<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453514</url>
  </required_header>
  <id_info>
    <org_study_id>Tibbitts_TIYoga_COVID</org_study_id>
    <nct_id>NCT04453514</nct_id>
  </id_info>
  <brief_title>Feasibility of a Brief Trauma-informed Yoga Intervention for Anxiety During the Coronavirus Disease (COVID-19) Pandemic</brief_title>
  <official_title>Cultivating Calm During COVID-19: A Feasibility Study of Video-based Trauma-informed Yoga</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Natural Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University of Natural Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will help the investigators understand whether it is feasible and acceptable for&#xD;
      people to practice trauma-informed yoga using a pre-recorded video. This study will also&#xD;
      explore the immediate effects of trauma-informed yoga on anxiety, mindfulness, and body&#xD;
      awareness. The results of this study will inform future research on remote delivery of&#xD;
      trauma-informed yoga for supporting psychological wellbeing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emerging data shows a high prevalence of anxiety during the first several months of the&#xD;
      COVID-19 pandemic in the United States. Accordingly, there have been calls for supportive&#xD;
      interventions for psychological health during the pandemic. Due to physical distancing&#xD;
      requirements, supportive interventions for psychological health will be most accessible if&#xD;
      they can be administered remotely. Trauma-informed yoga may support psychological health&#xD;
      during the COVID-19 pandemic, but research on remote delivery of trauma-informed yoga is&#xD;
      needed. The present study will evaluate the feasibility and acceptability of trauma-informed&#xD;
      yoga delivered remotely. In this study, the investigators will create an online delivery&#xD;
      platform within REDCap, a secure web application for research, that 1) hosts a 45-minute&#xD;
      video of a trauma-informed yoga practice, and 2) collects data on participants' present&#xD;
      moment experience of anxiety, mindfulness, and body awareness immediately before and after&#xD;
      the yoga practice. Feasibility and acceptability data will allow the investigators to&#xD;
      evaluate recruitment methods and refine the delivery method of trauma-informed yoga in a way&#xD;
      that aligns with participant preferences. The investigators will also evaluate the short-term&#xD;
      effects of trauma-informed yoga on state anxiety, state mindfulness, and body awareness. This&#xD;
      study will allow the investigators to pilot the remote delivery of trauma-informed yoga&#xD;
      during the ongoing, highly stressful COVID-19 pandemic and further develop trauma-informed&#xD;
      yoga as a supportive intervention for psychological health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">June 19, 2021</completion_date>
  <primary_completion_date type="Actual">June 19, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants enrolled over 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Total number of participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants enrolled per week over 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Count of participants enrolled each week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who enroll in the study over 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of participants who enroll out of the total who access the consent form</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who complete the study over 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of participants that reach the final page of the study out of the total who provided informed consent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of missing data over 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of participants who filled out less than 70% of the items per questionnaire; mean proportion of items skipped per questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who complete the 45-minute video over 3 months</measure>
    <time_frame>3 months</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form</measure>
    <time_frame>immediately before/after</time_frame>
    <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: &quot;indicate how you feel right now, in this moment.&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in state mindfulness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Mind subscale)</measure>
    <time_frame>immediately before/after</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in body awareness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Body subscale)</measure>
    <time_frame>immediately before/after</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">212</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Trauma-informed yoga video recording</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete a single trauma-informed yoga practice using a 45-minute guided video recording.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trauma-informed yoga video recording</intervention_name>
    <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.</description>
    <arm_group_label>Trauma-informed yoga video recording</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Has an internet connection&#xD;
&#xD;
          -  Willing to try a gentle yoga practice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot read or understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deanne Tibbitts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Natural Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National University of Natural Medicine</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Natural Medicine</investigator_affiliation>
    <investigator_full_name>Deanne Tibbitts, PhD</investigator_full_name>
    <investigator_title>Research Investigator</investigator_title>
  </responsible_party>
  <keyword>Yoga</keyword>
  <keyword>Mind-Body Therapies</keyword>
  <keyword>Complementary Therapies</keyword>
  <keyword>Online</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453514
org study id: Tibbitts_TIYoga_COVID
nct id: NCT04453514
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants enrolled over 3 months
time frame: 3 months
description: Total number of participants
measure: Number of participants enrolled per week over 3 months
time frame: 3 months
description: Count of participants enrolled each week
measure: Proportion of participants who enroll in the study over 3 months
time frame: 3 months
description: Proportion of participants who enroll out of the total who access the consent form
measure: Proportion of participants who complete the study over 3 months
time frame: 3 months
description: Proportion of participants that reach the final page of the study out of the total who provided informed consent
measure: Proportion of missing data over 3 months
time frame: 3 months
description: Proportion of participants who filled out less than 70% of the items per questionnaire; mean proportion of items skipped per questionnaire
measure: Proportion of participants who complete the 45-minute video over 3 months
time frame: 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
measure: 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
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.
measure: 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
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.
measure: 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
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.
arm group label: Trauma-informed yoga video recording
arm group type: Experimental
description: Participants will complete a single trauma-informed yoga practice using a 45-minute guided video recording.
intervention type: Behavioral
intervention name: Trauma-informed yoga video recording
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.
arm group label: Trauma-informed yoga video recording
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Deanne Tibbitts, PhD
role: Principal Investigator
affiliation: National University of Natural Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: National University of Natural Medicine
investigator full name: Deanne Tibbitts, PhD
investigator title: Research Investigator
mesh term: Anxiety Disorders