Tools for Wellbeing COVID-19 National Study of Undergraduate Students

June 2, 2020 updated by: Tracy F. H. Chang, Ph.D., Rutgers, The State University of New Jersey
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: Change from baseline stress at 1-Month
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Change from baseline stress at 1-Month
Stress
Time Frame: Change from baseline stress at 2-Month
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Change from baseline stress at 2-Month
Stress
Time Frame: Change from baseline stress in 3-Month
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Change from baseline stress in 3-Month
Wellbeing
Time Frame: Change from baseline wellbeing in 2-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Change from baseline wellbeing in 2-week
Wellbeing
Time Frame: Change from baseline wellbeing in 4-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Change from baseline wellbeing in 4-week
Wellbeing
Time Frame: Change from baseline wellbeing in 6-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Change from baseline wellbeing in 6-week
Wellbeing
Time Frame: Change from baseline wellbeing in 8-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Change from baseline wellbeing in 8-week
Wellbeing
Time Frame: Change from baseline wellbeing in 10-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Change from baseline wellbeing in 10-week
Wellbeing
Time Frame: Change from baseline wellbeing in 12-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Change from baseline wellbeing in 12-week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Change from baseline anxiety in 2-week
2-item PHQ-4, score 2-8, higher score higher anxiety
Change from baseline anxiety in 2-week
Anxiety
Time Frame: Change from baseline anxiety in 4-week
2-item PHQ-4, score 2-8, higher score higher anxiety
Change from baseline anxiety in 4-week
Anxiety
Time Frame: Change from baseline anxiety in 6-week
2-item PHQ-4, score 2-8, higher score higher anxiety
Change from baseline anxiety in 6-week
Anxiety
Time Frame: Change from baseline anxiety in 8-week
2-item PHQ-4, score 2-8, higher score higher anxiety
Change from baseline anxiety in 8-week
Anxiety
Time Frame: Change from baseline anxiety in 10-week
2-item PHQ-4, score 2-8, higher score higher anxiety
Change from baseline anxiety in 10-week
Anxiety
Time Frame: Change from baseline anxiety in 12-week
2-item PHQ-4, score 2-8, higher score higher anxiety
Change from baseline anxiety in 12-week
Depression
Time Frame: Change from baseline depression in 2-week
2-item PHQ-4, score 2-8, higher score higher depression
Change from baseline depression in 2-week
Depression
Time Frame: Change from baseline depression in 4-week
2-item PHQ-4, score 2-8, higher score higher depression
Change from baseline depression in 4-week
Depression
Time Frame: Change from baseline depression in 6-week
2-item PHQ-4, score 2-8, higher score higher depression
Change from baseline depression in 6-week
Depression
Time Frame: Change from baseline depression in 8-week
2-item PHQ-4, score 2-8, higher score higher depression
Change from baseline depression in 8-week
Depression
Time Frame: Change from baseline depression in 10-week
2-item PHQ-4, score 2-8, higher score higher depression
Change from baseline depression in 10-week
Depression
Time Frame: Change from baseline depression in 12-week
2-item PHQ-4, score 2-8, higher score higher depression
Change from baseline depression in 12-week
Resilience
Time Frame: Change from baseline resilience in 1-month
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Change from baseline resilience in 1-month
Resilience
Time Frame: Change from baseline resilience in 2-month
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Change from baseline resilience in 2-month
Resilience
Time Frame: Change from baseline resilience in 3-month
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Change from baseline resilience in 3-month
Positive Affect
Time Frame: Change from baseline positive affect in 2-week
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Change from baseline positive affect in 2-week
Positive Affect
Time Frame: Change from baseline positive affect in 4-week
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Change from baseline positive affect in 4-week
Positive Affect
Time Frame: Change from baseline positive affect in 6-week
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Change from baseline positive affect in 6-week
Positive Affect
Time Frame: Change from baseline positive affect in 8-week
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Change from baseline positive affect in 8-week
Positive Affect
Time Frame: Change from baseline positive affect in 10-week
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Change from baseline positive affect in 10-week
Positive Affect
Time Frame: Change from baseline positive affect in 12-week
10-item Positive Affect Scale, score - 10 to 50, higher score higher positive affect
Change from baseline positive affect in 12-week
Negative Affect
Time Frame: Change from baseline negative affect in 2-week
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Change from baseline negative affect in 2-week
Negative Affect
Time Frame: Change from baseline negative affect in 4-week
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Change from baseline negative affect in 4-week
Negative Affect
Time Frame: Change from baseline negative affect in 6-week
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Change from baseline negative affect in 6-week
Negative Affect
Time Frame: Change from baseline negative affect in 8-week
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Change from baseline negative affect in 8-week
Negative Affect
Time Frame: Change from baseline negative affect in 10-week
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Change from baseline negative affect in 10-week
Negative Affect
Time Frame: Change from baseline negative affect in 12-week
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard Medical School (HMS and HSDM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tracy F Chang, Ph.D., Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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