Mobile Smoking Treatment for Spanish-speaking Latinx Smokers

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).

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

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Impacto (Mobile App)
* Behavioral: Dejar de Fumar Asistente (Mobile App)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impacto<br>This is the mobile app to be developed and evaluated in this project. | Behavioral: Impacto (Mobile App)<br>* 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.<br>|
| Active Comparator: Dejar de Fumar Asistente<br>This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto. | Behavioral: Dejar de Fumar Asistente (Mobile App)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-Day Point Prevalence Smoking Abstinence | 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) | 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 | 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 | 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) | 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) | User satisfaction ratings scored on a 1-9 Likert scale with higher scores indicating better user satisfaction. | Weeks 2, 4, 6, and 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking Cessation, Mobile App, Anxiety Sensitivity