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Trial record 7 of 64 for:    MINDSET

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

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.

Condition or disease Intervention/treatment Phase
Psychology, Social Smoking Cessation Smoking (Tobacco) Addiction Behavioral: Growth Mindset Behavioral: SmartQuit Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
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
Official Title: Investigating a Technology Delivered Growth Mindset Intervention for Smoking Cessation.
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : January 17, 2018
Actual Study Completion Date : January 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

Control
Participants will get SmartQuit, but not the growth mindset intervention.
Behavioral: SmartQuit
This is an Acceptance and Commitment Therapy based intervention designed a smoking cessation smartphone application.




Primary Outcome Measures :
  1. 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

  2. Cessation of smoking [ Time Frame: 2 months ]
    30 day point prevalence abstinence [i.e. no smoking for the past 30 days]


Secondary Outcome Measures :
  1. Cessation of smoking [ Time Frame: 2 months ]
    7 day point prevalence abstinence [i.e. no smoking in past 7 days]


Other Outcome Measures:
  1. Mediation of engagement [ Time Frame: 2 months ]
    The effect of mindset intervention on engagement outcomes will be mediated by change in mindset.

  2. Mediation of cessation [ Time Frame: 2 months ]
    The effect of mindset intervention on cessation outcomes will be mediated by change in mindset.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.


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): NCT03174730


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03174730     History of Changes
Other Study ID Numbers: 8545
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fred Hutchinson Cancer Research Center:
smoking
smartphone
technology
addiction
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior