NCT04414371

Brief Summary

The study evaluates the effectiveness of yoga practices on reducing stress, negative emotion, anxiety, and depression and on increasing positive emotion, wellbeing and resilience. The study uses randomized wait-list control. All U.S. undergraduate students in 4-year universities and colleges age 18 or older are eligible to participate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 20, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

May 31, 2020

Last Update Submit

June 2, 2020

Conditions

StressAnxietyDepressionResilienceWellbeingMood

Keywords

yoga stress anxiety depression wellbeing COVID

Outcome Measures

Primary Outcomes (9)

  • Stress

    10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress

    Change from baseline stress at 1-Month

  • Stress

    10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress

    Change from baseline stress at 2-Month

  • Stress

    10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress

    Change from baseline stress in 3-Month

  • Wellbeing

    14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

    Change from baseline wellbeing in 2-week

  • Wellbeing

    14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

    Change from baseline wellbeing in 4-week

  • Wellbeing

    14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

    Change from baseline wellbeing in 6-week

  • Wellbeing

    14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

    Change from baseline wellbeing in 8-week

  • Wellbeing

    14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

    Change from baseline wellbeing in 10-week

  • Wellbeing

    14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

    Change from baseline wellbeing in 12-week

Secondary Outcomes (27)

  • Anxiety

    Change from baseline anxiety in 2-week

  • Anxiety

    Change from baseline anxiety in 4-week

  • Anxiety

    Change from baseline anxiety in 6-week

  • Anxiety

    Change from baseline anxiety in 8-week

  • Anxiety

    Change from baseline anxiety in 10-week

  • +22 more secondary outcomes

Study Arms (2)

Group 1 - Yoga Group

EXPERIMENTAL

Learn online yoga practices and practice daily for 12-weeks

Other: Yoga

Group 2 - Control Group

OTHER

waist-list control for 4-week, cross-over to yoga practice for 8-week

Other: Yoga

Interventions

YogaOTHER

Yoga Namaskar and Nadi Shuddhi

Group 1 - Yoga GroupGroup 2 - Control Group

Eligibility Criteria

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

You may qualify if:

  • or older
  • Enrolled in 4-year universities/colleges in 2020
  • Not graduate in May 2020

You may not qualify if:

  • Younger than 18
  • Not enrolled in 4-year universities/colleges in 2020
  • Graduate in May 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Publications (11)

  • Balasubramaniam M, Telles S, Doraiswamy PM. Yoga on our minds: a systematic review of yoga for neuropsychiatric disorders. Front Psychiatry. 2013 Jan 25;3:117. doi: 10.3389/fpsyt.2012.00117. eCollection 2012.

    PMID: 23355825BACKGROUND

  • Brems C. A Yoga Stress Reduction Intervention for University Faculty, Staff, and Graduate Students. Int J Yoga Therap. 2015;25(1):61-77. doi: 10.17761/1531-2054-25.1.61.

    PMID: 26667290BACKGROUND

  • Brunner D, Abramovitch A, Etherton J. A yoga program for cognitive enhancement. PLoS One. 2017 Aug 4;12(8):e0182366. doi: 10.1371/journal.pone.0182366. eCollection 2017.

    PMID: 28783749BACKGROUND

  • Bussing A, Michalsen A, Khalsa SB, Telles S, Sherman KJ. Effects of yoga on mental and physical health: a short summary of reviews. Evid Based Complement Alternat Med. 2012;2012:165410. doi: 10.1155/2012/165410. Epub 2012 Sep 13.

    PMID: 23008738BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • Froeliger BE, Garland EL, Modlin LA, McClernon FJ. Neurocognitive correlates of the effects of yoga meditation practice on emotion and cognition: a pilot study. Front Integr Neurosci. 2012 Jul 26;6:48. doi: 10.3389/fnint.2012.00048. eCollection 2012.

    PMID: 22855674BACKGROUND

  • Gard T, Noggle JJ, Park CL, Vago DR, Wilson A. Potential self-regulatory mechanisms of yoga for psychological health. Front Hum Neurosci. 2014 Sep 30;8:770. doi: 10.3389/fnhum.2014.00770. eCollection 2014.

    PMID: 25368562BACKGROUND

  • Schmalzl L, Powers C, Henje Blom E. Neurophysiological and neurocognitive mechanisms underlying the effects of yoga-based practices: towards a comprehensive theoretical framework. Front Hum Neurosci. 2015 May 8;9:235. doi: 10.3389/fnhum.2015.00235. eCollection 2015.

    PMID: 26005409BACKGROUND

  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PMID: 18696313BACKGROUND

  • Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

    PMID: 18042300BACKGROUND

  • Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.

    PMID: 32155789BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Yoga

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Tracy F Chang, Ph.D.

    Rutgers University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy F Chang, Ph.D.

CONTACT

2052666477tracy.chang@rutgers.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized waitlist control cross over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Extension Specialist

Study Record Dates

First Submitted

May 31, 2020

First Posted

June 4, 2020

Study Start

May 20, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)