Comparison of Mindfulness Meditation Tools For College Students

NCT ID: NCT03402009

Last Updated: 2019-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Stress Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental

independent meditation using web-based tools, apps, and EEG neurofeedback

Group Type EXPERIMENTAL

Apps

Intervention Type BEHAVIORAL

Apps and weblinks to coach self-guided meditation.

EEG neurofeedback

Intervention Type BEHAVIORAL

Device provides feedback based on EEG readings.

Active Control

independent meditation using web-based tools and apps

Group Type ACTIVE_COMPARATOR

Apps

Intervention Type BEHAVIORAL

Apps and weblinks to coach self-guided meditation.

Interventions

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Apps

Apps and weblinks to coach self-guided meditation.

Intervention Type BEHAVIORAL

EEG neurofeedback

Device provides feedback based on EEG readings.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* participants unable to adhere to the commitment required for the study will be excluded
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Blair Johnson

BoT Distinguished Professor of Psychological Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Blair T. Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut - BOT Distinguished Professor of Psychological Sciences

Locations

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University of Connecticut

Storrs, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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H17-224

Identifier Type: -

Identifier Source: org_study_id

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