NCT04023968

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

July 10, 2019

Last Update Submit

July 15, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

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

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

    3 months

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

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

    3 months

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

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

    3 months

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

    2 min average HRV at beginning of each laboratory visit

    3 months

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

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

    3 months

  • 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

    3 months

Secondary Outcomes (7)

  • Change in Mood and Anxiety Symptom Questionnaire (MASQ) from baseline to post-intervention

    3 months

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

    3 months

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

    3 months

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

    3 months

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

    3 months

  • +2 more secondary outcomes

Study Arms (2)

YESplus workshop

EXPERIMENTAL

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.

Behavioral: YESplus workshop

WOW! workshop

ACTIVE COMPARATOR

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.

Behavioral: WOW! workshop

Interventions

See description in "Arms" section.

YESplus workshop
WOW! workshopBEHAVIORAL

See description in "Arms" section.

WOW! workshop

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress, PsychologicalFractures, StressSocial Adjustment

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorFractures, BoneWounds and InjuriesSocial Behavior

Study Officials

  • John JB Allen, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 18, 2019

Study Start

September 16, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

July 18, 2019

Record last verified: 2019-07