StressNCT03402009
Comparison of Mindfulness Meditation Tools For College Students
A study testing Apps and EEG neurofeedback in people with Stress and Anxiety, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this study is to determine what tools best assist university students develop a personal meditation practice to self-manage stress. The two treatment conditions are 1) independent meditation using web-based tools and apps, and 2) independent meditation using web-based tools, apps and EEG-based… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Apps and EEG neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 31 Dec 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English literate, undergraduates and graduate students attending UConn ages 18 and above (unless they are registered with the participant pool), who agree with the initial terms, are willing to learn basic skills of mindfulness meditation, agree to practice meditating with assigned tools independently and feel able to adhere to the time commitment required for the study. Participants must not currently have a regular seated meditation practice (regular, meaning at least 1x per week).
Who cannot join
- participants unable to adhere to the commitment required for the study will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Assisting University Students Self-Manage Stress: Comparison of Mindfulness Meditation Tools
The purpose of this study is to determine what tools best assist university students develop a personal meditation practice to self-manage stress. The two treatment conditions are 1) independent meditation using web-based tools and apps, and 2) independent meditation using web-based tools, apps and EEG-based neurofeedback. Outcomes of interest include acceptability, adherence, changes in mental health (i.e., anxiety, stress), physical health (i.e., sleep, inflammation), resilience, and level of commitment to further practice. Factors related to self-regulation (i.e., interoceptive awareness, self-esteem) will also be assessed as potential outcome moderators.
Read the detailed description
Investigators will conduct a randomized controlled trial to evaluate strategies for assisting students develop a personal meditation practice. All participants will attend a mindfulness orientation, then begin the four-week intervention. During the intervention period, the treatment group will practice EEG-neurofeedback-assisted meditation using the Muse device (Interaxon) at least eight times over the four-week intervention period, and also practice mindfulness meditation on their own using their choice of tools (e.g., apps, weblinks, breath). The active control group will mirror the treatment group but will not have access to the EEG-neurofeedback device.
After a sufficient number of students register for the study who meet eligibility requirements, they will be provided with an option to enroll online in the first wave of the study, if their schedule allows, or be placed on a waitlist. Subsequent waves will take place throughout the semester(s) to accommodate additional participants. Enrolled participants will be asked to complete the pre-workshop questionnaire packet online, and attend an orientation session. During the orientation session, participants will first sign a consent form, provide a baseline saliva sample, then learn the basic technique of mindfulness meditation with an experienced meditation instructor. The orientation will also briefly explain the potential benefits of meditation from a scientific perspective, and emphasize the importance of establishing a daily practice, with the mindset that even one minute counts. Participants will then be asked to meditate for 3 minutes wearing the EEG device in order to get a baseline EEG reading. Following the orientation workshop, participants will be randomly assigned and notified via email into either the active control or treatment group along with group-specific instructions, and the 4-week intervention period will commence. Upon completion of the 4-week intervention, participants will be asked to complete post-intervention questionnaires online, then provide post-test measures of saliva, EEG reading during a 3 minute meditation. Participants will be debriefed, and those in the active control group will be given the option to use the EEG-neurofeedback. Follow-up surveys will be emailed to participants at 3, 6 and 12 months to examine if participants continue their meditation practice.
- Being tested
- Apps, EEG neurofeedback
- Keywords
- meditation, Mindfulness, stress, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppsBehavioural
Apps and weblinks to coach self-guided meditation.
EEG neurofeedbackBehavioural
Device provides feedback based on EEG readings.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | independent meditation using web-based tools, apps, and EEG neurofeedback Receives: Behavioral: Apps; Behavioral: EEG neurofeedback |
| Active Control | Active comparator | independent meditation using web-based tools and apps Receives: Behavioral: Apps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression, Anxiety, and Stress Scales-21
(DASS-21; Lovibond \& Lovibond, 1995): an abbreviated, 21-item, Likert-style scale to assess levels of distress on three subscales: depression, anxiety and stress, based on how one felt over the past week. The DASS-21 has been used in prior studies assessing the benefits of mindfulness in undergraduate students (Gallego et al., 2014). It consists of 21 items with seven items per subscale, scored on a four-point scale ranging from 0 = did not apply to me at all to 3 = applied to me very much or most of the time. The total score sums all items. Higher scores indicate higher levels of distress.
Measured: 5 weeks
Secondary outcomes (12)
Big Five personality
Big Five personality traits (Costa \& McCrae, 1992), which are openness, conscientiousness, extraversion, agreeableness, and neuroticism. These factors have been used to understand the relationship between personality and various academic behaviors. Respondents rate each item on a five-point scale from "strongly disagree" to "strongly agree." This scale been used extensively in psychology research and has demonstrated good internal consistency, test-retest reliability, and validity (Costa \& McCrae, 1992).
Measured: Baseline and 5 weeks
Pittsburgh Sleep Quality Index
Sleep quality will be assessed using the The Pittsburgh Sleep Quality Index (PSQI) (Buysse et al, 1989), a commonly used, validated and reliable measure of sleep quality.
Measured: Baseline and 5 weeks
Self-Regulation of Eating Scale
The Self-Regulation of Eating Behavior Questionnaire (SREBQ) is a short, Likert format questionnaire comprising of two dichotomous screener questions, one directional question to bring tempting foods to mind, and five Likert-format items assessing respondents' self-regulation of eating. The five Likert-format items span a five-point scale from 'Never' to 'Always'. The SREBQ has been shown to be reliable and valid (Kliemann et al., 2016).
Measured: Baseline and 5 weeks
MINDSENS (mindfulness)
a composite index consisting of selected items from two other mindfulness questionnaires (The Five Facet Mindfulness Questionnaire and Experiences Questionnaire) that showed the strongest response to practice.
Measured: Baseline and 5 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Interoceptive self-awareness. Interoception refers to the signaling and perception of internal bodily sensations, which we will assess using the validated Multidimensional Assessment of Interoceptive Awareness (MAIA) (Mehling et. al., 2009 and 2012). The MAIA is a relatively new scale, with good validity and reliability in studies to date (Mehling et. al., 2009 and 2012; Bornemann et. Al., 2014).
Measured: Baseline and 5 weeks
Emotion Regulation Questionnaire (ERQ)
) (Gross \& John, 2003). The ERQ assesses two specific emotion regulation strategies, suppression and reappraisal. The ERQ comprises 10 items (5 for suppression and 5 for reappraisal) rated from 1 (never do this) to 7 (always do this). The ERQ has demonstrated strong psychometric properties (Spaapen et al., 2014).
Measured: Baseline and 5 weeks
Experiences Questionnaire (decentering)
Decentering, a specific component of mindfulness related to learning how to separate from one's own thoughts and emotions, will be assessed with the Experiences Questionnaire (Fresco 2007).
Measured: Baseline and 5 weeks
Rosenberg (1965) self-esteem scale (RSES)
a self-esteem measure widely used in social-science research, with a scale of 0 (low) to 30 (high). It is a ten-item Likert-type scale with items answered on a four-point scale-from strongly agree to strongly disagree. It has been used extensively in research and has demonstrated good internal consistency, test-retest reliability, and validity.
Measured: Baseline and 5 weeks
Inflammatory cytokines (i.e., C-reactive protein, IL-6, and TNF-α)
Saliva samples will be obtained in-person, during pre- and post- assessments. Saliva samples will be stored for analysis to be performed at a later date, pending funding. Future analysis on saliva will be limited to assays on stress and health-related biomarkers and inflammatory cytokines (i.e., C-reactive protein, IL-6, and TNF-α). The "passive drool" method will be used to collect saliva samples, as described in Walsh et al., 2016.
Measured: Baseline and 5 weeks
State-Trait Anxiety Inventory (STAI)
Inventory aimed to measure one's awareness of their levels of both state and trait anxiety.
Measured: Baseline and 5 weeks
Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003)
The CD-RISC is a 25-item scale that measures the ability to cope with stress and adversity. Items include: "I am able to adapt when changes occur," "I tend to bounce back after illness, injury, or other hardships," and "I am able to handle unpleasant or painful feelings like sadness, fear, and anger." Respondents rate items on a scale from 0 ("not true at all") to 4 ("true nearly all the time"). A preliminary study of the psychometric properties of the CD-RISC in general population and patient samples showed it to have adequate internal consistency, test-retest reliability, and convergent and divergent validity (Connor \& Davidson, 2003). This measure has been used in studies that assess resilience across the lifespan (Campbell-Sills et al., 2006).
Measured: Baseline and 5 weeks
Perceived Stress Scale-4 (PSS4)
(PSS4) is an abbreviated, 4-item Likert format scale designed to measure the degree to which situations in one's life are appraised as stressful (Cohen et al., 1983). The PSS is a validated, publicly available, and widely used psychological instrument for measuring stress. Each item asks the participant to appraise his or her feelings and thoughts using a 5-point Likert scale (0 = never, 4 = very often)
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start5 Mar 2018
- Primary completion5 Dec 2018
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blair Johnson, University of Connecticut
- Investigators
- Blair T. Johnson, PhD, Principal investigator, University of Connecticut - BOT Distinguished Professor of Psychological Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402009
- Sponsor's protocol ID
- H17-224
- Status last verified
- Sep 2019
- First submitted
- 6 Dec 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for primary and secondary outcome measures will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisting University Students Self-Manage Stress: Comparison of Mindfulness Meditation Tools
- ClinicalTrials.gov ID
- NCT03402009
- Acronym / sponsor ID
- H17-224
- Keywords
- meditation, Mindfulness, stress, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Jan 2018 (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 what tools best assist university students develop a personal meditation practice to self-manage stress. The two treatment conditions are 1) independent meditation using web-based tools and apps, and 2) independent meditation using web-based tools, apps and EEG-based neurofeedback. Outcomes of interest include acceptability, adherence, changes in mental health (i.e., anxiety, stress), physical health (i.e., sleep, inflammation), resilience, and level of commitment to further practice. Factors related to self-regulation (i.e., interoceptive awareness, self-esteem) will also be assessed as potential outcome moderators.
Detailed description
Investigators will conduct a randomized controlled trial to evaluate strategies for assisting students develop a personal meditation practice. All participants will attend a mindfulness orientation, then begin the four-week intervention. During the intervention period, the treatment group will practice EEG-neurofeedback-assisted meditation using the Muse device (Interaxon) at least eight times over the four-week intervention period, and also practice mindfulness meditation on their own using their choice of tools (e.g., apps, weblinks, breath). The active control group will mirror the treatment group but will not have access to the EEG-neurofeedback device.
After a sufficient number of students register for the study who meet eligibility requirements, they will be provided with an option to enroll online in the first wave of the study, if their schedule allows, or be placed on a waitlist. Subsequent waves will take place throughout the semester(s) to accommodate additional participants. Enrolled participants will be asked to complete the pre-workshop questionnaire packet online, and attend an orientation session. During the orientation session, participants will first sign a consent form, provide a baseline saliva sample, then learn the basic technique of mindfulness meditation with an experienced meditation instructor. The orientation will also briefly explain the potential benefits of meditation from a scientific perspective, and emphasize the importance of establishing a daily practice, with the mindset that even one minute counts. Participants will then be asked to meditate for 3 minutes wearing the EEG device in order to get a baseline EEG reading. Following the orientation workshop, participants will be randomly assigned and notified via email into either the active control or treatment group along with group-specific instructions, and the 4-week intervention period will commence. Upon completion of the 4-week intervention, participants will be asked to complete post-intervention questionnaires online, then provide post-test measures of saliva, EEG reading during a 3 minute meditation. Participants will be debriefed, and those in the active control group will be given the option to use the EEG-neurofeedback. Follow-up surveys will be emailed to participants at 3, 6 and 12 months to examine if participants continue their meditation practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Apps, Behavioral: EEG neurofeedbackindependent meditation using web-based tools, apps, and EEG neurofeedback |
| Active Control | Active comparator | Behavioral: Appsindependent meditation using web-based tools and apps |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- English literate, undergraduates and graduate students attending UConn ages 18 and above (unless they are registered with the participant pool), who agree with the initial terms, are willing to learn basic skills of mindfulness meditation, agree to practice meditating with assigned tools independently and feel able to adhere to the time commitment required for the study. Participants must not currently have a regular seated meditation practice (regular, meaning at least 1x per week).
Key exclusion criteria (1 listed)
- participants unable to adhere to the commitment required for the study will be excluded
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 |
|---|---|---|
| AppsApps and weblinks to coach self-guided meditation. | Behavioural | Active Control, Experimental |
| EEG neurofeedbackDevice provides feedback based on EEG readings. | Behavioural | Experimental |
Primary outcome
Change in Depression, Anxiety, and Stress Scales-21
Time frame: 5 weeks
(DASS-21; Lovibond \& Lovibond, 1995): an abbreviated, 21-item, Likert-style scale to assess levels of distress on three subscales: depression, anxiety and stress, based on how one felt over the past week. The DASS-21 has been used in prior studies assessing the benefits of mindfulness in undergraduate students (Gallego et al., 2014). It consists of 21 items with seven items per subscale, scored on a four-point scale ranging from 0 = did not apply to me at all to 3 = applied to me very much or most of the time. The total score sums all items. Higher scores indicate higher levels of distress.
12 secondary outcomes
Big Five personality
Time frame: Baseline and 5 weeks
Pittsburgh Sleep Quality Index
Time frame: Baseline and 5 weeks
Self-Regulation of Eating Scale
Time frame: Baseline and 5 weeks
MINDSENS (mindfulness)
Time frame: Baseline and 5 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: Baseline and 5 weeks
Emotion Regulation Questionnaire (ERQ)
Time frame: Baseline and 5 weeks
Experiences Questionnaire (decentering)
Time frame: Baseline and 5 weeks
Rosenberg (1965) self-esteem scale (RSES)
Time frame: Baseline and 5 weeks
Inflammatory cytokines (i.e., C-reactive protein, IL-6, and TNF-α)
Time frame: Baseline and 5 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline and 5 weeks
Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003)
Time frame: Baseline and 5 weeks
Perceived Stress Scale-4 (PSS4)
Time frame: Baseline and 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for primary and secondary outcome measures will be made available upon request.
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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.
Blair T. Johnson, PhD principal investigator
University of Connecticut - BOT Distinguished Professor of Psychological Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apps and EEG neurofeedback in people with Stress and Anxiety, run by University of Connecticut 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Sep 2019. 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.
Are results available for this study?
Results are not available in the source record.
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?
Change in Depression, Anxiety, and Stress Scales-21 (time frame: 5 weeks). 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 Sep 2019.