Smartphone Application for Smoking Cessation

NCT ID: NCT02134509

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains behavioral strategies for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental App

This is a 3-week smartphone-based training program that trains behavioral strategies for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.

Group Type EXPERIMENTAL

Experimental App

Intervention Type BEHAVIORAL

It is comprised of twenty-two modules of 10-15 minutes each, designed to teach behavioral strategies for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules

Active comparator app

This is a 3-week smartphone application for smoking cessation in which smokers self-monitor their smoking habits, mood, and experience, to quit smoking with a target quit date of 3 weeks.

Group Type ACTIVE_COMPARATOR

Active Comparator App

Intervention Type BEHAVIORAL

It is comprised of 6 prompts per day asking individuals about their experience, behavior, and smoking habits, for 22-days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental App

It is comprised of twenty-two modules of 10-15 minutes each, designed to teach behavioral strategies for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules

Intervention Type BEHAVIORAL

Active Comparator App

It is comprised of 6 prompts per day asking individuals about their experience, behavior, and smoking habits, for 22-days.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Smoke 5+ cigarettes/day
* \< 3 months abstinence in the past year
* Have a smartphone
* Score greater than or equal to 8 of 10 on the Contemplation Ladder (Biener \& Abrams, 1991)

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Heart Association

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathleen A Garrison, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

Reference Type DERIVED
PMID: 35420700 (View on PubMed)

Sala M, Roos CR, Brewer JA, Garrison KA. Awareness, affect, and craving during smoking cessation: An experience sampling study. Health Psychol. 2021 Sep;40(9):578-586. doi: 10.1037/hea0001105. Epub 2021 Sep 27.

Reference Type DERIVED
PMID: 34570534 (View on PubMed)

Garrison KA, Pal P, O'Malley SS, Pittman BP, Gueorguieva R, Rojiani R, Scheinost D, Dallery J, Brewer JA. Craving to Quit: A Randomized Controlled Trial of Smartphone App-Based Mindfulness Training for Smoking Cessation. Nicotine Tob Res. 2020 Mar 16;22(3):324-331. doi: 10.1093/ntr/nty126.

Reference Type DERIVED
PMID: 29917096 (View on PubMed)

Garrison KA, Pal P, Rojiani R, Dallery J, O'Malley SS, Brewer JA. A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol. BMC Psychiatry. 2015 Apr 14;15:83. doi: 10.1186/s12888-015-0468-z.

Reference Type DERIVED
PMID: 25884648 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2K12DA000167-26

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1301011337

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mobile Sensing of Smoking Behavior
NCT02116283 COMPLETED NA
Quit Smoking Text Message Study
NCT06111755 COMPLETED NA