Clinical trial NCT03402009: Comparison of Mindfulness Meditation Tools For College Students
Official title: Assisting University Students Self-Manage Stress: Comparison of Mindfulness Meditation Tools
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Anxiety
Keywords: meditation
Mindfulness
stress
anxiety
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Depression, Anxiety, and Stress Scales-21
timeFrame: 5 weeks
Secondary outcomes:
measure: Big Five personality
timeFrame: Baseline and 5 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline and 5 weeks
measure: Self-Regulation of Eating Scale
timeFrame: Baseline and 5 weeks
measure: MINDSENS (mindfulness)
timeFrame: Baseline and 5 weeks
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Baseline and 5 weeks
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Baseline and 5 weeks
measure: Experiences Questionnaire (decentering)
timeFrame: Baseline and 5 weeks
measure: Rosenberg (1965) self-esteem scale (RSES)
timeFrame: Baseline and 5 weeks
measure: Inflammatory cytokines (i.e., C-reactive protein, IL-6, and TNF-α)
timeFrame: Baseline and 5 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline and 5 weeks
measure: Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003)
timeFrame: Baseline and 5 weeks
measure: Perceived Stress Scale-4 (PSS4)
timeFrame: Baseline and 5 weeks
Other outcomes:
measure: Long-term Follow-up Survey
timeFrame: 1, 6, and 12 months following completion of the satisfaction follow-up
measure: Satisfaction with Mindfulness Tools
timeFrame: 5 weeks
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut - BOT Distinguished Professor of Psychological Sciences
name: Blair T. Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: