Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety

Sponsor
Michael J. Zvolensky, Ph.D. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05288699
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
60
1
1
8.7
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aliento
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Brief Personalized Feedback Intervention for Latinx Hazardous Drinkers: A Community-Based Intervention
Anticipated Study Start Date :
Aug 9, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aliento

Participants complete the brief (~30 minute) intervention at baseline and will have access to intervention material for up to 1-month 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.

Outcome Measures

Primary Outcome Measures

  1. Alcohol Use Disorders Identification Test [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).

  2. Overall Anxiety Severity and Impairment Scale [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 Outcome Measures

  1. Motivation to Reduce Alcohol Consumption Scale [Change from Baseline Pre PFI completion to Baseline Post PFI completion]

    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).

  2. Modified Drinking Motives Questionnaire-Revised [Change from Baseline Pre PFI completion to Baseline Post PFI completion]

    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).

  3. Alcohol Attitudes Scale [Change from Baseline Pre PFI completion to Baseline Post PFI completion]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • endorsing current suicidal intention or a plan

  • concurrent use of medication for anxiety or depression

  • breath analysis estimating BAC above 0

  • current engagement in psychotherapy for anxiety or depression

Contacts and Locations

Locations

Site City State Country Postal Code
1 RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity Houston Texas United States 77204

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Michael J Zvolensky, University of Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael J. Zvolensky, Ph.D., Distinguished Professor, University of Houston
ClinicalTrials.gov Identifier:
NCT05288699
Other Study ID Numbers:
  • STUDY00003577
First Posted:
Mar 21, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael J. Zvolensky, Ph.D., Distinguished Professor, University of Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022