Clinical trial NCT04414371: Tools for Wellbeing COVID-19 National Study of Undergraduate Students
Official title: Tools for Wellbeing COVID-19 National Study of Undergraduate Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Anxiety
Depression
Resilience
Wellbeing
Mood
Keywords: yoga stress anxiety depression wellbeing COVID
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2020-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized waitlist control cross over
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stress
timeFrame: Change from baseline stress at 1-Month
measure: Stress
timeFrame: Change from baseline stress at 2-Month
measure: Stress
timeFrame: Change from baseline stress in 3-Month
measure: Wellbeing
timeFrame: Change from baseline wellbeing in 2-week
measure: Wellbeing
timeFrame: Change from baseline wellbeing in 4-week
measure: Wellbeing
timeFrame: Change from baseline wellbeing in 6-week
measure: Wellbeing
timeFrame: Change from baseline wellbeing in 8-week
measure: Wellbeing
timeFrame: Change from baseline wellbeing in 10-week
measure: Wellbeing
timeFrame: Change from baseline wellbeing in 12-week
Secondary outcomes:
measure: Anxiety
timeFrame: Change from baseline anxiety in 2-week
measure: Anxiety
timeFrame: Change from baseline anxiety in 4-week
measure: Anxiety
timeFrame: Change from baseline anxiety in 6-week
measure: Anxiety
timeFrame: Change from baseline anxiety in 8-week
measure: Anxiety
timeFrame: Change from baseline anxiety in 10-week
measure: Anxiety
timeFrame: Change from baseline anxiety in 12-week
measure: Depression
timeFrame: Change from baseline depression in 2-week
measure: Depression
timeFrame: Change from baseline depression in 4-week
measure: Depression
timeFrame: Change from baseline depression in 6-week
measure: Depression
timeFrame: Change from baseline depression in 8-week
measure: Depression
timeFrame: Change from baseline depression in 10-week
measure: Depression
timeFrame: Change from baseline depression in 12-week
measure: Resilience
timeFrame: Change from baseline resilience in 1-month
measure: Resilience
timeFrame: Change from baseline resilience in 2-month
measure: Resilience
timeFrame: Change from baseline resilience in 3-month
measure: Positive Affect
timeFrame: Change from baseline positive affect in 2-week
measure: Positive Affect
timeFrame: Change from baseline positive affect in 4-week
measure: Positive Affect
timeFrame: Change from baseline positive affect in 6-week
measure: Positive Affect
timeFrame: Change from baseline positive affect in 8-week
measure: Positive Affect
timeFrame: Change from baseline positive affect in 10-week
measure: Positive Affect
timeFrame: Change from baseline positive affect in 12-week
measure: Negative Affect
timeFrame: Change from baseline negative affect in 2-week
measure: Negative Affect
timeFrame: Change from baseline negative affect in 4-week
measure: Negative Affect
timeFrame: Change from baseline negative affect in 6-week
measure: Negative Affect
timeFrame: Change from baseline negative affect in 8-week
measure: Negative Affect
timeFrame: Change from baseline negative affect in 10-week
measure: Negative Affect
timeFrame: Change from baseline negative affect in 12-week
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Tracy F Chang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.