Clinical trial NCT05246202: Personalized Feedback Intervention for Latinx Drinkers With Anxiety
Official title: Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Anxiety
Keywords: Latinx
Hispanic
Personalized Feedback Intervention
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-02-18
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted 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 anxiety.

Detailed description: In the first phase, the investigators will collect qualitative and quantitative feedback from focus groups to refine intervention content and evaluate treatment acceptability and feasibility of a novel, brief, integrated, culturally adapted computer-based personalized feedback intervention (PFI). In the second phase, Latinx hazardous drinkers with clinical anxiety will be recruited and randomly assigned to either the refined culturally adapted anxiety-alcohol PFI (AA-PFI 2.0) or a control PFI (C-PFI). Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-, 3-, and 6-month follow-up data will be collected online remotely.

Eligibility criteria: Inclusion Criteria:

* Being between the age of 21 to 75 years of age
* Being self-identified as Latinx or Hispanic
* Fluent in Spanish
* Meeting criteria for current hazardous drinking pattern
* Meeting criteria for clinical anxiety
* Being able to provide written, informed consent

Exclusion Criteria:

* Being involved in alcohol or other substance use program
* Currently pregnant
* Current engagement in psychotherapy for anxiety

Primary outcomes:
measure: Motivation to Reduce Alcohol Consumption Scale
timeFrame: Change from Baseline Pre PFI completion to Baseline Post PFI completion
measure: Modified Drinking Motives Questionnaire-Revised
timeFrame: Change from Baseline Pre PFI completion to Baseline Post PFI completion
measure: Alcohol Attitudes Scale
timeFrame: Change from Baseline Pre PFI completion to Baseline Post PFI completion
Secondary outcomes:
measure: Overall Anxiety Severity and Impairment Scale
timeFrame: Change from Baseline Pre PFI Completion to 6-months Post PFI Completion
measure: Alcohol Use Disorders Identification Test
timeFrame: Change from Baseline Pre PFI Completion to 6-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 J Zvolensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: