Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information

Alcohol Consumption Clinical Trial

— Project ACE  

Official title:

Development and Preliminary Examination of Two Brief Personalized Feedback Interventions Focused on Lab-based and EMA Alcohol Cues to Reduce Hazardous Young Adult Alcohol Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05873556
• Other study ID #: STUDY00016989
• Secondary ID: R34AA027302
• Status: Completed
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: March 25, 2024

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 mainly focuses on providing 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Drinking Questionnaire	Total number of standard drinks consumed in a typical week	2-week
Primary	Daily Drinking Questionnaire	Total number of standard drinks consumed in a typical week	3-month
Primary	Brief Young Adult Alcohol Consequences Questionnaire	Total number of alcohol-related consequences endorsed	2-week
Primary	Brief Young Adult Alcohol Consequences Questionnaire	Total number of alcohol-related consequences endorsed	3-month
Primary	Penn Alcohol Craving Scale	Subjective craving for alcohol endorsed	2-week
Primary	Penn Alcohol Craving Scale	Subjective craving for alcohol endorsed	3-month