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Completed

NCT Number: NCT05392621

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.

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Key information

Conditions

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

A single Hatha yoga session designed to support stress management.

Deep Breathing

Behavioral

A single deep breathing exercise session designed to elicit relaxation and to assist in stress management.

Progressive Muscle Relaxation

Behavioral

A single session of progressive muscle relaxation designed to elicit relaxation.

Quiet sitting

Behavioral

A single session of quiet sitting.

Primary outcomes

  1. Recruitment Yield

    Time frame: Baseline

    Number consented/number contacted

  2. Completion Rate

    Time frame: The day following the session

    Number completed/number consented

  3. Acceptability of the intervention as assessed by survey

    Time frame: End of session

    Feedback survey of aspects of the program participants enjoyed and disliked

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

Optimizing Stress Management in College Students

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 26, 2022
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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