Personalized Feedback Intervention for Latinx Drinkers With Anxiety

University of Houston

Status: Enrolling

Conditions: Alcohol Abuse; Anxiety

Treatments: Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0; Behavioral: Control Personalized Feedback Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05246202

STUDY00003237

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Behavioral: Alcohol-Anxiety Personalized Feedback Intervention 2.0

Control personalized feedback intervention (C-PFI)

Active Comparator group

Description:

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

Treatment:

Behavioral: Control Personalized Feedback Intervention