Tools for Wellbeing COVID-19 National Study of Undergraduate Students

Depression Clinical Trial

Official title:

Tools for Wellbeing COVID-19 National Study of Undergraduate Students

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414371
• Other study ID #: Pro2020000953
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: Rutgers, The State University of New Jersey
• Contact: Tracy F Chang, Ph.D.
• Phone: 2052666477
• Email: tracy.chang[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mood
• Resilience
• Stress
• Wellbeing

Intervention

Other:
• Yoga
Yoga Namaskar and Nadi Shuddhi

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Harvard Medical School

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View Citation

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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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). pii: E1729. doi: 10.3390/ijerph17051729. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress	10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress	Change from baseline stress at 1-Month
Primary	Stress	10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress	Change from baseline stress at 2-Month
Primary	Stress	10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress	Change from baseline stress in 3-Month
Primary	Wellbeing	14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing	Change from baseline wellbeing in 2-week
Primary	Wellbeing	14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing	Change from baseline wellbeing in 4-week
Primary	Wellbeing	14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing	Change from baseline wellbeing in 6-week
Primary	Wellbeing	14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing	Change from baseline wellbeing in 8-week
Primary	Wellbeing	14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing	Change from baseline wellbeing in 10-week
Primary	Wellbeing	14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing	Change from baseline wellbeing in 12-week
Secondary	Anxiety	2-item PHQ-4, score 2-8, higher score higher anxiety	Change from baseline anxiety in 2-week
Secondary	Anxiety	2-item PHQ-4, score 2-8, higher score higher anxiety	Change from baseline anxiety in 4-week
Secondary	Anxiety	2-item PHQ-4, score 2-8, higher score higher anxiety	Change from baseline anxiety in 6-week
Secondary	Anxiety	2-item PHQ-4, score 2-8, higher score higher anxiety	Change from baseline anxiety in 8-week
Secondary	Anxiety	2-item PHQ-4, score 2-8, higher score higher anxiety	Change from baseline anxiety in 10-week
Secondary	Anxiety	2-item PHQ-4, score 2-8, higher score higher anxiety	Change from baseline anxiety in 12-week
Secondary	Depression	2-item PHQ-4, score 2-8, higher score higher depression	Change from baseline depression in 2-week
Secondary	Depression	2-item PHQ-4, score 2-8, higher score higher depression	Change from baseline depression in 4-week
Secondary	Depression	2-item PHQ-4, score 2-8, higher score higher depression	Change from baseline depression in 6-week
Secondary	Depression	2-item PHQ-4, score 2-8, higher score higher depression	Change from baseline depression in 8-week
Secondary	Depression	2-item PHQ-4, score 2-8, higher score higher depression	Change from baseline depression in 10-week
Secondary	Depression	2-item PHQ-4, score 2-8, higher score higher depression	Change from baseline depression in 12-week
Secondary	Resilience	6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience	Change from baseline resilience in 1-month
Secondary	Resilience	6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience	Change from baseline resilience in 2-month
Secondary	Resilience	6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience	Change from baseline resilience in 3-month
Secondary	Positive Affect	10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect	Change from baseline positive affect in 2-week
Secondary	Positive Affect	10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect	Change from baseline positive affect in 4-week
Secondary	Positive Affect	10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect	Change from baseline positive affect in 6-week
Secondary	Positive Affect	10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect	Change from baseline positive affect in 8-week
Secondary	Positive Affect	10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect	Change from baseline positive affect in 10-week
Secondary	Positive Affect	10-item Positive Affect Scale, score - 10 to 50, higher score higher positive affect	Change from baseline positive affect in 12-week
Secondary	Negative Affect	10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect	Change from baseline negative affect in 2-week
Secondary	Negative Affect	10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect	Change from baseline negative affect in 4-week
Secondary	Negative Affect	10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect	Change from baseline negative affect in 6-week
Secondary	Negative Affect	10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect	Change from baseline negative affect in 8-week
Secondary	Negative Affect	10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect	Change from baseline negative affect in 10-week
Secondary	Negative Affect	10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect	Change from baseline negative affect in 12-week