Clinical trial NCT05560425: Pilot Study on Training Emerging Adults Skills in Navigating College
Official title: Pilot Study on Mindfulness Meditation and Behavioral Flexibility Among Emerging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Cognitive Deficit in Attention
Keywords: Attentional Bias
Alcohol Misuse
Emerging Adults
Mindfulness Meditation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2022-09-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment randomized controlled trial feasibility study
Primary purpose: PREVENTION

Brief summary: Lifetime risk for developing an alcohol use disorder increases with earlier onset of alcohol consumption. This risk may reflect a tendency for escalated alcohol intake among youth due to immature executive control, leading to more frequent binge drinking, which is associated with more alcohol-related problems. Binge drinking is associated with deficits in behavioral flexibility, which may suggest impaired control networks that contribute to automatic behavior. Individuals with an alcohol or substance use disorder (A/SUD) exhibit attentional bias toward drug- or alcohol-related stimuli that have attained salience through consistent use. Reward history increases attention towards non-drug stimuli, even among individuals with no lifetime A/SUD. Preliminary data (from Dr. Boettiger's lab) from a nationally representative US adult sample using data collected via Prolific found that a questionnaire measure of mindfulness moderates the relationship between alcohol misuse and attention to reward. Given evidence that heavy alcohol drinking impairs behavioral flexibility, which in turn promotes escalating intake, insight into the relationship between mindfulness and behavioral flexibility could inspire new strategies to prevent alcohol and substance use disorders in people at elevated risk.

Detailed description: This is a feasibility pilot study of training freshman college students, with a history of alcohol binge drinking, mindfulness and meditation skills in 4 virtual visits. Before and after the virtual intervention, behavioral flexibility will be measured using a reward-driven attentional bias (Reward-AB) computerized task, and C-reactive protein (CRP) levels will be collected.

Upon arrival for the first visit, participants will be screened for any current alcohol intoxication or recent substance use, followed by a mental health assessment with the Mini-International Neuropsychiatric Interview (MINI). The participant will then have blood collected by finger prick, complete a Reward-AB task, and fill out some paper surveys. During visits 2 through 5, participants will complete virtual training on either mindfulness and meditation skills, or navigating college skills. Each visit will last approximately 90 minutes, starting with the completion of a few online surveys. Visit 6 is similar to visit 1, without the health interview. Participants will be contacted one month following the date of the 6th study visit to complete online surveys.

Visit 1:

* Written consent, MINI interview, urine drug screen and breathalyzer alcohol test, CRP assay, Reward-AB task.
* Randomization to either the Koru Mindfulness (KM) intervention or the Navigating College (NC) control group.

Visits 2-5:

* Surveys completed online through REDCap.
* 75 minutes of instructor-led discussion
* Breakout sessions for participants to share thoughts and experiences in response to instructor's prompt.

Visit 6:

Similar to visit 1, without repeating the MINI interview.

Follow-up:

One month after the conclusion of visit 6, participants will be contacted via email with a link to REDCap to complete several surveys.

Reward-Attentional Bias (Reward-AB) Task:

This computerized task will be used to measure attentional bias pre- and post-intervention. The task includes a training and testing portion, each of which are adapted from tasks that measure the influence of reward on visual attention.

Navigating College (NC) Control Group Training:

Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); Hungry, Angry, Lonely, and Tired (HALT), gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4).

Koru Mindfulness (KM) Intervention Training:

Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4).

Daily Logging of Skills:

Participants in the NC intervention will be asked to journal by hand or via Qualtrics every day for \>10 minutes, on anything related to the topics learned during that week's training visit. Participants in the KM intervention will be asked to practice every day for \>10 minutes any mindfulness or meditation skill previously learned during training visits, in addition to logging practice of skills and reflection on the experience using the Koru application.

Eligibility criteria: Inclusion Criteria:

* High school educated; college enrolled first-year student
* Medically healthy
* Ages 18-19
* Native-English speaker (or fluent \< 7 years old)
* Self-report of \>4 lifetime binge drinking episodes (\>4 drinks/2hours for females, \>5 drinks/2 hours for males).

Exclusion Criteria:

* Psychiatric disease (such as depression or psychosis) using the MINI \[25\]
* Systemic disease such as cancer, cardiovascular or inflammatory disease which could influence cognitive functioning
* Motor or visual disturbance (e.g., colorblind)
* Current use of psychoactive drugs (aside from moderate caffeine or alcohol), including prescription medications, or individuals with a known history of any substance use disorders (not including alcohol; including nicotine) or desire to seek treatment for excess substance (not including alcohol) use.

Primary outcomes:
measure: Participant Retention
timeFrame: 10 weeks
measure: Compliance With Independent Training of Skills
timeFrame: 6 weeks
Secondary outcomes:
measure: Average CEQ Ratings - Credibility Subscale
timeFrame: 1 week
measure: Average CEQ Ratings - Expectancy Subscale
timeFrame: 1 week
measure: Mean Change in Emotional Distress Scores
timeFrame: Baseline, Week 6
measure: Participant Satisfaction
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Charlotte Boettiger, PhD
role: PRINCIPAL_INVESTIGATOR
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