Personalized Feedback Intervention for Latinx Drinkers With Anxiety

NCT05246202 | Recruiting DMC

• 2 other identifiers: STUDY000032371R01AA029807-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse; Anxiety

Keywords

Latinx; Hispanic; Personalized Feedback Intervention

Outcome Measures

Primary Outcomes (3)

• Motivation to Reduce Alcohol Consumption Scale

  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

  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

  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 Outcomes (2)

• Overall Anxiety Severity and Impairment Scale

  Change from Baseline Pre PFI Completion to 6-months Post PFI Completion

• Alcohol Use Disorders Identification Test

  Change from Baseline Pre PFI Completion to 6-months Post PFI Completion

Study Arms (2)

Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)

EXPERIMENTAL

Participants complete the brief (\~20-30 minute) AA-PFI 2.0 at baseline.

Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0

Control personalized feedback intervention (C-PFI)

ACTIVE COMPARATOR

Participants complete the brief (\~20-30 minute) C-PFI at baseline.

Behavioral: Control Personalized Feedback Intervention

Interventions

Alcohol-Anxiety Personalized Feedback Intervention 2.0 BEHAVIORAL

AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety.

Also known as: AA-PFI 2.0

Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)

Control Personalized Feedback Intervention BEHAVIORAL

C-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.

Also known as: C-PFI

Control personalized feedback intervention (C-PFI)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

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

Interventions

Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Michael J Zvolensky, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Y Kauffman, Ph.D.

CONTACT

713-743-8056; bkauffma@central.uh.edu

Study Design

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

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: February 18, 2022
• Study Start: September 30, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)