NYCHA Mindfulness-based Smoking Cessation Intervention

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04334187
• Other study ID #: 19-01435
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: December 2021

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Number of participants who self reported abstinence	This will be self reported at the end of the treatment (2 months)	2 months