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

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Quit and Stay Quit Monday Model

• Registration Number: NCT04512248
• Lead Sponsor: NYU Langone Health

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Study Start: 2020-10-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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Exclusion Criteria

1. age < 18 years of age
2. Non-smoker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quit and Stay Quit Monday Model	Quit and Stay Quit Monday Model	-

Primary Outcome Measures

Name	Time	Method
Incidence of 3-month quit attempts	3 months	Phone surveys will be conducted to obtain information
Incidence of smoking cessation	3 months	Phone surveys will be conducted to obtain information
Number of participants who report satisfaction in intervention	3 months	Phone surveys will be conducted to obtain information

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States