NCT05392621

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

June 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

May 13, 2022

Last Update Submit

July 14, 2025

Conditions

Keywords

yogadeep breathingprogressive muscle relaxation

Outcome Measures

Primary Outcomes (3)

  • Recruitment Yield

    Number consented/number contacted

    Baseline

  • Completion Rate

    Number completed/number consented

    The day following the session

  • Acceptability of the intervention as assessed by survey

    Feedback survey of aspects of the program participants enjoyed and disliked

    End of session

Secondary Outcomes (5)

  • Perceived acceptability of the intervention package as assessed by the Acceptability of Intervention Measure (AIM)

    End of session

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

    End of session

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

    End of session

  • Perceived 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

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

Study Arms (8)

Yoga+Progressive Muscle Relaxation+Deep Breathing

EXPERIMENTAL

Participants engage in a single session combining yoga, progressive muscle relaxation, and deep breathing.

Behavioral: YogaBehavioral: Deep BreathingBehavioral: Progressive Muscle Relaxation

Yoga+Progressive Muscle Relaxation

EXPERIMENTAL

Participants engage in a single session combining yoga and progressive muscle relaxation

Behavioral: YogaBehavioral: Progressive Muscle Relaxation

Yoga+Deep Breathing

EXPERIMENTAL

Participants engage in a single session combining yoga and deep breathing.

Behavioral: YogaBehavioral: Deep Breathing

Yoga

EXPERIMENTAL

Participants engage in a single session of yoga.

Behavioral: Yoga

Progressive Muscle Relaxation+Deep Breathing

EXPERIMENTAL

Participants engage in a single session combining progressive muscle relaxation and deep breathing.

Behavioral: Deep BreathingBehavioral: Progressive Muscle Relaxation

Progressive Muscle Relaxation

EXPERIMENTAL

Participants engage in a single session of progressive muscle relaxation.

Behavioral: Progressive Muscle Relaxation

Deep Breathing

EXPERIMENTAL

Participants engage in a single session of deep breathing.

Behavioral: Deep Breathing

Quiet sitting

SHAM COMPARATOR

Participants engage in a low-touch relaxation condition.

Behavioral: Quiet sitting

Interventions

YogaBEHAVIORAL

A single Hatha yoga session designed to support stress management.

YogaYoga+Deep BreathingYoga+Progressive Muscle RelaxationYoga+Progressive Muscle Relaxation+Deep Breathing
Deep BreathingBEHAVIORAL

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

Deep BreathingProgressive Muscle Relaxation+Deep BreathingYoga+Deep BreathingYoga+Progressive Muscle Relaxation+Deep Breathing

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

Progressive Muscle RelaxationProgressive Muscle Relaxation+Deep BreathingYoga+Progressive Muscle RelaxationYoga+Progressive Muscle Relaxation+Deep Breathing
Quiet sittingBEHAVIORAL

A single session of quiet sitting.

Quiet sitting

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

MeSH Terms

Interventions

YogaAutogenic Training

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesHypnosisPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 26, 2022

Study Start

June 2, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations