Smoking CessationNCT02037360
Mobile Mindfulness Training for Smoking Cessation
A study testing Active Comparator App/Training and Experimental App/Training in people with Smoking Cessation, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training smartphone application on smoking cessation in smokers ages 18 to 65 years. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Active Comparator App/Training and Experimental App/Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,251 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2017
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be (a) 18-65 years of age; (b) smoke 5+ cigarettes/day, (c) < 3 months abstinence in the past year; (d) have a smartphone; and motivated to quit smoking.
Who cannot join
- There are no exclusion criteria. We aim to recruit a heterogeneous group, representative of the general population.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655
About this study
The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training smartphone application on smoking cessation in smokers ages 18 to 65 years.
Read the detailed description
In this study, a pilot phase will be carried out first to test feasibility and engagement of the tested intervention. Then in the randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains mindfulness for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.
- Conditions
- Smoking Cessation
- Being tested
- Active Comparator App/Training, Experimental App/Training
- Keywords
- Smoking, Cessation
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator 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
Experimental 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.
| 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: Active Comparator App/Training |
| 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: Experimental App/Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence at 6 months
Subjects will be assessed for smoking abstinence at a 6-month follow-up.
Measured: 6 months after beginning treatment
Secondary outcomes (1)
Point prevalence abstinence at 3 months
Subjects will be assessed for smoking abstinence at a 3-month follow-up.
Measured: 3 months after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionDec 2017
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 Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judson Brewer, University of Massachusetts, Worcester
- Investigators
- Judson Brewer, MD PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037360
- Sponsor's protocol ID
- 1305012015
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2014
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
PubMed 35420700
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Mindfulness Training for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02037360
- Acronym / sponsor ID
- 1305012015
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,251 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jan 2014 (estimated)
- 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.
The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training smartphone application on smoking cessation in smokers ages 18 to 65 years.
Detailed description
In this study, a pilot phase will be carried out first to test feasibility and engagement of the tested intervention. Then in the randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains mindfulness for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator App/Training | Active comparator | Behavioral: Active Comparator App/TrainingThis 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: Experimental App/TrainingThis 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
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be (a) 18-65 years of age; (b) smoke 5+ cigarettes/day, (c) < 3 months abstinence in the past year; (d) have a smartphone; and motivated to quit smoking.
Key exclusion criteria (1 listed)
- There are no exclusion criteria. We aim to recruit a heterogeneous group, representative of the general population.
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 |
|---|---|---|
| Active Comparator 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 |
| Experimental 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 |
Primary outcome
Point prevalence abstinence at 6 months
Time frame: 6 months after beginning treatment
Subjects will be assessed for smoking abstinence at a 6-month follow-up.
1 secondary outcome
Point prevalence abstinence at 3 months
Time frame: 3 months after beginning treatment
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 30 Jan 2018.
- Derived from this study: PubMed 35420700Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
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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.
Judson Brewer, MD PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator App/Training and Experimental App/Training in people with Smoking Cessation, run by University of Massachusetts, Worcester 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 30 Jan 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?
Point prevalence abstinence at 6 months (time frame: 6 months after beginning treatment). 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 NCT02037360, 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 30 Jan 2018.