The purpose of this study is to: Aim I: Test the efficacy of a mindfulness-based text messaging program for smoking cessation ("iQuit Mindfully"), both as a standalone intervention and in combination with in-person counseling; and Aim II: Investigate the mechanisms through which mindfulness training impacts smoking cessation.
This study is a 2 X 2 randomized controlled trial to investigate the effects of the iQuit Mindfully text messaging program, both as a standalone intervention and in combination with in-person counseling (Mindfulness-based Addiction Treatment; MBAT), compared to usual care. Participants will be randomized to one of four groups based on assignment to iQuit Mindfully text messages (yes/no) and in-person MBAT (yes/no): * Usual Care (self-help materials + nicotine patch and nicotine lozenge treatment) * MBAT (8 weekly virtual MBAT sessions + self-help materials + nicotine patch and nicotine lozenge treatment) * iQuit Mindfully (iQuit Mindfully text messages + self-help materials + nicotine patch and nicotine lozenge treatment) * MBAT + iQuit Mindfully (8 weekly virtual MBAT sessions + iQuit Mindfully text messages + self-help materials + nicotine patch and nicotine lozenge treatment) All study participants will receive self-help smoking cessation materials, including the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW). All study participants will also receive nicotine patches and lozenges. Assessments will occur at baseline and weeks 1, 3, 5, and 8. Follow-up assessments will occur at weeks 12 and 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
504
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.
Patch therapy (beginning quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 2 week of 14 mg patches, and 2 week of 7 mg patches. Patch therapy for participants who smoke less than 10 cigarettes/day will consist of 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Lozenge therapy (beginning quit day) for participants who smoke first cigarette within 30 minutes of waking up will consist of 8 weeks of 4mg lozenges. Lozenge therapy (beginning quit day) for participants who smoke first cigarette 30 minutes of more after they wake up will consist of 8 weeks of 2mg lozenges.
Georgia State University
Atlanta, Georgia, United States
Number of Participants With Confirmed Smoking Abstinence, 8 Weeks
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide \<6 ppm
Time frame: 8 weeks after the start of treatment
Number of Participants With Confirmed Smoking Abstinence, 12 Weeks
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide \<6 ppm
Time frame: 12 weeks after the start of treatment
Number of Participants With Confirmed Smoking Abstinence, 24 Weeks
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by carbon monoxide \< 6ppm and saliva cotinine \< 20 ng/ml
Time frame: 24 weeks after the start of treatment
Home Mindfulness Practice (Number of Days Per Week)
Self-reported frequency of home mindfulness practice (questionnaire; higher frequency means better outcome)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Dispositional Mindfulness (Mindful Attention Awareness Scale [MAAS])
Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; MAAS ranges 1-6)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Dispositional Mindfulness (Five Facet Mindfulness Questionnaire-Short Form [FFMQ-SF])
Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; FFMQ-SF ranges 24-120)
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Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008) and include the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW).
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.
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Self-compassion (Self-Compassion Scale-Short Form [SCS-SF])
Self-reported self-compassion (questionnaire; higher frequency means better outcome; SCS-SF ranges 1-5)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Stress (Perceived Stress Scale [PSS])
Self-reported stress (questionnaire; lower scores mean better outcome; PSS ranges 0-40)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Emotions (Positive and Negative Affect Schedule [PANAS])
Self-reported positive and negative emotions (questionnaire; lower scores on PANAS-Negative Affect mean better outcome; higher scores on PANAS-Positive Affect mean better outcome; PANAS-Negative Affect and Positive Affect each range 10-50)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Craving and Withdrawal (Wisconsin Smoking Withdrawal Scale [WSWS])
Self-reported craving and withdrawal (questionnaire; lower scores mean better outcome; subscale scores for each withdrawal symptom range 0-4)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Nicotine Dependence (Brief Wisconsin Dependence Motives Questionnaire [WISDM])
Self-reported nicotine dependence (questionnaire; lower scores mean better outcome; subscale scores for each aspect of dependence range 1-7)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Self-efficacy (Self-Efficacy Scale)
Self-reported self-efficacy to abstain from smoking (questionnaire; higher scores mean better outcome; subscale scores for managing positive affect, negative affect, and craving without smoking range 3-15)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Social Support (Multidimensional Scale of Perceived Social Support; Higher Scores Mean Better Outcome; Scores Range 1-7)
Self-reported perceived social support (questionnaire)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Program Evaluation (Questionnaire Developed for This Study to Evaluate Participants' Perceptions of the Helpfulness of Intervention Components, the Extent to Which They Would Recommend the Program to Others, and Suggestions for Improvement)
Feedback about interventions and perceived benefits (questionnaire; for quantitative questions, higher scores mean better outcome; for questions about helpfulness and recommending to others, scores range 1-10; for perceived benefits of program, scores range 1-5)
Time frame: 8 weeks after treatment