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CompletedNCT04453514Updated Jul 21, 2021

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

An interventional study of Trauma-informed yoga video recording in Anxiety, sponsored by National University of Natural Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-21.

Sponsored by National University of Natural Medicine · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
212
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety

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Keywords

  • Yoga
  • Mind-Body Therapies
  • Complementary Therapies
  • Online
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 212 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

National University of Natural Medicine is the lead sponsor of 38 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years of age or older
  • Has an internet connection
  • Willing to try a gentle yoga practice

Exclusion criteria

Exclusion Criteria:

  • Cannot read or understand English
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Trauma-informed yoga video recording

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

    Behavioral: Trauma-informed yoga video recording

Interventions

  • BehavioralTrauma-informed yoga 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.

06

What researchers measure

Primary outcomes

  1. Number of participants enrolled over 3 months

    Total number of participants

    Time frame: 3 months

  2. Number of participants enrolled per week over 3 months

    Count of participants enrolled each week

    Time frame: 3 months

  3. 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

    Time frame: 3 months

  4. 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

    Time frame: 3 months

  5. 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

    Time frame: 3 months

  6. 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

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: immediately before/after

  2. 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.

    Time frame: immediately before/after

  3. 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.

    Time frame: immediately before/after

07

Study locations

1 site
  • National University of Natural Medicine
    Portland, Oregon 97201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04453514
Lead sponsor
National University of Natural Medicine
Responsible party
Deanne Tibbitts, PhD (Research Investigator, National University of Natural Medicine) — Principal investigator
First posted
Jul 1, 2020
Start date
Jul 21, 2020
Primary completion
Jun 19, 2021
Completion
Jun 19, 2021
Last update
Jul 21, 2021

Study contacts

Deanne Tibbitts, PhD
principal investigator · National University of Natural Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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