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NYCHA Mindfulness-based Smoking Cessation Intervention

Sponsor
NYU Langone Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04334187
Collaborator
(none)
0
Enrollment
1
Arm
6
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Based addition treatment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility and Accessibility of a Mindfulness-based Smoking Cessation Intervention for NYCHA Residents
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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).

  3. 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).

  4. 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

Secondary Outcome Measures

  1. 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.

  2. Number of participants who self reported abstinence [2 months]

    This will be self reported at the end of the treatment (2 months)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Erin Rogers, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04334187
Other Study ID Numbers:
  • 19-01435
First Posted:
Apr 6, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 2, 2022