Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information

NCT ID: NCT05373706

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2023-05-01

Brief Summary

This study aims to develop a brief intervention that incorporates ecological momentary assessments (EMAs; i.e., four brief surveys per day for 17 days) to create personalized feedback targeting high-risk alcohol use among young adult drinkers. The intervention mainly focuses on providing feedback on individuals' drinking desire and how it varies as a function of a number of real-world factors. 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 will be used in a randomized controlled trial (RCT) comparing young adults who receive the intervention with those who only complete identical assessments.

Detailed Description

The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' own event-level, real-world experiences. The aim of the intervention is to increase young adults' awareness of their desire to drink as it varies as a function of a number of real-world factors including alcohol cues, social context, physical context, anticipation of later drinking, mood, and time of day. 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 EMAs but do not receive any personalized feedback. Assessments include an eligibility survey, baseline assessment, 17 days of EMAs (4x/day), and follow-up assessments occurring 2-weeks and 3-months post-intervention. The 2-week and 3-month follow-ups occurred 2-weeks and 3-months, respectively, from Day 17 of the EMA period, because the intervention was delivered on Day 17. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.

Conditions

Alcohol Drinking; Problem Drinking

Study Design

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

Study Groups

Cue Reactivity Personalized Feedback Intervention (PFI)

Participants randomized to the Cue Reactivity PFI condition will receive personalized feedback at the end of completing 17 days of ecological momentary assessments (EMAs) four times a day. The personalized feedback will be delivered online and contains information summarizing participants' desire to drink as it varied as a function of several real-world factors across the 17-day EMA period.

Group Type: EXPERIMENTAL

Alcohol Cue Reactivity Personalized Feedback Intervention

Intervention Type: BEHAVIORAL

This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.

Assessment-only control

Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Alcohol Cue Reactivity Personalized Feedback Intervention

This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 1) Between ages 18-24, 2) Lives in Washington state, 3) Reports drinking at least two days per week in the last six months, 4) Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month, 5) Open to changing drinking behavior, 6) Schedule allows for participation in study with daily surveys, 7) Able to attend Zoom training session, 8) Must have cellphone for daily surveys.

Exclusion Criteria

• 1) Actively seeking treatment for alcohol use, 2) 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

Research 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

1R34AA027302-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00014778

Identifier Type: -

Identifier Source: org_study_id