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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512248
• Other study ID #: 20-01247
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 smokers with a mental health condition.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of 3-month quit attempts	Phone surveys will be conducted to obtain information	3 months
Primary	Incidence of smoking cessation	Phone surveys will be conducted to obtain information	3 months
Primary	Number of participants who report satisfaction in intervention	Phone surveys will be conducted to obtain information	3 months