- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392621
Stress Management in College Students
Optimizing Stress Management in College Students
Stress is defined as a response to one's evaluation of physical, emotional, or environmental challenges or demands. While the experience of stress is common, chronic exposure to high levels of stress is associated with a host of negative interrelated psychological, physiological, and behavioral outcomes. Mental health problems such as anxiety and depression have a high correlation with stress. In addition, chronic diseases such as cardiovascular disease are also thought to be related to stress. For instance, research shows that stress increases blood lipids by changing cholesterol levels eventually leading to arterial thrombosis and stroke.
While stress affects individuals across their lifespan, college students face a unique combination of academic and life challenges that exacerbate their experience of stress, making them highly susceptible to high levels of stress. Additionally, technological advances such as social media can be a source of chronic stress for many. As exposure to high levels of persistent stress is likely to predispose young adults to a lifetime of poor health and unhealthy behaviors, this is especially imperative in finding low impact and attainable methods of stress management for this population.
Although a significant body of literature has addressed stress reduction techniques, most studies to date focus on intervention effects that accumulate over months of exposure, with many stress management programs lasting at minimum of 8 weeks. Previous research has found that interventions employing yoga, progressive muscle relaxation (PMR), and deep breathing exercise (DBE) significantly reduce stress levels. The relationship between yoga and stress reduction has been especially consistent across studies. It has been suggested that mindfulness may be the active agent in such programs. Intriguingly, Fountain et al., (2019) found a single 20-minute yoga session significantly decreased stress levels in college students. This raises the question of whether yoga, PMR, and/or DBE require repeated exposure to provide helpful stress-reducing effects, or whether benefits may be obtained in a single session. If so, college students who are unable to commit to an 8-week program will still benefit tremendously from a toolbox of stress reduction techniques, especially during high-stress periods (e.g., finals).
The purpose of this study is to examine whether an acute bout of yoga, PMR, and DBE, delivered alone and in combination, are feasible and acceptable components in a single-session stress-reduction program for college students, and to explore initial effects on stress. We will use an efficient factorial design to gather data on the feasibility and acceptability of each of these three components, and to explore the initial main effects on stress.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Winston Salem, North Carolina, United States, 27109
- Wake Forest University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergraduate college students
- Aged 18 -24 years
- Capable of engaging in physical activity as assessed via the physical activity readiness questionnaire (PAR-Q+)
- Willing to provide consent and attend a single stress intervention session lasting up to 60 minutes
- Agree to all study procedures and assessments
Exclusion Criteria:
- Outside of 18-24 years of age
- Unable to safely engage in physical activity
- Not an undergraduate student at Wake Forest University
- Unwilling to complete study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga+Progressive Muscle Relaxation+Deep Breathing
Participants engage in a single session combining yoga, progressive muscle relaxation, and deep breathing.
|
A single Hatha yoga session designed to support stress management.
A single deep breathing exercise session designed to elicit relaxation and to assist in stress management.
A single session of progressive muscle relaxation designed to elicit relaxation.
|
|
Experimental: Yoga+Progressive Muscle Relaxation
Participants engage in a single session combining yoga and progressive muscle relaxation
|
A single Hatha yoga session designed to support stress management.
A single session of progressive muscle relaxation designed to elicit relaxation.
|
|
Experimental: Yoga+Deep Breathing
Participants engage in a single session combining yoga and deep breathing.
|
A single Hatha yoga session designed to support stress management.
A single deep breathing exercise session designed to elicit relaxation and to assist in stress management.
|
|
Experimental: Yoga
Participants engage in a single session of yoga.
|
A single Hatha yoga session designed to support stress management.
|
|
Experimental: Progressive Muscle Relaxation+Deep Breathing
Participants engage in a single session combining progressive muscle relaxation and deep breathing.
|
A single deep breathing exercise session designed to elicit relaxation and to assist in stress management.
A single session of progressive muscle relaxation designed to elicit relaxation.
|
|
Experimental: Progressive Muscle Relaxation
Participants engage in a single session of progressive muscle relaxation.
|
A single session of progressive muscle relaxation designed to elicit relaxation.
|
|
Experimental: Deep Breathing
Participants engage in a single session of deep breathing.
|
A single deep breathing exercise session designed to elicit relaxation and to assist in stress management.
|
|
Sham Comparator: Quiet sitting
Participants engage in a low-touch relaxation condition.
|
A single session of quiet sitting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Yield
Time Frame: Baseline
|
Number consented/number contacted
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Baseline
|
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Completion Rate
Time Frame: The day following the session
|
Number completed/number consented
|
The day following the session
|
|
Acceptability of the intervention as assessed by survey
Time Frame: End of session
|
Feedback survey of aspects of the program participants enjoyed and disliked
|
End of session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived acceptability of the intervention package as assessed by the Acceptability of Intervention Measure (AIM)
Time Frame: End of session
|
A 4-item survey assessing perceived acceptability of a combination of intervention components
|
End of session
|
|
Perceived feasibility of delivering the intervention as assessed by the Feasibility of Intervention Measure (FIM)
Time Frame: End of session
|
A 4-item survey assessing perceived feasibility of a combination of intervention components
|
End of session
|
|
Perceived appropriateness of the intervention package as assessed by the Intervention Appropriateness Measure (IAM)
Time Frame: End of session
|
A 4-item survey assessing perceived appropriateness of a combination of intervention components
|
End of session
|
|
Perceived Stress
Time Frame: Pre-intervention, immediately preceding the single intervention session, immediately after completing the single intervention session, and 1 day after the single intervention session
|
The Perceived Stress Scale: A 10-item scale assessing the participants' perceived stress with final scores falling between 0 and 40 such that higher scores reflect more stress.
|
Pre-intervention, immediately preceding the single intervention session, immediately after completing the single intervention session, and 1 day after the single intervention session
|
|
Positive and negative affect
Time Frame: Pre-intervention, immediately preceding the single intervention session, immediately after completing the single intervention session, and 1 day after the single intervention session
|
The Positive and Negative Affect Schedule (PANAS): An 20-item assessment of both positive and negative affect.
The final scores are given on two subscales (positive affect and negative affect) ranging from 10-50 such that lower scores represent less of the affective state (i.e., less positive or negative affect) and 50 representing more of the affective state (i.e., more positive or negative affect).
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Pre-intervention, immediately preceding the single intervention session, immediately after completing the single intervention session, and 1 day after the single intervention session
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00024664
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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