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Clinical Trials/NCT05288699
NCT05288699
Recruiting
N/A

Brief Personalized Feedback Intervention for Latinx Hazardous Drinkers: A Community-Based Intervention

Michael J. Zvolensky, Ph.D.1 site in 1 country50 target enrollmentNovember 4, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alcohol Abuse
Sponsor
Michael J. Zvolensky, Ph.D.
Enrollment
50
Locations
1
Primary Endpoint
Alcohol Use Disorders Identification Test
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to develop and examine a culturally adapted, brief, integrated, Spanish language mobile health application for the Android platform, optimized to deliver a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Latinx hazardous drinkers with clinical anxiety.

Detailed Description

Investigators will develop a culturally adapted, brief, single-session, Spanish language, PFI delivered via a mobile health application for the Android platform through an iterative approach using expert input and focus groups. Next, Latinx hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Latinx hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects. Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-week, 1-month, and 3-months follow-up data will be collected remotely.

Registry
clinicaltrials.gov
Start Date
November 4, 2022
End Date
April 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Michael J. Zvolensky, Ph.D.
Responsible Party
Sponsor Investigator
Principal Investigator

Michael J. Zvolensky, Ph.D.

Distinguished Professor

University of Houston

Eligibility Criteria

Inclusion Criteria

  • 21 years of age or older
  • self-identified as Latinx or Hispanic
  • fluent in Spanish
  • current hazardous drinking pattern
  • current clinical anxiety
  • able to provide written, informed consent
  • owning an Android smartphone

Exclusion Criteria

  • currently involved in alcohol or other substance use program
  • concurrent use of medication for anxiety or depression
  • current engagement in psychotherapy for anxiety or depression

Outcomes

Primary Outcomes

Alcohol Use Disorders Identification Test

Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

The Alcohol Use Disorders Identification Test will be used to assess drinking quantity, craving, and related consequences to alcohol use. The 10 items are rated with various Likert-type scales. The measure produces a total score by adding all of the items of the measure with higher scores indicating greater problems with alcohol (possible range 0 to 40).

Overall Anxiety Severity and Impairment Scale

Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

The 5-item Overall Anxiety Severity and Impairment Scale will be used to assess anxiety symptom severity and impairment. Each of the items is rated on a Likert-type scale ranging from 0 to 4. Items are summed to produce a total score (possible range 0 to 20).

Secondary Outcomes

  • Alcohol Attitudes Scale(Change from Baseline Pre PFI completion to Baseline Post PFI completion)
  • Modified Drinking Motives Questionnaire-Revised(Change from Baseline Pre PFI completion to Baseline Post PFI completion)
  • Motivation to Reduce Alcohol Consumption Scale(Change from Baseline Pre PFI completion to Baseline Post PFI completion)

Study Sites (1)

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