Back to results

Mindset Intervention for Nicotine Dependence (MIND)

Primary Purpose

Psychology, Social, Smoking Cessation, Smoking (Tobacco) Addiction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Growth Mindset

SmartQuit

About this trial

This is an interventional treatment trial for Psychology, Social focused on measuring smoking, smartphone, technology, addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Growth mindset

Control

Arm Description

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.

Participants will get SmartQuit, but not the growth mindset intervention.

Outcomes

Primary Outcome Measures

Engagement with smoking cessation program

Number of times the smoking cessation app is opened, number of days logged in to smoking cessation app

Cessation of smoking

30 day point prevalence abstinence [i.e. no smoking for the past 30 days]

Secondary Outcome Measures

Cessation of smoking

7 day point prevalence abstinence [i.e. no smoking in past 7 days]

Full Information

NCT ID

NCT03174730

First Posted

April 19, 2017

Last Updated

February 2, 2018

Sponsor

Fred Hutchinson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03174730

Brief Title

Mindset Intervention for Nicotine Dependence

Acronym

MIND

Official Title

Investigating a Technology Delivered Growth Mindset Intervention for Smoking Cessation.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

May 26, 2017 (Actual)

Primary Completion Date

January 17, 2018 (Actual)

Study Completion Date

January 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychology, Social, Smoking Cessation, Smoking (Tobacco) Addiction

Keywords

smoking, smartphone, technology, addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

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.

Allocation

Randomized

Enrollment

398 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Growth mindset

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Other

Arm Description

Participants will get SmartQuit, but not the growth mindset intervention.

Intervention Type

Behavioral

Intervention Name(s)

Growth Mindset

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

SmartQuit

Intervention Description

This is an Acceptance and Commitment Therapy based intervention designed a smoking cessation smartphone application.

Primary Outcome Measure Information:

Title

Engagement with smoking cessation program

Description

Number of times the smoking cessation app is opened, number of days logged in to smoking cessation app

Time Frame

2 months

Title

Cessation of smoking

Description

30 day point prevalence abstinence [i.e. no smoking for the past 30 days]

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Cessation of smoking

Description

7 day point prevalence abstinence [i.e. no smoking in past 7 days]

Time Frame

2 months

Other Pre-specified Outcome Measures:

Title

Mediation of engagement

Description

The effect of mindset intervention on engagement outcomes will be mediated by change in mindset.

Time Frame

2 months

Title

Mediation of cessation

Description

The effect of mindset intervention on cessation outcomes will be mediated by change in mindset.

Time Frame

2 months

Title

Moderation by mindset

Description

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.

Time Frame

2 months

Title

Number of cigarettes smoked per day (reduction)

Description

Test to see whether there is reduced smoking in one arm compared to the other.

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31290404

Citation

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.

Results Reference

derived

Learn more about this trial

Mindset Intervention for Nicotine Dependence

We'll reach out to this number within 24 hrs