Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information

NCT05873556 | Completed Results

• 2 other identifiers: STUDY00016989R34AA027302
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Consumption

Outcome Measures

Primary Outcomes (4)

• Daily Drinking Questionnaire

  Number of standard drinks consumed on each day of a typical week during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week.

  Baseline, 2 week follow-up, and 3 month follow-up

• Heavy Episodic Drinking

  Participants were asked, "During the past two weeks, how many times did you have \[4/5 for females/males\] or more drinks at one sitting?". Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10.

  Baseline, 2 week follow-up, and 3 month follow-up

• Penn Alcohol Craving Scale

  Self-reported subjective alcohol craving during the past week. Response options were scored from "0" to "6" with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving.

  Baseline, 2 week follow-up, and 3 month follow-up

• Brief Young Adult Alcohol Consequences Questionnaire

  Participants responded "no" (0) or "yes" (1) to whether they experienced each of 24 consequences during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24. Higher values represent a worse outcome (i.e., more consequences).

  Baseline, 2 week follow-up, and 3 month follow-up

Study Arms (2)

Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

EXPERIMENTAL

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.

Behavioral: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

Assessment-only control

NO INTERVENTION

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.

Interventions

Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) 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.

Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Limitations and Caveats

This is a small pilot trial designed to collect feasibility and acceptability information. The study (enrollment through 3-month) went from May 2023 to March 2024; the COVID-19 pandemic may have impacted alcohol use and contexts of alcohol use. All findings are based on self-report of alcohol use. Analyses reported here restrict the sample to 93 to account for a programming error (subsequently fixed) where control participants were initially being incorrectly emailed a link to the feedback.

Results Point of Contact

• Title: Dr. Anne Fairlie
• Organization: University of Washington

afairlie@uw.edu

2062215896

Study Officials

• Jason Ramirez, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Anne Fairlie, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor: School of Medicine

Model Details: Participants will be randomly assigned to one of two conditions: (1) Personalized feedback based on reports from baseline and lab-session and (2) assessment-only control group.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: May 8, 2023
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data dictionaries and limited datasets can be made available starting in May 2024.
• Access Criteria: Individual requests to access data with intended purpose should be made to Drs. Fairlie and Ramirez and will be reviewed by the investigative team.

Locations

US (1)