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Headspace for Smoking Cessation
N/A
Waitlist Available
Led By Matthew Kirkpatrick, Ph.D.
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 min before the trier social stress test (tsst), and +5, +30, +60 min after tsst
Awards & highlights
Summary
This trial tests if using a mindfulness app called Headspace can help adult smokers quit by reducing cravings and stress. Participants will practice mindfulness exercises regularly and report their smoking behavior and feelings. The goal is to see if mindfulness can make it easier to stop smoking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 min before the trier social stress test (tsst), and +5, +30, +60 min after tsst
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 min before the trier social stress test (tsst), and +5, +30, +60 min after tsst
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Smoking Cessation Behavior at 14 days
Smoking Cessation Behavior at 30 days
Secondary study objectives
App training adherence
Cessation Motivation
Stress-related feelings of "anxious"
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MindfulnessExperimental Treatment1 Intervention
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 II: PsychoeducationPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Headspace
2020
N/A
~220
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,268 Total Patients Enrolled
Matthew Kirkpatrick, Ph.D.Principal InvestigatorAssociate Professor of Research
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