Alcohol-ROC-Training

ConditionsBinge Drinking Heavy Drinking Young Adult Heavy Drinker

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-26

SponsorYale University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Mindfulness-Based Treatment-Regulation of Craving
Behavioral
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.
Cognitive-Based Therapy-Regulation of Craving
Behavioral
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

Treatment groups

177 Participants

are divided into 3 treatment groups

Group A: Mindfulness-Based TreatmentExperimental treatment 1 intervention

Group B: Cognitive Behavioral TherapyExperimental treatment 1 intervention

Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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).

Time frame

From baseline to 2-weeks post-intervention and to the 10-week follow-up

Secondary outcomes

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.

Time frame