An interventional study of Headspace and TEDTalk in Smoking Cessation, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
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.
Behavioral: Headspace
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.
Behavioral: TEDTalk
A smartphone application that provides users with mindfulness and meditation sessions.
Also known as: Mindfulness
A smartphone application that provides users with psychoeducational audio recordings from TEDTalk.
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.
Time frame: 14 days after start of quit attempt
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.
Time frame: 30 days after start of quit attempt
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.
Time frame: baseline (start of the study) and 30 days after start of quit attempt
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.
Time frame: 14 days after starting app training
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"
Time frame: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
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"
Time frame: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
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"
Time frame: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
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"
Time frame: 1 min before the Trier Social Stress Test (TSST), and +5, +30, +60 min after TSST
Plan to share: Yes — The investigators plan on sharing deidentified data with other researchers by request.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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