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Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety

Primary Purpose

Alcohol Abuse, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aliento
Sponsored by
Michael J. Zvolensky, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Latinx, Hispanic, Personalized Feedback Intervention

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aliento

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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).
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.

Full Information

First Posted
March 10, 2022
Last Updated
October 24, 2022
Sponsor
Michael J. Zvolensky, Ph.D.
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05288699
Brief Title
Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety
Official Title
Brief Personalized Feedback Intervention for Latinx Hazardous Drinkers: A Community-Based Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Anticipated)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael J. Zvolensky, Ph.D.
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Anxiety
Keywords
Latinx, Hispanic, Personalized Feedback Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aliento
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aliento
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol Use Disorders Identification Test
Description
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).
Time Frame
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Title
Overall Anxiety Severity and Impairment Scale
Description
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).
Time Frame
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Secondary Outcome Measure Information:
Title
Motivation to Reduce Alcohol Consumption Scale
Description
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).
Time Frame
Change from Baseline Pre PFI completion to Baseline Post PFI completion
Title
Modified Drinking Motives Questionnaire-Revised
Description
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).
Time Frame
Change from Baseline Pre PFI completion to Baseline Post PFI completion
Title
Alcohol Attitudes Scale
Description
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.
Time Frame
Change from Baseline Pre PFI completion to Baseline Post PFI completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Y Kauffman, Ph.D.
Phone
713-743-8056
Email
bkauffma@central.uh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aniqua Salwa, B.A.
Phone
713-743-8056
Email
asalwa@central.uh.edu
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety

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