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Completed

NCT Number: NCT05560425

Pilot Study on Training Emerging Adults Skills in Navigating College

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.

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Key information

Conditions

Alcohol Abuse Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Cognitive Deficit in Attention Mental Disorders Substance-Related Disorders

Age range

18 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-3270, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Koru Mindfulness (KM) Training

Behavioral

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

Navigating College (NC) Training

Behavioral

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.

Primary outcomes

  1. Participant Retention

    Time frame: 10 weeks

    Participant retention will be measured by the percentage of enrolled participants remaining in the study after 6 visits.

  2. Compliance With Independent Training of Skills

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Average CEQ Ratings - Credibility Subscale

    Time frame: 1 week

    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.

  2. Average CEQ Ratings - Expectancy Subscale

    Time frame: 1 week

    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.

  3. Mean Change in Emotional Distress Scores

    Time frame: Baseline, Week 6

    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.

  4. Participant Satisfaction

    Time frame: 5 weeks

    Feedback will be collected the same day as each training visit, using a simple survey designed on Qualtrics.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

Pilot Study on Mindfulness Meditation and Behavioral Flexibility Among Emerging Adults

Acronym: SINC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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