Pilot Study on Training Emerging Adults Skills in Navigating College (SINC)

Pilot Study on Mindfulness Meditation and Behavioral Flexibility Among Emerging Adults

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Abuse; Cognitive Deficit in Attention
• Intervention / Treatment: Behavioral: Navigating College (NC) Training; Behavioral: Koru Mindfulness (KM) Training

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-3270
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 15 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Navigating College (NC) Training; Control Group	Behavioral: Navigating College (NC) Training; With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. 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); HALT, gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
Experimental: Koru Mindfulness (KM) Training; Study Group	Behavioral: Koru Mindfulness (KM) Training; The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. 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). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.; Other Names: Koru Basic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Retention	Participant retention will be measured by the percentage of enrolled participants remaining in the study after 6 visits.	10 weeks
Compliance With Independent Training of Skills	To determine participant compliance with training skills learned during each of the 4 virtual visits, the average number of journal entries logged during the 4 weeks of training, for each group, is calculated as a total score (6 times/week x 4 weeks = 24). Scores range from 0 to 24, with higher scores indicating greater compliance with independent training.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average CEQ Ratings - Credibility Subscale	The Credibility subscale of the Credibility/Expectancy Questionnaire (CEQ) measures the the credibility of an intervention in clinical studies. The word "therapy" is replaced with "intervention" and modified to reflect the intent of the intervention (i.e., to improve skills in navigating college). Three items are each scored on a range from 0-9 and averaged together for a credibility rating, with high scores indicating greater perceived credibility of the intervention.	1 week
Average CEQ Ratings - Expectancy Subscale	The Expectancy subscale of the Credibility/Expectancy Questionnaire (CEQ) measures the the expectancy of an intervention in clinical studies. The word "therapy" is replaced with "intervention" and modified to reflect the intent of the intervention (i.e., to improve skills in navigating college). Three items are each scored on a range from 0-9 and averaged together for an expectancy rating, with high scores indicating greater perceived expectancy of positive outcomes of the intervention.	1 week
Mean Change in Emotional Distress Scores	The Depression, Anxiety and Stress Scale-21 (DASS-21) is composed of three self-report scales that measure depression, anxiety and stress. Items are rated on a Likert-type scale (0=Did not apply to me at all, to 3=Applied to me very much, or most of the time). Scores for the three subscales are calculated by summing the scores for the relevant items. The severity rating for Depression are Normal: 0-4, Mild: 5-6, Moderate: 7-10, Severe: 11-13, and Extremely Severe: 14-21; for Stress the ratings are Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, and Extremely Severe 17-21; and for Anxiety the ratings are Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, and Extremely Severe: 10-21. The total DASS-21 score is calculated by summing all three subscales, with a range from 0-63. For all scales, higher scores indicate greater emotional distress.	Baseline, Week 6
Participant Satisfaction	Feedback will be collected the same day as each training visit, using a simple survey designed on Qualtrics.	5 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Charlotte Boettiger, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Carmody J, Baer RA. Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J Behav Med. 2008 Feb;31(1):23-33. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25.
• Mehrabian A, Russell JA. A questionnaire measure of habitual alcohol use. Psychol Rep. 1978 Dec;43(3 Pt 1):803-6. doi: 10.2466/pr0.1978.43.3.803. No abstract available.
• Gass JT, Glen WB Jr, McGonigal JT, Trantham-Davidson H, Lopez MF, Randall PK, Yaxley R, Floresco SB, Chandler LJ. Adolescent alcohol exposure reduces behavioral flexibility, promotes disinhibition, and increases resistance to extinction of ethanol self-administration in adulthood. Neuropsychopharmacology. 2014 Oct;39(11):2570-83. doi: 10.1038/npp.2014.109. Epub 2014 May 13.
• Sey NYA, Gomez-A A, Madayag AC, Boettiger CA, Robinson DL. Adolescent intermittent ethanol impairs behavioral flexibility in a rat foraging task in adulthood. Behav Brain Res. 2019 Nov 5;373:112085. doi: 10.1016/j.bbr.2019.112085. Epub 2019 Jul 15.
• Chanon VW, Sours CR, Boettiger CA. Attentional bias toward cigarette cues in active smokers. Psychopharmacology (Berl). 2010 Oct;212(3):309-20. doi: 10.1007/s00213-010-1953-1. Epub 2010 Jul 29.
• Field M, Marhe R, Franken IH. The clinical relevance of attentional bias in substance use disorders. CNS Spectr. 2014 Jun;19(3):225-30. doi: 10.1017/S1092852913000321. Epub 2013 May 13.
• Field M, Werthmann J, Franken I, Hofmann W, Hogarth L, Roefs A. The role of attentional bias in obesity and addiction. Health Psychol. 2016 Aug;35(8):767-80. doi: 10.1037/hea0000405.
• Masiero M, Lucchiari C, Maisonneuve P, Pravettoni G, Veronesi G, Mazzocco K. The Attentional Bias in Current and Former Smokers. Front Behav Neurosci. 2019 Jul 10;13:154. doi: 10.3389/fnbeh.2019.00154. eCollection 2019.
• Meyer KN, Sheridan MA, Hopfinger JB. Reward history impacts attentional orienting and inhibitory control on untrained tasks. Atten Percept Psychophys. 2020 Nov;82(8):3842-3862. doi: 10.3758/s13414-020-02130-y.
• Greeson JM, Juberg MK, Maytan M, James K, Rogers H. A randomized controlled trial of Koru: a mindfulness program for college students and other emerging adults. J Am Coll Health. 2014;62(4):222-33. doi: 10.1080/07448481.2014.887571.
• Anderson BA, Laurent PA, Yantis S. Value-driven attentional capture. Proc Natl Acad Sci U S A. 2011 Jun 21;108(25):10367-71. doi: 10.1073/pnas.1104047108. Epub 2011 Jun 6.
• Anderson BA, Kim H, Britton MK, Kim AJ. Measuring attention to reward as an individual trait: the value-driven attention questionnaire (VDAQ). Psychol Res. 2020 Nov;84(8):2122-2137. doi: 10.1007/s00426-019-01212-3. Epub 2019 Jun 12.
• Spear LP. Effects of adolescent alcohol consumption on the brain and behaviour. Nat Rev Neurosci. 2018 Apr;19(4):197-214. doi: 10.1038/nrn.2018.10. Epub 2018 Feb 15. Erratum In: Nat Rev Neurosci. 2018 Jul;19(7):439. doi: 10.1038/s41583-018-0007-2.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness Meditation; Attentional Bias; Emerging Adults; Alcohol Misuse
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Cognitive Dysfunction; Alcoholism; Cognition Disorders
• Other Study ID Numbers: 21-1486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No