AzTrials
AzTrials

StressSWWNCT04023968

Student Wellness Workshop Study

A study testing YESplus workshop and WOW! workshop in people with Stress and Stress, Psychological, run by University of Arizona.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

While efficacy of Sudarshan Kriya Yoga (SKY) has been demonstrated in a number of prior studies, little is known about the effects of SKY taught as part of the Your Enlightened Side (YESplus) workshop designed for college students. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Stress, Psychological, Stress Reaction
What is being tested?
YESplus workshop and WOW! workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
No sites listed yet
Study dates
16 Sep 2015to 1 Apr 2017
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 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Current identification with student status, which may include undergraduate, graduate, continuing studies, or post-baccalaureate/pre-doctoral.

Who cannot join

  • No history of panic disorder, psychosis, or mania (with or without psychotic features), which may be risk factors for adverse effects of the yogic breathing intervention. These symptoms will be pre-screened via online questionnaire. The use of psychoactive medication will be monitored via sleep diary.
  • No current substance dependence, assessed via online self-report pre-screening questionnaire.
  • No current use of medications with known effects on sleep or stress physiology including antidepressants (SSRI, SNSI, NDRI, atypical, TCA, MAOI), anitpsychotics, benzodiazepines, non-benzodiazepine receptor agonists, melatonin and melatonin receptor agonists, orexin/hypocretin receptor antagonists, barbiturates, mood stabilizers, anticonvulsants, anticholinergics, first generation antihistamines, and stimulants including NRI, antihypertensives, opioids, or systemic (non-topical) corticosteroids.

About this study

Official title: Effects of Two Psychosocial Wellness Workshops on Sleep, Stress Management and Well-being: Exploration of Psychophysiological Mechanisms

While efficacy of Sudarshan Kriya Yoga (SKY) has been demonstrated in a number of prior studies, little is known about the effects of SKY taught as part of the Your Enlightened Side (YESplus) workshop designed for college students. Thus, this study aims to assess the effects of YESplus on well-being, including sleep patterns, and physiological stress response.

Read the detailed description

The transition from adolescence to adulthood, particularly for college students, is accompanied by several major life changes and challenges. For many individuals, this is a period when one moves away from home, begins interacting with different peer groups, and has greater financial and academic responsibilities. The emotional stress associated with these changes is correlated with less time devoted to sleep, increased alcohol intake reduced academic performance and increased rates of anxiety disorders and/or depression.

Your Enlightened Side (plus more) (YESplus) is a life skills workshop with a strong emphasis on breathing practices for reducing stress and increasing well-being. Additional stress management tools including meditation, yoga, and interpersonal exercises that impart social emotional learning skills and stress reduction strategies complement the breathing techniques.

The central practice taught in YESplus is a unique rhythmical breathing technique called Sudarshan Kriya. It is taught along with two preparatory breathing practices: an advanced form of Ujjayi breathing (breathing against airway resistance) and bhastrika (forceful nasal breathing). Collectively, these three breathing practices are referred to as Sudarshan Kriya Yoga (SKY).

Prior literature has demonstrated significant improvements in psychological and physiological outcomes of SKY in adults, including decreases in subjective stress, clinical and subclinical depression and anxiety, posttraumatic stress symptoms,impulsivity, and tobacco use, as well as increases in calm, mental focus, emotion regulation, and overall well-being.

However, little is known about the effects of SKY specifically taught in the YESplus workshop format designed for college students. One randomized controlled trial has demonstrated attenuated levels of subjective stress and several hematological parameters, including lymphocytes and platelet count, during exam periods following SKY training. These findings have not yet been replicated, and the extent to which the effects of YESplus generalize to other health-related changes such as cardiovascular function remain unclear.

Addressing the gap in the literature described above and to provide further preliminary data on the specific effects of YESplus on well-being and stress physiology, this study aims to evaluate measures of self-reported wellness across a variety of questionnaires, in addition to changes in heart rate variability and salivary cortisol levels with a stress induction task. To control for expectancy effects, overall time spent with the workshop, social contact, and exposure to cognitive stress management strategies that may influence the observed effects of YESplus not specific to the yogic breathing and deep social connectedness at the core of the YESplus targets, a comparison workshop with all of these potential supplementary contributors will be included, titled "Wisdom On Wellness" (WOW!).

Participation will include three laboratory visits at pre-workshop (T1), post-workshop (T2), and 1-2 month follow-up (T3) time points and four workshop sessions described below.

Screening: Interested participants will first be directed to an online pre-screening survey. The survey will begin with a prompt describing the study and requiring understanding via checkbox that the survey is for screening purposes. The survey will collect information such as name, e-mail address, date of birth, motivation for the study, student status, prior contemplative practice experience, ability to meet the time commitment, panic and bipolar symptoms, and potential affiliation with other participants. If any of the exclusion criteria indicated above are met, the participant will be notified of ineligibility.

Enrollment and randomization: Eligible participants will be first grouped in clusters with any other participants with known affiliations stated in the online screener, in order to minimize possibility of learning about material of the other workshop, then assigned a workshop via random number generator.

Laboratory Visits: In-person laboratory visits will be conducted at the University of Arizona Respiratory Physiology Laboratory on the main UA campus. Workshops will be conducted in various buildings on the main UA campus depending on reservation availability.

Actigraphy, sleep diary, online questionnaires and practice logs measures will be completely remotely after the instruments are provided to participants during an in-laboratory visit.

In addition to actigraphy, sleep diary, online questionnaires, and home practice logs (for T2 and T3 time points) the following data will be collected during each laboratory visit: electrocardiography (ECG) with concurrent respiratory inductance plethysmography (RIP) and pulse oximetry recordings, as well as salivary cortisol at baseline, post-stress induction task, 30-min post-stress-induction-onset, and 45-min post. ECG, RIP belts, and pulse oximetry will be recorded continuously, in addition to the designated resting recording periods.

Workshop evaluations: Both workshop participants and instructors will complete a brief questionnaire at two time points (end of Day 1 and end of Day 4) during the workshop to indicate expectation of workshop benefit.

Stress Induction. The Maastricht Acute Stress Test (MAST), a previously described and increasingly used stress induction task will be utilized. A research staff member in a white laboratory coat will explain that the session will be video-recorded to then be coded afterwards by trained raters, provide background information regarding performance norms, and express an expected ability of the participant to perform comparably. Next, the researcher will provide instructions for the task that will be guided by a Powerpoint presentation. The MAST consists of a 10 minute acute stress phase that combines elements of both the commonly used Cold Pressor Test and Trier Social Stress Test, adding an element of uncertainty by cycling between these two tests at slightly unpredictable time intervals. For the hand immersion trials (HIT), participants will insert their dominant hand and wrist in a bucket of ice water (approximately 2° C) for up to 90 seconds. Participants are instructed they may remove their hand at any time. Upon removal, participants will place their hand on a towel and immediately begin a serial subtraction task, for which participants will be instructed to count backwards by 13, 17, or 18 from a randomly selected number between 2013 and 2073, with interjections to start over from the beginning if any calculations are incorrect. Neutral or negative feedback will be provided throughout the task, including comments such as "That's wrong. Start over" and "You're going too slowly."

Being tested
YESplus workshop, WOW! workshop
Medical subject headings
Stress, Psychological, Fractures, Stress, Social Adjustment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YESplus workshopBehavioural

    See description in "Arms" section.

  • WOW! workshopBehavioural

    See description in "Arms" section.

Study groups in NCT04023968
Study groupRoleWhat they receive
YESplus workshopExperimentalYour Enlightened Side, plus more (YESplus) is an four-day, 15-hour integrative life skills workshop with a strong emphasis on breathing techniques and social connectedness. In addition to specific contemplative techniques such as yoga, mindfulness meditation, and compassion meditation that help cultivate inner peace, YESplus incorporates discussions and other activities to facilitate social connectedness, leadership, and community service. During the workshop, participants have ample time to learn and practice the Sudarshan Kriya Yoga (SKY) technique, as well as to ask questions. SKY has four sequential, form- and rhythm-specific breathing components interspersed with normal breathing while sitting in a relaxed position with eyes closed, followed by Yoga Nidra. A certified instructor with a minimum of 1,000 hours of SKY instruction training will lead each workshop.
Receives: Behavioral: YESplus workshop
WOW! workshopActive comparatorA comparison workshop titled "Wisdom On Wellness" (WOW!) will be implemented to control for potential expectancy effects, time commitment, group-based interactions, and wisdom/knowledge of YESplus that is anticipated to have beneficial effects on stress management and well-being, allowing for more rigorous evaluation of the contemplative practices and other activities unique to the YESplus workshop. This workshop differs from YESplus due to the increased focus on cognitive approaches to conceptualizing and managing stress (e.g. thoughts about the past and future versus present moment), and absence of physical or somatic activities.
Receives: Behavioral: WOW! workshop

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Perceived Stress Scale (PSS) from baseline to post-intervention

    self-report questionnaire; range: 0-40, higher scores indicate higher perceived stress

    Measured: 3 months

  2. Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention

    self-report questionnaire; range: 0-21, higher scores indicate higher sleep disturbance

    Measured: 3 months

  3. Change in Social Connectedness (SC) from baseline to post-intervention

    self-report questionnaire; range: 20-120, higher scores indicate higher perceived social connectedness

    Measured: 3 months

  4. Change in Resting heart rate variability (HRV) from baseline to post-intervention

    2 min average HRV at beginning of each laboratory visit

    Measured: 3 months

  5. Change in HRV reactivity to stress induction from baseline to post-intervention

    average HRV during stress induction, minus baseline from that laboratory visit

    Measured: 3 months

  6. Change in HRV recovery from stress induction from baseline to post-intervention

    average HRV 30 min after stress induction, minus baseline from that laboratory visit

    Measured: 3 months

Secondary outcomes (7)
  1. Change in Mood and Anxiety Symptom Questionnaire (MASQ) from baseline to post-intervention

    self-report questionnaire; range: 26-130, higher scores indicate higher severity of mood symptoms

    Measured: 3 months

  2. Change in Big Five personality inventory (BFI) subscale scores from baseline to post-intervention

    self-report questionnaire; subscales include the following, with higher scores indicating higher levels of the descriptive name: Extraversion (range: 8-40), Agreeableness (range: 9-45); Conscientiousness (range: 9-45); Neuroticism (range: 8-40); Openness (range: 10-50);

    Measured: 3 months

  3. Change in Rosenberg Self-Esteem Scale (RSES) from baseline to post-intervention

    self-report questionnaire; range: 0-30, higher scores indicate higher self-esteem

    Measured: 3 months

  4. Change in Satisfaction With Life Scale (SWL) from baseline to post-intervention

    self-report questionnaire; range: 5-35, higher scores indicate higher satisfaction with life

    Measured: 3 months

  5. Change in Heart Rate (HR) from baseline to post-intervention

    following same analysis approach as HRV

    Measured: 3 months

  6. Change in Respiratory Rate (RR) from baseline to post-intervention

    following same analysis approach as HRV

    Measured: 3 months

  7. Change in Respiratory Sinus Arrhythmia (RSA) from baseline to post-intervention

    following same analysis approach as HRV

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2019
  2. Study start16 Sep 2015
  3. Primary completion1 Apr 2017
  4. Study completion1 Apr 2017

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04023968
Sponsor's protocol ID
1508074542A003
Acronym
SWW
Status last verified
Jul 2019
First submitted
10 Jul 2019
Last updated
18 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing YESplus workshop and WOW! workshop in people with Stress and Stress, Psychological, run by University of Arizona.

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 1 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: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Perceived Stress Scale (PSS) from baseline to post-intervention (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Jul 2019.

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