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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT04512248
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
12.9
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Behavioral: Quit and Stay Quit Monday Model
N/A

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

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two-group, parallel-randomized controlled trialTwo-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 :
Oct 1, 2020
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Oct 30, 2021

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Incidence of 3-month quit attempts [3 months]

    Phone surveys will be conducted to obtain information

  2. Incidence of smoking cessation [3 months]

    Phone surveys will be conducted to obtain information

  3. Number of participants who report satisfaction in intervention [3 months]

    Phone surveys will be conducted to obtain information

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1NYU Langone HealthNew YorkNew YorkUnited States10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Erin Rogers, DrPH, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04512248
Other Study ID Numbers:
  • 20-01247
First Posted:
Aug 13, 2020
Last Update Posted:
Jan 5, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 5, 2022