Tools for Wellbeing COVID-19 National Study of Undergraduate Students

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tools for Wellbeing COVID-19 National Study of Undergraduate Students

Conditions
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Stress, Anxiety, Depression, Resilience, Wellbeing, Mood

Intervention / Treatment
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* Other: Yoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized waitlist control cross over
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yoga stress anxiety depression wellbeing COVID