Alcohol-ROC-Training

Study Overview
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Brief Summary
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The goal of the proposed study is to examine whether brief training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (ROC-T) visits, a post-intervention assessment visit, and 1-2 phone/online follow up assessments.The two active conditions of ROC-T are based on cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT).

Detailed Description
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This is a Stage 1B Randomized-Controlled Trial (RCT). 177 heavy drinking young adult participants will be randomized to 4 x 45-minute web-based sessions of (1) CBT-ROC-T training, (2) MBT-ROC-T, or (3) CONTROL (no strategy) delivered over three weeks. Participants will be enrolled for 16 weeks (three weeks pre-, three weeks during, and ten weeks post-intervention).

Official Title
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Brief Training for Heavy Drinking Young Adults: Regulation of Alcohol Craving

Conditions
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Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker

Intervention / Treatment
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* Behavioral: Mindfulness-Based Treatment-Regulation of Craving
* Behavioral: Cognitive-Based Therapy-Regulation of Craving


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Young adults ages 18-26 years, who (2) report ≥ 3 heavy drinking days (i.e., heavy drinking defined by >3 drinks for women, >4 drinks for men) in the prior month; (3) are motivated to quit or reduce drinking; (4) are fluent in English and have a 6th grade or higher reading level; (5) have access to a computer with working internet; (6) use a working smartphone; (7) can commit to the full length of the protocol; and (8) are willing to be randomized to intervention condition. Exclusion Criteria: (1) Current (past 12 months) clinically-severe alcohol use disorder (AUD; e.g., history of seizures, delirium, or hallucinations during withdrawal) or current severe alcohol withdrawal; (2) Current (past 12 months) clinically-severe substance use disorder (except tobacco) or current severe drug withdrawal; (3) serious other psychiatric illness by history or examination; (4) severe or unstable physical disease within the past 6 months; (5) psychoactive medications (e.g., mood stabilizers) that have not been at a stable dose; (6) current use of any investigational medication; (7) color blindness; (8) biological females who are pregnant; and (9) notable dislike to any particular type of alcoholic beverage depicted in study stimuli; (8) Participants who will not complete at least 70% of past day EMA reports in the pre-intervention phase will not be randomized.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Treatment<br>Using mindfulness and meditative strategies to control craving | Behavioral: Mindfulness-Based Treatment-Regulation of Craving<br>* Participants will be trained in using the MBT-based mindfulness strategy as described above (notice craving and accept the feeling without judgment or reaction). Participants will then be instructed to think of accepting and non-reactive responses when they see the instruction ACCEPT during ROC-T. On each trial, participants will receive an instruction and then be exposed to a novel alcohol image for 6 seconds. On 25% of the trials, they will see the LOOK instruction, and be allowed to experience craving (as baseline). On 75% of the trials, participants will see ACCEPT and then practice thinking about the negative consequences of drinking. After the picture disappears, they will rate their craving on every trial using a 1-5 Likert scale.<br>* Other names: MBT-ROC;|
| Experimental: Cognitive Behavioral Therapy<br>Thinking of negative consequences to control craving | Behavioral: Cognitive-Based Therapy-Regulation of Craving<br>* Participants will be trained in using the CBT strategy by first considering and reading about the negative consequences of drinking. Participants will then be instructed to think of those negative consequences (Focus on the negative consequences associated with drinking) when they see the instruction REFRAME during ROC-T.On each trial, participants will receive an instruction and then be exposed to a novel alcohol image for 6 seconds. On 25% of the trials, they will see the LOOK instruction, and be allowed to experience craving (as baseline). On 75% of the trials, participants will see REFRAME and then practice thinking about the negative consequences of drinking. After the picture disappears, they will rate their craving on every trial using a 1-5 Likert scale<br>* Other names: CBT-ROC;|
| No Intervention: Control<br>No regulatory strategy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of heavy drinking days | Self-reports of daily alcohol use via smartphone-based ecological momentary assessment (EMA) is the primary source for this outcome variable, with Timeline Follow-Back (TLFB) data inserted to replace missing data from EMA. A heavy drinking day is defined as more than 3 or 4 standard drinks per day for women/men. | From baseline to 2-weeks post-intervention and to the 10-week follow-up | 
| Change in average estimated blood alcohol concentration (eBAC) per drinking day | Daily self-reports of alcohol use via smartphone-based ecological momentary assessment (EMA) is the primary source for this outcome variable, with Timeline Follow-Back (TLFB) data inserted to replace missing data from EMA. Estimated blood alcohol concentration (eBAC) is based on number of standard drinks reported per day, duration of drinking, and total body water (based on sex, age, height, and weight). | From baseline to 2-weeks post-intervention and to the 10-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alcohol-related negative consequences | Daily self-reports of alcohol-related negative consequences (Brief Young Adult Alcohol Consequences Questionnaire) via smartphone-based ecological momentary assessment (EMA) is the primary source for this outcome variable. Total scores range from 0 to 24, with higher scores indicating greater alcohol-related negative consequences. | From baseline to 2-weeks post-intervention and the 10-week follow-up | 
| Reduction in World Health Organization (WHO) drinking risk level | Drinking risk levels are based on grams of pure alcohol per day in a given period and include abstinent (0 grams males/females), low risk (1 to 40g males/1 to 20g females), medium risk (41 to 60g males/21 to 40g females), high risk (61 to 100g males/41 to 60g females), or very high risk (greater to or equal to 101g males/61g females). | From baseline to 2-weeks post-intervention and the 10-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Regulation of Craving, Cognitive Behavioral Therapy, Neurocognitive Training, Mindfulness-Based Therapy