Clinical trial NCT04453514: Feasibility of a Brief Trauma-informed Yoga Intervention for Anxiety During the Coronavirus Disease (COVID-19) Pandemic
Official title: Cultivating Calm During COVID-19: A Feasibility Study of Video-based Trauma-informed Yoga
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Yoga
Mind-Body Therapies
Complementary Therapies
Online
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants enrolled over 3 months
timeFrame: 3 months
measure: Number of participants enrolled per week over 3 months
timeFrame: 3 months
measure: Proportion of participants who enroll in the study over 3 months
timeFrame: 3 months
measure: Proportion of participants who complete the study over 3 months
timeFrame: 3 months
measure: Proportion of missing data over 3 months
timeFrame: 3 months
measure: Proportion of participants who complete the 45-minute video over 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form
timeFrame: immediately before/after
measure: Mean change in state mindfulness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Mind subscale)
timeFrame: immediately before/after
measure: Mean change in body awareness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Body subscale)
timeFrame: immediately before/after
Other outcomes:
Locations:
city: Portland
country: United States
facility: National University of Natural Medicine
state: Oregon
Study officials:
affiliation: National University of Natural Medicine
name: Deanne Tibbitts, PhD
role: PRINCIPAL_INVESTIGATOR
References: