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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Oregon
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Natural Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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