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Mobile Smoking Treatment for Spanish-speaking Latinx Smokers

Not Applicable
Conditions
Smoking Cessation
Interventions
Behavioral: Dejar de Fumar Asistente (Mobile App)
Behavioral: Impacto (Mobile App)
Registration Number
NCT04417075
Lead Sponsor
University of Houston
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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
38
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dejar de Fumar AsistenteDejar de Fumar Asistente (Mobile App)This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto.
ImpactoImpacto (Mobile App)This is the mobile app to be developed and evaluated in this project.
Primary Outcome Measures
NameTimeMethod
7-Day Point Prevalence Smoking AbstinenceEnd 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)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 Outcome Measures
NameTimeMethod
Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)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.

User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)Weeks 2, 4, 6, and 8

User satisfaction ratings scored on a 1-9 Likert scale with higher scores indicating better user satisfaction.

Change in Mood and Anxiety SymptomsBaseline 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.

Change in Anxiety SensitivityBaseline and Weeks 2, 4, 6, and end of treatment (Week 8)

Anxiety sensitivity will be assessed using the Anxiety Sensitivity Index-3 (ASI-3).

Trial Locations

Locations (1)

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston

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Houston, Texas, United States

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