- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03029819
iQuit Mindfully: Text Messaging for Smoking Cessation
iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
Study Overview
Status
Conditions
Detailed Description
This study is a pilot investigation of mindfulness-based smoking cessation treatment incorporating between-session text messaging ("iQuit Mindfully"). Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages).
All participants will receive in-person group treatment based on the 8-week MBAT protocol in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco dependence and psychological well-being will be assessed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Georgia State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18-65 years
- current smoker with history of >5 cigarettes/day for past year (and expired carbon monoxide >6 parts per million [ppm])
- motivated to quit within next 30 days
- valid home address in the greater Atlanta, Georgia area
- functioning telephone number
- own a mobile phone with text messaging capacity
- can speak, read, and write in English
- at least a sixth-grade level of health literacy
Exclusion Criteria:
- contraindication for nicotine patch
- active substance abuse/dependence
- regular use of tobacco products other than cigarettes
- current use of tobacco cessation medications
- pregnancy or lactation
- household member enrolled in the study
- current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic medications
- clinically significant depressive symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Mindfulness-based Addiction Treatment (MBAT)
Nicotine patch; self-help guide; MBAT
|
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al.
Clinical practice guideline for treating tobacco use and dependence, 2008).
Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches.
Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
Other Names:
|
EXPERIMENTAL: iQuit Mindfully
Nicotine patch; self-help guide; MBAT; text messaging
|
iQuit Mindfully involves text messages on each day between treatment sessions.
The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Other Names:
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al.
Clinical practice guideline for treating tobacco use and dependence, 2008).
Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches.
Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Abstinence
Time Frame: End of Treatment (8 weeks)
|
Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide <6 parts per million (ppm)
|
End of Treatment (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Engagement
Time Frame: Over the 8-week treatment period
|
Number of participants who respond to interactive text messages
|
Over the 8-week treatment period
|
Participant Ratings
Time Frame: End of Treatment (8 weeks)
|
Perceived Text Message Helpfulness (minimum value 1 ["not at all helpful"], maximum value 10 ["extremely helpful"], higher scores mean better outcome)
|
End of Treatment (8 weeks)
|
Attrition
Time Frame: End of treatment (8 weeks)
|
Number of participants who do not attend end-of-treatment session
|
End of treatment (8 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Cigarettes Smoked Per Day
Time Frame: End of treatment (8 weeks)
|
Self-reported number of cigarettes smoked per day (questionnaire)
|
End of treatment (8 weeks)
|
Weekly Mindfulness Practice
Time Frame: Throughout treatment period (8 weeks)
|
Self-reported average weekly mindfulness practice (questionnaire)
|
Throughout treatment period (8 weeks)
|
Self-reported Mindfulness and Psychological Functioning
Time Frame: End of treatment (8 weeks)
|
Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)
|
End of treatment (8 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Claire A Spears, Ph.D., Georgia State University
Publications and helpful links
General Publications
- Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117.
- Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
- Spears CA, Abroms LC, Glass CR, Hedeker D, Eriksen MP, Cottrell-Daniels C, Tran BQ, Wetter DW. Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 24;7(6):e13059. doi: 10.2196/13059.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23AT008442 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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