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Mindset Intervention for Nicotine Dependence (MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174730
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE April 19, 2017
First Posted Date  ICMJE June 2, 2017
Last Update Posted Date February 6, 2018
Actual Study Start Date  ICMJE May 26, 2017
Actual Primary Completion Date January 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
  • Engagement with smoking cessation program [ Time Frame: 2 months ]
    Number of times the smoking cessation app is opened, number of days logged in to smoking cessation app
  • Cessation of smoking [ Time Frame: 2 months ]
    30 day point prevalence abstinence [i.e. no smoking for the past 30 days]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03174730 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
Cessation of smoking [ Time Frame: 2 months ]
7 day point prevalence abstinence [i.e. no smoking in past 7 days]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2017)
  • Mediation of engagement [ Time Frame: 2 months ]
    The effect of mindset intervention on engagement outcomes will be mediated by change in mindset.
  • Mediation of cessation [ Time Frame: 2 months ]
    The effect of mindset intervention on cessation outcomes will be mediated by change in mindset.
  • Moderation by mindset [ Time Frame: 2 months ]
    Mindset at baseline moderates the treatment effect such that engagement and cessation outcomes improve more for those smokers who start the study with a fixed mindset.
  • Number of cigarettes smoked per day (reduction) [ Time Frame: 2 months ]
    Test to see whether there is reduced smoking in one arm compared to the other.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mindset Intervention for Nicotine Dependence
Official Title  ICMJE Investigating a Technology Delivered Growth Mindset Intervention for Smoking Cessation.
Brief Summary This study evaluates a new digitally delivered mindset based intervention in addition to a smartphone application (app) for smoking cessation. Participants will be provided an app (SmartQuit) that teaches them skills to quit, and will be randomly assigned to either receive a growth mindset intervention or to a control group.
Detailed Description

Want to quit smoking? Welcome to the MIND Study, conducted by researchers at Seattle's Fred Hutchinson Cancer Research Center.

Join now to get a smartphone app-based quit smoking program that includes:

  • Personalized plans for quitting
  • Help with dealing with urges to smoke
  • Information on nicotine withdrawal
  • Help staying motivated
  • Tracking progress with quitting
  • A certificate of completion once you complete the program
  • Scientifically-based information on quit medications

The MIND study gives you all these and more to help you quit smoking and live a happier, healthier life. For more information, visit mind.fredhutch.org.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All participants will gain access to SmartQuit, a smartphone based app with tools for quitting smoking. In order to test whether the growth mindset intervention is effective, smokers will be randomly assigned to either an experimental group, where they will additionally get growth mindset content or to a control group.
Masking: Single (Participant)
Masking Description:
In order to control for expectancy or placebo effects, participants will be told that the study is designed to test the method of delivery of content (email vs. smartphone). They will not be aware that one group is getting something extra that the control group is not getting.
Primary Purpose: Treatment
Condition  ICMJE
  • Psychology, Social
  • Smoking Cessation
  • Smoking (Tobacco) Addiction
Intervention  ICMJE
  • Behavioral: Growth Mindset
    The intervention is aimed at creating more flexible thinking about addiction to tobacco. Participants will be sent tips by email to help foster the belief that people can overcome addiction to smoking.
  • Behavioral: SmartQuit
    This is an Acceptance and Commitment Therapy based intervention designed a smoking cessation smartphone application.
Study Arms  ICMJE
  • Experimental: Growth mindset
    In addition to SmartQuit (the app), study participants will receive the content in the form on one growth mindset tip (sent in an email) per day starting on the first day of the study. Email exercises will be sent out every 3 days and there are a total of 8 emails.
    Interventions:
    • Behavioral: Growth Mindset
    • Behavioral: SmartQuit
  • Control
    Participants will get SmartQuit, but not the growth mindset intervention.
    Intervention: Behavioral: SmartQuit
Publications * Sridharan V, Shoda Y, Heffner J, Bricker J. A Pilot Randomized Controlled Trial of a Web-Based Growth Mindset Intervention to Enhance the Effectiveness of a Smartphone App for Smoking Cessation. JMIR Mhealth Uhealth. 2019 Jul 9;7(7):e14602. doi: 10.2196/14602.

*   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: October 10, 2017)
398
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2017)
300
Actual Study Completion Date  ICMJE January 17, 2018
Actual Primary Completion Date January 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

(1) age 18 or older, (2) smokes at least five cigarettes daily for at least past 12 months, (3) wants to quit in the next 30 days, (4) interested in learning skills to quit smoking, (5) resides in US, (6) has at least daily access to their own smartphone, (7) knows how to login and download a smartphone application from their smartphone, (8) willing and able to read in English, (9) not participating in other smoking cessation interventions (including our other intervention studies). To increase follow-up retention, eligibility criteria also include: (10) willing to complete one follow-up survey, (11) provide email, phone, and mailing address.

Exclusion Criteria:

Opposite of inclusion.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT03174730
Other Study ID Numbers  ICMJE 8545
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fred Hutchinson Cancer Research Center
Verification Date February 2018

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