Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
Not Applicable
Completed
- Conditions
- Cigarette Smoking
- Interventions
- Behavioral: Mindfulness-Based Addiction TreatmentBehavioral: Self-help materialsBehavioral: iQuit Mindfully
- Registration Number
- NCT04965181
- Lead Sponsor
- Georgia State University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully Nicotine Replacement Therapy 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. iQuit Mindfully Nicotine Replacement Therapy 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. Mindfulness-based Addiction Treatment (MBAT) Nicotine Replacement Therapy 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. Usual Care Nicotine Replacement Therapy 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. iQuit Mindfully Self-help materials 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. Mindfulness-based Addiction Treatment (MBAT) Mindfulness-Based Addiction Treatment 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. Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully Self-help materials 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. Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully iQuit Mindfully 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. iQuit Mindfully iQuit Mindfully 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. Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully Mindfulness-Based Addiction Treatment 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. Mindfulness-based Addiction Treatment (MBAT) Self-help materials 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. Usual Care Self-help materials 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.
- Primary Outcome Measures
Name Time Method Number of participants with confirmed smoking abstinence, 8 weeks 8 weeks after the start of treatment Self-report of not smoking in the past 7 days (not even a puff), confirmed by expired carbon monoxide \<6 ppm
Number of participants with confirmed smoking abstinence, 12 weeks 12 weeks after the start of treatment Self-report of not smoking in the past 7 days (not even a puff), confirmed by expired carbon monoxide \<6 ppm
Number of participants with confirmed smoking abstinence, 24 weeks 24 weeks after the start of treatment Self-report of not smoking in the past 7 days (not even a puff), confirmed by saliva cotinine \< 20 ng/ml
- Secondary Outcome Measures
Name Time Method Dispositional mindfulness (Mindful Attention Awareness Scale [MAAS]) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; MAAS ranges 1-6)
Dispositional mindfulness (Five Facet Mindfulness Questionnaire-Short Form [FFMQ-SF]) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; FFMQ-SF ranges 24-120)
Stress (Perceived Stress Scale [PSS]) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment Self-reported stress (questionnaire; lower scores mean better outcome; PSS ranges 0-40)
Nicotine dependence (Brief Wisconsin Dependence Motives Questionnaire [WISDM]) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment Self-reported nicotine dependence (questionnaire; lower scores mean better outcome; subscale scores for each aspect of dependence range 1-7)
Self-efficacy (Self-Efficacy Scale) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment 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)
Home mindfulness practice (number of days per week) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment Self-reported frequency of home mindfulness practice (questionnaire; higher frequency means better outcome)
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) 8 weeks after treatment 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)
Emotions (Positive and Negative Affect Schedule [PANAS]) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment 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)
Craving and withdrawal (Wisconsin Smoking Withdrawal Scale [WSWS]) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment Self-reported craving and withdrawal (questionnaire; lower scores mean better outcome; subscale scores for each withdrawal symptom range 0-4)
Self-compassion (Self-Compassion Scale-Short Form [SCS-SF]) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment Self-reported self-compassion (questionnaire; higher frequency means better outcome; SCS-SF ranges 1-5)
Social support (Multidimensional Scale of Perceived Social Support; higher scores mean better outcome; scores range 1-7) During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment Self-reported perceived social support (questionnaire)
Trial Locations
- Locations (1)
Georgia State University
🇺🇸Atlanta, Georgia, United States