Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information

NCT05373706 | Completed Results

• 2 other identifiers: STUDY000147781R34AA027302-01A1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Problem Drinking

Keywords

Alcohol; Intervention; Young Adults; Personalized Feedback

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

• Number of Heavy Episodic Drinking Occasions

  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.

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

Study Arms (2)

Cue Reactivity Personalized Feedback Intervention (PFI)

EXPERIMENTAL

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.

Behavioral: Alcohol Cue Reactivity Personalized Feedback Intervention

Assessment-only control

NO INTERVENTION

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

Interventions

Alcohol Cue Reactivity Personalized Feedback Intervention BEHAVIORAL

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

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, 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.

You may not qualify if:

• \) Actively seeking treatment for alcohol use, 2) 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, 98155, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

This is a small pilot trial designed to collect feasibility and acceptability information. Study data were collected during the COVID-19 pandemic from April 2022 through May 2023, which may have impacted alcohol use and contexts of alcohol use among young adult participants. All findings are based on self-report of alcohol use.

Results Point of Contact

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

afairlie@uw.edu

(206) 221-5896

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: Research Assistant Professor: School of Medicine

Model Details: Participants will be randomly assigned to one of two conditions (Personalized feedback and assessment-only control group).

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: April 29, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Data dictionaries and limited datasets can be made available starting in February 2023.
• 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)