NYCHA Mindfulness-based Smoking Cessation Intervention

NCT04334187 | Withdrawn DMC

• 1 other identifier: 19-01435
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Number of participants who adhered to the Mindfulness based addiction treatment

  3 months

• Number of participants who self reported abstinence

  2 months

Study Arms (1)

Smoke Cessation Group

EXPERIMENTAL

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

Interventions

Mindfulness Based addition treatment BEHAVIORAL

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.

Smoke Cessation Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Erin Rogers

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 6, 2020
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.