Alcohol AbuseSINCNCT05560425
Pilot Study on Training Emerging Adults Skills in Navigating College
A study testing Koru Mindfulness (KM) Training and Navigating College (NC) Training in people with Alcohol Abuse and Cognitive Deficit in Attention, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Cognitive Deficit in Attention
- What is being tested?
- Koru Mindfulness (KM) Training and Navigating College (NC) Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 19 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-3270
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Abuse, Cognitive Deficit in Attention
- Being tested
- Koru Mindfulness (KM) Training, Navigating College (NC) Training
- Keywords
- Attentional Bias, Alcohol Misuse, Emerging Adults, Mindfulness Meditation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Koru Mindfulness (KM) TrainingBehavioural
Also called Koru Basic
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) TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Navigating College (NC) Training | Active comparator | Control Group Receives: Behavioral: Navigating College (NC) Training |
| Koru Mindfulness (KM) Training | Experimental | Study Group Receives: Behavioral: Koru Mindfulness (KM) Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention
Participant retention will be measured by the percentage of enrolled participants remaining in the study after 6 visits.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6
Participant Satisfaction
Feedback will be collected the same day as each training visit, using a simple survey designed on Qualtrics.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start11 Sep 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment randomized controlled trial feasibility study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Charlotte Boettiger, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560425
- Sponsor's protocol ID
- 21-1486
- Acronym
- SINC
- Status last verified
- Apr 2024
- First submitted
- 26 Sep 2022
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 29467469Mehrabian 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.
PubMed 740823Gass 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.
PubMed 24820536Sey 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.
PubMed 31319133Chanon 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.
PubMed 20668841Field 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.
PubMed 23663386Field 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.
PubMed 27505196Masiero 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.
PubMed 31354446Meyer 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.
PubMed 32935290Greeson 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.
PubMed 24499130Anderson 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.
PubMed 21646524Anderson 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.
PubMed 31190092Carmody 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.
PubMed 17899351
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Mindfulness Meditation and Behavioral Flexibility Among Emerging Adults
- ClinicalTrials.gov ID
- NCT05560425
- Acronym / sponsor ID
- SINC / 21-1486
- Conditions
- Alcohol Abuse, Cognitive Deficit in Attention
- Keywords
- Attentional Bias, Alcohol Misuse, Emerging Adults, Mindfulness Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- parallel assignment randomized controlled trial feasibility study
| Arm | Type | Receives |
|---|---|---|
| Navigating College (NC) Training | Active comparator | Behavioral: Navigating College (NC) TrainingControl Group |
| Koru Mindfulness (KM) Training | Experimental | Behavioral: Koru Mindfulness (KM) TrainingStudy Group |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Koru Mindfulness (KM) TrainingAlso: Koru BasicThe 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. | Behavioural | Koru Mindfulness (KM) Training |
| Navigating College (NC) TrainingWith 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. | Behavioural | Navigating College (NC) Training |
Primary outcome
Participant Retention
Time frame: 10 weeks
Participant retention will be measured by the percentage of enrolled participants remaining in the study after 6 visits.
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.
4 secondary outcomes
Average CEQ Ratings - Credibility Subscale
Time frame: 1 week
Average CEQ Ratings - Expectancy Subscale
Time frame: 1 week
Mean Change in Emotional Distress Scores
Time frame: Baseline, Week 6
Participant Satisfaction
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29467469Spear 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.
- Background: PubMed 740823Mehrabian 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.
- Background: PubMed 24820536Gass 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.
- Background: PubMed 31319133Sey 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.
- Background: PubMed 20668841Chanon 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.
- Background: PubMed 23663386Field 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.
- Background: PubMed 27505196Field 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.
- Background: PubMed 31354446Masiero 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.
- Background: PubMed 32935290Meyer 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.
- Background: PubMed 24499130Greeson 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.
- Background: PubMed 21646524Anderson 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.
- Background: PubMed 31190092Anderson 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.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Alcohol Abuse
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Not yet recruiting
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Alcohol, Cannabis
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Recruiting
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Alcohol Abuse, Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Boettiger, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Koru Mindfulness (KM) Training and Navigating College (NC) Training in people with Alcohol Abuse and Cognitive Deficit in Attention, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560425, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.