Mobile Smoking Treatment for Hispanic Individuals Who Smoke | NCT06586034

Studies
Mobile Smoking Treatment for Hispanic Individuals Who Smoke

NCT06586034

Sponsor

University of Houston

Status

Not yet recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

56Estimated

Phase

Not Applicable

Conditions

Smoking Cessation

Interventions

Impacto (Mobile App)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2025Estimated

Primary Completion Date

Feb 2026Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

Sep 3, 2024

First Submission Date that Met QC Criteria

Sep 3, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael J. Zvolensky, Ph.D., Hugh Roy and Lillie Cranz Cullen Distinguished University Professor, University of HoustonPrincipal Investigator

Lead Sponsor

University of HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The specific aims of the project are to develop and test a mobile application for smoking cessation for Hispanic individuals who smoke called Impacto.

Detailed Description

A total of 56 Hispanic individuals who smoke will be recruited for this project. Six (6) participants will complete usability/functionality testing of Impacto 2.0 in the English language for both iOS and Android. Following usability/functionality testing, a field test with 50 adult Hispanic individuals who smoke (50% English-speaking and 50% Spanish-speaking) will be recruited nationally and will receive Impacto 2.0 (50% Android and iOS platforms).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Impacto	Experimental	This is the mobile application to be developed and evaluated in this project.	Behavioral: Impacto (Mobile App)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impacto (Mobile App)	Behavioral	This is the mobile app to be developed and evaluated in this project. It is designed for both English and Spanish languages and is culturally tailored for Hispanic/Latino/Latinx individuals who smoke. Impacto will be developed for both iOS and Android platforms. The mobile app aims to aid smoking cessation by targeting elevated anxiety sensitivity.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
7-Day Point Prevalence Smoking Abstinence	7-day point prevalence smoking status (verification via carbon monoxide).	End of treatment (Week 8)

Secondary Outcomes

Measure	Description	Time Frame
Anxiety Sensitivity	Anxiety sensitivity will be assessed using the Short Scale Anxiety Sensitivity Index (SSASI).	Baseline, week 4, and end of treatment (Week 8)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) being Hispanic, 2) at least 18 years of age, 2) currently smoking (i.e., at least 5 cigarettes/day) biochemically verified by a CO > 7, 3), meeting criteria for high AS (cut-off score of 5 on the Short Scale Anxiety Sensitivity Index), 4) motivation to quit > 5 on a 10 pt. scale, 5) able to provide informed consent, 6) has daily access to their own iPhone or Android smartphone, and 7) is a fluent English or Spanish speaker.

Exclusion Criteria:

1) current participation in substance abuse treatment, 2) in psychotherapy for anxiety or depression, 3) concurrent use of medication for anxiety or depression, 4) active suicidality (ideation, intent, and/or plan), or 5) current psychosis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Justin M Shepherd, PhD	Contact	713-743-8056		jmsheph4@central.uh.edu

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided