NCT02134509

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
511

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

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

May 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 16, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

May 7, 2014

Last Update Submit

April 14, 2020

Conditions

Smoking

Keywords

Cigarette smoking

Outcome Measures

Primary Outcomes (1)

  • Point prevalence abstinence at 6 months

    Subjects will be assessed for smoking abstinence at a 6-month follow-up.

    6 months after beginning treatment

Secondary Outcomes (1)

  • Point prevalence abstinence at 3 months

    3 months after beginning treatment

Study Arms (2)

Experimental App

EXPERIMENTAL

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.

Behavioral: Experimental App

Active comparator app

ACTIVE COMPARATOR

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.

Behavioral: Active Comparator App

Interventions

Experimental AppBEHAVIORAL

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

Experimental App
Active Comparator AppBEHAVIORAL

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

Active comparator app

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Related Publications (4)

  • 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.

    PMID: 35420700DERIVED

  • 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.

    PMID: 34570534DERIVED

  • 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.

    PMID: 29917096DERIVED

  • 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.

    PMID: 25884648DERIVED

MeSH Terms

Conditions

SmokingCigarette Smoking

Condition Hierarchy (Ancestors)

BehaviorTobacco SmokingTobacco Use

Study Officials

  • Kathleen A Garrison, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 9, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

April 16, 2020

Record last verified: 2020-01

Locations

US(1)