Clinical trial NCT06416059: A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking
Official title: A Mobile-Delivered Personalized Feedback Intervention for Black Individuals Who Engage in Hazardous Drinking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Anxiety
Keywords: African American
Black
Personalized Feedback Intervention
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Alcohol Use Disorders Identification Test
timeFrame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
measure: Overall Anxiety Severity and Impairment Scale
timeFrame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Secondary outcomes:
measure: Motivation to Reduce Alcohol Consumption Scale
timeFrame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
measure: Modified Drinking Motives Questionnaire-Revised
timeFrame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
measure: Alcohol Attitudes Scale
timeFrame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Other outcomes:
Locations:
city: Houston
country: United States
facility: RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
state: Texas
Study officials:
affiliation: University of Houston
name: Michael Zvolensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: