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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

Study Summary

This trial will test the effects of a mindfulness training intervention compared to a control intervention on smoking behavior.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 min before the trier social stress test (tsst), and +5, +30, +60 min after tsst
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 min before the trier social stress test (tsst), and +5, +30, +60 min after tsst for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Smoking Cessation Behavior at 14 days
Smoking Cessation Behavior at 30 days
Secondary outcome measures
App training adherence
Cessation Motivation
Stress-related feelings of "anxious"
+3 more

Trial 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

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,105 Total Patients Enrolled
Matthew Kirkpatrick, Ph.D.Principal InvestigatorAssociate Professor of Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants currently being accepted for this research trial?

"Affirmative. Clinicaltrials.gov attests to the fact that this medical trial, initially posted on December 8th 2020, is actively enrolling patients at present. Two hundred individuals need to be recruited from 1 clinical site."

Answered by AI

What ultimate purposes are being sought through this research?

"The primary aim of this brief clinical trial, which will be monitored for a period spanning two weeks post-abstinence initiation, is to assess Smoking cessation Behavior at 30 days. Secondary objectives include Stress-related feelings such as "stress" and "anxiety", as measured by visual analog scales (VAS) ranging from 0 ("not at all") to 100 ("extremely"). Additionally, the Adherence to app use across 28 sessions (2 per day over 14 days) shall also be investigated."

Answered by AI

What is the cap on overall enrollment for this experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial is still accepting participants; it was created on December 8th 2020 and last updated June 27th 2022. Two hundred patients are being recruited from a single location."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Keck School of Medicine of USC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Mindfulness Training for Smoking Cessation
Matthew Kirkpatrick 2020. "Mindfulness Training for Smoking Cessation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05440903.
~49 spots leftby Apr 2025
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