Anxiety Clinical Trial
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.
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.
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