A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking

NCT06416059 | Recruiting DMC

• 2 other identifiers: STUDY00004389R41AA031398
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse; Anxiety

Keywords

African American; Black; Personalized Feedback Intervention

Outcome Measures

Primary Outcomes (2)

• 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). 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

  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 Outcomes (3)

• 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 Arms (1)

Mobile Application

EXPERIMENTAL

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

Interventions

Mobile Application BEHAVIORAL

The mobile application is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety,

Mobile Application

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Houston: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

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

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Zvolensky, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Y Redmond, Ph.D.

CONTACT

713-743-8056; restorestudy94@gmail.com

Michael J Zvolensky, Ph.D.

CONTACT

713-743-8595; restorestudy94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)