Personalized Feedback Intervention for Latinx Drinkers With Anxiety

NCT ID: NCT05246202

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Abuse Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

Alcohol-Anxiety Personalized Feedback Intervention 2.0

Intervention Type 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.

Control personalized feedback intervention (C-PFI)

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

Group Type ACTIVE_COMPARATOR

Control Personalized Feedback Intervention

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Control Personalized Feedback Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AA-PFI 2.0 C-PFI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael J. Zvolensky, Ph.D.

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael J Zvolensky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Brooke Y Kauffman, Ph.D.

Role: CONTACT

713-743-8056

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aniqua Salwa, B.A.

Role: primary

713-743-8056

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01AA029807-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003237

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Personalizing Treatment Delivery
NCT05821634 RECRUITING NA
Multi-Component Breath Alcohol Intervention
NCT06124898 ACTIVE_NOT_RECRUITING NA
Behavioral Alcohol Responses (BAR) Study
NCT03467191 ACTIVE_NOT_RECRUITING EARLY_PHASE1