Smoking Cessation
Conditions
Keywords
Mindfulness, Meditation
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.
Interventions
BEHAVIORALHeadspace
A smartphone application that provides users with mindfulness and meditation sessions.
BEHAVIORALTEDTalk
A smartphone application that provides users with psychoeducational audio recordings from TEDTalk.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Intervention model description
Between-groups study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation Behavior at 14 days | 14 days after start of quit attempt | 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. |
| Smoking Cessation Behavior at 30 days | 30 days after start of quit attempt | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress-related feelings of anxious | 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST | 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 |
| Stress-related feelings of relaxed | 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST | 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 |
| Cessation Motivation | baseline (start of the study) and 30 days after start of quit attempt | 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. |
| Stress-related feelings of urge to smoke | 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST | 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 |
| Stress-related feelings of stressed | 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST | 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 |
| App training adherence | 14 days after starting app training | 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. |
Countries
United States
Outcome results
None listed