Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Behavioral: Mindfulness-Based Addiction Treatment
* Drug: Nicotine Replacement Therapy
* Behavioral: Self-help materials
* Behavioral: iQuit Mindfully


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age current smoker with history of >3 cigarettes/day (and expired carbon monoxide [CO] >6ppm) motivated to quit within next 30 days valid home address in the greater Atlanta, GA area functioning telephone number can speak, read, and write in English Exclusion Criteria: contraindication for nicotine patch or nicotine lozenge active substance abuse/dependence current suicidal ideation current use of tobacco cessation medications pregnancy, planning to become pregnant in the next 5 months, or lactation household member enrolled in the study enrolled in previous smoking cessation study based on mindfulness and/or text messaging at Georgia State University

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully<br>Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, iQuit Mindfully text messages, and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke >10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute Clearing the Air booklet and a referral to the Tobacco Cessation Quitline. | Behavioral: Mindfulness-Based Addiction Treatment<br>* Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.<br>* Other names: MBAT;Drug: Nicotine Replacement Therapy<br>* 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.<br>* Other names: Generic Nicotine Lozenge;Behavioral: Self-help materials<br>* 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).<br>Behavioral: iQuit Mindfully<br>* 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.<br>* Other names: Mindfulness-based text messaging for smoking cessation;|
| Experimental: iQuit Mindfully<br>Participants will receive iQuit Mindfully text messages and nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke >10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute Clearing the Air booklet and a referral to the Tobacco Cessation Quitline. | Drug: Nicotine Replacement Therapy<br>* 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.<br>* Other names: Generic Nicotine Lozenge;Behavioral: Self-help materials<br>* 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).<br>Behavioral: iQuit Mindfully<br>* 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.<br>* Other names: Mindfulness-based text messaging for smoking cessation;|
| Experimental: Mindfulness-based Addiction Treatment (MBAT)<br>Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke >10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute Clearing the Air booklet and a referral to the Tobacco Cessation Quitline. | Behavioral: Mindfulness-Based Addiction Treatment<br>* Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.<br>* Other names: MBAT;Drug: Nicotine Replacement Therapy<br>* 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.<br>* Other names: Generic Nicotine Lozenge;Behavioral: Self-help materials<br>* 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).<br>|
| Active Comparator: Usual Care<br>Participants in the usual care condition are provided with nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke >10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute Clearing the Air booklet and a referral to the Tobacco Cessation Quitline. | Drug: Nicotine Replacement Therapy<br>* 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.<br>* Other names: Generic Nicotine Lozenge;Behavioral: Self-help materials<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with confirmed smoking abstinence, 8 weeks | Self-report of not smoking in the past 7 days (not even a puff), confirmed by expired carbon monoxide <6 ppm | 8 weeks after the start of treatment | 
| Number of participants with confirmed smoking abstinence, 12 weeks | Self-report of not smoking in the past 7 days (not even a puff), confirmed by expired carbon monoxide <6 ppm | 12 weeks after the start of treatment | 
| Number of participants with confirmed smoking abstinence, 24 weeks | Self-report of not smoking in the past 7 days (not even a puff), confirmed by saliva cotinine < 20 ng/ml | 24 weeks after the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home mindfulness practice (number of days per week) | Self-reported frequency of home mindfulness practice (questionnaire; higher frequency means better outcome) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 8 weeks after treatment |