Mindfulness Training for Smoking Cessation

NCT ID: NCT05440903

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2023-05-31

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mindfulness

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.

Group Type: EXPERIMENTAL

Headspace

Intervention Type: BEHAVIORAL

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

Psychoeducation

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.

Group Type: PLACEBO_COMPARATOR

TEDTalk

Intervention Type: BEHAVIORAL

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

Interventions

Headspace

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

Intervention Type: BEHAVIORAL

TEDTalk

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Mindfulness

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Matthew Kirkpatrick

Associate Professor of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Kirkpatrick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Research

Locations

Keck School of Medicine of USC

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35863695 (View on PubMed)

Other Identifiers

UP-20-00900

Identifier Type: -

Identifier Source: org_study_id