Personalized Feedback Intervention for Latinx Drinkers With Anxiety

Sponsor
University of Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT05246202
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
255
1
2
45.7
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0
  • Behavioral: Control Personalized Feedback Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
255 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention
Actual Study Start Date :
Aug 9, 2022
Anticipated Primary Completion Date :
May 31, 2026
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Motivation to Reduce Alcohol Consumption Scale [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).

    2. Modified Drinking Motives Questionnaire-Revised [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).

    3. Alcohol Attitudes Scale [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.

    Secondary Outcome Measures

    1. Overall Anxiety Severity and Impairment Scale [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).

    2. Alcohol Use Disorders Identification Test [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • Endorsement of current suicidal intention or a plan,

    • Meeting criteria for current or past psychotic symptoms

    • Breath analysis estimating BAC above 0

    • Currently pregnant

    • Current engagement in psychotherapy for anxiety

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity Houston Texas United States 77204

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Michael J Zvolensky, Ph.D., University of Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael J. Zvolensky, Ph.D., Distinguished Professor, University of Houston
    ClinicalTrials.gov Identifier:
    NCT05246202
    Other Study ID Numbers:
    • STUDY00003237
    • 1R01AA029807-01
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael J. Zvolensky, Ph.D., Distinguished Professor, University of Houston
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 10, 2022