NYCHA Mindfulness-based Smoking Cessation Intervention

Not Applicable

Withdrawn

• Conditions: Tobacco Use

• Registration Number: NCT04334187
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Study Start: 2021-06
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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