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Personalized Feedback Intervention for Latinx Drinkers With Anxiety

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05246202
Enrollment
250
Registered
2022-02-18
Start date
2022-09-30
Completion date
2026-05-31
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Anxiety

Keywords

Latinx, Hispanic, Personalized Feedback Intervention

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.

Interventions

BEHAVIORALAlcohol-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.

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

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
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 * Currently pregnant * Current engagement in psychotherapy for anxiety

Design outcomes

Primary

MeasureTime frameDescription
Motivation to Reduce Alcohol Consumption ScaleChange from Baseline Pre PFI completion to Baseline Post PFI completionThe 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).
Modified Drinking Motives Questionnaire-RevisedChange from Baseline Pre PFI completion to Baseline Post PFI completionThe 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).
Alcohol Attitudes ScaleChange from Baseline Pre PFI completion to Baseline Post PFI completionThe 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

MeasureTime frameDescription
Overall Anxiety Severity and Impairment ScaleChange from Baseline Pre PFI Completion to 6-months Post PFI CompletionThe 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).
Alcohol Use Disorders Identification TestChange from Baseline Pre PFI Completion to 6-months Post PFI CompletionThe 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).

Countries

United States

Contacts

Primary ContactBrooke Y Kauffman, Ph.D.
bkauffma@central.uh.edu713-743-8056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026