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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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).
- 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.
- 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.
- Conditions
- MBSR-STEM, PMR-STEM, MBSR-NON-STEM, PMR -NON-STEM
- 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 group | Role | What they receive |
|---|---|---|
| MBSR - STEM | Experimental | STEM MAJOR in COLLEGE randomized to receive Mindfulness-based Stress Reduction intervention Receives: Behavioral: Stress Reduction: MBSR |
| MBSR - non-STEM | Experimental | Non-STEM MAJOR in COLLEGE randomized to receive Mindfulness-based Stress Reduction intervention Receives: Behavioral: Stress Reduction: MBSR |
| PMR - STEM | Experimental | STEM MAJOR in COLLEGE randomized to receive Progressive Muscle Relaxation intervention Receives: Behavioral: Stress Reduction : PMR |
| PMR - Non-STEM | Experimental | Non-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.
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)
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)
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)
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)
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)
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)
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.
- First posted17 May 2022
- Study start17 Jan 2022
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MBSR-STEMStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea M. Spaeth, PhD, Rutgers, The State University of New Jersey
- Investigators
- Pranav Reddy, Study director, Rutgers University, Department of Kinesiology and Health -Andrea Spaeth, PhD, Principal investigator, Rutgers University, Department of Kinesiology and Health -
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stress Management Interventions on STEM and Non-STEM Students
- ClinicalTrials.gov ID
- NCT05376306
- Acronym / sponsor ID
- Pro2021001528
- Conditions
- MBSR-STEM, PMR-STEM, MBSR-NON-STEM, PMR -NON-STEM
- Keywords
- stress, sleep, STEM, non-STEM, students, stress interventions, PMR, MBSR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 17 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.
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).
- 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.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBSR - STEM | Experimental | Behavioral: Stress Reduction: MBSRSTEM MAJOR in COLLEGE randomized to receive Mindfulness-based Stress Reduction intervention |
| MBSR - non-STEM | Experimental | Behavioral: Stress Reduction: MBSRNon-STEM MAJOR in COLLEGE randomized to receive Mindfulness-based Stress Reduction intervention |
| PMR - STEM | Experimental | Behavioral: Stress Reduction : PMRSTEM MAJOR in COLLEGE randomized to receive Progressive Muscle Relaxation intervention |
| PMR - Non-STEM | Experimental | Behavioral: Stress Reduction : PMRNon-STEM MAJOR in COLLEGE randomized to receive Progressive Muscle Relaxation intervention |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Stress Reduction: MBSRFour activities, one each week - raising body awareness, sitting meditation, mindful yoga, expanding awareness meditation. | Behavioural | MBSR - STEM, MBSR - non-STEM |
| Stress Reduction : PMRProgressively tensing and releasing each muscle group from head to toe in a specific order. | Behavioural | PMR - Non-STEM, PMR - STEM |
Primary outcome
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.
6 secondary outcomes
Anxiety Symptoms
Time frame: 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)
Sleep quality
Time frame: 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)
Mood
Time frame: 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)
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 26 Oct 2022.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Pranav Reddy study director
Rutgers University, Department of Kinesiology and Health -
Andrea Spaeth, PhD principal investigator
Rutgers University, Department of Kinesiology and Health -
1 site in 1 country: see every site and its status.
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.