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Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512248
Recruitment Status : Completed
First Posted : August 13, 2020
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Quit and Stay Quit Monday Model Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-group, parallel-randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : October 30, 2021
Actual Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Quit and Stay Quit Monday Model Behavioral: Quit and Stay Quit Monday Model
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.
No Intervention: Usual Care


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of 3-month quit attempts [ Time Frame: 3 months ]
    Phone surveys will be conducted to obtain information

  2. Incidence of smoking cessation [ Time Frame: 3 months ]
    Phone surveys will be conducted to obtain information

  3. Number of participants who report satisfaction in intervention [ Time Frame: 3 months ]
    Phone surveys will be conducted to obtain information


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age ≥ 18 years old
  2. Has smoked a cigarette in the past 30 days, even a puff
  3. 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
  4. Interested in quitting smoking
  5. English language
  6. Has a phone that can receive text messages
  7. Able to provide informed consent

Exclusion Criteria:

  1. age < 18 years of age
  2. Non-smoker
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512248


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Erin Rogers, DrPH NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04512248    
Other Study ID Numbers: 20-01247
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No