Mobile Smoking Treatment for Spanish-speaking Latinx Smokers

June 3, 2020 updated by: Michael J. Zvolensky, Ph.D., University of Houston

Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers

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

Study Overview

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77204
        • Recruiting
        • Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Impacto
This is the mobile app to be developed and evaluated in this project.
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.
ACTIVE_COMPARATOR: Dejar de Fumar Asistente
This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Point Prevalence Smoking Abstinence
Time Frame: End of treatment (Week 8)
Self-reported 7-day point prevalence smoking status. Verification via carbon monoxide at end of treatment (10 weeks).
End of treatment (Week 8)
Change in Smoking Rate (# cigarettes per day)
Time Frame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
We will assess the number of cigarettes smoking at each time point.
Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Sensitivity
Time Frame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
Anxiety sensitivity will be assessed using the Anxiety Sensitivity Index-3 (ASI-3).
Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
Change in Mood and Anxiety Symptoms
Time Frame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
The Mood and Anxiety Symptom Questionnaire (MASQ) is well-validated measure and will be used to assess anxiety/depressive symptoms.
Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)
Time Frame: Daily over the course of the 8 weeks of participant study involvement
We will access these data via the "back end" of the Impacto server to evaluate whether the criterion of 75% daily adherence (i.e., app use on 75% of all possible days) has been achieved.
Daily over the course of the 8 weeks of participant study involvement
User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)
Time Frame: Weeks 2, 4, 6, and 8
User satisfaction ratings scored on a 1-9 Likert scale with higher scores indicating better user satisfaction.
Weeks 2, 4, 6, and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2020

Primary Completion (ANTICIPATED)

July 31, 2020

Study Completion (ANTICIPATED)

July 31, 2020

Study Registration Dates

First Submitted

May 30, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00001567
  • 1R41DA048692-01 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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