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

NCT ID: NCT04512248

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-10-30

Brief Summary

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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

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-group, parallel-randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Quit and Stay Quit Monday Model

Group Type EXPERIMENTAL

Quit and Stay Quit Monday Model

Intervention Type 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.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Rogers, DrPH

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

References

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Vojjala M, Wysota CN, Oketunbi O, King Q, Rogers ES. Integrating the "Quit and Stay Quit Monday" Model into Smoking Cessation Services for Smokers with Mental Health Conditions: A Pilot Randomized Controlled Trial. J Smok Cessat. 2023 Jul 22;2023:8165232. doi: 10.1155/2023/8165232. eCollection 2023.

Reference Type DERIVED
PMID: 37521160 (View on PubMed)

Other Identifiers

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20-01247

Identifier Type: -

Identifier Source: org_study_id

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