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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
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 group | Role | What they receive |
|---|---|---|
| Yoga+Progressive Muscle Relaxation+Deep Breathing | Experimental | Participants 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 Relaxation | Experimental | Participants engage in a single session combining yoga and progressive muscle relaxation Receives: Behavioral: Yoga; Behavioral: Progressive Muscle Relaxation |
| Yoga+Deep Breathing | Experimental | Participants engage in a single session combining yoga and deep breathing. Receives: Behavioral: Yoga; Behavioral: Deep Breathing |
| Yoga | Experimental | Participants engage in a single session of yoga. Receives: Behavioral: Yoga |
| Progressive Muscle Relaxation+Deep Breathing | Experimental | Participants engage in a single session combining progressive muscle relaxation and deep breathing. Receives: Behavioral: Deep Breathing; Behavioral: Progressive Muscle Relaxation |
| Progressive Muscle Relaxation | Experimental | Participants engage in a single session of progressive muscle relaxation. Receives: Behavioral: Progressive Muscle Relaxation |
| Deep Breathing | Experimental | Participants engage in a single session of deep breathing. Receives: Behavioral: Deep Breathing |
| Quiet sitting | Sham comparator | Participants 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.
Recruitment Yield
Number consented/number contacted
Measured: Baseline
Completion Rate
Number completed/number consented
Measured: The day following the session
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)
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
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
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
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
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.
- First posted26 May 2022
- Study start2 Jun 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Fanning, Wake Forest University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Stress Management in College Students
- ClinicalTrials.gov ID
- NCT05392621
- Acronym / sponsor ID
- IRB00024664
- Conditions
- Stress
- Keywords
- yoga, deep breathing, progressive muscle relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- 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).
| Arm | Type | Receives |
|---|---|---|
| Yoga+Progressive Muscle Relaxation+Deep Breathing | Experimental | Behavioral: Yoga, Behavioral: Deep Breathing, Behavioral: Progressive Muscle RelaxationParticipants engage in a single session combining yoga, progressive muscle relaxation, and deep breathing. |
| Yoga+Progressive Muscle Relaxation | Experimental | Behavioral: Yoga, Behavioral: Progressive Muscle RelaxationParticipants engage in a single session combining yoga and progressive muscle relaxation |
| Yoga+Deep Breathing | Experimental | Behavioral: Yoga, Behavioral: Deep BreathingParticipants engage in a single session combining yoga and deep breathing. |
| Yoga | Experimental | Behavioral: YogaParticipants engage in a single session of yoga. |
| Progressive Muscle Relaxation+Deep Breathing | Experimental | Behavioral: Deep Breathing, Behavioral: Progressive Muscle RelaxationParticipants engage in a single session combining progressive muscle relaxation and deep breathing. |
| Progressive Muscle Relaxation | Experimental | Behavioral: Progressive Muscle RelaxationParticipants engage in a single session of progressive muscle relaxation. |
| Deep Breathing | Experimental | Behavioral: Deep BreathingParticipants engage in a single session of deep breathing. |
| Quiet sitting | Sham comparator | Behavioral: Quiet sittingParticipants engage in a low-touch relaxation condition. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaA single Hatha yoga session designed to support stress management. | Behavioural | Yoga, Yoga+Deep Breathing, Yoga+Progressive Muscle Relaxation, Yoga+Progressive Muscle Relaxation+Deep Breathing |
| Deep BreathingA single deep breathing exercise session designed to elicit relaxation and to assist in stress management. | Behavioural | Deep Breathing, Progressive Muscle Relaxation+Deep Breathing, Yoga+Deep Breathing, Yoga+Progressive Muscle Relaxation+Deep Breathing |
| Progressive Muscle RelaxationA single session of progressive muscle relaxation designed to elicit relaxation. | Behavioural | Progressive Muscle Relaxation, Progressive Muscle Relaxation+Deep Breathing, Yoga+Progressive Muscle Relaxation, Yoga+Progressive Muscle Relaxation+Deep Breathing |
| Quiet sittingA single session of quiet sitting. | Behavioural | Quiet sitting |
Primary outcome
Recruitment Yield
Time frame: Baseline
Number consented/number contacted
Completion Rate
Time frame: The day following the session
Number completed/number consented
Acceptability of the intervention as assessed by survey
Time frame: End of session
Feedback survey of aspects of the program participants enjoyed and disliked
5 secondary outcomes
Perceived acceptability of the intervention package as assessed by the Acceptability of Intervention Measure (AIM)
Time frame: End of session
Perceived feasibility of delivering the intervention as assessed by the Feasibility of Intervention Measure (FIM)
Time frame: End of session
Perceived appropriateness of the intervention package as assessed by the Intervention Appropriateness Measure (IAM)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.