Back to resultsBrief ROC Training Effects on Alcohol Drinking
Primary Purpose
Binge Drinking, Heavy Drinking, Young Adult
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regulation of craving
Control (NO REGULATION)
Sponsored by
About this trial
This is an interventional treatment trial for Binge Drinking focused on measuring Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Regulation of craving, Cognitive behavioral therapy, Neurocognitive training, Emotion regulation, Alcohol
Eligibility Criteria
Inclusion Criteria:
- Adults ages 18-25
- Capability of performing the experimental tasks (e.g., can read, able to use computers)
- Native or fluent speaker of English
- Provides informed consent
- Normal or corrected-to-normal vision
- Willing to commit to the full length of the protocol
- Heavy drinking or binge-drinking
Exclusion Criteria.
- Present DSM disorders, apart from alcohol use disorders
- Reports of neurological or systemic disorders that can cause cognitive impairment
- Minor cognitive impairment evidenced by an inability to correctly understand study information
- Reports entirely no interest in reducing the amount of drinking (Alcohol Contemplation Ladder score of 9 or 10).
Sites / Locations
- Clinical & Affective Neuroscience LabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CRAVING REGULATION
CONTROL (NO REGULATION)
Arm Description
In the CRAVING REGULATION condition, participants will first read a brief essay about the adverse consequences of drinking alcohol. Then, participants may complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will be trained to use the information to inform the strategy they will use in the regulation of craving training (ROC-T). A single trial in the regulation of craving training will have two possible instructions: (a) STRATEGY: implement the strategy ("bring to mind the negative facts from the essay") and (b) LOOK: to merely observe the image and allow natural responses to come. Participants will follow the instructions; followed by an alcohol-related picture, a brief delay, and will then rate their craving. Participants will then be instructed to use this strategy in daily life situations when they might drink.
In the CONTROL condition, participants will first read a brief essay about a non-alcohol-related topic (e.g., color perception). Then, participants will complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will view images of objects that are unrelated to alcohol. Furthermore, participants in the control condition will not practice any strategy in the regulation of craving task (ROC-T). That is, in the CONTROL condition, participants would merely observe the image and allow natural responses to come (i.e., LOOK instruction) and rate how colorful is each item (this controls for task time and experiment setting).
Outcomes
Primary Outcome Measures
Timeline followback (TLFB)
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Secondary Outcome Measures
Frequency of regulating drinking + craving.
Participants will be asked to report their craving regulation (if any) since the intervention. In order to assess the level of craving regulation the participants will answer several questions in our craving regulation questionnaire. This assessment will include questions about the number of attempts at craving regulation, the number of times the participant intended to regulate craving, one's confidence in one's ability to regulate craving, the level of motivation to regulate drinking before each drinking episode, and the participant's intention to regulate drinking in the future. Finally, participants will be asked how many times they were thinking of negative consequences in general and while experiencing alcohol craving.
Timeline followback (TLFB)
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03928626
Brief Title
Brief ROC Training Effects on Alcohol Drinking
Official Title
Brief ROC Training Effects on Alcohol Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of the proposed study is to examine whether a single session of training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of (1) a basic screening (phone and/or online) and an in-person visit, to determine eligibility and conduct pre-intervention baseline assessments; (2) a training (ROC-T) visit, (3) a post-intervention assessment visit, and (4) 1-2 phone/online follow-up assessments.
The study will take up to 10 hours of the participants' time.
Detailed Description
The investigators propose to test the efficacy of such training by randomizing 120 individuals who report alcohol drinking to the following conditions: (1) a brief training in cognitive regulation and (2) a control or no-training condition. Training will be delivered in a computerized session (approximately 60 minutes). If randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy while viewing images of alcoholic drinks. The strategy would be to follow instructions to think about the adverse outcomes associated with continued alcohol drinking. If randomized into the control condition, participants will only view non-alcohol-related images with no use of strategy. After all the training sessions are completed, participants will complete several follow-ups. The investigators will evaluate the effects of training on alcohol drinking pre- and post-training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Alcohol Drinking, Alcohol Drinking in College, Drinking Behavior, Drunkenness, Drinking Excessive, Drinking Problem, Drink Too Much, College Drinking
Keywords
Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Regulation of craving, Cognitive behavioral therapy, Neurocognitive training, Emotion regulation, Alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRAVING REGULATION
Arm Type
Active Comparator
Arm Description
In the CRAVING REGULATION condition, participants will first read a brief essay about the adverse consequences of drinking alcohol. Then, participants may complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will be trained to use the information to inform the strategy they will use in the regulation of craving training (ROC-T). A single trial in the regulation of craving training will have two possible instructions: (a) STRATEGY: implement the strategy ("bring to mind the negative facts from the essay") and (b) LOOK: to merely observe the image and allow natural responses to come. Participants will follow the instructions; followed by an alcohol-related picture, a brief delay, and will then rate their craving. Participants will then be instructed to use this strategy in daily life situations when they might drink.
Arm Title
CONTROL (NO REGULATION)
Arm Type
Placebo Comparator
Arm Description
In the CONTROL condition, participants will first read a brief essay about a non-alcohol-related topic (e.g., color perception). Then, participants will complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will view images of objects that are unrelated to alcohol. Furthermore, participants in the control condition will not practice any strategy in the regulation of craving task (ROC-T). That is, in the CONTROL condition, participants would merely observe the image and allow natural responses to come (i.e., LOOK instruction) and rate how colorful is each item (this controls for task time and experiment setting).
Intervention Type
Behavioral
Intervention Name(s)
Regulation of craving
Other Intervention Name(s)
Neurocognitive training
Intervention Description
Participants in the ROC-T condition will be trained to use a strategy that instructs them to think of the negative outcomes associated with alcohol drinking while looking at alcohol-related images.
Intervention Type
Behavioral
Intervention Name(s)
Control (NO REGULATION)
Other Intervention Name(s)
Sham (No regulation)
Intervention Description
In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come
Primary Outcome Measure Information:
Title
Timeline followback (TLFB)
Description
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Time Frame
Baseline (first visit) to post-intervention (an average of one week after first visit)
Secondary Outcome Measure Information:
Title
Frequency of regulating drinking + craving.
Description
Participants will be asked to report their craving regulation (if any) since the intervention. In order to assess the level of craving regulation the participants will answer several questions in our craving regulation questionnaire. This assessment will include questions about the number of attempts at craving regulation, the number of times the participant intended to regulate craving, one's confidence in one's ability to regulate craving, the level of motivation to regulate drinking before each drinking episode, and the participant's intention to regulate drinking in the future. Finally, participants will be asked how many times they were thinking of negative consequences in general and while experiencing alcohol craving.
Time Frame
Will be measured at post-intervention (one week after first visit)
Title
Timeline followback (TLFB)
Description
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Time Frame
First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults ages 18-25
Capability of performing the experimental tasks (e.g., can read, able to use computers)
Native or fluent speaker of English
Provides informed consent
Normal or corrected-to-normal vision
Willing to commit to the full length of the protocol
Heavy drinking or binge-drinking
Exclusion Criteria.
Present DSM disorders, apart from alcohol use disorders
Reports of neurological or systemic disorders that can cause cognitive impairment
Minor cognitive impairment evidenced by an inability to correctly understand study information
Reports entirely no interest in reducing the amount of drinking (Alcohol Contemplation Ladder score of 9 or 10).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hedy Kober, PhD
Phone
203-737-5641
Email
hedy.kober@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Berger, PhD
Phone
203-298-2177
Email
uri.berger@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uri Berger, PhD
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
Clinical & Affective Neuroscience Lab
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilofar Vafaie, PhD
Phone
203-737-4714
Email
nilo.vafay@yale.edu
First Name & Middle Initial & Last Name & Degree
Hedy Kober, Ph.D.
First Name & Middle Initial & Last Name & Degree
Uri Berger, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers.
Learn more about this trial
Brief ROC Training Effects on Alcohol Drinking
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