Stress Clinical Trial
— SWWOfficial title:
Effects of Two Psychosocial Wellness Workshops on Sleep, Stress Management and Well-being: Exploration of Psychophysiological Mechanisms
Verified date | July 2019 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | April 1, 2017 |
Est. primary completion date | April 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Arizona |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Change in Resting heart rate variability (HRV) from baseline to post-intervention | 2 min average HRV at beginning of each laboratory visit | 3 months | |
Primary | 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 | |
Primary | 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 | 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 | 3 months | |
Secondary | 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); | 3 months | |
Secondary | Change in Rosenberg Self-Esteem Scale (RSES) from baseline to post-intervention | self-report questionnaire; range: 0-30, higher scores indicate higher self-esteem | 3 months | |
Secondary | 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 | 3 months | |
Secondary | Change in Heart Rate (HR) from baseline to post-intervention | following same analysis approach as HRV | 3 months | |
Secondary | Change in Respiratory Rate (RR) from baseline to post-intervention | following same analysis approach as HRV | 3 months | |
Secondary | Change in Respiratory Sinus Arrhythmia (RSA) from baseline to post-intervention | following same analysis approach as HRV | 3 months |
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