Mindfulness Training for Smoking Cessation

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University of Southern California

Status

Completed

Conditions

Smoking Cessation

Treatments

Behavioral: TEDTalk
Behavioral: Headspace

Study type

Interventional

Funder types

Other

Identifiers

NCT05440903
UP-20-00900

Details and patient eligibility

About

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.

Enrollment

213 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

213 participants in 2 patient groups, including a placebo group

Mindfulness
Experimental group
Description:
Participants in the experimental arm are asked to use a mindfulness smartphone application called Headspace. Headspace offers pre-recorded introductory mindfulness meditation audio instructions guided by experienced meditation teachers. Study participants are instructed to voluntarily complete 10 minutes of Headspace twice per day for 14 days, a total recommended dose of 280 minutes. Mindfulness practice begins the day after the baseline interview (i.e., intervention day 1). Participants are encouraged to listen at two separate times each day to support habit formation and to maximize daily exposure with low time burden. As participants have minimal prior experience with mindfulness attributed to the study eligibility criteria, all recommended trainings are at the beginner level. Participants have access to all sessions offered and are not restricted to a particular sequence.
Treatment:
Behavioral: Headspace
Psychoeducation
Placebo Comparator group
Description:
Participants in the psychoeducation arm listen to TEDTalks audio recordings by experts on field-specific topics. Study participants are instructed to complete 10 minutes of TEDTalks twice per day for 14 days. Sessions were selected by the study team to be of interest to the public yet not include content on meditation, smoking, or content appearing to cue behavior change associated with smoking. Like the Mindfulness condition, participants in the Psychoeducation condition begin the practice the day after the baseline interview. Participants are told to listen at two separate times each day to maximize daily exposure with low time burden. Additionally, participants are instructed to listen with "full mindful attention and return attention to the audio when attention drifts" to match the Mindfulness instruction and emphasize the importance of sustaining attention for each 10-minute period. Participants have access to all sessions offered and are not restricted to a particular sequence.
Treatment:
Behavioral: TEDTalk

Trial contacts and locations

1

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Central trial contact

Kendrick J Canizales, B.S.

Data sourced from clinicaltrials.gov

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