search
Back to results

Tools for Wellbeing COVID-19 National Study of Undergraduate Students

Primary Purpose

Stress, Anxiety, Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring yoga stress anxiety depression wellbeing COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rutgers UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group 1 - Yoga Group

Group 2 - Control Group

Arm Description

Learn online yoga practices and practice daily for 12-weeks

waist-list control for 4-week, cross-over to yoga practice for 8-week

Outcomes

Primary Outcome Measures

Stress
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Stress
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Stress
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

Secondary Outcome Measures

Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Resilience
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Resilience
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Resilience
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score higher positive affect
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect

Full Information

First Posted
May 31, 2020
Last Updated
June 2, 2020
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Harvard Medical School (HMS and HSDM)
search

1. Study Identification

Unique Protocol Identification Number
NCT04414371
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Harvard Medical School (HMS and HSDM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depression, Resilience, Wellbeing, Mood
Keywords
yoga stress anxiety depression wellbeing COVID

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized waitlist control cross over
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Yoga Group
Arm Type
Experimental
Arm Description
Learn online yoga practices and practice daily for 12-weeks
Arm Title
Group 2 - Control Group
Arm Type
Other
Arm Description
waist-list control for 4-week, cross-over to yoga practice for 8-week
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
Yoga Namaskar and Nadi Shuddhi
Primary Outcome Measure Information:
Title
Stress
Description
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Time Frame
Change from baseline stress at 1-Month
Title
Stress
Description
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Time Frame
Change from baseline stress at 2-Month
Title
Stress
Description
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Time Frame
Change from baseline stress in 3-Month
Title
Wellbeing
Description
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Time Frame
Change from baseline wellbeing in 2-week
Title
Wellbeing
Description
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Time Frame
Change from baseline wellbeing in 4-week
Title
Wellbeing
Description
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Time Frame
Change from baseline wellbeing in 6-week
Title
Wellbeing
Description
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Time Frame
Change from baseline wellbeing in 8-week
Title
Wellbeing
Description
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Time Frame
Change from baseline wellbeing in 10-week
Title
Wellbeing
Description
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Time Frame
Change from baseline wellbeing in 12-week
Secondary Outcome Measure Information:
Title
Anxiety
Description
2-item PHQ-4, score 2-8, higher score higher anxiety
Time Frame
Change from baseline anxiety in 2-week
Title
Anxiety
Description
2-item PHQ-4, score 2-8, higher score higher anxiety
Time Frame
Change from baseline anxiety in 4-week
Title
Anxiety
Description
2-item PHQ-4, score 2-8, higher score higher anxiety
Time Frame
Change from baseline anxiety in 6-week
Title
Anxiety
Description
2-item PHQ-4, score 2-8, higher score higher anxiety
Time Frame
Change from baseline anxiety in 8-week
Title
Anxiety
Description
2-item PHQ-4, score 2-8, higher score higher anxiety
Time Frame
Change from baseline anxiety in 10-week
Title
Anxiety
Description
2-item PHQ-4, score 2-8, higher score higher anxiety
Time Frame
Change from baseline anxiety in 12-week
Title
Depression
Description
2-item PHQ-4, score 2-8, higher score higher depression
Time Frame
Change from baseline depression in 2-week
Title
Depression
Description
2-item PHQ-4, score 2-8, higher score higher depression
Time Frame
Change from baseline depression in 4-week
Title
Depression
Description
2-item PHQ-4, score 2-8, higher score higher depression
Time Frame
Change from baseline depression in 6-week
Title
Depression
Description
2-item PHQ-4, score 2-8, higher score higher depression
Time Frame
Change from baseline depression in 8-week
Title
Depression
Description
2-item PHQ-4, score 2-8, higher score higher depression
Time Frame
Change from baseline depression in 10-week
Title
Depression
Description
2-item PHQ-4, score 2-8, higher score higher depression
Time Frame
Change from baseline depression in 12-week
Title
Resilience
Description
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Time Frame
Change from baseline resilience in 1-month
Title
Resilience
Description
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Time Frame
Change from baseline resilience in 2-month
Title
Resilience
Description
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Time Frame
Change from baseline resilience in 3-month
Title
Positive Affect
Description
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Time Frame
Change from baseline positive affect in 2-week
Title
Positive Affect
Description
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Time Frame
Change from baseline positive affect in 4-week
Title
Positive Affect
Description
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Time Frame
Change from baseline positive affect in 6-week
Title
Positive Affect
Description
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Time Frame
Change from baseline positive affect in 8-week
Title
Positive Affect
Description
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Time Frame
Change from baseline positive affect in 10-week
Title
Positive Affect
Description
10-item Positive Affect Scale, score - 10 to 50, higher score higher positive affect
Time Frame
Change from baseline positive affect in 12-week
Title
Negative Affect
Description
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Time Frame
Change from baseline negative affect in 2-week
Title
Negative Affect
Description
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Time Frame
Change from baseline negative affect in 4-week
Title
Negative Affect
Description
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Time Frame
Change from baseline negative affect in 6-week
Title
Negative Affect
Description
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Time Frame
Change from baseline negative affect in 8-week
Title
Negative Affect
Description
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Time Frame
Change from baseline negative affect in 10-week
Title
Negative Affect
Description
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Time Frame
Change from baseline negative affect in 12-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy F Chang, Ph.D.
Phone
2052666477
Email
tracy.chang@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy F Chang, Ph.D.
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy F Chang, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23355825
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.
Results Reference
background
PubMed Identifier
26667290
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.
Results Reference
background
PubMed Identifier
28783749
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.
Results Reference
background
PubMed Identifier
23008738
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.
Results Reference
background
PubMed Identifier
6668417
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.
Results Reference
background
PubMed Identifier
22855674
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.
Results Reference
background
PubMed Identifier
25368562
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.
Results Reference
background
PubMed Identifier
26005409
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.
Results Reference
background
PubMed Identifier
18696313
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.
Results Reference
background
PubMed Identifier
18042300
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.
Results Reference
background
PubMed Identifier
32155789
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.
Results Reference
background

Learn more about this trial

Tools for Wellbeing COVID-19 National Study of Undergraduate Students

We'll reach out to this number within 24 hrs