Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
1 other identifier
interventional
70
1 country
1
Brief 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 smokers with a mental health condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 13, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedJanuary 5, 2022
December 1, 2021
1.1 years
August 11, 2020
December 14, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of 3-month quit attempts
Phone surveys will be conducted to obtain information
3 months
Incidence of smoking cessation
Phone surveys will be conducted to obtain information
3 months
Number of participants who report satisfaction in intervention
Phone surveys will be conducted to obtain information
3 months
Study Arms (2)
Quit and Stay Quit Monday Model
EXPERIMENTALUsual Care
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- age \< 18 years of age
- Non-smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Related Publications (1)
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.
PMID: 37521160DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Rogers, DrPH
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 13, 2020
Study Start
October 1, 2020
Primary Completion
October 30, 2021
Study Completion
October 30, 2021
Last Updated
January 5, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to ERIN.ROGERS@NYULANGONE.ORG. To gain access, data requestors will need to sign a data access agreement.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.