Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Alcohol Abuse
• Intervention / Treatment: Behavioral: Aliento

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brooke Y Kauffman, Ph.D.; Phone Number: 713-743-8056; Email: bkauffma@central.uh.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • Recruiting
      • RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
      • Contact: Aniqua Salwa, B.A.; Phone Number: 713-743-8056; Email: asalwa@central.uh.edu
      • Principal Investigator: Michael J Zvolensky, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aliento; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation to Reduce Alcohol Consumption Scale	The 1-item Motivation to Reduce Alcohol Consumption Scale will be used to measure current motivation/intention to reduce alcohol. Participants will be asked to select the statement that best describes their motivation/intention to reduce drinking (e.g., "I really want to cut down on drinking alcohol and intend to in the next month"). Higher scores on this measure indicate greater motivation/intention to reduce alcohol consumption (possible range (0-7).	Change from Baseline Pre PFI completion to Baseline Post PFI completion
Modified Drinking Motives Questionnaire-Revised	The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 4-item "Coping-anxiety" subscale will be used as a measure of expectancies of drinking to reduce/cope with anxiety. The measure utilizes a 5-point Likert scale ranging from 1 (almost never/never) to 5 (almost always/always). Scores are averaged with higher scores indicating greater expectancies of drinking to reduce/cope with anxiety (possible range 1 to 5).	Change from Baseline Pre PFI completion to Baseline Post PFI completion
Alcohol Attitudes Scale	The 7-item Alcohol Attitudes Scale will be utilized to measure maladaptive attitudes for drinking (e.g., "Drinking alcohol is good"). Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). Scores will be averaged to create a composite score (possible range 1 to 7). Higher scores indicate greater maladaptive attitudes for drinking.	Change from Baseline Pre PFI completion to Baseline Post PFI completion

Collaborators and Investigators

• Sponsor: Michael J. Zvolensky, Ph.D.
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Michael J Zvolensky, University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hispanic; Latinx; Personalized Feedback Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: STUDY00003577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No