Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Houston
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- 7-Day Point Prevalence Smoking Abstinence
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Impacto
This is the mobile app to be developed and evaluated in this project.
Intervention: Impacto (Mobile App) (Behavioral)
Dejar de Fumar Asistente
This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto.
Intervention: Dejar de Fumar Asistente (Mobile App) (Behavioral)
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))
Investigators
Michael J. Zvolensky, Ph.D.
Hugh Roy and Lillie Cranz Cullen Distinguished University Professor
University of Houston