Cigarette Smoking
Conditions
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.
Interventions
BEHAVIORALMindfulness-Based Addiction Treatment
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.
DRUGNicotine Replacement Therapy
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.
BEHAVIORALSelf-help materials
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).
BEHAVIORALiQuit Mindfully
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.
Sponsors
Georgia State University
University of Chicago
University of Utah
George Washington University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Confirmed Smoking Abstinence, 8 Weeks | 8 weeks after the start of treatment | 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 |
| Number of Participants With Confirmed Smoking Abstinence, 12 Weeks | 12 weeks after the start of treatment | 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 |
| Number of Participants With Confirmed Smoking Abstinence, 24 Weeks | 24 weeks after the start of treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClaire A Spears, Ph.D
Georgia State University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-based Addiction Treatment (MBAT) + 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. | 141 |
| 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. | 146 |
| Mindfulness-based Addiction Treatment (MBAT) 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. | 147 |
| Usual Care 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. | 70 |
| Total | 504 |
Baseline characteristics
| Characteristic | Usual Care | Total | Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully | iQuit Mindfully | Mindfulness-based Addiction Treatment (MBAT) |
|---|---|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 12.7 | 50.4 years STANDARD_DEVIATION 12.7 | 49.7 years STANDARD_DEVIATION 12.8 | 49.8 years STANDARD_DEVIATION 12.3 | 50.3 years STANDARD_DEVIATION 13.1 |
| Cigarettes smoked per day at baseline | 13.6 Number of cigarettes per day STANDARD_DEVIATION 7.6 | 14.7 Number of cigarettes per day STANDARD_DEVIATION 8.2 | 14.7 Number of cigarettes per day STANDARD_DEVIATION 7.3 | 15.4 Number of cigarettes per day STANDARD_DEVIATION 9.8 | 14.5 Number of cigarettes per day STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 18 Participants | 5 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 486 Participants | 136 Participants | 140 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 12 Participants | 3 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 325 Participants | 94 Participants | 91 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 26 Participants | 6 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 18 Participants | 4 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) White | 16 Participants | 122 Participants | 34 Participants | 35 Participants | 37 Participants |
| Sex: Female, Male Female | 32 Participants | 199 Participants | 57 Participants | 54 Participants | 56 Participants |
| Sex: Female, Male Male | 38 Participants | 305 Participants | 84 Participants | 92 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 141 | 0 / 146 | 2 / 147 | 0 / 70 |
| other Total, other adverse events | 7 / 141 | 12 / 146 | 12 / 147 | 8 / 70 |
| serious Total, serious adverse events | 0 / 141 | 1 / 146 | 0 / 147 | 0 / 70 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully | Number of Participants With Confirmed Smoking Abstinence, 12 Weeks | 17 Participants |
| iQuit Mindfully | Number of Participants With Confirmed Smoking Abstinence, 12 Weeks | 27 Participants |
| Mindfulness-based Addiction Treatment (MBAT) | Number of Participants With Confirmed Smoking Abstinence, 12 Weeks | 22 Participants |
| Usual Care | Number of Participants With Confirmed Smoking Abstinence, 12 Weeks | 9 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully | Number of Participants With Confirmed Smoking Abstinence, 24 Weeks | 18 Participants |
| iQuit Mindfully | Number of Participants With Confirmed Smoking Abstinence, 24 Weeks | 22 Participants |
| Mindfulness-based Addiction Treatment (MBAT) | Number of Participants With Confirmed Smoking Abstinence, 24 Weeks | 16 Participants |
| Usual Care | Number of Participants With Confirmed Smoking Abstinence, 24 Weeks | 8 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully | Number of Participants With Confirmed Smoking Abstinence, 8 Weeks | 13 Participants |
| iQuit Mindfully | Number of Participants With Confirmed Smoking Abstinence, 8 Weeks | 29 Participants |
| Mindfulness-based Addiction Treatment (MBAT) | Number of Participants With Confirmed Smoking Abstinence, 8 Weeks | 26 Participants |
| Usual Care | Number of Participants With Confirmed Smoking Abstinence, 8 Weeks | 12 Participants |
Secondary
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
Secondary
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)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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