Mindset Intervention for Nicotine Dependence

Study Overview
=================
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.

Official Title
-----------------
Investigating a Technology Delivered Growth Mindset Intervention for Smoking Cessation.

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

Intervention / Treatment
-----------------
* Behavioral: Growth Mindset
* Behavioral: SmartQuit


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth mindset<br>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<br>* 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.<br>Behavioral: SmartQuit<br>* This is an Acceptance and Commitment Therapy based intervention designed a smoking cessation smartphone application.<br>|
| Other: Control<br>Participants will get SmartQuit, but not the growth mindset intervention. | Behavioral: SmartQuit<br>* This is an Acceptance and Commitment Therapy based intervention designed a smoking cessation smartphone application.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement with smoking cessation program | Number of times the smoking cessation app is opened, number of days logged in to smoking cessation app | 2 months | 
| Cessation of smoking | 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 | 7 day point prevalence abstinence [i.e. no smoking in past 7 days] | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, smartphone, technology, addiction