Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions
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|ClinicalTrials.gov Identifier: NCT04512248|
Recruitment Status : Completed
First Posted : August 13, 2020
Last Update Posted : January 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Quit and Stay Quit Monday Model||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|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|
|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|
- 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
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
|United States, New York|
|NYU Langone Health|
|New York, New York, United States, 10016|
|Principal Investigator:||Erin Rogers, DrPH||NYU Langone Health|