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Clinical Trials/NCT04417075
NCT04417075
Unknown
Not Applicable

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

University of Houston1 site in 1 country38 target enrollmentFebruary 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
University of Houston
Enrollment
38
Locations
1
Primary Endpoint
7-Day Point Prevalence Smoking Abstinence
Last Updated
5 years ago

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
February 21, 2020
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael J. Zvolensky, Ph.D.

Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

University of Houston

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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

Outcomes

Primary Outcomes

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).

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.

Secondary Outcomes

  • Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)(Daily over the course of the 8 weeks of participant study involvement)
  • User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)(Weeks 2, 4, 6, and 8)
  • Change in Mood and Anxiety Symptoms(Baseline and Weeks 2, 4, 6, and end of treatment (Week 8))
  • Change in Anxiety Sensitivity(Baseline and Weeks 2, 4, 6, and end of treatment (Week 8))

Study Sites (1)

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