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Student Wellness Workshop Study (SWW)

Primary Purpose

Stress, Stress, Psychological, Stress Reaction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
YESplus workshop
WOW! workshop
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    YESplus workshop

    WOW! workshop

    Arm Description

    Your 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.

    A 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.

    Outcomes

    Primary Outcome Measures

    Change in Perceived Stress Scale (PSS) from baseline to post-intervention
    self-report questionnaire; range: 0-40, higher scores indicate higher perceived stress
    Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention
    self-report questionnaire; range: 0-21, higher scores indicate higher sleep disturbance
    Change in Social Connectedness (SC) from baseline to post-intervention
    self-report questionnaire; range: 20-120, higher scores indicate higher perceived social connectedness
    Change in Resting heart rate variability (HRV) from baseline to post-intervention
    2 min average HRV at beginning of each laboratory visit
    Change in HRV reactivity to stress induction from baseline to post-intervention
    average HRV during stress induction, minus baseline from that laboratory visit
    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

    Secondary Outcome Measures

    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
    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);
    Change in Rosenberg Self-Esteem Scale (RSES) from baseline to post-intervention
    self-report questionnaire; range: 0-30, higher scores indicate higher self-esteem
    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
    Change in Heart Rate (HR) from baseline to post-intervention
    following same analysis approach as HRV
    Change in Respiratory Rate (RR) from baseline to post-intervention
    following same analysis approach as HRV
    Change in Respiratory Sinus Arrhythmia (RSA) from baseline to post-intervention
    following same analysis approach as HRV

    Full Information

    First Posted
    July 10, 2019
    Last Updated
    July 15, 2019
    Sponsor
    University of Arizona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04023968
    Brief Title
    Student Wellness Workshop Study
    Acronym
    SWW
    Official Title
    Effects of Two Psychosocial Wellness Workshops on Sleep, Stress Management and Well-being: Exploration of Psychophysiological Mechanisms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 16, 2015 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    April 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arizona

    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
    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."

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Stress, Psychological, Stress Reaction, Adjustment, Adjustment, Social, Adjustment, Emotional

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    YESplus workshop
    Arm Type
    Experimental
    Arm Description
    Your 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.
    Arm Title
    WOW! workshop
    Arm Type
    Active Comparator
    Arm Description
    A 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    YESplus workshop
    Intervention Description
    See description in "Arms" section.
    Intervention Type
    Behavioral
    Intervention Name(s)
    WOW! workshop
    Intervention Description
    See description in "Arms" section.
    Primary Outcome Measure Information:
    Title
    Change in Perceived Stress Scale (PSS) from baseline to post-intervention
    Description
    self-report questionnaire; range: 0-40, higher scores indicate higher perceived stress
    Time Frame
    3 months
    Title
    Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention
    Description
    self-report questionnaire; range: 0-21, higher scores indicate higher sleep disturbance
    Time Frame
    3 months
    Title
    Change in Social Connectedness (SC) from baseline to post-intervention
    Description
    self-report questionnaire; range: 20-120, higher scores indicate higher perceived social connectedness
    Time Frame
    3 months
    Title
    Change in Resting heart rate variability (HRV) from baseline to post-intervention
    Description
    2 min average HRV at beginning of each laboratory visit
    Time Frame
    3 months
    Title
    Change in HRV reactivity to stress induction from baseline to post-intervention
    Description
    average HRV during stress induction, minus baseline from that laboratory visit
    Time Frame
    3 months
    Title
    Change in HRV recovery from stress induction from baseline to post-intervention
    Description
    average HRV 30 min after stress induction, minus baseline from that laboratory visit
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Change in Mood and Anxiety Symptom Questionnaire (MASQ) from baseline to post-intervention
    Description
    self-report questionnaire; range: 26-130, higher scores indicate higher severity of mood symptoms
    Time Frame
    3 months
    Title
    Change in Big Five personality inventory (BFI) subscale scores from baseline to post-intervention
    Description
    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);
    Time Frame
    3 months
    Title
    Change in Rosenberg Self-Esteem Scale (RSES) from baseline to post-intervention
    Description
    self-report questionnaire; range: 0-30, higher scores indicate higher self-esteem
    Time Frame
    3 months
    Title
    Change in Satisfaction With Life Scale (SWL) from baseline to post-intervention
    Description
    self-report questionnaire; range: 5-35, higher scores indicate higher satisfaction with life
    Time Frame
    3 months
    Title
    Change in Heart Rate (HR) from baseline to post-intervention
    Description
    following same analysis approach as HRV
    Time Frame
    3 months
    Title
    Change in Respiratory Rate (RR) from baseline to post-intervention
    Description
    following same analysis approach as HRV
    Time Frame
    3 months
    Title
    Change in Respiratory Sinus Arrhythmia (RSA) from baseline to post-intervention
    Description
    following same analysis approach as HRV
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John JB Allen, PhD
    Organizational Affiliation
    University of Arizona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Student Wellness Workshop Study

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