Mindfulness Training for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Examining the Effects of Brief Mindfulness Training on Smoking Quit Attempts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440903
• Other study ID #: UP-20-00900
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Headspace
A smartphone application that provides users with mindfulness and meditation sessions.
• TEDTalk
A smartphone application that provides users with psychoeducational audio recordings from TEDTalk.

Locations

Country	Name	City	State
United States	Keck School of Medicine of USC	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation Behavior at 14 days	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.	14 days after start of quit attempt
Primary	Smoking Cessation Behavior at 30 days	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.	30 days after start of quit attempt
Secondary	Cessation Motivation	change in motivation to quit (or stay quit) as measured by the Contemplation Ladder, a visual graphic used to select current level of quit motivation (0="no thought of quitting"; 10="taking action to quit"). A higher number indicates greater motivation to quit smoking.	baseline (start of the study) and 30 days after start of quit attempt
Secondary	App training adherence	Adherence to app use will be calculated as the number of times an individual used the app out of a total of 28 sessions (2 session per day for 14 days). A higher number indicates better adherence.	14 days after starting app training
Secondary	Stress-related feelings of "anxious"	visual analog scales of "I feel anxious" using the scale (0="not at all" to 100="extremely"). A higher number indicates greater feelings of "anxious"	1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
Secondary	Stress-related feelings of "relaxed"	visual analog scales of "I feel relaxed" using the scale (0="not at all" to 100="extremely"). A higher number indicates greater feelings of "relaxed"	1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
Secondary	Stress-related feelings of "stressed"	visual analog scales of "I feel stressed" using the scale (0="not at all" to 100="extremely"). A higher number indicates greater feelings of "stressed"	1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
Secondary	Stress-related feelings of "urge to smoke"	visual analog scales of "I have an urge to smoke" using the scale (0="not at all" to 100="extremely"). A higher number indicates greater feelings of "urge to smoke"	1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST