Mindfulness Training for Smoking Cessation

Examining the Effects of Brief Mindfulness Training on Smoking Quit Attempts

Sponsors

Lead Sponsor: University of Southern California

Source University of Southern California
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.

Overall Status Recruiting
Start Date 2020-12-08
Completion Date 2023-05-31
Primary Completion Date 2023-05-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Smoking Cessation Behavior at 14 days 14 days after start of quit attempt
Smoking Cessation Behavior at 30 days 30 days after start of quit attempt
Secondary Outcome
Measure Time Frame
Cessation Motivation baseline (start of the study) and 30 days after start of quit attempt
App training adherence 14 days after starting app training
Stress-related feelings of "anxious" 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
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 "stressed" 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
Enrollment 200
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Headspace

Description: A smartphone application that provides users with mindfulness and meditation sessions.

Arm Group Label: Mindfulness

Other Name: Mindfulness

Intervention Type: Behavioral

Intervention Name: TEDTalk

Description: A smartphone application that provides users with psychoeducational audio recordings from TEDTalk.

Arm Group Label: Psychoeducation

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Matthew Kirkpatrick, Ph.D. Principal Investigator Associate Professor of Research
Overall Contact

Last Name: Kendrick J Canizales, B.S.

Phone: ‪(323) 362-6632‬

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Keck School of Medicine of USC Kendrick J Canizales Matthew Kirkpatrick, Ph.D. Principal Investigator
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Southern California

Investigator Full Name: Matthew Kirkpatrick

Investigator Title: Associate Professor of Research

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Mindfulness

Type: Experimental

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.

Label: Psychoeducation

Type: Placebo Comparator

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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Between-groups study design

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description: The investigators and majority of study staff are blinded. The only individuals who are unblinded to a participant's conditions do not conduct data collection nor interact with participants beyond assigning participants to a condition and explaining the protocol for MT or control app training. Participants are aware of their condition, but do not know that the protocol is being measured as the variable of interest, nor that other participants are assigned to different conditions.

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