NCT04453514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

June 30, 2020

Last Update Submit

July 20, 2021

Conditions

Anxiety

Keywords

YogaMind-Body TherapiesComplementary TherapiesOnline

Outcome Measures

Primary Outcomes (6)

  • Number of participants enrolled over 3 months

    Total number of participants

    3 months

  • Number of participants enrolled per week over 3 months

    Count of participants enrolled each week

    3 months

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form

    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)

    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)

    immediately before/after

Study Arms (1)

Trauma-informed yoga video recording

EXPERIMENTAL

Participants will complete a single trauma-informed yoga practice using a 45-minute guided video recording.

Behavioral: Trauma-informed yoga video recording

Interventions

Trauma-informed yoga video recordingBEHAVIORAL

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.

Trauma-informed yoga video recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cannot read or understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Deanne Tibbitts, PhD

    National University of Natural Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Investigator

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 1, 2020

Study Start

July 21, 2020

Primary Completion

June 19, 2021

Study Completion

June 19, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

US(1)