NCT06586034

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 3, 2024

Last Update Submit

September 3, 2024

Conditions

Smoking Cessation

Keywords

Mobile AppSmoking CessationHispanic/Latino

Outcome Measures

Primary Outcomes (1)

  • 7-Day Point Prevalence Smoking Abstinence

    7-day point prevalence smoking status (verification via carbon monoxide).

    End of treatment (Week 8)

Secondary Outcomes (1)

  • Anxiety Sensitivity

    Baseline, week 4, and end of treatment (Week 8)

Study Arms (1)

Impacto

EXPERIMENTAL

This is the mobile application to be developed and evaluated in this project.

Behavioral: Impacto (Mobile App)

Interventions

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.

Impacto

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Justin M Shepherd, PhD

CONTACT

713-743-8056jmsheph4@central.uh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

April 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09