Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information

NCT ID: NCT05873556

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2024-03-25

Brief Summary

This study aims to develop a brief intervention that uses information from a lab-based cue reactivity protocol to create personalized feedback targeting high-risk alcohol use among young adults who drink alcohol. The intervention provides feedback on individuals' drinking desire, mood, willingness to drink, and alcohol demand by comparing scores before and after viewing and smelling an alcoholic beverage in the lab session. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention is used in a randomized controlled trial (RCT) comparing young adults who receive the brief, online intervention to those who did not receive the brief, online intervention. Participants in both groups complete baseline, lab-based cue reactivity protocol, 2-week follow-up and 3-month follow-up.

Detailed Description

The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' responses from a baseline survey and from a lab-based cue reactivity protocol. The aim of the intervention is to increase young adults' awareness of how alcohol cues may affect their desire to drink, mood, willingness to drink, and alcohol demand both in relation to lab-based exposure to an alcohol beverage of their choice and also more broadly in everyday life. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking.

This brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the assessments and lab protocol but do not receive any personalized feedback. Online assessments include an eligibility survey, baseline assessment, and follow-up assessments occurring 2-weeks and 3-months post-intervention. Everyone has one in-person session to complete the lab-based cue reactivity protocol after the baseline assessment has been completed online. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.

Conditions

Alcohol Consumption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

Participants randomized to the Lab-based Cue Reactivity PFI condition view the online personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.

Group Type: EXPERIMENTAL

Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

Intervention Type: BEHAVIORAL

This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.

Assessment-only control

Participants randomized to the control group do not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between ages 18-24
• Lives in Washington state
• Reports drinking at least two days per week in the last six months
• Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month
• Open to changing drinking behavior
• Must be willing to come to our Seattle study office for session visit
• Provide an email address and phone number for study communication

Exclusion Criteria

• Actively seeking treatment for alcohol use
• Currently participating in another study in our research center regarding young adult drinking behavior

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jason Ramirez

Acting Assistant Professor: School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Ramirez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Anne Fairlie, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34AA027302

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00016989

Identifier Type: -

Identifier Source: org_study_id