NYCHA Mindfulness-based Smoking Cessation Intervention

Study Overview
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Brief Summary
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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).

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

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

Conditions
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Tobacco Use

Intervention / Treatment
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* Behavioral: Mindfulness Based addition treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoke Cessation Group<br>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<br>* 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.<br>|

What is the study measuring?
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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 |