Mobile Smoking Treatment for Spanish-speaking Latinx Smokers

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04417075
• Other study ID #: STUDY00001567
• Secondary ID: 1R41DA048692-01
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: June 2020
• Source: University of Houston
• Contact: Justin M Shepherd, M.A.
• Phone: 713-743-8056
• Email: jmsheph4[@]central.uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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