- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05376306
Stress Interventions in STEM and Non-STEM
Effects of Stress Management Interventions on STEM and Non-STEM Students
The purpose of this study is to determine if (1) stress management intervention response depends on college major and (2) if there is a difference in effectiveness between Mindfulness Based Stress Reduction (MBSR) and Progressive Muscle Relaxation (PMR).
A. Objectives The goal of this study is to determine if STEM and non-STEM students respond differently to stress management interventions (SMIs) and to measure if MBSR and PMR are effective for reducing stress and improving sleep, mood, anxiety and depression symptoms.
B. Research Question(s) Aim #1: Determine if the type of SMI (PMR or MBSR) has different efficacies on STEM vs nonSTEM students for reducing stress and improving sleep, mood, anxiety and depression in university students.
Aim #2: Determine if administration of a SMI improves self-reported stress, sleep quality, mood, anxiety and depression in university students.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stress is a common response throughout all populations but has been associated with a 20% increase in the last thirty years. There are positive aspects to stress but high levels of consistent stress can be detrimental on the individual. In 2014, 77% of all Americans reported regularly experiencing physical symptoms of stress and 73% reported regularly experiencing the psychological effects caused by stress, with 33% feeling that they are dealing with extreme stress. When stress levels remain high for prolonged periods of time, individuals can experience the risk of development or worsening of sleep issues. There is abundant evidence that stress can cause changes in sleep time, fragmented sleep patterns, time taken to fall asleep, etc. Dysregulation of sleep is associated with worsening and development of mental health disorders like anxiety and depression. Stress can also adversely impact health due to its effect on suppressing the immune system and has a major impact on the severity of negative moods in individuals.
College students are a subset of the population that are vulnerable to experiencing extreme and prolonged stress, and in turn, poor sleep quality and depressive and anxiety symptoms. College students are a unique population as they are living in a critical period experiencing major environmental and psychological challenges and adaptations. Nearly 60% of all college students are reporting facing higher than average stress which is at an all-time high. College students already report poor sleep hygiene and quality which makes the impact of stress more profound on their health. Depressive symptoms across universities worldwide show that up to 50% of college students are facing depressive symptoms regularly. In a separate study, it was found that 3 out of 4 American college students in 2017 have experienced a sense of overwhelming anxiety. There is also a strong association with self-reported low sleep quality and experience of depression or depressive symptoms and anxiety symptoms, indicating the high levels of stress in college students are indirectly responsible for mental health concerns.
Stress in college students has become more prevalent in the past year due to the COVID-19 pandemic which resulted in many students living at home and having a virtual education. In 2020, individuals aged 18-23 (Gen Z adults) were reported as having the highest stress levels compared to other age groups. 87% of Gen Z adults in college reported that education and uncertainty about academics due to the COVID-19 pandemic were the reason for the higher stress levels. Gen Z adults were also most likely to report depressive symptoms with 34% saying that their mental health was worse than the prior year. In a separate study, sleep patterns in 86% of college students during the pandemic were shown to have been severely disrupted. Increased stress as a consequence of the pandemic has had direct effects on stress which has in turn deteriorated sleep quality and the mental health of college age kids.
Efforts to reduce stress in college age kids have been studied in the past. One such study looks at the efficacy of using a mindfulness meditation mobile app which was shown to reduce stress and improve sleep disturbances. Mindfulness, cognitive, and behavioral intervention programs have also been administered with evidence that they can be effective in stress reduction in college students. Prior studies have tested the effects of stress reduction interventions on a general college student population without taking into account differences within the types of stress that college students face. A major contributor to stress for college students is the major they choose- specifically whether the student chooses a STEM major or a non-STEM major. STEM majors consist of the most stressful fields of study according to Indiana University's National 2016 Study of Student Engagement. Self-reported scores of stress were the highest among STEM students and STEM students were also more likely to pull more all-nighters, have more homework, and less sleep compared to humanities majors. STEM majors also report studying and preparing the most number of hours compared to other majors.
STEM students also differ from non-STEM students with regards to engagement with their institution. Non-STEM college students displayed higher integrative and learning skills and scored higher on Higher Order Thinking surveys compared to STEM students. These differences in cognitive behaviors could result in stress interventions that require deeper reflection like Mental Imagery and Mindfulness Interventions to be more effective in non-STEM students than in STEM students. Understanding these differences in how STEM and non-STEM students respond to different stress interventions can allow students and universities to help alleviate the adverse effects of stress.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New Jersey
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New Brunswick, New Jersey, United States, 08901
- Rutgers Sleep Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- They must be a current Rutgers University undergraduate student
- They are between the ages of 18 and 23
- They must have a declared major o They must be English speaking
- They must be able to comprehend all procedures and measures
- They are willing to complete all study procedures including the 6 week SMI
Exclusion Criteria:
- They currently have or have a history of sleep apnea
- They are a double major, with one major in STEM and the other in non-STEM
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MBSR - STEM
STEM MAJOR in COLLEGE randomized to receive Mindfulness-based Stress Reduction intervention
|
Four activities, one each week - raising body awareness, sitting meditation, mindful yoga, expanding awareness meditation.
|
|
Experimental: MBSR - non-STEM
Non-STEM MAJOR in COLLEGE randomized to receive Mindfulness-based Stress Reduction intervention
|
Four activities, one each week - raising body awareness, sitting meditation, mindful yoga, expanding awareness meditation.
|
|
Experimental: PMR - STEM
STEM MAJOR in COLLEGE randomized to receive Progressive Muscle Relaxation intervention
|
Progressively tensing and releasing each muscle group from head to toe in a specific order.
|
|
Experimental: PMR - Non-STEM
Non-STEM MAJOR in COLLEGE randomized to receive Progressive Muscle Relaxation intervention
|
Progressively tensing and releasing each muscle group from head to toe in a specific order.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self Reported Stress
Time Frame: up to study completion, average of 1 month
|
The Perceived Stress Questionnaire (PSQ) is used to determine a patient's subjective perceived stress.
|
up to study completion, average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Symptoms
Time Frame: Pre and post intervention (up to study completion, average of 1 month)
|
The Beck Anxiety Inventory (BIA) is used to assess self-reported anxiety symptoms.
|
Pre and post intervention (up to study completion, average of 1 month)
|
|
Depressive Symptoms
Time Frame: Pre and post intervention (up to study completion, average of 1 month)
|
The Beck Depression Inventory (BDI) is designed to evaluate the severity of depression in normal and psychiatric populations.
|
Pre and post intervention (up to study completion, average of 1 month)
|
|
Sleep quality
Time Frame: Pre and post intervention (up to study completion, average of 1 month)
|
The Sleep Quality Scale (SQS) is used to measure sleep quality.
|
Pre and post intervention (up to study completion, average of 1 month)
|
|
Sleep quality
Time Frame: Pre and post intervention (up to study completion, average of 1 month)
|
The Pittsburgh Sleep Quality Index (PSQI) is used to measure sleep quality.
|
Pre and post intervention (up to study completion, average of 1 month)
|
|
Mood
Time Frame: Pre and post intervention (up to study completion, average of 1 month)
|
The Abbreviated Profile of Mood States is used to assess self-reported mood states.
|
Pre and post intervention (up to study completion, average of 1 month)
|
|
Sleep Hygiene
Time Frame: Pre and post intervention (up to study completion, average of 1 month)
|
The Sleep Hygiene Index (SHI) was used to measure self-reported sleep hygiene.
|
Pre and post intervention (up to study completion, average of 1 month)
|
Collaborators and Investigators
Investigators
- Study Director: Pranav Reddy, Rutgers University, Department of Kinesiology and Health -
- Principal Investigator: Andrea Spaeth, PhD, Rutgers University, Department of Kinesiology and Health -
Publications and helpful links
Helpful Links
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro2021001528
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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