Tools for Wellbeing COVID-19 National Study of Undergraduate Students

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Detailed Description

The purpose of this project is to widely disseminate a system of yoga tools to university students, faculty, and staff internationally to buffer the psychological impact of the COVID-19 pandemic. A recent study finds that stress, anxiety, and depression are the major psychological responses to COVID-19 during the early outbreaks in China (Wang et al., 2020). Globally, universities have closed campuses and moved learning, teaching, and working online with a very short notice. CDC suggests that keeping physically active and meditation are among the key activities to maintain a strong immune system and mental health during quarantine. Studies have documented physical and mental benefits of yoga practices (Balasubramaniam, Telles, & Doraiswamy, 2013; Brems, 2015; Brunner, Abramovitch, & Etherton, 2017; Büssing, Michalsen, Telles, Sherman, & Khalsa, 2012) This project introduces a system of yoga tools to buffer the psychological impact of COVID-19. This system of yoga tools is designed by Sadhguru Jaggi Vasudev, a yogi, mystic, author, and founder of the Isha Foundation. The Isha foundation is a volunteer-based international non-profit organization, offering yoga and meditation programs for human wellbeing and global harmony. In partnership with the Isha Foundation and Harvard University Medical School, the study will document the short-term and long-term effects of these yogic practices on stress, mood, wellbeing, resilience, and academic engagement for students and work engagement for faculty and staff during this challenging time.

Interventions

  • Other: Yoga
    • Yoga Namaskar and Nadi Shuddhi

Arms, Groups and Cohorts

  • Experimental: Group 1 – Yoga Group
    • Learn online yoga practices and practice daily for 12-weeks
  • Other: Group 2 – Control Group
    • waist-list control for 4-week, cross-over to yoga practice for 8-week

Clinical Trial Outcome Measures

Primary Measures

  • Stress
    • Time Frame: Change from baseline stress at 1-Month
    • 10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
  • Stress
    • Time Frame: Change from baseline stress at 2-Month
    • 10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
  • Stress
    • Time Frame: Change from baseline stress in 3-Month
    • 10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
  • Wellbeing
    • Time Frame: Change from baseline wellbeing in 2-week
    • 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
  • Wellbeing
    • Time Frame: Change from baseline wellbeing in 4-week
    • 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
  • Wellbeing
    • Time Frame: Change from baseline wellbeing in 6-week
    • 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
  • Wellbeing
    • Time Frame: Change from baseline wellbeing in 8-week
    • 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
  • Wellbeing
    • Time Frame: Change from baseline wellbeing in 10-week
    • 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
  • Wellbeing
    • Time Frame: Change from baseline wellbeing in 12-week
    • 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

Secondary Measures

  • Anxiety
    • Time Frame: Change from baseline anxiety in 2-week
    • 2-item PHQ-4, score 2-8, higher score higher anxiety
  • Anxiety
    • Time Frame: Change from baseline anxiety in 4-week
    • 2-item PHQ-4, score 2-8, higher score higher anxiety
  • Anxiety
    • Time Frame: Change from baseline anxiety in 6-week
    • 2-item PHQ-4, score 2-8, higher score higher anxiety
  • Anxiety
    • Time Frame: Change from baseline anxiety in 8-week
    • 2-item PHQ-4, score 2-8, higher score higher anxiety
  • Anxiety
    • Time Frame: Change from baseline anxiety in 10-week
    • 2-item PHQ-4, score 2-8, higher score higher anxiety
  • Anxiety
    • Time Frame: Change from baseline anxiety in 12-week
    • 2-item PHQ-4, score 2-8, higher score higher anxiety
  • Depression
    • Time Frame: Change from baseline depression in 2-week
    • 2-item PHQ-4, score 2-8, higher score higher depression
  • Depression
    • Time Frame: Change from baseline depression in 4-week
    • 2-item PHQ-4, score 2-8, higher score higher depression
  • Depression
    • Time Frame: Change from baseline depression in 6-week
    • 2-item PHQ-4, score 2-8, higher score higher depression
  • Depression
    • Time Frame: Change from baseline depression in 8-week
    • 2-item PHQ-4, score 2-8, higher score higher depression
  • Depression
    • Time Frame: Change from baseline depression in 10-week
    • 2-item PHQ-4, score 2-8, higher score higher depression
  • Depression
    • Time Frame: Change from baseline depression in 12-week
    • 2-item PHQ-4, score 2-8, higher score higher depression
  • Resilience
    • Time Frame: Change from baseline resilience in 1-month
    • 6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
  • Resilience
    • Time Frame: Change from baseline resilience in 2-month
    • 6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
  • Resilience
    • Time Frame: Change from baseline resilience in 3-month
    • 6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
  • Positive Affect
    • Time Frame: Change from baseline positive affect in 2-week
    • 10-item Positive Affect Scale, score – 10 to 50, higher score more positive affect
  • Positive Affect
    • Time Frame: Change from baseline positive affect in 4-week
    • 10-item Positive Affect Scale, score – 10 to 50, higher score more positive affect
  • Positive Affect
    • Time Frame: Change from baseline positive affect in 6-week
    • 10-item Positive Affect Scale, score – 10 to 50, higher score more positive affect
  • Positive Affect
    • Time Frame: Change from baseline positive affect in 8-week
    • 10-item Positive Affect Scale, score – 10 to 50, higher score more positive affect
  • Positive Affect
    • Time Frame: Change from baseline positive affect in 10-week
    • 10-item Positive Affect Scale, score – 10 to 50, higher score more positive affect
  • Positive Affect
    • Time Frame: Change from baseline positive affect in 12-week
    • 10-item Positive Affect Scale, score – 10 to 50, higher score higher positive affect
  • Negative Affect
    • Time Frame: Change from baseline negative affect in 2-week
    • 10-item Negative Affect Scale, score – 10 to 50, higher score higher negative affect
  • Negative Affect
    • Time Frame: Change from baseline negative affect in 4-week
    • 10-item Negative Affect Scale, score – 10 to 50, higher score higher negative affect
  • Negative Affect
    • Time Frame: Change from baseline negative affect in 6-week
    • 10-item Negative Affect Scale, score – 10 to 50, higher score higher negative affect
  • Negative Affect
    • Time Frame: Change from baseline negative affect in 8-week
    • 10-item Negative Affect Scale, score – 10 to 50, higher score higher negative affect
  • Negative Affect
    • Time Frame: Change from baseline negative affect in 10-week
    • 10-item Negative Affect Scale, score – 10 to 50, higher score higher negative affect
  • Negative Affect
    • Time Frame: Change from baseline negative affect in 12-week
    • 10-item Negative Affect Scale, score – 10 to 50, higher score higher negative affect

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Collaborator
    • Harvard Medical School
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tracy F. H. Chang, Ph.D., Associate Extension Specialist – Rutgers, The State University of New Jersey
  • Overall Official(s)
    • Tracy F Chang, Ph.D., Principal Investigator, Rutgers University
  • Overall Contact(s)
    • Tracy F Chang, Ph.D., 2052666477, tracy.chang@rutgers.edu

References

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.

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.

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.

Büssing 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. Epub 2012 Sep 13.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96.

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.

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.

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.

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.

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.

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). pii: E1729. doi: 10.3390/ijerph17051729.

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