Brief ROC Training Effects on Alcohol Drinking
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|ClinicalTrials.gov Identifier: NCT03928626|
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : May 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Behavioral: Regulation of craving Behavioral: Control (NO REGULATION)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Brief ROC Training Effects on Alcohol Drinking|
|Actual Study Start Date :||April 10, 2019|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Active Comparator: CRAVING REGULATION
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.
Behavioral: Regulation of craving
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.
Other Name: Neurocognitive training
Placebo Comparator: CONTROL (NO REGULATION)
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).
Behavioral: Control (NO REGULATION)
In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come
Other Name: Sham (No regulation)
- Timeline followback (TLFB) [ Time Frame: Baseline (first visit) to post-intervention (an average of one week after first visit) ]The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
- Frequency of regulating drinking + craving. [ Time Frame: Will be measured at post-intervention (one week after first visit) ]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) [ Time Frame: First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit) ]The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928626
|Contact: Hedy Kober, PhDfirstname.lastname@example.org|
|Contact: Uri Berger, PhDemail@example.com|
|United States, Connecticut|
|Clinical & Affective Neuroscience Lab||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Nilofar Vafaie, PhD 203-737-4714 firstname.lastname@example.org|
|Principal Investigator: Hedy Kober, Ph.D.|
|Sub-Investigator: Uri Berger, Ph.D.|
|Study Director:||Uri Berger, PhD||Yale University|