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Clinical Trials/NCT05440903
NCT05440903
Completed
N/A

Examining the Effects of Brief Mindfulness Training on Smoking Quit Attempts

University of Southern California1 site in 1 country213 target enrollmentDecember 8, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
University of Southern California
Enrollment
213
Locations
1
Primary Endpoint
Smoking Cessation Behavior at 30 days
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Participants will complete this study remotely, either at home or at their preferred location using an online platform. The investigators propose to test the effects of a mindfulness training [MT: Headspace] intervention compared to a time and attention psycho-education control [control: TedTalks] among N=200 adult smokers of a nicotine product. Previous studies suggest that mindfulness training may be beneficial in reducing craving during tobacco abstinence. During the study, participants will complete baseline questionnaires, followed by two weeks of daily MT or control training and self-report on questionnaires assessing affect, cognition, and smoking behavior using Ecological Momentary Assessment (EMA) for remote data capture. Following this two weeks of training, participants will complete a smoking quit attempt and complete daily EMA questionnaires for two weeks. The first day of the smoking quit attempt will include a remote Zoom video session following overnight smoking abstinence. During this session the participants will complete a remote stressor task (Trier Social Stress Test, TSST), and the investigators will collect EMA data on affect and smoking behavior before and after the TSST. One month after the start of the quit attempt, participants will complete a phone call as a follow-up to assess smoking behavior over the previous 30 days, and to complete a debriefing. Study objectives are to test the effect of MT on: (1) smoking lapses during the follow-up periods; and (2) stress (affect, smoking urge, withdrawal symptoms) during the TSST.

Registry
clinicaltrials.gov
Start Date
December 8, 2020
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew Kirkpatrick

Associate Professor of Research

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age
  • Smoke at least 5 cig/day for the past year
  • English fluency
  • Motivation to quit smoking in next 30 days, or willing to make a practice quit attempt
  • Reside in California
  • Have remote video capability (i.e., computer, laptop, tablet with working camera and audio) in order to complete all data collection procedures (Note that the study does not have resources to provide these materials)
  • Have working smartphone capable of downloading the app for EMA assessments

Exclusion Criteria

  • Current use of any nicotine replacement products (i.e., nicotine patch, gum, lozenge) or smoking cessation medications (i.e., Chantix, Bupropion, Wellbutrin, Zyban)
  • Current mindfulness or meditation practice of greater than 5 minutes each day.

Outcomes

Primary Outcomes

Smoking Cessation Behavior at 30 days

Time Frame: 30 days after start of quit attempt

7-day point prevalence abstinence (i.e., no cigarettes smoked in the previous 7 days). 0=did not smoke; 1=smoked at least one cigarette.

Smoking Cessation Behavior at 14 days

Time Frame: 14 days after start of quit attempt

7-day point prevalence abstinence (i.e., no cigarettes smoked in the previous 7 days). 0=did not smoke; 1=smoked at least one cigarette.

Secondary Outcomes

  • Stress-related feelings of "anxious"(1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST)
  • App training adherence(14 days after starting app training)
  • Stress-related feelings of "relaxed"(1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST)
  • Stress-related feelings of "urge to smoke"(1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST)
  • Stress-related feelings of "stressed"(1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST)
  • Cessation Motivation(baseline (start of the study) and 30 days after start of quit attempt)

Study Sites (1)

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