Mobile Smoking Treatment for Spanish-speaking Latinx Smokers
Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers
2 other identifiers
interventional
38
1 country
1
Brief Summary
The specific aims of the project are to develop and test a Spanish language, mobile app for smoking cessation called Impacto.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2020
CompletedFirst Submitted
Initial submission to the registry
May 30, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedJune 4, 2020
June 1, 2020
5 months
May 30, 2020
June 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Change in Anxiety Sensitivity
Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
Change in Mood and Anxiety Symptoms
Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)
Daily over the course of the 8 weeks of participant study involvement
User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)
Weeks 2, 4, 6, and 8
Study Arms (2)
Impacto
EXPERIMENTALThis is the mobile app to be developed and evaluated in this project.
Dejar de Fumar Asistente
ACTIVE COMPARATORThis is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto.
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.
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.
Eligibility Criteria
You may qualify if:
- \) 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.
You may not qualify if:
- \) 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Houstonlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
Houston, Texas, 77204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hugh Roy and Lillie Cranz Cullen Distinguished University Professor
Study Record Dates
First Submitted
May 30, 2020
First Posted
June 4, 2020
Study Start
February 21, 2020
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
June 4, 2020
Record last verified: 2020-06