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Recruitment for the study proved to be a significant challenge, raising important concerns about its overall feasibility.
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This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking. |
|
| Craving-to-Quit app | Experimental | Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls. |
|
| Group Mindfulness Training | Experimental | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicoderm C-Q Transdermal Product | Drug | 6 weeks of nicotine replacement therapy patches |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Smoking Abstinence | Number of participants who self-report of not smoking in the past 7-days, not even a puff, confirmed by expired carbon monoxide (CO) level of < 10 ng/ml. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Cigarettes Smoked Per Day | Self-reported number of cigarettes smoked per day by each participant (Question is: "On average, how many cigarettes do you smoke per day?. Calculated as # of cigarettes reported at Baseline minus # of cigarettes reported at 3-month follow-up) | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taghrid Asfar, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| St. Jude Children's Research Hospital |
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The Usual Care Arm was the arm of the intervention where participants would receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy, and self-help materials to quit smoking. Unfortunately, the study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm, which would occur after sufficient enrollment in the mindfulness training arm. As a result, no participants were enrolled in the Usual Care Arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking. Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Brief advice on quitting smoking: Standard advice on how to quit smoking. Self-help smoking cessation materials: Written materials on how to quit smoking including contact info for state tobacco quitline. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 2, 2024 |
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| Orientation session | Behavioral | This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. |
|
| Craving-to-Quit app | Behavioral | The app is comprised of 22 modules for 22 days, 5-15 minutes each, designed to teach MT using audio, video, and animation. The app also includes other features such as social support (quit friend sign-ups, the tip of the week), activity feed (to track interaction with the app), and my morning stats (to track smoking). |
|
| Two brief follow-up phone calls | Behavioral | The first phone call will occur one day before the quit date to remind participants about their quit date and provide support. The second will occur at the end of treatment (around day 60 after quit date) to review progress, provide support, and schedule the 3-month follow-up visit. Each phone call will last approximately 15 minutes. |
|
| Group MT sessions | Behavioral | Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
|
| Brief advice on quitting smoking | Behavioral | Standard advice on how to quit smoking. |
|
| Self-help smoking cessation materials | Behavioral | Written materials on how to quit smoking including contact info for state tobacco quitline. |
|
| Number of Participants With Reported Relapse |
Relapse is defined as smoking at least once/week on two consecutive weeks. |
| 3 months |
| Usability of the Craving-to-Quit App | How usable participants found the app measured by the absolute number of times logged into the app. | 3 months |
| Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use | How usable participants found the app measured by self-reported number of completed days for the app. | 3 months |
| Usability of the Craving-to-Quit App as Assessed by the Comfortability With the App | How usable participants found the app measured by the comfortability of the app via questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with the app. | 3 months |
| Acceptability | Assessed by 3 items "How satisfied were you with the intervention?", "How likely are you to recommend this intervention to a friend?" and "How useful was the intervention?" Each question is scored from 0-10 with the higher score indicating increased acceptability. | 3 months |
| Feasibility of Recruitment as Assessed Via Enrollment Rate | Percentage of enrolled in each arm out of the 44 that were originally recruited (number recruited divided by number enrolled multiplied by 100). A feasible recruitment is defined as an enrollment rate of 70% or higher. | Baseline |
| Attrition | Defined as the number of participants not having a final visit at the end of treatment, categories include mortality, withdrawal from the study, transfer to non-study clinics, loss to follow-up without identifiable cause. | 3 months |
| Memphis |
| Tennessee |
| 38105 |
| United States |
| FG001 | Craving-to-Quit App | Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Craving-to-Quit app: The app is comprised of 22 modules for 22 days, 5-15 minutes each, designed to teach MT using audio, video, and animation. The app also includes other features such as social support (quit friend sign-ups, the tip of the week), activity feed (to track interaction with the app), and my morning stats (to track smoking). Two brief follow-up phone calls: The first phone call will occur one day before the quit date to remind participants about their quit date and provide support. The second will occur at the end of treatment (around day 60 after quit date) to review progress, provide support, and schedule the 3-month follow-up visit. Each phone call will last approximately 15 minutes. |
| FG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm; therefore, no participants were enrolled in the Usual Care Arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking. Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Brief advice on quitting smoking: Standard advice on how to quit smoking. Self-help smoking cessation materials: Written materials on how to quit smoking including contact info for state tobacco quitline. |
| BG001 | Craving-to-Quit App | Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Craving-to-Quit app: The app is comprised of 22 modules for 22 days, 5-15 minutes each, designed to teach MT using audio, video, and animation. The app also includes other features such as social support (quit friend sign-ups, the tip of the week), activity feed (to track interaction with the app), and my morning stats (to track smoking). Two brief follow-up phone calls: The first phone call will occur one day before the quit date to remind participants about their quit date and provide support. The second will occur at the end of treatment (around day 60 after quit date) to review progress, provide support, and schedule the 3-month follow-up visit. Each phone call will last approximately 15 minutes. |
| BG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years, based on the difference between the date of birth provided at baseline compared to the date of consent. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | There were 3 participants that were randomized to a group, but did not complete a baseline; thus we can't verify their gender. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Number of Participants With Confirmed Smoking Abstinence | Number of participants who self-report of not smoking in the past 7-days, not even a puff, confirmed by expired carbon monoxide (CO) level of < 10 ng/ml. | Due to difficulties in enrollment, we could not recruit participants for usual care arm. | Posted | Count of Participants | Participants | 3 months |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Number of Cigarettes Smoked Per Day | Self-reported number of cigarettes smoked per day by each participant (Question is: "On average, how many cigarettes do you smoke per day?. Calculated as # of cigarettes reported at Baseline minus # of cigarettes reported at 3-month follow-up) | Due to difficulties in recruitment, no one was added to Usual Care Arm. | Posted | Mean | Standard Deviation | change in cigarettes/day | Baseline, 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reported Relapse | Relapse is defined as smoking at least once/week on two consecutive weeks. | Due to difficulties in recruitment, we were not able to recruit participants for the Usual Care Arm. | Posted | Count of Participants | Participants | 3 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Usability of the Craving-to-Quit App | How usable participants found the app measured by the absolute number of times logged into the app. | Only 2 people from the Craving to Quit App arm answered for the 3-month follow-up. | Posted | Count of Participants | Participants | 3 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use | How usable participants found the app measured by self-reported number of completed days for the app. | Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm.We did not have enough people from the Craving-to-Quit arm do the 3-month follow-up to collect or analyze this data. | Posted | Count of Participants | Participants | 3 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Usability of the Craving-to-Quit App as Assessed by the Comfortability With the App | How usable participants found the app measured by the comfortability of the app via questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with the app. | Number of participants from this treatment arm who responded to the 3-month follow-up. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Acceptability | Assessed by 3 items "How satisfied were you with the intervention?", "How likely are you to recommend this intervention to a friend?" and "How useful was the intervention?" Each question is scored from 0-10 with the higher score indicating increased acceptability. | Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm. Only 5 people answered the 3 month follow-up for their corresponding groups (2 for Craving to Quit, 3 for Group Mindfulness Training). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Feasibility of Recruitment as Assessed Via Enrollment Rate | Percentage of enrolled in each arm out of the 44 that were originally recruited (number recruited divided by number enrolled multiplied by 100). A feasible recruitment is defined as an enrollment rate of 70% or higher. | Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm. | Posted | Count of Participants | Participants | Baseline |
| ||||||||||||||||||||||||||||||||||
| Secondary | Attrition | Defined as the number of participants not having a final visit at the end of treatment, categories include mortality, withdrawal from the study, transfer to non-study clinics, loss to follow-up without identifiable cause. | Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm. | Posted | Number | participants | 3 months |
|
3 months
Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm. There were no participants assigned to the Usual Care Arm; therefore, the at-risk number is zero for this arm.
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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 | Usual Care | Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking. Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Brief advice on quitting smoking: Standard advice on how to quit smoking. Self-help smoking cessation materials: Written materials on how to quit smoking including contact info for state tobacco quitline. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Craving-to-Quit App | Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Craving-to-Quit app: The app is comprised of 22 modules for 22 days, 5-15 minutes each, designed to teach MT using audio, video, and animation. The app also includes other features such as social support (quit friend sign-ups, the tip of the week), activity feed (to track interaction with the app), and my morning stats (to track smoking). Two brief follow-up phone calls: The first phone call will occur one day before the quit date to remind participants about their quit date and provide support. The second will occur at the end of treatment (around day 60 after quit date) to review progress, provide support, and schedule the 3-month follow-up visit. Each phone call will last approximately 15 minutes. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. | 0 | 9 | 0 | 9 | 0 | 9 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Taghrid Asfar | University of Miami | +1 (901)-371-7229 | tasfar@miami.edu |
| May 6, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Non-Hispanic Black |
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| Hispanic |
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| Asian/Asian American/Pacific Islander |
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| Other |
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| Unknown/Not Reported |
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| self-report of quitting confirmed by CO < 10 ng/ml |
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| OG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
|
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| OG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
|
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| OG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
|
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| OG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
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| OG002 | Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
|
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| OG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
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| OG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
|
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| OG002 | Group Mindfulness Training | Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT). Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches Orientation session: This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment. Group MT sessions: Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes. |
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