Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety

NCT05288699 | Recruiting DMC

• 1 other identifier: STUDY00003577
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse; Anxiety

Keywords

Latinx; Hispanic; Personalized Feedback Intervention

Outcome Measures

Primary Outcomes (2)

• Alcohol Use Disorders Identification Test

  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).

  Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

• Overall Anxiety Severity and Impairment Scale

  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).

  Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

Secondary Outcomes (3)

• Motivation to Reduce Alcohol Consumption 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

• Alcohol Attitudes Scale

  Change from Baseline Pre PFI completion to Baseline Post PFI completion

Study Arms (1)

Aliento

EXPERIMENTAL

Participants complete the brief (\~30 minute) intervention at baseline and will have access to intervention material for up to 3-months after the baseline appointment via the mobile health application.

Behavioral: Aliento

Interventions

Aliento BEHAVIORAL

Aliento is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety delivered via a mobile application.

Aliento

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael J. Zvolensky, Ph.D.: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael J Zvolensky

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Y Kauffman, Ph.D.

CONTACT

713-743-8056; bkauffma@central.uh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 21, 2022
• Study Start: November 4, 2022
• Primary Completion: February 28, 2025
• Study Completion: April 30, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)