StressNCT04414371
Tools for Wellbeing COVID-19 National Study of Undergraduate Students
A study testing Yoga in people with Stress and Anxiety, run by Rutgers, The State University of New Jersey at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 or older
- Enrolled in 4-year universities/colleges in 2020
- Not graduate in May 2020
Who cannot join
- Younger than 18
- Not enrolled in 4-year universities/colleges in 2020
- Graduate in May 2020
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rutgers University
New Brunswick, New Jersey, 08901
Tracy F Chang, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Stress, Anxiety, Depression, Resilience, Wellbeing, Mood
- Being tested
- Yoga
- Keywords
- yoga stress anxiety depression wellbeing COVID
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Yoga Namaskar and Nadi Shuddhi
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Yoga Group | Experimental | Learn online yoga practices and practice daily for 12-weeks Receives: Other: Yoga |
| Group 2 - Control Group | Other | waist-list control for 4-week, cross-over to yoga practice for 8-week Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Measured: Change from baseline stress at 1-Month
Stress
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Measured: Change from baseline stress at 2-Month
Stress
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Measured: Change from baseline stress in 3-Month
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Measured: Change from baseline wellbeing in 2-week
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Measured: Change from baseline wellbeing in 4-week
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Measured: Change from baseline wellbeing in 6-week
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Measured: Change from baseline wellbeing in 8-week
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Measured: Change from baseline wellbeing in 10-week
Wellbeing
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Measured: Change from baseline wellbeing in 12-week
Secondary outcomes (27)
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Measured: Change from baseline anxiety in 2-week
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Measured: Change from baseline anxiety in 4-week
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Measured: Change from baseline anxiety in 6-week
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Measured: Change from baseline anxiety in 8-week
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Measured: Change from baseline anxiety in 10-week
Anxiety
2-item PHQ-4, score 2-8, higher score higher anxiety
Measured: Change from baseline anxiety in 12-week
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Measured: Change from baseline depression in 2-week
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Measured: Change from baseline depression in 4-week
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Measured: Change from baseline depression in 6-week
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Measured: Change from baseline depression in 8-week
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Measured: Change from baseline depression in 10-week
Depression
2-item PHQ-4, score 2-8, higher score higher depression
Measured: Change from baseline depression in 12-week
Resilience
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Measured: Change from baseline resilience in 1-month
Resilience
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Measured: Change from baseline resilience in 2-month
Resilience
6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience
Measured: Change from baseline resilience in 3-month
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Measured: Change from baseline positive affect in 2-week
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Measured: Change from baseline positive affect in 4-week
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Measured: Change from baseline positive affect in 6-week
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Measured: Change from baseline positive affect in 8-week
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect
Measured: Change from baseline positive affect in 10-week
Positive Affect
10-item Positive Affect Scale, score - 10 to 50, higher score higher positive affect
Measured: Change from baseline positive affect in 12-week
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Measured: Change from baseline negative affect in 2-week
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Measured: Change from baseline negative affect in 4-week
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Measured: Change from baseline negative affect in 6-week
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Measured: Change from baseline negative affect in 8-week
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Measured: Change from baseline negative affect in 10-week
Negative Affect
10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect
Measured: Change from baseline negative affect in 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start20 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized waitlist control cross over
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Tracy F. H. Chang, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Tracy F Chang, Ph.D., Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414371
- Sponsor's protocol ID
- Pro2020000953
- Status last verified
- Jun 2020
- First submitted
- 31 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23355825Brems 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.
PubMed 26667290Brunner 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.
PubMed 28783749Bussing 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.
PubMed 23008738Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Froeliger 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.
PubMed 22855674Gard 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.
PubMed 25368562Schmalzl 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.
PubMed 26005409Smith 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.
PubMed 18696313Tennant 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.
PubMed 18042300Wang 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.
PubMed 32155789
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tools for Wellbeing COVID-19 National Study of Undergraduate Students
- ClinicalTrials.gov ID
- NCT04414371
- Acronym / sponsor ID
- Pro2020000953
- Conditions
- Stress, Anxiety, Depression, Resilience, Wellbeing, Mood
- Keywords
- yoga stress anxiety depression wellbeing COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized waitlist control cross over
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Yoga Group | Experimental | Other: YogaLearn online yoga practices and practice daily for 12-weeks |
| Group 2 - Control Group | Other | Other: Yogawaist-list control for 4-week, cross-over to yoga practice for 8-week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 or older
- Enrolled in 4-year universities/colleges in 2020
- Not graduate in May 2020
Key exclusion criteria (3 listed)
- Younger than 18
- Not enrolled in 4-year universities/colleges in 2020
- Graduate in May 2020
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga Namaskar and Nadi Shuddhi | Other | Group 1 - Yoga Group, Group 2 - Control Group |
Primary outcome
Stress
Time frame: Change from baseline stress at 1-Month
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Stress
Time frame: Change from baseline stress at 2-Month
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Stress
Time frame: Change from baseline stress in 3-Month
10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress
Wellbeing
Time frame: Change from baseline wellbeing in 2-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
Time frame: Change from baseline wellbeing in 4-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
Time frame: Change from baseline wellbeing in 6-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
Time frame: Change from baseline wellbeing in 8-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
Time frame: Change from baseline wellbeing in 10-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
Wellbeing
Time frame: Change from baseline wellbeing in 12-week
14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing
27 secondary outcomes
Anxiety
Time frame: Change from baseline anxiety in 2-week
Anxiety
Time frame: Change from baseline anxiety in 4-week
Anxiety
Time frame: Change from baseline anxiety in 6-week
Anxiety
Time frame: Change from baseline anxiety in 8-week
Anxiety
Time frame: Change from baseline anxiety in 10-week
Anxiety
Time frame: Change from baseline anxiety in 12-week
Depression
Time frame: Change from baseline depression in 2-week
Depression
Time frame: Change from baseline depression in 4-week
Depression
Time frame: Change from baseline depression in 6-week
Depression
Time frame: Change from baseline depression in 8-week
Depression
Time frame: Change from baseline depression in 10-week
Depression
Time frame: Change from baseline depression in 12-week
Resilience
Time frame: Change from baseline resilience in 1-month
Resilience
Time frame: Change from baseline resilience in 2-month
Resilience
Time frame: Change from baseline resilience in 3-month
Positive Affect
Time frame: Change from baseline positive affect in 2-week
Positive Affect
Time frame: Change from baseline positive affect in 4-week
Positive Affect
Time frame: Change from baseline positive affect in 6-week
Positive Affect
Time frame: Change from baseline positive affect in 8-week
Positive Affect
Time frame: Change from baseline positive affect in 10-week
Positive Affect
Time frame: Change from baseline positive affect in 12-week
Negative Affect
Time frame: Change from baseline negative affect in 2-week
Negative Affect
Time frame: Change from baseline negative affect in 4-week
Negative Affect
Time frame: Change from baseline negative affect in 6-week
Negative Affect
Time frame: Change from baseline negative affect in 8-week
Negative Affect
Time frame: Change from baseline negative affect in 10-week
Negative Affect
Time frame: Change from baseline negative affect in 12-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 23355825Balasubramaniam 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.
- Background: PubMed 26667290Brems 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.
- Background: PubMed 28783749Brunner 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.
- Background: PubMed 23008738Bussing 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 22855674Froeliger 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.
- Background: PubMed 25368562Gard 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.
- Background: PubMed 26005409Schmalzl 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.
- Background: PubMed 18696313Smith 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.
- Background: PubMed 18042300Tennant 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.
- Background: PubMed 32155789Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy F Chang, Ph.D. principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Stress and Anxiety, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracy F Chang, Ph.D. (2052666477, tracy.chang@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Change from baseline stress at 1-Month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414371, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.