Smoking CessationNCT04417075
Mobile Smoking Treatment for Spanish-speaking Latinx Smokers
A study testing Impacto (Mobile App) and Dejar de Fumar Asistente (Mobile App) in people with Smoking Cessation, run by University of Houston at 1 site in United States.
Trial summary
The specific aims of the project are to develop and test a Spanish language, mobile app for smoking cessation called Impacto. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Impacto (Mobile App) and Dejar de Fumar Asistente (Mobile App)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
Houston, Texas, 77204
Pamella Nizio, B.S., 713-743-8056, niziopam@gmail.com
Justin M Shepherd, M.A, 713-743-8056, jmsheph4@central.uh.edu
About this study
Official title: Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers
The specific aims of the project are to develop and test a Spanish language, mobile app for smoking cessation called Impacto.
Read the 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).
- Conditions
- Smoking Cessation
- Being tested
- Impacto (Mobile App), Dejar de Fumar Asistente (Mobile App)
- Keywords
- Smoking Cessation, Mobile App, Anxiety Sensitivity
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacto (Mobile App)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Impacto | Experimental | This is the mobile app to be developed and evaluated in this project. Receives: Behavioral: Impacto (Mobile App) |
| Dejar de Fumar Asistente | Active comparator | This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto. Receives: Behavioral: Dejar de Fumar Asistente (Mobile App) |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Point Prevalence Smoking Abstinence
Self-reported 7-day point prevalence smoking status. Verification via carbon monoxide at end of treatment (10 weeks).
Measured: End of treatment (Week 8)
Change in Smoking Rate (# cigarettes per day)
We will assess the number of cigarettes smoking at each time point.
Measured: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
Secondary outcomes (4)
Change in Anxiety Sensitivity
Anxiety sensitivity will be assessed using the Anxiety Sensitivity Index-3 (ASI-3).
Measured: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
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.
Measured: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
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.
Measured: Daily over the course of the 8 weeks of participant study involvement
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.
Measured: Weeks 2, 4, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start21 Feb 2020
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael J. Zvolensky, Ph.D., University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417075
- Sponsor's protocol ID
- STUDY00001567
- Other IDs
- 1R41DA048692-01
- Status last verified
- Jun 2020
- First submitted
- 30 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers
- ClinicalTrials.gov ID
- NCT04417075
- Acronym / sponsor ID
- STUDY00001567
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Mobile App, Anxiety Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impacto | Experimental | Behavioral: Impacto (Mobile App)This is the mobile app to be developed and evaluated in this project. |
| Dejar de Fumar Asistente | Active comparator | Behavioral: Dejar de Fumar Asistente (Mobile App)This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Impacto |
| 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. | Behavioural | Dejar de Fumar Asistente |
Primary outcome
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).
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.
4 secondary outcomes
Change in Anxiety Sensitivity
Time frame: 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)
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
User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)
Time frame: Weeks 2, 4, 6, and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impacto (Mobile App) and Dejar de Fumar Asistente (Mobile App) in people with Smoking Cessation, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin M Shepherd, M.A. (713-743-8056, jmsheph4@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point Prevalence Smoking Abstinence (time frame: End of treatment (Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.