Smoking CessationNCT02943499
Mechanisms of Mindfulness for Smoking Cessation
A study testing App/Training and Smartphone in people with Smoking Cessation, run by Brown University at 1 site in United States.
Trial summary
The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- App/Training and Smartphone
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-65 years of age
- Smoke 10+ cigarettes/day
- < 3 months abstinence in the past year
- Have a smartphone; and motivated to quit smoking
- Score >18 of 20 on Action subscale of the Readiness to Change Questionnaire
Who cannot join
- Any usage of psychotropic medication: not on a stable dosage 6+ months
- Prior participation in a mindfulness course or regular meditation practice (>20 min/week)
- Serious psychiatric, cognitive, or medical disorder
- MRI contraindications
- Structural brain damage as well as other brain abnormalities revealed by the MRI
- Claustrophobia
Show all 13Show fewer
- Not being fluent in English
- Recreational drug use
- Pregnant women
- History of a neurological disorder
- Current participation in a smoking study
- Adults unable to consent
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655
About this study
Official title: Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.
The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.
- Conditions
- Smoking Cessation
- Being tested
- App/Training, Smartphone
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App/TrainingBehavioural
This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones
App/TrainingBehavioural
It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.
SmartphoneDevice
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator App/Training | Active comparator | This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date. Receives: Behavioral: App/Training; Device: Smartphone |
| Experimental App/Training | Experimental | This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks. Receives: Behavioral: App/Training; Device: Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Judson Brewer, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943499
- Sponsor's protocol ID
- 1R61AT009337-01
- Status last verified
- Nov 2019
- First submitted
- 21 Oct 2016
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.
- ClinicalTrials.gov ID
- NCT02943499
- Acronym / sponsor ID
- 1R61AT009337-01
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- Oct 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Posted 12 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator App/Training | Active comparator | Behavioral: App/Training, Device: SmartphoneThis is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date. |
| Experimental App/Training | Experimental | Behavioral: App/Training, Device: SmartphoneThis is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21-65 years of age
- Smoke 10+ cigarettes/day
- < 3 months abstinence in the past year
- Have a smartphone; and motivated to quit smoking
- Score >18 of 20 on Action subscale of the Readiness to Change Questionnaire
Key exclusion criteria (13 listed)
- Any usage of psychotropic medication: not on a stable dosage 6+ months
- Prior participation in a mindfulness course or regular meditation practice (>20 min/week)
- Serious psychiatric, cognitive, or medical disorder
- MRI contraindications
- Structural brain damage as well as other brain abnormalities revealed by the MRI
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 |
|---|---|---|
| App/TrainingThis is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones | Behavioural | Active Comparator App/Training |
| App/TrainingIt is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules. | Behavioural | Experimental App/Training |
| Smartphone | Device | Active Comparator App/Training, Experimental App/Training |
Primary outcome
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
Time frame: 1 month
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 App/Training and Smartphone in people with Smoking Cessation, run by Brown University 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 5 inclusion and 13 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 19 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2019.