Clinical trial NCT05440903: Mindfulness Training for Smoking Cessation
Official title: Examining the Effects of Brief Mindfulness Training on Smoking Quit Attempts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Mindfulness
Meditation
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between-groups study design
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Smoking Cessation Behavior at 14 days
timeFrame: 14 days after start of quit attempt
measure: Smoking Cessation Behavior at 30 days
timeFrame: 30 days after start of quit attempt
Secondary outcomes:
measure: Cessation Motivation
timeFrame: baseline (start of the study) and 30 days after start of quit attempt
measure: App training adherence
timeFrame: 14 days after starting app training
measure: Stress-related feelings of "anxious"
timeFrame: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
measure: Stress-related feelings of "relaxed"
timeFrame: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
measure: Stress-related feelings of "stressed"
timeFrame: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
measure: Stress-related feelings of "urge to smoke"
timeFrame: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
Study officials:
affiliation: Associate Professor of Research
name: Matthew Kirkpatrick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Black DS, Kirkpatrick M. Test of daily app-based mindfulness meditation preceding a planned smoking quit attempt date on abstinence: Protocol for a randomized controlled trial recruiting across the 58 counties of California. Contemp Clin Trials. 2022 Sep;120:106855. doi: 10.1016/j.cct.2022.106855. Epub 2022 Jul 18.