Smoking CessationNCT04512248
Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
A study testing Quit and Stay Quit Monday Model in people with Smoking Cessation, run by NYU Langone Health at 1 site in United States.
Trial summary
The Quit and Stay Quit Monday model is an innovative smoking cessation approach that guides smokers' behavior without requiring additional resources. The investigator will conduct a randomized control trial evaluating the effectiveness of this model as compared to usual smoking cessation care in a population of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Quit and Stay Quit Monday Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years old
- Has smoked a cigarette in the past 30 days, even a puff
- Has been diagnosed with a mental health condition or received care from a mental health clinic within the NYU Langone Health system in the prior 12 months
- Interested in quitting smoking
- English language
- Has a phone that can receive text messages
- Able to provide informed consent
Who cannot join
- age < 18 years of age
- Non-smoker
Trial locations and contacts
1 site in 1 country.
About this study
The Quit and Stay Quit Monday model is an innovative smoking cessation approach that guides smokers' behavior without requiring additional resources. The investigator will conduct a randomized control trial evaluating the effectiveness of this model as compared to usual smoking cessation care in a population of smokers with a mental health condition.
Read the detailed description
The overall objective of this proposal is to innovate the tobacco treatment paradigm for smokers with mental health conditions (MHC) by integrating the Quit and Stay Quit Monday Model into smoking cessation services for this vulnerable population.
The investigator will conduct a two-group, parallel-randomized controlled trial (RCT). The target population will be generated by the NYU Langone electronic medical record (EMR). The investigator will proactively contact patients to offer enrollment and randomize participants 1:1 to one of two groups (n=50/group): (1) Quit and Stay Quit Monday Model or (2) Usual Care. For evaluation, phone surveys will be conducted at baseline and 3-months to assess quit attempts, intervention satisfaction, and smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- Quit and Stay Quit Monday Model
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit and Stay Quit Monday ModelBehavioural
Participants randomized to the study intervention will receive: (1) 2 telephone smoking cessation coaching calls; (2) enrollment into SmokefreeTXT; and (3) enrollment in the iquitmonday.org weekly email newsletter. The telephone coaches will ask these participants to identify a future Monday as their quit date and provide coaching to achieve a Monday quit. The coaches will also enter the selected Monday as the patient's quit day when enrolling the patient into SmokefreeTXT.
| Study group | Role | What they receive |
|---|---|---|
| Quit and Stay Quit Monday Model | Experimental | Not described Receives: Behavioral: Quit and Stay Quit Monday Model |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 3-month quit attempts
Phone surveys will be conducted to obtain information
Measured: 3 months
Incidence of smoking cessation
Phone surveys will be conducted to obtain information
Measured: 3 months
Number of participants who report satisfaction in intervention
Phone surveys will be conducted to obtain information
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Oct 2020
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
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 NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group, parallel-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Rogers, DrPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512248
- Sponsor's protocol ID
- 20-01247
- Status last verified
- Dec 2021
- First submitted
- 11 Aug 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Publications
Vojjala M, Wysota CN, Oketunbi O, King Q, Rogers ES. Integrating the "Quit and Stay Quit Monday" Model into Smoking Cessation Services for Smokers with Mental Health Conditions: A Pilot Randomized Controlled Trial. J Smok Cessat. 2023 Jul 22;2023:8165232. doi: 10.1155/2023/8165232. eCollection 2023.
PubMed 37521160
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
- ClinicalTrials.gov ID
- NCT04512248
- Acronym / sponsor ID
- 20-01247
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 13 Aug 2020 (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.
The Quit and Stay Quit Monday model is an innovative smoking cessation approach that guides smokers' behavior without requiring additional resources. The investigator will conduct a randomized control trial evaluating the effectiveness of this model as compared to usual smoking cessation care in a population of smokers with a mental health condition.
Detailed description
The overall objective of this proposal is to innovate the tobacco treatment paradigm for smokers with mental health conditions (MHC) by integrating the Quit and Stay Quit Monday Model into smoking cessation services for this vulnerable population.
The investigator will conduct a two-group, parallel-randomized controlled trial (RCT). The target population will be generated by the NYU Langone electronic medical record (EMR). The investigator will proactively contact patients to offer enrollment and randomize participants 1:1 to one of two groups (n=50/group): (1) Quit and Stay Quit Monday Model or (2) Usual Care. For evaluation, phone surveys will be conducted at baseline and 3-months to assess quit attempts, intervention satisfaction, and smoking cessation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-group, parallel-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Quit and Stay Quit Monday Model | Experimental | Behavioral: Quit and Stay Quit Monday Model |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥ 18 years old
- Has smoked a cigarette in the past 30 days, even a puff
- Has been diagnosed with a mental health condition or received care from a mental health clinic within the NYU Langone Health system in the prior 12 months
- Interested in quitting smoking
- English language
Key exclusion criteria (2 listed)
- age < 18 years of age
- Non-smoker
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 |
|---|---|---|
| Quit and Stay Quit Monday ModelParticipants randomized to the study intervention will receive: (1) 2 telephone smoking cessation coaching calls; (2) enrollment into SmokefreeTXT; and (3) enrollment in the iquitmonday.org weekly email newsletter. The telephone coaches will ask these participants to identify a future Monday as their quit date and provide coaching to achieve a Monday quit. The coaches will also enter the selected Monday as the patient's quit day when enrolling the patient into SmokefreeTXT. | Behavioural | Quit and Stay Quit Monday Model |
Primary outcome
Incidence of 3-month quit attempts
Time frame: 3 months
Phone surveys will be conducted to obtain information
Incidence of smoking cessation
Time frame: 3 months
Phone surveys will be conducted to obtain information
Number of participants who report satisfaction in intervention
Time frame: 3 months
Phone surveys will be conducted to obtain information
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 5 Jan 2022.
- Derived from this study: PubMed 37521160Vojjala M, Wysota CN, Oketunbi O, King Q, Rogers ES. Integrating the "Quit and Stay Quit Monday" Model into Smoking Cessation Services for Smokers with Mental Health Conditions: A Pilot Randomized Controlled Trial. J Smok Cessat. 2023 Jul 22;2023:8165232. doi: 10.1155/2023/8165232. eCollection 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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.
Erin Rogers, DrPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quit and Stay Quit Monday Model in people with Smoking Cessation, run by NYU Langone Health 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 7 inclusion and 2 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 5 Jan 2022. 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?
Incidence of 3-month quit attempts (time frame: 3 months). The study lists 3 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 NCT04512248, 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 5 Jan 2022.