NYCHA Mindfulness-based Smoking Cessation Intervention

Feasibility and Accessibility of a Mindfulness-based Smoking Cessation Intervention for NYCHA Residents

The study will assess feasibility, accessibility and impact of a mindfulness-based smoking cessation group intervention for New York City Housing Authority (NYCHA) residents. Residents who smoke to receive an 8-week intervention. Participants will also be offered 4 weeks of nicotine replacement therapy (NRT).

Study Overview

• Status: Withdrawn
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: Mindfulness Based addition treatment

Detailed Description

The primary objective of this research is to examine the feasibility, accessibility and impact of a mindfulness-based smoking cessation program for NYCHA residents.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥18 years
• Current smoker (>= 5 cigarettes per day). Dual tobacco users are eligible as long as their primary tobacco product is cigarettes.
• Ready to quit smoking cigarettes within 30 days
• Able to attend the 8 weekly MBAT sessions at the scheduled days/times
• NYCHA resident
• English language
• Able to provide informed consent

Exclusion Criteria:

• Pregnant or breastfeeding
• Patient Health Questionnaire-2 (PHQ-2) score indicating current risk for depression
• Self-reported diagnosis of schizophrenia, bipolar disorder, schizotypal disorder or other psychotic disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Smoke Cessation Group; Mindfulness-based smoking cessation sessions will follow the mindfulness based addiction treatment (MBAT) intervention for smoking cessation. Sessions are in group format for two hours, weekly. Two groups of sessions with about 10 participants per group will be organized.

Behavioral: Mindfulness Based addition treatment; The intervention is comprised of 8 weekly group MBAT sessions. Two weekly groups of about 10 participants each will be conducted. All participants will also have the option to receive nicotine patches, gum, or lozenges for four weeks as part of their time in the study. Participants will complete surveys at enrollment (baseline), immediately after their last MBAT session (around 2 months after enrollment) and one month after completing treatment (3 months post-enrollment). Surveys will assess primary and secondary outcomes and satisfaction with the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who perceive the Mindfulness based addiction treatment as useful at time of Enrollment	Participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys at enrollment (baseline).	Baseline
Number of participants who perceive the Mindfulness based addiction treatment as useful after last MBAT session.	Number of participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys after their last MBAT session (2 months after enrollment).	2 months
Number of participants who perceive the Mindfulness based addiction treatment as useful post treatment	Participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys one month after completing treatment (3 months post-enrollment).	3 months
Number of participants who perceive the Mindfulness based addiction treatment as effective	Participants who self-report 7-day abstinence in the final follow up survey (3 months) will provide a biochemically validated saliva sample	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who adhered to the Mindfulness based addiction treatment	This will be reported in the number of sessions attended and completed mindfulness exercises in between the sessions.	3 months
Number of participants who self reported abstinence	This will be self reported at the end of the treatment (2 months)	2 months

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19-01435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Erin.rogers@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No