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

Anxiety Clinical Trial

Official title:

Cultivating Calm During COVID-19: A Feasibility Study of Video-based Trauma-informed Yoga

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453514
• Other study ID #: Tibbitts_TIYoga_COVID
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: June 19, 2021

Study information

• Verified date: July 2021
• Source: National University of Natural Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The results of this study will inform future research on remote delivery of trauma-informed yoga for supporting psychological wellbeing.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: June 19, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	National University of Natural Medicine	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National University of Natural Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants enrolled over 3 months	Total number of participants	3 months
Primary	Number of participants enrolled per week over 3 months	Count of participants enrolled each week	3 months
Primary	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	3 months
Primary	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	3 months
Primary	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	3 months
Primary	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	3 months
Secondary	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.	immediately before/after
Secondary	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.	immediately before/after
Secondary	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.	immediately before/after