Mobile Smoking Treatment for Spanish-speaking Latinx Smokers

NCT ID: NCT04417075

Last Updated: 2020-06-04

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-21

Study Completion Date

2020-07-31

Brief Summary

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The specific aims of the project are to develop and test a Spanish language, mobile app for smoking cessation called Impacto.

Detailed Description

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A total of 38 Spanish-speaking, Latinx smokers with high anxiety sensitivity (AS) will be recruited for this project. Eight (8) participants will complete user interviews in Spanish and thirty (30) participants will participate in a randomized controlled trial (RCT) for smoking cessation. Participants will be randomized to receive either the Impacto mobile app or a generic, Spanish language, smoking cessation, mobile app control (Dejar de Fumar Asistente).

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Impacto

This is the mobile app to be developed and evaluated in this project.

Group Type EXPERIMENTAL

Impacto (Mobile App)

Intervention Type BEHAVIORAL

This is the mobile app to be developed and evaluated in this project. It is designed for Spanish-speaking, Latinx smokers with high anxiety sensitivity and will be built for the Android platform. The app will include components to address and remediate anxiety sensitivity, as well as having smoking cessation components.

Dejar de Fumar Asistente

This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto.

Group Type ACTIVE_COMPARATOR

Dejar de Fumar Asistente (Mobile App)

Intervention Type BEHAVIORAL

Dejar de Fumar Asistente (English version called: Quit Tracker: Stop Smoking) is a popular, free third party mobile application aimed at helping smokers quit smoking. This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto. This mobile app is well established as a smoking cessation app for Spanish-speaking, Latinx smokers. The app includes smoking cessation components but does not have a specific emphasis on anxiety sensitivity.

Interventions

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Impacto (Mobile App)

This is the mobile app to be developed and evaluated in this project. It is designed for Spanish-speaking, Latinx smokers with high anxiety sensitivity and will be built for the Android platform. The app will include components to address and remediate anxiety sensitivity, as well as having smoking cessation components.

Intervention Type BEHAVIORAL

Dejar de Fumar Asistente (Mobile App)

Dejar de Fumar Asistente (English version called: Quit Tracker: Stop Smoking) is a popular, free third party mobile application aimed at helping smokers quit smoking. This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto. This mobile app is well established as a smoking cessation app for Spanish-speaking, Latinx smokers. The app includes smoking cessation components but does not have a specific emphasis on anxiety sensitivity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1\) 18 to 55 year of age, 2) current smoker (i.e., at least 6 cigarettes/day), 3) not currently engaged in smoking cessation treatment, 4), high anxiety sensitivity (AS) score defined as an ASI-III score of ≥ 23, 5) motivation to quit \> 5 on a 10 pt. scale, 6) Spanish speaking, and 7) currently own an Android-compatible mobile phone.

Exclusion Criteria

1\) use of other tobacco products (including e-cigarettes), 2) current non-nicotine substance dependence and/or current or intended participation in a concurrent substance abuse treatment, 3) ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression, or 4) active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Zvolensky, Ph.D.

Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Justin M Shepherd, M.A.

Role: CONTACT

713-743-8056

Facility Contacts

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Pamella Nizio, B.S.

Role: primary

713-743-8056

Justin M Shepherd, M.A

Role: backup

713-743-8056

Other Identifiers

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1R41DA048692-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001567

Identifier Type: -

Identifier Source: org_study_id

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