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Mobile Smoking Treatment for Spanish-speaking Latinx Smokers

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04417075
Enrollment
38
Registered
2020-06-04
Start date
2020-02-21
Completion date
2020-07-31
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Smoking Cessation, Mobile App, Anxiety Sensitivity

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).

Interventions

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.

BEHAVIORALDejar 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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).
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.
Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)Daily over the course of the 8 weeks of participant study involvementWe 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 8User satisfaction ratings scored on a 1-9 Likert scale with higher scores indicating better user satisfaction.

Countries

United States

Contacts

Primary ContactJustin M Shepherd, M.A.
jmsheph4@central.uh.edu713-743-8056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026