Brief ROC Training Effects on Alcohol Drinking

Not Applicable

Terminated

• Conditions: Alcohol Drinking in College; Drinking Behavior; Drunkenness; Young Adult; Heavy Drinking; Drinking Excessive; Heavy Drinker; Alcohol Drinking; Drink Too Much; Binge Drinking
• Interventions: Behavioral: Control (NO REGULATION); Behavioral: Regulation of craving

• Registration Number: NCT03928626
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-26
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1. Adults ages 18-25
2. Capability of performing the experimental tasks (e.g., can read, able to use computers)
3. Native or fluent speaker of English
4. Provides informed consent
5. Normal or corrected-to-normal vision
6. Willing to commit to the full length of the protocol
7. Heavy drinking or binge-drinking

Exclusion Criteria.

1. Present DSM disorders, apart from alcohol use disorders
2. Reports of neurological or systemic disorders that can cause cognitive impairment
3. Minor cognitive impairment evidenced by an inability to correctly understand study information
4. Reports entirely no interest in reducing the amount of drinking (Alcohol Contemplation Ladder score of 9 or 10).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL (NO REGULATION)	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).
CRAVING REGULATION	Regulation of craving	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.

Primary Outcome Measures

Name	Time	Method
Timeline followback (TLFB)	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of regulating drinking + craving.	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)	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.

Trial Locations

Locations (1)

Clinical & Affective Neuroscience Lab; 🇺🇸 New Haven, Connecticut, United States