NCT03174730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2018

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

April 19, 2017

Last Update Submit

February 2, 2018

Conditions

Psychology, SocialSmoking CessationSmoking (Tobacco) Addiction

Keywords

smokingsmartphonetechnologyaddiction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Cessation of smoking

    2 months

Other Outcomes (4)

  • Mediation of engagement

    2 months

  • Mediation of cessation

    2 months

  • Moderation by mindset

    2 months

  • +1 more other outcomes

Study Arms (2)

Growth mindset

EXPERIMENTAL

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 MindsetBehavioral: SmartQuit

Control

OTHER

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

Behavioral: SmartQuit

Interventions

Growth MindsetBEHAVIORAL

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.

Growth mindset
SmartQuitBEHAVIORAL

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

ControlGrowth mindset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • 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.

    PMID: 31290404DERIVED

MeSH Terms

Conditions

Smoking CessationSmokingBehavior, Addictive

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorCompulsive BehaviorImpulsive Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2017

First Posted

June 2, 2017

Study Start

May 26, 2017

Primary Completion

January 17, 2018

Study Completion

January 17, 2018

Last Updated

February 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)