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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

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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Experimental App Behavioral: Active Comparator App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Smartphone Application for Smoking Cessation
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134509


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
American Heart Association
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kathleen A Garrison, PhD Yale University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02134509    
Other Study ID Numbers: 1301011337
2K12DA000167-26 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: January 2020
Keywords provided by Yale University:
Cigarette smoking