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Clinical Trials/NCT06416059
NCT06416059
Recruiting
Not Applicable

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

University of Houston1 site in 1 country50 target enrollmentMay 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Abuse
Sponsor
University of Houston
Enrollment
50
Locations
1
Primary Endpoint
Overall Anxiety Severity and Impairment Scale
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
August 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael J. Zvolensky, Ph.D.

Distinguished Professor

University of Houston

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Motivation to Reduce Alcohol Consumption Scale(Change from Baseline Pre PFI Completion to 3-months Post PFI Completion)
  • Modified Drinking Motives Questionnaire-Revised(Change from Baseline Pre PFI Completion to 3-months Post PFI Completion)
  • Alcohol Attitudes Scale(Change from Baseline Pre PFI Completion to 3-months Post PFI Completion)

Study Sites (1)

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