Tools for Wellbeing COVID-19 National Study of Undergraduate Students

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 Overview

• Status: Unknown
• Conditions: Depression; Wellbeing; Stress; Anxiety; Resilience; Mood
• Intervention / Treatment: Other: Yoga

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers University
      • Contact: Tracy F Chang, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Yoga Group; Learn online yoga practices and practice daily for 12-weeks	Other: Yoga; Yoga Namaskar and Nadi Shuddhi
Other: Group 2 - Control Group; waist-list control for 4-week, cross-over to yoga practice for 8-week	Other: Yoga; Yoga Namaskar and Nadi Shuddhi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Harvard Medical School (HMS and HSDM)
• Investigators: Principal Investigator: Tracy F Chang, Ph.D., Rutgers University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. doi: 10.1186/1477-7525-5-63.
• 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):1729. doi: 10.3390/ijerph17051729.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 31, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: yoga stress anxiety depression wellbeing COVID
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Pro2020000953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No