Personalized Feedback Intervention for Latinx Drinkers With Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246202
• Other study ID #: STUDY00003237
• Secondary ID: 1R01AA029807-01
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2024
• Source: University of Houston
• Contact: Brooke Y Kauffman, Ph.D.
• Phone: 713-743-8056
• Email: bkauffma[@]central.uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Anxiety
• Anxiety Disorders

Intervention

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.
• Control Personalized Feedback Intervention
C-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.

Locations

Country	Name	City	State
United States	RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Overall Anxiety Severity and Impairment Scale	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
Secondary	Alcohol Use Disorders Identification Test	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