Trials / Recruiting
RecruitingNCT05491551
Alcohol-ROC-Training
Brief Training for Heavy Drinking Young Adults: Regulation of Alcohol Craving
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 177 (estimated)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 18 Years – 26 Years
- Healthy volunteers
- Not accepted
Summary
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
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Mindfulness-Based Treatment-Regulation of Craving | 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. |
| BEHAVIORAL | Cognitive-Based Therapy-Regulation of Craving | 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 |
Timeline
- Start date
- 2022-09-28
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2022-08-08
- Last updated
- 2026-02-19
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05491551. Inclusion in this directory is not an endorsement.