Recruiting

Observational Study

Sponsor:

Michael J. Zvolensky, Ph.D.

Code:

NCT05288699

Conditions

Alcohol Abuse

Anxiety

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Aliento

Study Details

Brief summary:

The purpose of this study is to develop and examine a culturally adapted, brief, integrated, Spanish language mobile health application for the Android platform, optimized to deliver a 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 clinical anxiety.

Conditions

Alcohol Abuse

Anxiety

Study ID

NCT05288699

Start date

Nov 4, 2022

Status verified date

May, 2024

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Feb 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 21 years of age or older
  • self-identified as Latinx or Hispanic
  • fluent in Spanish
  • current hazardous drinking pattern
  • current clinical anxiety
  • able to provide written, informed consent
  • owning an Android smartphone

Exclusion Criteria:

  • currently involved in alcohol or other substance use program
  • concurrent use of medication for anxiety or depression
  • current engagement in psychotherapy for anxiety or depression

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aliento

Participants complete the brief (\~30 minute) intervention at baseline and will have access to intervention material for up to 3-months after the baseline appointment via the mobile health application.

Interventions

Aliento

Aliento is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety delivered via a mobile application.

Primary outcome measure

  • Alcohol Use Disorders Identification Test [ Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion ]
  • Overall Anxiety Severity and Impairment Scale [ Time Frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion ]

Central Contacts and Locations

Central contacts

Brooke Y Kauffman, Ph.D.

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

Locations

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

Recruiting

Houston, Texas, United States, 77204

Contacts

Principal Investigator:

Michael J Zvolensky, Ph.D.

More Information

Sponsor

Michael J. Zvolensky, Ph.D.

Last update posted

May 14, 2024

Last verified

May, 2024

Keywords

  • Latinx
  • Hispanic
  • Personalized Feedback Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael J. Zvolensky, Ph.D. on 2024-05-14.