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AnxietyNCT04453514

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

A study testing Trauma-informed yoga video recording in people with Anxiety, run by National University of Natural Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety
What is being tested?
Trauma-informed yoga video recording
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteUnited States
Study dates
21 Jul 2020to 19 Jun 2021
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Cannot read or understand English

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National University of Natural Medicine

    Portland, Oregon, 97201

Other trials in United States

About this study

Official title: 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.

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.

Conditions
Anxiety
Being tested
Trauma-informed yoga video recording
Keywords
Yoga, Mind-Body Therapies, Complementary Therapies, Online
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-informed yoga video recordingBehavioural

    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.

Study groups in NCT04453514
Study groupRoleWhat they receive
Trauma-informed yoga video recordingExperimentalParticipants will complete a single trauma-informed yoga practice using a 45-minute guided video recording.
Receives: Behavioral: Trauma-informed yoga video recording

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants enrolled over 3 months

    Total number of participants

    Measured: 3 months

  2. Number of participants enrolled per week over 3 months

    Count of participants enrolled each week

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 3 months

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: immediately before/after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start21 Jul 2020
  3. Primary completion19 Jun 2021
  4. Study completion19 Jun 2021

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04453514
Sponsor's protocol ID
Tibbitts_TIYoga_COVID
Status last verified
Jul 2021
First submitted
30 Jun 2020
Last updated
21 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Trauma-informed yoga video recording in people with Anxiety, run by National University of Natural Medicine 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 3 inclusion and 1 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 21 Jul 2021. 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?

Number of participants enrolled over 3 months (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04453514.

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 21 Jul 2021.

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