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StressNCT05392621

Stress Management in College Students

A study testing Yoga, Deep Breathing and Progressive Muscle Relaxation in people with Stress, run by Wake Forest University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Stress
What is being tested?
Yoga, Deep Breathing and Progressive Muscle Relaxation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteUnited States
Study dates
2 Jun 2022to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest University

    Winston-Salem, North Carolina, 27109

Other trials in United States

About this study

Official title: 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.

Read more

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.

Conditions
Stress
Being tested
Yoga, Deep Breathing, Progressive Muscle Relaxation, Quiet sitting
Keywords
yoga, deep breathing, progressive muscle relaxation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogaBehavioural

    A single Hatha yoga session designed to support stress management.

  • Deep BreathingBehavioural

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

  • Progressive Muscle RelaxationBehavioural

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

  • Quiet sittingBehavioural

    A single session of quiet sitting.

Study groups in NCT05392621
Study groupRoleWhat they receive
Yoga+Progressive Muscle Relaxation+Deep BreathingExperimentalParticipants engage in a single session combining yoga, progressive muscle relaxation, and deep breathing.
Receives: Behavioral: Yoga; Behavioral: Deep Breathing; Behavioral: Progressive Muscle Relaxation
Yoga+Progressive Muscle RelaxationExperimentalParticipants engage in a single session combining yoga and progressive muscle relaxation
Receives: Behavioral: Yoga; Behavioral: Progressive Muscle Relaxation
Yoga+Deep BreathingExperimentalParticipants engage in a single session combining yoga and deep breathing.
Receives: Behavioral: Yoga; Behavioral: Deep Breathing
YogaExperimentalParticipants engage in a single session of yoga.
Receives: Behavioral: Yoga
Progressive Muscle Relaxation+Deep BreathingExperimentalParticipants engage in a single session combining progressive muscle relaxation and deep breathing.
Receives: Behavioral: Deep Breathing; Behavioral: Progressive Muscle Relaxation
Progressive Muscle RelaxationExperimentalParticipants engage in a single session of progressive muscle relaxation.
Receives: Behavioral: Progressive Muscle Relaxation
Deep BreathingExperimentalParticipants engage in a single session of deep breathing.
Receives: Behavioral: Deep Breathing
Quiet sittingSham comparatorParticipants engage in a low-touch relaxation condition.
Receives: Behavioral: Quiet sitting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Yield

    Number consented/number contacted

    Measured: Baseline

  2. Completion Rate

    Number completed/number consented

    Measured: The day following the session

  3. Acceptability of the intervention as assessed by survey

    Feedback survey of aspects of the program participants enjoyed and disliked

    Measured: End of session

Secondary outcomes (5)
  1. Perceived acceptability of the intervention package as assessed by the Acceptability of Intervention Measure (AIM)

    A 4-item survey assessing perceived acceptability of a combination of intervention components

    Measured: End of session

  2. Perceived feasibility of delivering the intervention as assessed by the Feasibility of Intervention Measure (FIM)

    A 4-item survey assessing perceived feasibility of a combination of intervention components

    Measured: End of session

  3. Perceived appropriateness of the intervention package as assessed by the Intervention Appropriateness Measure (IAM)

    A 4-item survey assessing perceived appropriateness of a combination of intervention components

    Measured: End of session

  4. Perceived Stress

    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.

    Measured: Pre-intervention, immediately preceding the single intervention session, immediately after completing the single intervention session, and 1 day after the single intervention session

  5. Positive and negative affect

    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).

    Measured: Pre-intervention, immediately preceding the single intervention session, immediately after completing the single intervention session, and 1 day after the single intervention session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start2 Jun 2022
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
This is a 2x2x2 randomized factorial pilot trial. Participants will be randomized to receive one of 8 possible combinations of yoga (yes/no), progressive muscle relaxation (yes/no), or deep breathing (yes/no).
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05392621
Sponsor's protocol ID
IRB00024664
Status last verified
Jul 2025
First submitted
13 May 2022
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Yoga, Deep Breathing and Progressive Muscle Relaxation in people with Stress, run by Wake Forest University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Yield (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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