Cigarette Smoking
Conditions
Brief summary
The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.
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.
Interventions
BEHAVIORALMindfulness-based Addiction Treatment
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).
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.
BEHAVIORALSelf-Help guide
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).
DRUGNicotine Patch
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Utah
The Catholic University of America
George Washington University
University of Chicago
Georgia State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Engagement | Over the 8-week treatment period | Number of participants who respond to interactive text messages |
| Participant Ratings | 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) |
| Attrition | End of treatment (8 weeks) | Number of participants who do not attend end-of-treatment session |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weekly Mindfulness Practice | Throughout treatment period (8 weeks) | Self-reported average weekly mindfulness practice (questionnaire) |
| Self-reported Mindfulness and Psychological Functioning | End of treatment (8 weeks) | Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire) |
| Number of Cigarettes Smoked Per Day | End of treatment (8 weeks) | Self-reported number of cigarettes smoked per day (questionnaire) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-based Addiction Treatment (MBAT) Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: 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 guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: 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. | 33 |
| iQuit Mindfully Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: 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).
iQuit 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.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: 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. | 38 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Removed due to disruptive behavior | 0 | 1 |
Baseline characteristics
| Characteristic | Mindfulness-based Addiction Treatment (MBAT) | iQuit Mindfully | Total |
|---|---|---|---|
| Age, Continuous | 45.6 Years STANDARD_DEVIATION 12 | 45.6 Years STANDARD_DEVIATION 12.4 | 45.6 Years STANDARD_DEVIATION 12 |
| Baseline cigarettes per day | 18.8 Cigarettes per day STANDARD_DEVIATION 9.3 | 14.4 Cigarettes per day STANDARD_DEVIATION 9.4 | 16.5 Cigarettes per day STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 37 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 34 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 13 Participants | 21 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 39 |
| other Total, other adverse events | 7 / 33 | 5 / 39 |
| serious Total, serious adverse events | 0 / 33 | 0 / 39 |
Outcome results
Primary
Smoking Abstinence
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)
Time frame: End of Treatment (8 weeks)
Population: Available data for smoking abstinence were analyzed because coding missing data as smoking can severely bias results. Accordingly, the overall number of participants analyzed for smoking abstinence was 55.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) | Smoking Abstinence | 4 Participants |
| iQuit Mindfully | Smoking Abstinence | 8 Participants |
p-value: 0.52Chi-squared
Secondary
Attrition
Number of participants who do not attend end-of-treatment session
Time frame: End of treatment (8 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) | Attrition | 9 Participants |
| iQuit Mindfully | Attrition | 8 Participants |
Secondary
Participant Engagement
Number of participants who respond to interactive text messages
Time frame: Over the 8-week treatment period
Population: Only participants in the iQuit Mindfully condition were included in this analysis because MBAT participants did not receive text messages.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iQuit Mindfully | Participant Engagement | 34 Participants |
Secondary
Participant Ratings
Perceived Text Message Helpfulness (minimum value 1 \[not at all helpful\], maximum value 10 \[extremely helpful\], higher scores mean better outcome)
Time frame: End of Treatment (8 weeks)
Population: Only participants in the iQuit Mindfully condition were included in this analysis because those in MBAT did not receive text messages.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iQuit Mindfully | Participant Ratings | 8.0 units on a scale | Standard Deviation 2.4 |
Other Pre-specified
Number of Cigarettes Smoked Per Day
Self-reported number of cigarettes smoked per day (questionnaire)
Time frame: End of treatment (8 weeks)
Other Pre-specified
Self-reported Mindfulness and Psychological Functioning
Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)
Time frame: End of treatment (8 weeks)
Other Pre-specified
Weekly Mindfulness Practice
Self-reported average weekly mindfulness practice (questionnaire)
Time frame: Throughout treatment period (8 weeks)