A Mindfulness Based Application for Smoking Cessation
MBSC
1 other identifier
interventional
5
1 country
1
Brief Summary
Cigarette smoking is the leading cause of preventable death and disability in the world. Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually. Additional effective, safe, and accessible treatments for nicotine dependence are needed due to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent evidence supports the central role of craving in maintaining nicotine dependence, and neither behavioral nor replacement therapies directly target the relationship between cravings and smoking. Mindfulness therapy has been found to be effective in teaching strategies to decouple the association between craving and smoking. Mindfulness based smoking therapy (MT) has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has recently translated this program into a mobile device application (app) for smoking cessation. With Dr. Brewer's consultation, we propose to assess the feasibility of implementation of a MT mobile application in local hospital and community clinics and the effectiveness of the MT mobile application compared to a National Cancer Institute (NCI) QuitPal behavioral change group. We will examine smoking results at end of treatment and 2 and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined to be effective in a mobile phone application, this finding will be a significant step in providing an additional effective and safe treatment for smokers wishing to quit or cut down on their intake, and will be especially important in providing treatment options for marginalized or hard-to-access individuals wishing to reduce cigarette intake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 29, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedApril 17, 2019
April 1, 2019
3 years
October 29, 2013
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking behavior
We will assess number of cigarettes smoked and CO levels
6 months
Secondary Outcomes (1)
Craving
6 months
Study Arms (2)
Mindfulness Based Therapy
EXPERIMENTALCraving to Quit mobile application is provided for participants
Behavioral Smoking Cessation
ACTIVE COMPARATORNCI Quit Pal via a mobile phone application is provided for participants
Interventions
Mindfulness based interventions are provided via a mobile phone application.
Behavioral Smoking Cessation intervention is a behaviorally based intervention is provided via a mobile phone application.
Eligibility Criteria
You may qualify if:
- Males and females who have given written informed consent
- years of age or older
- Smoke an average of a minimum of five cigarettes per day
- Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of mindfulness techniques
- Express a wish to quit smoking
- A score at least in the "contemplation" range, as assessed via the Readiness to Change questionnaire (Heather \& McCambridge, 2013)
- Willingness to participate in mindfulness techniques
- Able to attend all clinic visits without interruption
You may not qualify if:
- Any current Axis I DSM-IV-TR psychiatric disorder other than alcohol abuse, marijuana abuse, or nicotine dependence that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality
- Serious medical comorbidity requiring medical intervention or close supervision, including seizures, pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation
- Suicide attempt in the last thirty days
- Gross neurological disease
- Mental retardation, which will be assessed by the PI, postdoctoral fellows, and doctoral students in clinical psychology
- Minors below the legal smoking age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (1)
Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
PMID: 35420700DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer K Penberthy, PhD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Psychiatry and Neurobehavioral Sciences
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 13, 2013
Study Start
September 1, 2013
Primary Completion
September 1, 2016
Study Completion
October 1, 2018
Last Updated
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share