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Feasibility of a Brief Trauma-informed Yoga Intervention for Anxiety During the Coronavirus Disease (COVID-19) Pandemic

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-informed yoga video recording
Sponsored by
National University of Natural Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Yoga, Mind-Body Therapies, Complementary Therapies, Online

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National University of Natural Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trauma-informed yoga video recording

Arm Description

Participants will complete a single trauma-informed yoga practice using a 45-minute guided video recording.

Outcomes

Primary Outcome Measures

Number of participants enrolled over 3 months
Total number of participants
Number of participants enrolled per week over 3 months
Count of participants enrolled each week
Proportion of participants who enroll in the study over 3 months
Proportion of participants who enroll out of the total who access the consent form
Proportion of participants who complete the study over 3 months
Proportion of participants that reach the final page of the study out of the total who provided informed consent
Proportion of missing data over 3 months
Proportion of participants who filled out less than 70% of the items per questionnaire; mean proportion of items skipped per questionnaire
Proportion of participants who complete the 45-minute video over 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

Secondary Outcome Measures

Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form
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.
Mean change in state mindfulness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Mind subscale)
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.
Mean change in body awareness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Body subscale)
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.

Full Information

First Posted
June 30, 2020
Last Updated
July 20, 2021
Sponsor
National University of Natural Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04453514
Brief Title
Feasibility of a Brief Trauma-informed Yoga Intervention for Anxiety During the Coronavirus Disease (COVID-19) Pandemic
Official Title
Cultivating Calm During COVID-19: A Feasibility Study of Video-based Trauma-informed Yoga
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
June 19, 2021 (Actual)
Study Completion Date
June 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Natural Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Yoga, Mind-Body Therapies, Complementary Therapies, Online

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trauma-informed yoga video recording
Arm Type
Experimental
Arm Description
Participants will complete a single trauma-informed yoga practice using a 45-minute guided video recording.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-informed yoga video recording
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants enrolled over 3 months
Description
Total number of participants
Time Frame
3 months
Title
Number of participants enrolled per week over 3 months
Description
Count of participants enrolled each week
Time Frame
3 months
Title
Proportion of participants who enroll in the study over 3 months
Description
Proportion of participants who enroll out of the total who access the consent form
Time Frame
3 months
Title
Proportion of participants who complete the study over 3 months
Description
Proportion of participants that reach the final page of the study out of the total who provided informed consent
Time Frame
3 months
Title
Proportion of missing data over 3 months
Description
Proportion of participants who filled out less than 70% of the items per questionnaire; mean proportion of items skipped per questionnaire
Time Frame
3 months
Title
Proportion of participants who complete the 45-minute video over 3 months
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form
Description
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.
Time Frame
immediately before/after
Title
Mean change in state mindfulness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Mind subscale)
Description
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.
Time Frame
immediately before/after
Title
Mean change in body awareness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Body subscale)
Description
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.
Time Frame
immediately before/after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deanne Tibbitts, PhD
Organizational Affiliation
National University of Natural Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Natural Medicine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility of a Brief Trauma-informed Yoga Intervention for Anxiety During the Coronavirus Disease (COVID-19) Pandemic

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