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Smartphone Application for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02134509
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : April 16, 2020
Sponsor:
Collaborators:
American Heart Association
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE May 7, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date April 16, 2020
Study Start Date  ICMJE October 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
Point prevalence abstinence at 6 months [ Time Frame: 6 months after beginning treatment ]
Subjects will be assessed for smoking abstinence at a 6-month follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
Point prevalence abstinence at 3 months [ Time Frame: 3 months after beginning treatment ]
Subjects will be assessed for smoking abstinence at a 3-month follow-up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smartphone Application for Smoking Cessation
Official Title  ICMJE Smartphone Application for Smoking Cessation
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking
Intervention  ICMJE
  • Behavioral: 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
  • Behavioral: Active Comparator App
    It is comprised of 6 prompts per day asking individuals about their experience, behavior, and smoking habits, for 22-days.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Experimental App
  • Active Comparator: 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.
    Intervention: Behavioral: Active Comparator App
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2016)
511
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
140
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134509
Other Study ID Numbers  ICMJE 1301011337
2K12DA000167-26 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • American Heart Association
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Kathleen A Garrison, PhD Yale University
PRS Account Yale University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP