Clinical trial NCT05392621: Stress Management in College Students
Official title: Optimizing Stress Management in College Students
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Keywords: yoga
deep breathing
progressive muscle relaxation
Lead sponsor: Wake Forest University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Yield
timeFrame: Baseline
measure: Completion Rate
timeFrame: The day following the session
measure: Acceptability of the intervention as assessed by survey
timeFrame: End of session
Secondary outcomes:
measure: Perceived acceptability of the intervention package as assessed by the Acceptability of Intervention Measure (AIM)
timeFrame: End of session
measure: Perceived feasibility of delivering the intervention as assessed by the Feasibility of Intervention Measure (FIM)
timeFrame: End of session
measure: Perceived appropriateness of the intervention package as assessed by the Intervention Appropriateness Measure (IAM)
timeFrame: End of session
measure: Perceived Stress
timeFrame: Pre-intervention, immediately preceding the single intervention session, immediately after completing the single intervention session, and 1 day after the single intervention session
measure: Positive and negative affect
timeFrame: Pre-intervention, immediately preceding the single intervention session, immediately after completing the single intervention session, and 1 day after the single intervention session
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
References: