Personalized Feedback Intervention for Latinx Drinkers With Anxiety

June 6, 2024 updated by: Michael J. Zvolensky, Ph.D., University of Houston

Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

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 Locations

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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)
Participants complete the brief (~20-30 minute) AA-PFI 2.0 at baseline.
Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0
AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety.
Other Names:
  • AA-PFI 2.0
Active Comparator: Control personalized feedback intervention (C-PFI)
Participants complete the brief (~20-30 minute) C-PFI at baseline.
Behavioral: Control Personalized Feedback Intervention
C-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.
Other Names:
  • C-PFI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motivation to Reduce Alcohol Consumption Scale
Time Frame: Change from Baseline Pre PFI completion to Baseline 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 Baseline Post PFI completion
Modified Drinking Motives Questionnaire-Revised
Time Frame: Change from Baseline Pre PFI completion to Baseline Post PFI completion
The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 4-item "Coping-anxiety" subscale 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 Baseline Post PFI completion
Alcohol Attitudes Scale
Time Frame: Change from Baseline Pre PFI completion to Baseline 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 Baseline Post PFI completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Anxiety Severity and Impairment Scale
Time Frame: Change from Baseline Pre PFI Completion to 6-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).
Change from Baseline Pre PFI Completion to 6-months Post PFI Completion
Alcohol Use Disorders Identification Test
Time Frame: Change from Baseline Pre PFI Completion to 6-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).
Change from Baseline Pre PFI Completion to 6-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 J 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)

September 30, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003237
  • 1R01AA029807-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan 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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