Psychology, SocialMINDNCT03174730
Mindset Intervention for Nicotine Dependence
A study testing Growth Mindset and SmartQuit in people with Psychology, Social and Smoking Cessation, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychology, Social, Smoking Cessation, Smoking (Tobacco) Addiction
- What is being tested?
- Growth Mindset and SmartQuit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 17 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Opposite of inclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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.
- Being tested
- Growth Mindset, SmartQuit
- Keywords
- smoking, smartphone, technology, addiction
- Medical subject headings
- Smoking Cessation, Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth MindsetBehavioural
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.
SmartQuitBehavioural
This is an Acceptance and Commitment Therapy based intervention designed a smoking cessation smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Growth Mindset; Behavioral: SmartQuit |
| Control | Other | Participants will get SmartQuit, but not the growth mindset intervention. Receives: Behavioral: SmartQuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement with smoking cessation program
Number of times the smoking cessation app is opened, number of days logged in to smoking cessation app
Measured: 2 months
Cessation of smoking
30 day point prevalence abstinence [i.e. no smoking for the past 30 days]
Measured: 2 months
Secondary outcomes (1)
Cessation of smoking
7 day point prevalence abstinence [i.e. no smoking in past 7 days]
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start26 May 2017
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychology, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174730
- Sponsor's protocol ID
- 8545
- Acronym
- MIND
- Status last verified
- Feb 2018
- First submitted
- 19 Apr 2017
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31290404
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating a Technology Delivered Growth Mindset Intervention for Smoking Cessation.
- ClinicalTrials.gov ID
- NCT03174730
- Acronym / sponsor ID
- MIND / 8545
- Keywords
- smoking, smartphone, technology, addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Growth mindset | Experimental | Behavioral: Growth Mindset, Behavioral: SmartQuitIn 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. |
| Control | Other | Behavioral: SmartQuitParticipants will get SmartQuit, but not the growth mindset intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Opposite of inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth MindsetThe 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. | Behavioural | Growth mindset |
| SmartQuitThis is an Acceptance and Commitment Therapy based intervention designed a smoking cessation smartphone application. | Behavioural | Control, Growth mindset |
Primary outcome
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
Cessation of smoking
Time frame: 2 months
30 day point prevalence abstinence [i.e. no smoking for the past 30 days]
1 secondary outcome
Cessation of smoking
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Derived from this study: PubMed 31290404Sridharan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Mindset and SmartQuit in people with Psychology, Social and Smoking Cessation, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with smoking cessation program (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03174730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.