Clinical trial NCT04023968: Student Wellness Workshop Study
Official title: Effects of Two Psychosocial Wellness Workshops on Sleep, Stress Management and Well-being: Exploration of Psychophysiological Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Stress, Psychological
Stress Reaction
Adjustment
Adjustment, Social
Adjustment, Emotional
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. Thus, this study aims to assess the effects of YESplus on well-being, including sleep patterns, and physiological stress response.

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."

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Perceived Stress Scale (PSS) from baseline to post-intervention
timeFrame: 3 months
measure: Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention
timeFrame: 3 months
measure: Change in Social Connectedness (SC) from baseline to post-intervention
timeFrame: 3 months
measure: Change in Resting heart rate variability (HRV) from baseline to post-intervention
timeFrame: 3 months
measure: Change in HRV reactivity to stress induction from baseline to post-intervention
timeFrame: 3 months
measure: Change in HRV recovery from stress induction from baseline to post-intervention
timeFrame: 3 months
Secondary outcomes:
measure: Change in Mood and Anxiety Symptom Questionnaire (MASQ) from baseline to post-intervention
timeFrame: 3 months
measure: Change in Big Five personality inventory (BFI) subscale scores from baseline to post-intervention
timeFrame: 3 months
measure: Change in Rosenberg Self-Esteem Scale (RSES) from baseline to post-intervention
timeFrame: 3 months
measure: Change in Satisfaction With Life Scale (SWL) from baseline to post-intervention
timeFrame: 3 months
measure: Change in Heart Rate (HR) from baseline to post-intervention
timeFrame: 3 months
measure: Change in Respiratory Rate (RR) from baseline to post-intervention
timeFrame: 3 months
measure: Change in Respiratory Sinus Arrhythmia (RSA) from baseline to post-intervention
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: John JB Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: