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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT008442 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| University of Utah | OTHER |
| The Catholic University of America | OTHER |
| George Washington University |
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The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) | Active Comparator | Nicotine patch; self-help guide; MBAT |
|
| iQuit Mindfully | Experimental | Nicotine patch; self-help guide; MBAT; text messaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based Addiction Treatment | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | End of Treatment (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Engagement | Number of participants who respond to interactive text messages | Over the 8-week treatment period |
| Participant Ratings | Perceived Text Message Helpfulness (minimum value 1 ["not at all helpful"], maximum value 10 ["extremely helpful"], higher scores mean better outcome) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Smoked Per Day | Self-reported number of cigarettes smoked per day (questionnaire) | End of treatment (8 weeks) |
| Weekly Mindfulness Practice | Self-reported average weekly mindfulness practice (questionnaire) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire A Spears, Ph.D. | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27213492 | Background | Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117. | |
| 18617085 | Background | Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 72 participants were enrolled in the study. However, one participant was removed due to disruptive behavior in the in-person group treatment, for a final analytic sample of 71 (33 in MBAT and 38 in iQuit Mindfully).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Count of Participants | Participants | End of Treatment (8 weeks) |
|
Reported over the period of treatment (8 weeks) and 1 month follow-up, for a total of 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild nicotine patch side effects | General disorders | Systematic Assessment | Mild nicotine patch side effects (itching, nausea, abnormal dreams, nervousness) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claire Spears | Georgia State University School of Public Health | 4044139335 | cspears@gsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2016 | Dec 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| University of Chicago | OTHER |
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| iQuit Mindfully | Behavioral | 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. |
|
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| Self-Help guide | Behavioral | 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). |
|
| Nicotine Patch | Drug | 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. |
|
|
| End of Treatment (8 weeks) |
| Attrition | Number of participants who do not attend end-of-treatment session | End of treatment (8 weeks) |
| Throughout treatment period (8 weeks) |
| Self-reported Mindfulness and Psychological Functioning | Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire) | End of treatment (8 weeks) |
| 31237242 | Derived | Spears CA, Abroms LC, Glass CR, Hedeker D, Eriksen MP, Cottrell-Daniels C, Tran BQ, Wetter DW. Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 24;7(6):e13059. doi: 10.2196/13059. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline cigarettes per day | Mean | Standard Deviation | Cigarettes per day |
|
| OG001 | 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. |
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| Secondary | Participant Engagement | Number of participants who respond to interactive text messages | Only participants in the iQuit Mindfully condition were included in this analysis because MBAT participants did not receive text messages. | Posted | Count of Participants | Participants | Over the 8-week treatment period |
|
|
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| Secondary | Participant Ratings | Perceived Text Message Helpfulness (minimum value 1 ["not at all helpful"], maximum value 10 ["extremely helpful"], higher scores mean better outcome) | Only participants in the iQuit Mindfully condition were included in this analysis because those in MBAT did not receive text messages. | Posted | Mean | Standard Deviation | units on a scale | End of Treatment (8 weeks) |
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| Secondary | Attrition | Number of participants who do not attend end-of-treatment session | Posted | Count of Participants | Participants | End of treatment (8 weeks) |
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| Other Pre-specified | Number of Cigarettes Smoked Per Day | Self-reported number of cigarettes smoked per day (questionnaire) | Not Posted | End of treatment (8 weeks) | Participants |
| Other Pre-specified | Weekly Mindfulness Practice | Self-reported average weekly mindfulness practice (questionnaire) | Not Posted | Throughout treatment period (8 weeks) | Participants |
| Other Pre-specified | Self-reported Mindfulness and Psychological Functioning | Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire) | Not Posted | End of treatment (8 weeks) | Participants |
| 0 |
| 33 |
| 0 |
| 33 |
| 7 |
| 33 |
| EG001 | 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. | 0 | 39 | 0 | 39 | 5 | 39 |
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