Posted (Actual)
July 21, 2021
Last Update Submitted That Met QC Criteria
July 20, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tibbitts_TIYoga_COVID
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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