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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05560425
Other study ID # 21-1486
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date December 20, 2023

Study information

Verified date April 2024
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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.
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.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

References & Publications (13)

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Outcome

Type Measure Description Time frame Safety issue
Primary Participant retention Participant retention will be measured by the percentage of participants remaining in the study after 6 visits. 10 weeks
Primary Compliance with independent training of skills To determine participant compliance with training skills learned during each of the 4 virtual visits, the total number of journal entries logged during the 4 weeks of training is calculated as a total score. Total scores range from 0 to 24, with higher scores indicating greater compliance with independent training. 6 weeks
Secondary Expectancy of interventions The Credibility/Expectancy Questionnaire (CEQ) is a 6-item questionnaire composed of two self-report scales that measure the the credibility and 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). Four items are rated on a 1-9 Likert-type scale (0=not at all, to 9=very much), and two items are rated on a Likert-type percentage scale (0 to 100%). Credibility ratings are calculated by taking the mean of the first three items of the CEQ, and expectancy rating is calculated by taking the score from one question. 1 week
Secondary Emotional distress 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. 10 weeks
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