A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking

June 12, 2024 updated by: Michael J. Zvolensky, Ph.D., University of Houston

A Mobile-Delivered Personalized Feedback Intervention for Black Individuals Who Engage in Hazardous Drinking

The purpose of this study is to develop and examine a culturally adapted, mobile health application for the Android and iOS platform. The application uses 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 Black hazardous drinkers with clinical anxiety.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators will develop a culturally adapted, brief, single-session PFI delivered via a mobile health application for the Android and iOS platform through an iterative approach using expert input and semi-structured interview sessions. Next, Black hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Black 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 Zoom; baseline and post-treatment data will be collected via Zoom 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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • Recruiting
        • RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
        • Principal Investigator:
          • Michael J Zvolensky, Ph.D.
        • Contact:
        • Principal Investigator:
          • Richard A Brown, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being 21 years of age or older
  • Self-identifying as Black or African American
  • Meeting criteria for current hazardous drinking pattern
  • Meeting criteria for clinical anxiety
  • Being able to provide written, informed consent
  • Owning a smartphone.

Exclusion Criteria:

  • Current participation in alcohol or other substance abuse treatment
  • Engaged in psychotherapy for anxiety or depression
  • Concurrent use of medication for anxiety or depression
  • Being pregnant by self-report
  • Residence outside of the United States confirmed via survey geolocation
  • Inability to provide a valid United States-issued driver's license or identification card to verify identity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Application
Participants complete a 45 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: Mobile Application
The mobile application is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use Disorders Identification Test
Time Frame: 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). A higher score indicates a worse outcome.
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Overall Anxiety Severity and Impairment Scale
Time Frame: 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). A higher score indicates a worse outcome.
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
Time Frame: Change from Baseline Pre PFI Completion to 3-months 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).
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Modified Drinking Motives Questionnaire-Revised
Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 28-item questionnaire 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 3-months Post PFI Completion
Alcohol Attitudes Scale
Time Frame: Change from Baseline Pre PFI Completion to 3-months 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.
Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Houston

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Michael Zvolensky, Ph.D., University of Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004389
  • R41AA031398 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are currently no plans 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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