Mindset Intervention for Nicotine Dependence (MIND)

February 2, 2018 updated by: Fred Hutchinson Cancer Center

Investigating a Technology Delivered Growth Mindset Intervention for Smoking Cessation.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mediation of engagement
Time Frame: 2 months
The effect of mindset intervention on engagement outcomes will be mediated by change in mindset.
2 months
Mediation of cessation
Time Frame: 2 months
The effect of mindset intervention on cessation outcomes will be mediated by change in mindset.
2 months
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.
2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2017

Primary Completion (Actual)

January 17, 2018

Study Completion (Actual)

January 17, 2018

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 2, 2017

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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