- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417075
Mobile Smoking Treatment for Spanish-speaking Latinx Smokers
Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Justin M Shepherd, M.A.
- Phone Number: 713-743-8056
- Email: jmsheph4@central.uh.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- Recruiting
- Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
-
Contact:
- Pamella Nizio, B.S.
- Phone Number: 713-743-8056
- Email: niziopam@gmail.com
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Contact:
- Justin M Shepherd, M.A
- Phone Number: 713-743-8056
- Email: jmsheph4@central.uh.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Impacto
This is the mobile app to be developed and evaluated in this project.
|
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.
|
ACTIVE_COMPARATOR: Dejar de Fumar Asistente
This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
End of treatment (Week 8)
|
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.
|
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
Time Frame: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
|
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
Time Frame: Baseline 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.
|
Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
|
Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)
Time Frame: 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.
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Daily over the course of the 8 weeks of participant study involvement
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User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)
Time Frame: Weeks 2, 4, 6, and 8
|
User satisfaction ratings scored on a 1-9 Likert scale with higher scores indicating better user satisfaction.
|
Weeks 2, 4, 6, and 8
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00001567
- 1R41DA048692-01 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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