Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05288699
• Other study ID #: STUDY00003577
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: University of Houston
• Contact: Brooke Y Kauffman, Ph.D.
• Phone: 713-743-8056
• Email: bkauffma[@]central.uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Anxiety

Intervention

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.

Locations

Country	Name	City	State
United States	RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Michael J. Zvolensky, Ph.D.	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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