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MBSR-STEMPhase 1NCT05376306

Stress Interventions in STEM and Non-STEM

A Phase 1 study testing Stress Reduction: MBSR and Stress Reduction : PMR in people with MBSR-STEM and PMR-STEM, run by Rutgers, The State University of New Jersey 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

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. Read more about this study

Who is it for?
Ages 18 to 23 yearsHealthy volunteers can take part
Conditions the study is for
MBSR-STEM, PMR-STEM, MBSR-NON-STEM
What is being tested?
Stress Reduction: MBSR and Stress Reduction : PMR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
17 Jan 2022to 1 May 2022
Phase
Phase 1
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 23 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rutgers Sleep Lab

    New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: 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).

  1. 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.
  2. 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.

Read the 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.

Being tested
Stress Reduction: MBSR, Stress Reduction : PMR
Keywords
stress, sleep, STEM, non-STEM, students, stress interventions, PMR, MBSR

What participants receive

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

  • Stress Reduction: MBSRBehavioural

    Four activities, one each week - raising body awareness, sitting meditation, mindful yoga, expanding awareness meditation.

  • Stress Reduction : PMRBehavioural

    Progressively tensing and releasing each muscle group from head to toe in a specific order.

Study groups in NCT05376306
Study groupRoleWhat they receive
MBSR - STEMExperimentalSTEM MAJOR in COLLEGE randomized to receive Mindfulness-based Stress Reduction intervention
Receives: Behavioral: Stress Reduction: MBSR
MBSR - non-STEMExperimentalNon-STEM MAJOR in COLLEGE randomized to receive Mindfulness-based Stress Reduction intervention
Receives: Behavioral: Stress Reduction: MBSR
PMR - STEMExperimentalSTEM MAJOR in COLLEGE randomized to receive Progressive Muscle Relaxation intervention
Receives: Behavioral: Stress Reduction : PMR
PMR - Non-STEMExperimentalNon-STEM MAJOR in COLLEGE randomized to receive Progressive Muscle Relaxation intervention
Receives: Behavioral: Stress Reduction : PMR

What is being measured

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

  1. Self Reported Stress

    The Perceived Stress Questionnaire (PSQ) is used to determine a patient's subjective perceived stress.

    Measured: up to study completion, average of 1 month

Secondary outcomes (6)
  1. Anxiety Symptoms

    The Beck Anxiety Inventory (BIA) is used to assess self-reported anxiety symptoms.

    Measured: Pre and post intervention (up to study completion, average of 1 month)

  2. Depressive Symptoms

    The Beck Depression Inventory (BDI) is designed to evaluate the severity of depression in normal and psychiatric populations.

    Measured: Pre and post intervention (up to study completion, average of 1 month)

  3. Sleep quality

    The Sleep Quality Scale (SQS) is used to measure sleep quality.

    Measured: Pre and post intervention (up to study completion, average of 1 month)

  4. Sleep quality

    The Pittsburgh Sleep Quality Index (PSQI) is used to measure sleep quality.

    Measured: Pre and post intervention (up to study completion, average of 1 month)

  5. Mood

    The Abbreviated Profile of Mood States is used to assess self-reported mood states.

    Measured: Pre and post intervention (up to study completion, average of 1 month)

  6. Sleep Hygiene

    The Sleep Hygiene Index (SHI) was used to measure self-reported sleep hygiene.

    Measured: Pre and post intervention (up to study completion, average of 1 month)

Timeline

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

  1. First posted17 May 2022
  2. Study start17 Jan 2022
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05376306
Sponsor's protocol ID
Pro2021001528
Status last verified
Oct 2022
First submitted
16 Mar 2022
Last updated
26 Oct 2022
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 Phase 1 study testing Stress Reduction: MBSR and Stress Reduction : PMR in people with MBSR-STEM and PMR-STEM, run by Rutgers, The State University of New Jersey 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 2 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 26 Oct 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Self Reported Stress (time frame: up to study completion, average of 1 month). 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 26 Oct 2022.

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