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OpenTrials
Completed

NCT Number: NCT04512248

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 years old
  • Has smoked a cigarette in the past 30 days, even a puff
  • 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
  • Interested in quitting smoking
  • English language
  • Has a phone that can receive text messages
  • Able to provide informed consent

Exclusion criteria

  • age < 18 years of age
  • Non-smoker

Treatment and study plan

Quit and Stay Quit Monday Model

Behavioral

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2020
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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