Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
Phase: NA
Conditions: Cigarette Smoking
Sponsor: Georgia State University

1 
 
 
 
STUDY PROTOCOL 
 
STUDY TITLE: 
Mindfulness-based Smoking Cessation Enhanced with Mobile Technology  
 
DATE OF DOCUMENT: 
June 14, 2021 
 
PRINCIPAL INVESTIGATOR: 
Claire Adams Spears, Ph.D., Associate Professor 
Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University 
 
FUNDING: 
National Cancer Institute R01CA237004 (“Mindfulness-based Smoking Cessation Enhanced with 
Mobile Technology for Low-Income Smokers”) 
 
CO-INVESTIGATORS: 
• 
Michael Eriksen, Sc.D., Regents’ Professor, School of Public Health, Georgia State University  
• 
Matt Hayat, Ph.D., Professor of Biostatistics, School of Public Health, Georgia State University  
• 
David W. Wetter, Ph.D., Professor, University of Utah and Huntsman Cancer Institute 
• 
Donald Hedeker, Ph.D., Professor of Biostatistics, University of Chicago  
 
CONSULTANTS: 
• 
Lorien Abroms, Sc.D., Professor, George Washington University School of Public Health 
(Consultant regarding text messaging intervention) 
• 
Mark Dannenfelser, MA, LPC, Founding Director, Mindfulness Center of Atlanta (study     
therapist) 
• 
Stephanie Swann, PhD, Owner and Instructor, Atlanta Mindfulness Institute (study     
therapist) 
 
PARTICIPATING STUDY SITE: 
School of Public Health, Georgia State University 
PI: Claire Adams Spears, Ph.D., Associate Professor 
Telephone: 404-413-9335 
Email: cspears@gsu.edu 
 

2 
 
 
 
TABLE OF CONTENTS 
Page 
 
Tool Revision History .............................................................................................................. 3 
PRÉCIS .................................................................................................................................. 4 
1. STUDY OBJECTIVES ............................................................................................................ 5 
2. BACKGROUND AND RATIONALE ........................................................................................ 6 
3. STUDY DESIGN ..................................................................................................................... 7 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ......................................................... 8 
5. STUDY INTERVENTIONS .................................................................................................... 10 
6. STUDY PROCEDURES ....................................................................................................... 12 
7. SAFETY ASSESSMENTS .................................................................................................... 17 
8. INTERVENTION DISCONTINUATION ................................................................................. 17 
9. STATISTICAL CONSIDERATIONS ...................................................................................... 18 
10. DATA COLLECTION AND QUALITY ASSURANCE ........................................................... 20 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................................. 22 
12. PUBLICATION OF RESEARCH FINDINGS ....................................................................... 22 
13. REFERENCES ................................................................................................................... 23 
 
 
 
 
 

3 
 
 
 
Tool Revision History 
 
Version Number: 1 
Version Date: 2/10/20 
Version Number: 2 
Version Date: 2/01/21 
Changes: 
• 
Additional safety precautions were added for the context of the COVID-19 pandemic. 
• 
Eight weeks of nicotine patches will be provided (vs. the 6 weeks originally proposed). 
• 
Text messages include quotes sharing the experiences of former smokers in our program. 
These messages are all anonymous and described as being from either “Mike” or “Kim,” 
depending on the participant’s preference.  
• 
Telephone consent will be documented using REDCap. 
• 
Questionnaires were updated.  
Version Number: 3 
Version Date: 5/19/21  
Changes: 
• 
Mindfulness group sessions will be delivered virtually (via Zoom) rather than in person. This 
change was made for participant safety during the COVID-19 pandemic and also to increase 
intervention scalability. In-person study assessments at weeks 8, 12, and 24 will take place in 
person at GSU, with phone/online surveys as back-up. Surveys at weeks 1, 3, and 5 will be 
administered online, or by phone depending on participant preference.  
• 
In addition to nicotine patches, participants will be provided nicotine lozenges. Accordingly, the 
following contraindications for nicotine lozenges have been added to the exclusion criteria: 
high blood pressure not controlled with medication; stomach ulcers; and diabetes that is not 
controlled with medication.  
• 
Since participants will not come for as many in-person sessions, they will be given 4 weeks of 
nicotine replacement therapy (NRT) at baseline and the other 4 weeks of NRT will be mailed 
when needed.  
• 
The requirement for participants to have adequate health literacy was removed.  
• 
A program evaluation question was added for the usual care condition.  
• 
Trialfacts will assist with the social media recruitment. 
Version Number: 4 
Version Date: 5/26/21  
Change: 
• 
Participants will be excluded if they are currently pregnant, plan to become pregnant in the 
next 5 months, or breastfeeding. In the unlikely case that a woman becomes pregnant during 
the study (since we are now excluding those who plan to become pregnant), she will still have 
access to behavioral treatment depending on her treatment condition, but she will be referred 
to her healthcare provider to inquire about and potentially obtain nicotine replacement therapy. 
Version Number: 5 
Version Date: 6/14/21  
Change: 
• 
The schedule of questionnaires was updated, and participant compensation was updated. 

4 
 
 
 
PRÉCIS 
 
Study Title 
iQuit Mindfully: Mindfulness-based Smoking Cessation Enhanced with Mobile Technology 
 
Objectives  
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.  
Aim II: Investigate the mechanisms through which mindfulness training impacts smoking cessation. 
 
Design, Interventions and Outcomes   
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 treatment) 
• 
MBAT (8 weekly virtual MBAT sessions + self-help materials + nicotine patch treatment) 
• 
iQuit Mindfully (iQuit Mindfully text messages + self-help materials + nicotine patch treatment) 
• 
MBAT + iQuit Mindfully (8 weekly virtual MBAT sessions + iQuit Mindfully text messages + 
self-help materials + nicotine patch 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. Assessments will 
occur at baseline and weeks 1, 3, 5, 8, 12, and 24. Primary outcomes are smoking abstinence at 8 
weeks after the start of treatment (7-day abstinence, biochemically verified by expired carbon 
monoxide <6 ppm), 12 weeks after the start of treatment (3 month follow-up; 7-day abstinence, 
biochemically verified by expired carbon monoxide <6 ppm), and 24 weeks after the start of treatment 
(6-month follow-up; 7-day abstinence, biochemically verified by saliva cotinine < 20 ng/ml). Secondary 
outcomes include frequency of home mindfulness practice and self-reported levels of mindfulness, 
emotions, craving, withdrawal, dependence, self-efficacy, and social support.  
 
Sample Size and Population  
Participants will include English-speaking adult smokers (ages 18 and above). Recruitment will target 
a racially/ethnically diverse sample of individuals with relatively low income levels, with a target 
sample size of 485 (maximum 500). 
 

5 
 
 
 
1. STUDY OBJECTIVES 
 
Study aims are to 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 examine underlying mechanisms of mindfulness treatment. Approximately 485 
participants (maximum 500) will be randomized to one of four groups:  
• 
Usual Care (self-help materials + nicotine patch treatment) 
• 
MBAT (8 weekly virtual MBAT sessions + self-help materials + nicotine patch treatment) 
• 
iQuit Mindfully (iQuit Mindfully text messages + self-help materials + nicotine patch treatment) 
• 
MBAT + iQuit Mindfully (8 weekly virtual MBAT sessions + iQuit Mindfully text messages + 
self-help materials + nicotine patch 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. Assessments will 
occur at baseline and weeks 1, 3, 5, 8, 12, and 24. Primary outcomes are smoking abstinence at 8 
weeks after the start of treatment (7-day abstinence, biochemically verified by expired carbon 
monoxide <6 ppm), 12 weeks after the start of treatment (3 month follow-up; 7-day abstinence, 
biochemically verified by expired carbon monoxide <6 ppm), and 24 weeks after the start of treatment 
(6-month follow-up; 7-day abstinence, biochemically verified by saliva cotinine < 20 ng/ml). Secondary 
outcomes include frequency of home mindfulness practice and self-reported levels of mindfulness, 
emotions, craving, withdrawal, dependence, self-efficacy, and social support. Aims and hypotheses 
are outlined below: 
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.  
We hypothesize that: 
1a) MBAT + iQuit Mindfully will result in higher rates of smoking cessation and lapse recovery than 
MBAT, which will produce higher cessation and lapse recovery than UC. iQuit Mindfully as a 
standalone intervention will also produce higher cessation and lapse recovery than UC. 
1b) As an exploratory aim, we will examine whether poverty status moderates treatment efficacy                            
(i.e., poverty status will predict worse cessation outcomes in MBAT but not MBAT + iQuit 
Mindfully). 
Aim II. Investigate the mechanisms through which mindfulness training impacts smoking cessation. 
Participants will complete questionnaires from baseline through 24 weeks after the start of treatment, 
in addition to intensive diary assessments for 6 contiguous weeks during treatment. We hypothesize 
that:  
2a) Compared to UC, the mindfulness treatment arms (MBAT, iQuit Mindfully, and MBAT + iQuit 
Mindfully) will increase mindfulness; reduce negative affect (NA) and volatility of NA (i.e., greater 
affective stability); increase positive affect; reduce craving and withdrawal; and increase self-
efficacy and social support, all of which will mediate effects of the mindfulness-based treatment 
arms vs. UC on abstinence. 
2b) Compared to UC, MBAT, iQuit Mindfully, and MBAT + iQuit Mindfully will all attenuate links 
between NA/craving and smoking. That is, in addition to reducing NA and craving (2a), 
mindfulness training is hypothesized to weaken the relationships between NA/craving and 
smoking.  

6 
 
 
 
2c) Compared to MBAT, MBAT + iQuit Mindfully will produce stronger effects on the above 
mechanisms (2a, 2b). Mechanisms outlined in 2a will mediate effects of MBAT + iQuit Mindfully 
vs. MBAT on abstinence. 
 
2. BACKGROUND AND RATIONALE 
 
Tobacco use, a primary behavioral risk factor for cancer, is the leading cause of preventable 
morbidity and mortality in the U.S.1-5 Only 7% of smokers quit each year despite most indicating an 
interest in quitting.6 Adults with low socioeconomic status (SES) and members of certain racial/ethnic 
minority groups (e.g., African Americans) are less likely to quit and consequently experience profound 
tobacco-related cancer disparities.6-10 There is an urgent need to improve upon evidence-based 
smoking cessation interventions to better serve these populations. Mindfulness training substantially 
increases rates of smoking cessation and lapse recovery.11,12 There is a dearth of research on 
mindfulness in low-SES and racial/ethnic minority groups, but these interventions do show promise for 
smoking cessation in these populations.12-14 However, additional support may be needed for low-SES 
smokers, who experience significant day-to-day barriers to quitting and have lower access to smoking 
cessation resources.  
Mobile health technology (“mHealth”) could increase treatment engagement and provide vital 24/7 
support to improve cessation outcomes for low-SES smokers. Personalized, interactive mHealth 
messages might encourage participants to use mindfulness and other smoking cessation techniques 
in the moments when they need them most, thus enhancing treatment effectiveness. Based on 
iterative feedback from low-SES smokers, we developed a text messaging program (“iQuit Mindfully”) 
as an adjunct to in-person mindfulness-based smoking cessation treatment. In a pilot study (N=71), 
participants were highly engaged and benefited from tailored, in-the-moment strategies and social 
support from the mHealth messages.15 Notably, whereas poverty status predicted worse cessation 
outcomes among participants receiving only in-person treatment, poverty status was unrelated to 
cessation among those receiving iQuit Mindfully. In fact, 23.1% of participants living in poverty who 
received iQuit Mindfully achieved biochemically-confirmed abstinence at end of treatment and 1-
month follow-up, while none of those living in poverty quit in the in-person-only treatment.16 Building 
on this initial work, we incorporated participant feedback to further increase interactivity and 
personalization so that iQuit Mindfully can more flexibly adapt to participants’ changing needs. We 
have also developed a version of iQuit Mindfully that can be implemented as a standalone program 
(i.e., without weekly MBAT sessions). Pending clinical trial results, iQuit Mindfully could be highly 
scalable and cost-effective as a standalone program.  
 
 

7 
 
 
 
3. STUDY DESIGN 
 
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 virtual counseling 
(Mindfulness-based Addiction Treatment; MBAT), compared to usual care. Participants will be 
randomized to one of 4 groups based on assignment to iQuit Mindfully text messages (yes/no) and 
virtual MBAT (yes/no) as shown below:  
 
Mindfulness-Based Addiction Treatment 
(MBAT; virtual group treatment) 
No 
Yes 
 
iQuit Mindfully 
(text messages) 
No 
Usual Care 
MBAT 
Yes 
iQuit Mindfully 
MBAT + iQuit Mindfully 
 
The four conditions are: 
• 
Usual Care (self-help materials + nicotine patch treatment) 
• 
MBAT (8 weekly virtual MBAT sessions + self-help materials + nicotine patch treatment) 
• 
iQuit Mindfully (iQuit Mindfully text messages + self-help materials + nicotine patch treatment) 
• 
MBAT + iQuit Mindfully (8 weekly virtual MBAT sessions + iQuit Mindfully text messages + 
self-help materials + nicotine patch 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. Assessments will 
occur at baseline and weeks 1, 3, 5, 8, 12, and 24. Primary outcomes are smoking abstinence at 8 
weeks after the start of treatment (7-day abstinence, biochemically verified by expired carbon 
monoxide <6 ppm), 12 weeks after the start of treatment (3 month follow-up; 7-day abstinence, 
biochemically verified by expired carbon monoxide <6 ppm), and 24 weeks after the start of treatment 
(6-month follow-up; 7-day abstinence, biochemically verified by saliva cotinine < 20 ng/ml). Secondary 
outcomes include frequency of home mindfulness practice and self-reported levels of mindfulness, 
emotions, craving, withdrawal, dependence, self-efficacy, and social support. 
 
 

8 
 
 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
 
Participants will include English-speaking adult smokers (ages 18 and above). Recruitment will target 
a racially/ethnically diverse sample of individuals with relatively low income levels.  
 
Inclusion criteria are:  
• 
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 are:  
• 
contraindication for nicotine patch or nicotine lozenge 
• 
active substance abuse/dependence or clinically significant depressive symptoms 
• 
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 (PI Spears 2017-2020 studies entitled “Mindfulness-based Smoking 
Cessation Treatment,” “Qualitative Study of Text Messages for Smoking Cessation,” iQuit 
iText Study: Feasibility Study of Mindfulness and Text Messaging for Quitting Smoking,” or 
“Evaluation of Mindfulness and Text Messaging for Smoking Cessation”) 
 
Recruitment and Enrollment Procedures  
Recruitment will focus on flyers; print, radio, and social media; community outreach; and partnerships 
with local healthcare systems, with targeted recruitment of low-income and racially/ethnically diverse 
smokers in Atlanta, GA. Study flyers and example social media recruitment advertisements are 
attached.  
 
Participants will be recruited through flyers (posted at local clinics/community health centers and other 
community organizations (e.g., YMCA, libraries, non-profit organizations, organizations serving the 
LGBTQ community, etc.); on and near GSU campuses; in coffee shops, restaurants, and stores 
selling tobacco products; near MARTA train/bus stops, shelters, etc.) and media (e.g., radio; print 
media in local newspapers/magazines (both online and paper versions); through GSU digital signage; 
and on MARTA buses/trains). Participants may also share flyers or the survey link with other 
individuals who are interested in participating.  
 
The research team will attend meetings sponsored by county and state health departments to speak 
with stakeholders and hand out recruitment flyers. We will give presentations, talk with staff, and 
provide flyers at local clinics and community organizations. For example, we will provide both print 
and digital flyers to contacts affiliated with Grady Hospital System; Fulton, DeKalb and other County 
Boards of Health; Atlanta-based universities; community health centers (e.g., HEALing Community 
Center, Mercy Care, etc.); primary care practices; health fairs; and other healthcare and community 
organizations. Information about the study will also be provided to the GSU community (e.g., through 
presentations and print and digital flyers).  
 
Online recruitment strategies will entail targeted ads posted on social media and internet advertising 
channels including Facebook, Google Adwords, Instagram, Reddit, YouTube, Twitter, Craigslist, 
Nextdoor, etc. Ads will be tailored according to the platform (e.g., reliance on text vs. images) and the 
target audience’s digital native lifestyle (e.g., informal vs. formal tone), to encourage high levels of 

9 
 
 
 
participation (e.g., clear calls to action). Ads will include content to appeal to a broad range of adult 
smokers who are interested in quitting. We will monitor ad performance closely and make timely 
decisions to improve content or change social media channel strategies as appropriate. Example 
recruitment images and text for social media advertisements are attached. The digital flyer will also be 
shared through GSU social media and online platforms (e.g., Craigslist, Nextdoor), with a link 
provided to the Qualtrics online screener. Individuals who are interested in the study will either call our 
research office to complete telephone screening (with verbal informed consent; see details below) or 
click on a link to be taken to an online (GSU-hosted Qualtrics) screener survey (with online informed 
consent; see details below). Individuals will also be able to share the link to the online screener with 
others who might be interested.  
 
Trialfacts will assist with the social media recruitment. Trialfacts creates compliant advertisements 
used in its social media recruitment strategy. Trialfacts creates a mobile and tablet friendly study Web 
page, which is the central destination for all interested patients. Trialfacts promotes the study to its 
database of 60,000+ volunteers interested in participating in clinical trials. Trialfacts accesses highly 
targeted patients searching online for relevant health information and treatment options through social 
media i.e. Facebook, Instagram, Youtube, Reddit, Quora, Craigslist, and Google search. Trialfacts 
creates and manages an automated pre-screening solution (online survey that asks the same 
eligibility criteria in our IRB-approved online screener). Information about those individuals who pass 
the pre-screening is sent immediately via email in a password-protected PDF and in a private referral 
spreadsheet to the study staff. Data is stored in a secure Google Drive folder (more details about 
Trialfacts privacy policy can be found here: https://trialfacts.com/privacy-policy/). Trialfacts will delete 
all information at the conclusion of recruitment at Dr. Spears’ request. Participants may also request 
that Trialfacts delete their information at any time. As with all participants who complete screening 
online, for participants are recruited through Trial Facts, GSU research staff will follow-up with a 
phone call to confirm eligibility and tell these individuals more about the study.  
 
Enrollment will be ongoing over approximately 3 years. For people who are interested in participating 
but not able to participate at the time that they initially call (e.g., if the session times do not work for 
their current schedule), the study team will ask if they would like to be contacted at a later date (within 
the next year) to see if they may be able to participate.  
 
For our previous smoking cessation study at GSU, the inclusion criteria were slightly more rigid. For 
example, interested individuals were excluded if they also used tobacco products other than 
cigarettes. Given that use of other tobacco products (e.g., cigars, little cigars, cigarillos) is common 
among low-income adult smokers, we believe it is important to include these people and help them 
quit smoking cigarettes as well as other tobacco products. Accordingly, we will contact individuals who 
expressed interest in our previous smoking cessation study and did not qualify at that time but might 
meet the current eligibility criteria. We will describe the current study and if they are interested, they 
will complete the same screening procedures as other potential participants. 
 
Randomization. Randomization will take place at the end of the baseline session, after baseline 
assessments have been administered. Stratified permutated block randomization will be implemented. 
Block randomization can achieve balance in the number of assignments to each treatment group. This 
form of randomization can be conducted within each stratum (i.e., stratified permutated block design) 
in efforts to achieve both covariate balance and treatment balance.17 Given the dangers of over-
stratification (e.g., with too many strata, there may be insufficient numbers of participants within each 
block), researchers have recommended using one or two stratification variables that are expected to 
be most strongly associated with the outcome.17 Stratification will be conducted with respect to 
race/ethnicity and poverty status, both of which are predictors of smoking cessation success.  
 
 

10 
 
 
 
5. STUDY INTERVENTIONS 
  
Nicotine Replacement Therapy (all conditions). Nicotine patch therapy for participants who 
smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 
weeks of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 
weeks of 14 mg patches and 4 weeks of 7 mg patches. Nicotine lozenge therapy for participants who 
smoke their first cigarette within 30 minutes of waking will consist of 8 weeks of 4mg mini lozenges (6-
9 4mg mini lozenges per day). Nicotine lozenge therapy for participants who smoke their first cigarette 
over 30 minutes of waking will consist of 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per 
day). 
Participants will receive 4 weeks of nicotine patches and lozenges at baseline, and they will be 
mailed the additional 4 weeks of nicotine replacement therapy when needed. Research staff will 
confirm participants’ mailing addresses with them over the phone and notify them of the mail date for 
the nicotine patches and lozenges. Patches will be mailed to participants in padded envelopes via 
certified mail with 2-day delivery. The package will include the nicotine patch instructions and a cover 
page indicating: “When you receive this, please call [Research staff telephone number] so that we can 
go over it with you.” Participants will also be told to call research staff with any side effects or 
questions.  
In the unlikely case that a woman becomes pregnant during the study (since we are now 
excluding those who plan to become pregnant), she will still have access to all of the behavioral 
treatment depending on her treatment condition (MBAT groups, text messages, self-help materials), 
but she will be referred to her healthcare provider to inquire about and potentially obtain nicotine 
replacement therapy 
 
Self-Help Materials (all conditions). All participants will be given evidence-based self-help 
materials for smoking cessation (based on the Treating Tobacco Use and Dependence Clinical 
Practice Guideline).18 Materials include the “Clearing the Air” booklet developed by the NCI and a 
referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW). Paper materials will be given at 
baseline and then reviewed in detail at treatment session 1 (with additional copies provided as 
needed). 
 
MBAT Treatment (MBAT and MBAT + iQuit Mindfully conditions). Participants in the MBAT 
and MBAT + iQuit Mindfully conditions will receive virtual group counseling based on the Mindfulness-
Based Addiction Treatment (MBAT) group protocol.19 Mr. Dannenfelser (certified mindfulness-based 
stress reduction teacher and licensed professional counselor), Dr. Swann (certified mindfulness-
based stress reduction teacher and licensed clinical social worker) and/or their trained colleagues will 
lead MBAT sessions. MBAT closely follows Mindfulness-based Cognitive Therapy (MBCT) 
procedures, but replaces the depression-related material with nicotine dependence-related material. 
MBAT consists of 8 weekly 2-hour sessions. The core aims are to: 1) become more aware of 
thoughts, feelings, and sensations from moment to moment, 2) develop a different way of relating to 
thoughts, feelings, and sensations, and 3) obtain the ability to disengage attention and choose skillful 
responses to thoughts, feelings, and situations. Participants are encouraged to choose their own quit 
date between day 7 and day 30 of the program. Sessions 1-4 concentrate on learning how to direct 
and focus attention. Participants become aware of how little attention is usually paid to activities in 
their daily life (“automatic pilot”). Next, they learn how to not only notice that the mind is wandering, 
but to bring it back to focus on the breath. Participants learn how a wandering mind can increase 
negative thoughts and feelings (e.g., fantasies about smoking can lead to feelings of anger about 
being deprived). Engaging in these thoughts can escalate to severe craving such that it becomes 
more difficult to enact purposeful, adaptive responses. By bringing attention back to the present, one 
can disengage from unhelpful thoughts and deal with the situation more flexibly (e.g., one could note 

11 
 
 
 
that craving is a sensation as opposed to an imperative and notice it nonjudgmentally until it passes, 
choose to engage in a coping behavior, or bring attention back to the breath). MBAT emphasizes daily 
practice in several forms: sitting meditation, body scan meditation, walking meditation, eating 
meditation, and gentle yoga. Each of these practices share a focus on awareness of the breath. By 
offering a menu of practices, differing preferences and learning styles can be accommodated. 
Sessions 5-8 focus on continued development of awareness of the present, along with expansion of 
techniques for dealing with thoughts, feelings, and situations.  
Zoom group sessions will be audio and video recorded. These recordings will be used to assess 
treatment fidelity. Also, if a group member is unable to attend a session they may make it up by 
watching the video recording. They will only be able to do this by making an appointment with study 
staff, who will play the recording while on Zoom with the participant. 
 
iQuit Mindfully Text Messages (iQuit Mindfully and MBAT + iQuit Mindfully conditions).  
Participants the iQuit Mindfully and MBAT + iQuit Mindfully conditions will receive text messages 
throughout the 8-week treatment period, as well as less frequent messages during the follow-up 
period depending on participant preferences. Upland Mobile Commons, a service that supports the 
development and implementation of automated SMS applications, will be used to build the automated 
text message system and send and receive the text messages. iQuit Mindfully text messages were 
designed to encourage participants to practice mindfulness (e.g., reminders for informal practice, such 
as awareness of the breath throughout the day, and reminders for formal practice such as the body 
scan and sitting meditation). They also remind participants to use specific strategies to aid in 
cessation (e.g., removing cues to smoke, reaching out for social support, and trying other coping 
techniques from the MBAT protocol 19). The messages are designed to be interactive. That is, 
participants are asked questions through a series of flow logic (e.g., “Would you like to practice 
mindfulness right now?”; if participant replies yes, they are then provided a mindfulness technique; 
later asked about how it went; and provided encouragement for continued practice). Participants can 
also text CRAVE, STRESS, SLIP, or FACT at any point to receive additional text message support for 
coping with cravings, stress, smoking lapses, or to receive facts about the effects of smoking, 
respectively. Participants can also answer “group poll” questions so that they later receive a text with 
the most common responses (without any identifying information). Text messages include quotes 
sharing the experiences of former smokers in our program. These messages are all anonymous and 
described as being from either “Mike” or “Kim,” depending on the participant’s preference. Participants 
can also text keywords (MIND, BODY, 3MIN) to receive a phone call with a short recording of a 
mindfulness practice after receiving a prompting text message. Participants will be given small pocket 
cards with basic information on the text messaging program and reminders about the text keywords. 
Messages are personalized based on first names, personal reasons for quitting, and amount of 
money to be saved based on individual smoking habits and price paid per pack. Texts are also 
tailored based on responses to text questions (e.g., whether or not they have smoked or practiced 
mindfulness). Texts include messages timed around major holidays and personalized messages on 
participants’ birthdays. Picture messages are included based on our initial qualitative work. Our 
previously developed program sent 2-3 messages per day during Week 1, 3-4/day during Week 2, 4-
5/day during Week 3, 5-7/day during Week 4, 6-7/day during Week 5, 4/day during Week 6, and 3-
4/day during Week 7 (See Appendix for example text messages and Spears et al. 201920 for details 
on the pilot study). Based on feedback from our previous message testing, message timing and 
frequency is more flexible and personalized for the current project. This study offers participants the 
option to be included in the frequency of their choice (e.g.: very low, low, medium, high, very high) as 
well as a 12-hour time slot of their choice (e.g.: 7am-7pm or 10am-10pm). Text messages will 
periodically ask participants about their preferred text message frequency and timing so that 
participants can change their message schedule as needed.  

12 
 
 
 
Financial Compensation and Retention Procedures. Participants receive financial 
compensation for the time and inconvenience associated with participation, as well as parking 
validation/MARTA vouchers to defray the cost of travel. Participants will be compensated up to $30 for 
assessments during weeks 1, 3, and 5, for a total of $90. (Specifically, for each of the week 1, 3 and 5 
assessments, which take place online, participants will be compensated $25 for doing the survey and 
a $5 bonus if they do it within 24 hours). Participants will be compensated $40 for the assessment 
completed at week 8 (this is an in-person visit). Participants will be compensated $60 for the first post-
treatment follow-up assessment at week 12 and $70 for the second post-treatment follow-up 
assessment at week 24 (both follow-up visits are in-person visits). Participants will also be 
compensated $5 per survey for the every other day surveys, for a total of $120 for all 6 weeks. 
Maximum compensation per person for completing all aspects of the study is $380. 
 
Other procedures to increase adherence include: 1) reminder phone calls, emails and text 
messages (including checking in with participants between baseline and start of treatment, during 
treatment and during follow-up period as well as messages timed on participants’ birthdays and major 
holidays), 2) requiring a phone number and valid home address so that participants can be contacted, 
and 3) obtaining names, addresses, and phone numbers of up to three collaterals who can provide 
information on participants’ whereabouts if necessary. Written permission to contact the collaterals will 
be obtained from participants during the baseline session.  
 
Participants who do not complete assessments or attend in-person visits will be contacted via 
phone, email, text message, and/or mail to reschedule or (if not able to reschedule) provide self-
reported smoking status and feedback about the program/reasons for discontinuation. These 
individuals will also be emailed a link to the REDCap survey assessment.   
 
   6. STUDY PROCEDURES  
6.1 
Schedule of Treatment Procedures and Evaluations 
 
 
 
Weeks  
 
 
Phone/
Online 
Screen 
Base-
line 
1 
Start of 
Tx 
2 
3 
4 
 
5 
6 
7 
8 
End of 
Tx 
12 (3 
Month 
Follow-
Up) 
24 (6 
Month 
Follow-
Up) 
Telephone/Online Screening 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Compensation 
 
 
$30 
 
$30 
 
 
$30 
 
 
$40 
$60 
$70 
Electronic Diary Assessments 
 
Every other day surveys from week 2 to week 8; $5 per survey for up to $120 total 
 
 
TREATMENT PROCEDURES 
 
 
 
 
 
 
 
 
 
 
 
 
 
Virtual MBAT groups (MBAT & 
MBAT + iQuit Mindfully conditions) 
 
 
Tx 1 
Tx 2 
Tx 3 
Tx 4 
 
Tx 5 
Tx 6 
Tx 7 
Tx 8 
 
 
iQuit Mindfully text messages 
(iQuit Mindfully & MBAT + iQuit 
Mindfully conditions) 
 
Text messages based upon participants’ choice  
in frequency and timing of messages 
 
 
Self-Help Materials (all conditions) 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
Nicotine Replacement Therapy 
Dispensation (all) 
 
 
Participants receive 4 weeks of patches and lozenges in person at baseline, 
and then the remaining 4 weeks of patches are mailed.  
 
 
IN-PERSON ELIGIBILITY 
 
 
 
 
 
 
 
 
 
 
 
 
 
Carbon Monoxide 
 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
Cotinine (Saliva Sample) 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Screening for Depression and 
Substance Dependence 
 
X 
 
 
 
 
 
 
 
 
 
 
 
SMOKING  
 
 
 
 
 
 
 
 
 
 
 
 
 
Information for Setting Up Text 
Messages 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Tobacco History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Smoking Status, use of other 
tobacco products, electronic vapor 
products, NRT, pharmacotherapy 
 
X 
X 
 
X 
 
 
X 
 
 
X 
X 
X 

13 
 
 
 
 
Phone/
Online 
Screen 
Base-
line 
1 
Start of 
Tx 
2 
3 
4 
 
5 
6 
7 
8 
End of 
Tx 
12 (3 
Month 
Follow-
Up) 
24 (6 
Month 
Follow-
Up) 
Additional Resources Used for 
Smoking Cessation 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
Wisconsin Inventory of Smoking 
Dependence Motives (WISDM) 
 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
Wisconsin Smoking Withdrawal 
Scale (WSWS) 
 
 
X 
 
X 
 
 
X 
 
 
X 
X 
X 
Self-Efficacy Scale 
 
X 
X 
 
X 
 
 
X 
 
 
X 
X 
X 
MINDFULNESS 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mindfulness Attention Awareness 
Scale (MAAS) 
 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
Five Facet Mindfulness 
Questionnaire (FFMQ short form) 
 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
Mindfulness Practice Frequency 
 
 
 
 
X 
 
 
X 
 
 
X 
X 
X 
Self-Compassion Scale (short 
form) 
 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
STRESS/ NEGATIVE AFFECT 
 
 
 
 
 
 
 
 
 
 
 
 
 
Perceived Stress Scale 
 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
Positive and Negative Affect Scale 
 
X 
X 
 
X 
 
 
X 
 
 
X 
X 
X 
Experiences with Discrimination  
 
X 
 
 
 
 
 
 
 
 
 
 
 
SOCIAL SUPPORT 
 
 
 
 
 
 
 
 
 
 
 
 
 
Multidimensional Scale of 
Perceived Social Support 
 
 
X 
 
 
 
 
 
 
 
X 
X 
X 
Group Climate Questionnaire 
(MBAT & MBAT + iQuit Mindfully) 
 
 
 
 
 
 
 
 
 
 
X 
 
 
PROGRAM EVALUATION 
 
 
 
 
 
 
 
 
 
 
 
 
 
Text Message Feedback 
 
 
 
 
X  
 
 
X  
 
 
 
X 
X 
Perceived Benefits 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
Program Evaluation Questionnaire 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
6.2 
Description of Evaluations  
 
Screening Evaluation and Consenting Procedure 
 
Telephone Screening. Interested individuals who prefer to complete initial screening by telephone 
will be given a detailed description of the study over the phone. The voluntary nature of the study will 
be emphasized, and it will be made clear that if they decide not to participate, there will be no 
repercussions. Research staff will read the telephone consent form to potential participants and 
answer any questions. After provision of verbal informed consent (a Waiver of Documentation of 
Consent has been included in the GSU IRB protocol), the research staff member will document verbal 
consent and sign and date the consent form through REDCap. Potential participants will then be 
screened for inclusion/exclusion and answer questions about demographic information (to be 
documented through Qualtrics as noted below). Eligible individuals who are interested in participating 
will be scheduled for an initial in-person session. Participants will receive a reminder telephone call, 
text, and/or email on the day before their scheduled session. 
 
Online Screening. Individuals who click on the study link through an advertisement or digital flyer will 
be taken to an online (GSU-hosted Qualtrics) screener survey. Before beginning the survey, 
participants will be given information about the study, including the voluntary nature of the study, 
through an online informed consent form. After providing consent, participants can complete the 
survey online. Data collected via this screener survey will be encrypted with access limited to select 
study personnel. Eligible individuals who are interested in participating will provide their contact 
information in order for research staff to contact them by phone to confirm eligibility and answer any 

14 
 
 
 
questions. Eligible individuals who are interested in participating will then be scheduled for an initial in-
person session. Participants will receive a reminder telephone call, text, and/or email on the day 
before their scheduled session. Qualtrics includes survey protection features to prevent people from 
taking an online survey more than once. If it appears that an individual has attempted more than one 
screening method (e.g., telephone and online), research staff will call the person again to confirm 
eligibility and resolve any inconsistencies if needed.  
 
In-Person Baseline Visit and Consent Procedure. Following the telephone or online screener, 
interested individuals will attend an in-person session to finalize eligibility, engage in further 
discussion about the study, and provide written informed consent.  
 
Before in-person assessment of eligibility criteria, participants will review the consent form for in-
person screening. Study personnel will offer an opportunity for participants to ask questions and have 
them answered, the consent form for in-person screening will be signed and dated by the participant 
and staff member, and a copy of this form will be given to the participants. Then, in order to confirm 
eligibility, participants will provide a breath sample for assessment of expired carbon monoxide. 
Health literacy will be assessed with the Rapid Estimate of Adult Literacy in Medicine (REALM21), and 
for the proposed study participants who have at least a sixth-grade level will be eligible. Individuals 
who decline or are ineligible will be given self-help materials and referral to other cessation programs. 
In addition, potential participants will complete the Patient Health Questionnaire-2 PHQ-2; 22,23 and 
Severity of Dependence Scale (SDS24) in order to screen for clinically significant depressive 
symptoms and substance dependence, respectively. Individuals who are not eligible for these reasons 
will be provided with appropriate mental health referrals in addition to smoking cessation referrals.  
 
Next, the research staff will engage eligible individuals in a discussion of pros and cons of 
participating, as well as participants’ ambivalence about behavior change and research participation 
(these methods have been suggested to improve retention25). 
 
For eligible individuals who are interested in participating, study personnel will initiate the informed 
consent process which will include: 1) A thorough review of the Informed Consent Form (ICF; see 
Appendix), particularly study procedures; 2) Study personnel will offer an opportunity for participants 
to ask questions and have them answered; 3) The ICF will be signed and dated by the participant and 
staff member; and 4) A copy of the ICF will be given to the participants. 
 
Participants will be given the choice of using their own tablet or laptop computer or one provided by 
the study. For participants in MBAT and MBAT + iQuit Mindfully conditions, study personnel will 
explain the requirements for joining the treatment session via the video conferencing program, Zoom. 
Research staff will conduct separate sessions with participants to ensure they can access Zoom. 
 
Participants who choose to use the basic tablet provided by the study will include those who: 
 
-do not own a tablet or other device with a web camera, 
 
-do not have access to consistent wireless internet needed to join virtual group sessions, or 
 
-prefer to use a study tablet 
 
Participants will be given the choice of using their own mobile phone or one provided by the study. For 
participants in the iQuit Mindfully and MBAT + iQuit Mindfully conditions, study personnel will explain 
the text messaging procedures in detail and send a test message to the participant, who will respond 
and ask any questions. 
 
Participants who choose to use the basic cellphone provided by the study will include those who: 
 
-do not own a wireless cellphone, 

15 
 
 
 
-do not own a wireless cellphone that can receive and send phone calls, SMS and MMS 
messages, 
  
-prefer to use a study phone, or 
 
-do not have consistent phone service with a working number 
 
These participants will have the option of borrowing a study device for the duration of the study. The 
research team will explain to participants that all wireless devices must be returned. Mobile phones 
must be returned by the final week 24 assessment, and tablets must be returned at the week 8 
assessment. Wireless devices that are borrowed will be wiped upon returning them to the research 
team. All sim-cards will be wiped clean. New sim-cards will be used for each participant requesting a 
phone. All data collected via text message will be stored either on the Mobile Commons platform or 
the REDCap platform. No data will be saved to the device. For text messages and all other data 
remaining on the study devices when they are turned in from participants, the research team will wipe 
and reset the device. 
 
Individuals who would like to participate and express informed consent will then be asked to complete 
questionnaires (see Appendix). Questionnaires will be administered through REDCap, to be taken 
either in-person at GSU (baseline and weeks 8, 12, and 24) or off site (REDCap links to be 
emailed/texted when participants do not come to GSU in person). See Table 6.1 for schedule of 
questionnaire assessments. Descriptions of the assessments are provided below: 
 
• 
The Telephone Screening assesses eligibility criteria and demographic characteristics, 
including age, race, ethnicity, education, employment, and income.  
• 
The Patient Health Questionnaire-2 PHQ-2; 22,23 is a 2-item questionnaire designed to screen 
for symptoms of depression. Participants are asked, “Over the last 2 weeks, how often have 
you been bothered by the following problems?”: “feeling down, depressed or hopeless” and 
“little interest or pleasure in doing things.” These items which correspond to the two core 
diagnostic criteria for Major Depressive Disorder; 26 are rated on a 0-3 scale (0 = not at all, 3 = 
nearly every day). Individuals with scores of 3 or above which has been identified as the cut-
off for obtaining optimal sensitivity and specificity for identifying depressive disorders; 22,23 will 
not be eligible but will be provided with appropriate mental health referrals.  
• 
The Severity of Dependence Scale (SDS) is a 5-item questionnaire that measures the extent 
of psychological dependence on illicit drugs in the past 12 months.24 The scale has been 
validated for several illicit drugs including cannabis, cocaine, amphetamines, benzodiazepines, 
and heroin. Each of the five items is scored on a 4-point scale ranging from 0 (Never/Almost 
Never) to 3 (Always/Nearly Always) and summed for a total score. Individuals with scores of 4 
or higher27,28 will not be eligible but will be provided with appropriate mental health referrals. 
 
• 
The Information for Setting Up Text Messages questions assess participants’ amount of 
money spent on cigarettes, personal reasons for quitting, preferences about timing and 
frequency of text messages, and quit date. This information is incorporated into iQuit Mindfully 
to personalize the content, frequency and timing of text messages.  
• 
Tobacco History assesses onset of regular smoking, previous quit attempts, abstinence 
history, smoking rate, and partner smoking status. This includes the Heaviness of Smoking 
Index comprises two items from the Fagerström Test for Nicotine Dependence (FTND) 29: self-
reported average number of cigarettes smoked per day and time to first cigarette upon waking 
(“time to first cigarette”). The HSI is a strong indicator of nicotine dependence 30. 
• 
Smoking Status (SRNT) surveys tobacco use, use of other tobacco products, and nicotine 
replacement medications. Smoking Abstinence will be assessed according to the SRNT 
guidelines 31, which suggest reporting point prevalence abstinence (i.e., no smoking during 

16 
 
 
 
past week), continuous abstinence (i.e., no smoking since quit date), and time to relapse (i.e., 
any tobacco use over 7 consecutive days or 2 consecutive weeks). All self-reported 
abstinence will be biochemically confirmed by CO<6ppm. Use of novel tobacco products (e.g., 
e-cigarettes and heated tobacco products) will also be assessed. Participants will also indicate 
which forms of nicotine replacement therapy and/or pharmacotherapy (if any) they used in the 
past week.   
• 
Additional resources used for smoking cessation will ask participants about various strategies 
for quitting smoking (e.g., acupuncture, hypnosis, other text messaging programs or mobile 
apps). This will allow the researchers to capture resources participants might be using to help 
them quit smoking apart from what they receive in the study.  
• 
The Brief Wisconsin Dependence Motives Questionnaire32 is a 37-item measures that yields 
an overall dependence score and subscale scores for other dimensions (i.e., cognitive 
enhancement, affective enhancement, automaticity, affiliative attachment, loss of control, 
craving, cue exposure/associative processes, social/environmental goals, taste/sensory 
processes, weight control, tolerance). 
• 
The Wisconsin Smoking Withdrawal Scale 33 includes subscales for anger, anxiety, sadness, 
concentration difficulty, craving, hunger, and sleep. All subscales have excellent internal 
consistency and validity.34  
• 
The Self-Efficacy Scale assesses confidence for resisting smoking urges in specific types of 
situations (e.g., when feeling stressed, when with friends) 35 Subscales include negative affect, 
pleasure, social image, social influence, and diet. Scores are predictive of relapse.36 
• 
The Mindful Attention Awareness Scale MAAS; 37 is a 15-item self-report measure of 
dispositional mindfulness that has shown good reliability and validity.37 
• 
The Five-Facet Mindfulness Questionnaire-Short Form38 is a 24-item self-report questionnaire 
of facets of dispositional mindfulness. The scale yields five factors: 1) Nonreactivity, 2) 
Observing, 3) Acting with Awareness, 4) Describing/Labeling with Words, and 5) Nonjudging 
of Experience, with strong psychometric properties.  
• 
The Self-Compassion Scale Short Form45 is a 12-item self-report measure of self-compassion. 
Subscales include self-kindness, self-judgement, common humanity, isolation, mindfulness, 
and over-identification.45 
• 
Participants will fill out a Mindfulness Practice Log12 to indicate how frequently they practice 
each of the mindfulness techniques taught in treatment.  
• 
The Perceived Stress Scale39 is a 10-item self-report measure of the extent to which 
individuals view their lives as stressful. The scale shows good psychometric properties.  
• 
The Positive and Negative Affect Schedule (PANAS 40) is a 20-item self-report measure of 
affective experience yielding two factors (Positive and Negative Affect) with strong 
psychometric properties 40. 
• 
The Multidimensional Scale of Perceived Social Support41 is a 12-item scale, with subscales 
assessing perceived social support from family, friends, and significant others.  
• 
The Group Climate Questionnaire (GCQ-S)48 is a 12-item self-report scale which measures 
climate and cohesion of the group (only applicable for MBAT participants). Sub-scales include 
engaged, conflict, and avoiding.48 
• 
Participants will be asked to provide feedback about their experiences receiving the text 
messages (Text Message Feedback). 

17 
 
 
 
• 
Participants will complete 4 items to indicate perceived benefits of the quit smoking program. 
As described by Hoeppner et al. (2017),42 participants rate the extent to which the program 
gave them confidence to quit smoking, made them think that it was worthwhile to quit, made 
them feel that someone cared if they quit, and made them feel that they knew the right steps to 
take to quit. Items are rated from 1 (completely disagree) to 5 (completely agree). 
• 
Participants will complete Program Evaluations to provide for their feedback about and 
suggestions for improving the intervention (both MBAT and iQuit Mindfully text messages). 
Usual care participants will answer 1 program evaluation question: “On the scale below, 
please circle the number that best represents whether you would recommend this quit 
smoking program (or something similar) for others who are interested in quitting smoking.” 
(rated on 1-10 scale).  
The maximum time between telephone screening and enrollment will be 1 month. The maximum time 
between baseline assessment and start of treatment will be 1 month. However, we will employ a 
variety of strategies to ensure that these timeframes are as short as possible. For example, in order to 
reduce the time between telephone screening and baseline we will offer a variety of days and times 
for baseline assessment. We will also time our recruitment efforts around planned baseline 
assessments to maximize potential participants’ interest (in order to prevent longer wait time to accrue 
a sufficient number of participants to start a group). 
 
Electronic Diary Assessments. Electronic Diary Assessments (also referred to as short-surveys) will 
be administered in the evening on every other day from Week 2 to Week 8, thus capturing key 
processes surrounding quitting smoking. Diary assessments will assess smoking behavior (“How 
many cigarettes did you smoke today?”) and each of the hypothesized mechanisms (mindfulness, 
emotions, craving and withdrawal, self-efficacy, and social support). Participants will also indicate their 
mindfulness practice that day (See Appendix). Participants will receive an email and/or text with the 
REDCap link to the electronic diary assessment survey. Both participant-initiated options allow 
respondents to complete assessments at a time that is convenient to them between that evening and 
the next morning (by 9am). 
 
Saliva Samples for Cotinine Analysis. At the last study visit (approximately 24 weeks after the start 
of treatment), participants will provide a saliva sample by placing an oral swab under their tongue for 
1-2 minutes (Salimetrics; https://www.salimetrics.com/collection-method/oral-swab-saliva-collection-
device/). Per Salimetrics instructions, consumption of alcohol, caffeine, nicotine and prescription/over-
the-counter medications within the past 12 hours, as well as presence of oral diseases or injury, will 
be documented. Participants will rinse their mouth with water to remove any food residue and wait at 
least 10 minutes after rinsing before collecting saliva. The saliva sample will then be stored in a 
locked freezer situated in a locked room in the GSU Urban Life Building, only coded with an ID 
number and no personally identifying information. Swabs will be mailed to the Salimetrics lab for 
cotinine analysis, and the Salimetrics lab will discard the saliva after 1 year. Self-reported 7-day 
abstinence will be confirmed by saliva cotinine <20 ng/ml.12,43 Use of NRT and other nicotine-
containing products (e.g., e-cigarettes) will be assessed to ensure that saliva cotinine levels are not 
affected by non-combusted nicotine products. Participants who do not attend the in-person 24-week 
assessment visit will be asked to provide a saliva cotinine sample via mail. 
 
*Procedures for Participant and Research Team Safety in the Context of the COVID-19 
Pandemic  
The current study design involves in-person sessions at GSU. During the COVID-19 pandemic, in-
person procedures will follow the Georgia State Standard Public Health Precautions for On-Campus 
Visits Related to Human Subjects Research. For example: 

18 
 
 
 
• 
Pre-visit phone screening and arrival phone screening will be conducted to inquire about 
possible COVID-19 symptoms and exposure.  
• 
Visitors cleared for study visits will be advised that they must wear face mask coverage while 
on campus. Research staff will also wear masks.  
• 
Signage to encourage hand hygiene, respiratory hygiene, cough etiquette, and social 
distancing will be posted in and around the Waiting Area and Research Space. 
• 
All visitors will be directed to wash hands or use hand sanitizer upon entry to Waiting 
Area/Research Space. Hand sanitizer will be provided.  
• 
Researchers will wash hands or use hand sanitizer prior to and after each participant visit. 
• 
Frequently touched surfaces will be cleaned and disinfected before and after study visits.  
• 
Chairs will be placed at least 6 feet apart to maintain social distance.  
• 
The research space will be regularly cleaned by Facilities Management. 
It is possible that people who smoke cigarettes may be at higher risk for COVID-19 
(https://www.who.int/news-room/commentaries/detail/smoking-and-covid-19). Accordingly, the 
following additional measures are proposed during the COVID-19 pandemic: 
• 
The research team will provide a new disposable mask and pair of gloves to each participant 
for each in-person visit. After that, treatment groups will be held virtually using a video 
conferencing program, Zoom. Since some participants may not have the appropriate space or 
technology to join virtually, the research team will give them the option to borrow a tablet study 
device for 8 weeks. 
• 
If participants do not have access to a private or quiet place to join the weekly group session, 
they can come to campus and join in a separate room at GSU. They will still be able to use a 
GSU computer with internet and camera to join the live group sessions. 
• 
Participating in a video conference session presents no more than minimal risk of harm to 
subjects. The purpose of the video conference is to be able to continue providing the quit 
smoking group to participants while minimizing the risk of exposure to COVID-19 through 
elimination of in-person group sessions. 
*Strategies for Promoting Engagement with Virtual Group Sessions: 
We will use the following strategies to promote engagement: 
• 
Participants in MBAT and MBAT + iQuit will be able to borrow a study tablet for the 8 weeks of 
the program. This will ensure all participants have equal access to join sessions through the 
video conferencing software, Zoom.  
• 
Participants will attend an in-person baseline session at GSU, where research staff will help 
them set up Zoom, practice using Zoom, and troubleshoot any issues. Participants will be 
given a packet of Zoom instructions/tips to take with them. For those who will be joining virtual 
sessions from home, study staff will discuss ways to ensure that they have a quiet, private 
location as best as possible. They will also be encouraged to use a virtual background for 
privacy, and study staff will help them set this up.   
• 
Participants will be given the option to join virtual groups in an individual room at GSU. In our 
pilot study virtual sessions, some participants did not have a private place to join. Being able to 
use a tablet in a private room at GSU would provide a solution.  
• 
MBAT participants will attend a group Zoom orientation within two weeks before the first 
treatment session. This will give them a chance to meet each other, practice using Zoom 
together (e.g., muting/unmuting, turning camera on and off), and ask questions of the study 
staff.  

19 
 
 
 
• 
When participants connect to Zoom, study staff will admit them individually into a separate 
breakout room to ensure that they are in a private location and troubleshoot any issues.  
• 
We will encourage participants to join Zoom sessions a few minutes early so that they have a 
chance to get to know their fellow group members better.  
• 
Both mindfulness instructors (certified Mindfulness-Based Stress Reduction teachers through 
the University of Massachusetts Medical School) have experience leading online mindfulness 
groups through Zoom and will draw on their past experience. For example, they will encourage 
participants to stay unmuted during discussion to facilitate natural conversation (unless there 
is excessive background noise); mute participants during mindfulness practices; and provide 
brief breaks.  
 
*GSU continues to update guidelines for on-campus research. We will follow updated guidelines as 
they become available. 
 
7. SAFETY ASSESSMENTS  
 
Reporting of Adverse Events and Serious Adverse Events  
 
An adverse event (AE) is defined as any unfavorable and unintended diagnosis, symptom, sign, 
syndrome or disease which either occurs during the study, having been absent at baseline, or if 
present at baseline, appears to worsen. Adverse events are to be recorded regardless of their 
relationship to the study intervention.   
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that results in death, 
is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results 
in persistent or significant disability/incapacity, or is a congenital anomaly. 
 
Dr. Spears will conduct daily oversight of participant safety, and will meet regularly with staff to review 
progress and discuss any problems or concerns. Adverse events that are not deemed “serious 
adverse events” will be included in the final report to the investigators, IRB, and NCI.  
SAEs that are unanticipated, serious, and possibly related to the study intervention will be reported to 
the IRB and NCI in accordance with requirements. Georgia State University defines an unanticipated 
event as an event that was (1) unforeseen; (2) more likely than not related to the research; and (3) 
either caused harm to participants or others, or placed them at increased risk of harm. Unanticipated 
events include any harm or injury (physical, psychological, social or economic) or other unexpected 
events occurring during the course of participation in a research study. As required by the GSU IRB, 
Dr. Spears will report a summary of each unanticipated event to the IRB using the IRB Unanticipated 
Event form within 7 business days.  
Unexpected fatal or life-threatening SAEs related to the intervention will also be reported to the NCI 
Program Officer and investigators within 7 days. Other serious and unexpected AEs related to the 
intervention will be reported to the NCI Program Official within 15 days. Anticipated or unrelated SAEs 
will be handled in a less urgent manner but will be reported to the IRB and NCI.  
 
8. INTERVENTION DISCONTINUATION  
 
This study will be stopped prior to its completion if: (1) the intervention is associated with adverse 
effects that call into question the safety of the intervention; (2) any new information becomes available 
during the trial that necessitates stopping the trial; or (3) other situations occur that might warrant 
stopping the trial. 

20 
 
 
 
 
 

21 
 
 
 
9. STATISTICAL CONSIDERATIONS AND DATA ANALYSES 
 
We will conduct both intent-to-treat (ITT) and per protocol analyses. ITT includes all participants 
that were randomized, regardless of compliance, withdrawal, and other events after randomization. A 
strength of ITT is that it is based on original randomization. However, effect estimation using ITT may 
be conservative and misleading with increasing attrition. Per protocol analysis considers only 
participants who fully complied and completed the study. Per protocol is less conservative and may 
reflect true treatment differences for those with full compliance. Including both approaches will provide 
a more complete understanding of treatment effects.  
Analyses will be performed using SAS. Descriptive statistics for all measurements will be reported. 
Frequency distributions will be created to screen for any coding or entry errors. Frequency 
distributions summarize categorical data, and measures of central tendency and dispersion will 
summarize continuous data. All data will be examined for bivariate relationships with the outcomes 
and with each other. All analyses will control for demographics (age, gender, race/ethnicity, education 
level, partner status) and baseline nicotine dependence (cigarettes per day and time to first cigarette). 
The overall study level of significance will be α=.05. 
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 virtual 
counseling.  
 The relationship between treatment condition and each dichotomous study outcome (smoking 
cessation, lapse recovery) will be assessed with a generalized linear mixed model (GzLMM) with a 
Binomial distribution and logit link function. This is an appropriate statistical model with repeated 
measures data collected over time.44 A 2-level multilevel GzLMM will be specified, with time nested 
within subject. This approach will properly account for the multilevel data structure. Fixed effects 
considered in each model will include demographics, baseline nicotine dependence, treatment 
condition and time as main effects, and a treatment condition by time interaction. Testing of 
covariance structure will be conducted, and information criteria will be used to assess model fit and 
selection. Linear contrasts will be built into the analysis to estimate specific comparative effects of all 
treatment conditions. To test treatment effects on primary smoking cessation outcomes, repeated 
measures outcomes will be biochemically-confirmed 7-day point prevalence abstinence at weeks 8, 
12, and 24. To test treatment effects on lapse recovery, this analysis will also be conducted among 
participants classified as smoking at the last treatment session.12 In addition, gender and 
race/ethnicity will be assessed as potential moderators of treatment effects. 
The moderating effect of poverty status will be examined with the addition of a poverty status by 
treatment condition interaction into the models described in 1a). This will be tested using both 
dichotomous (i.e., below vs. at or above federal poverty threshold) and continuous poverty status 
variables (i.e., depth of poverty as indicated by income-to-poverty ratio and income deficit/surplus) 
according to U.S. Census guidelines.45,46 
Aim II. Investigate the mechanisms through which mindfulness training impacts smoking 
cessation.  
Hypotheses regarding mechanisms will be tested with both traditional questionnaire data (collected 
from baseline through 24 weeks after the start of treatment) and electronic diary data (collected for 6 
continuous weeks during treatment), separately. Mediation testing will be conducted regardless of 
statistical significance of intervention effects because of statistical, conceptual, and practical reasons 
for testing mediation in such cases.47 Volatility will be calculated using the mean square successive 

22 
 
 
 
difference (MSSD;48 average of the squared difference between successive observations at times i + 
1 and i) to capture both within-person variability and temporal instability. Mediation will be examined 
with multilevel mediation analyses for binary outcomes in the developed GzLMM. Bootstrapping with 
5000 replications will be used to estimate standard errors and p-values for indirect effects. In addition 
to mediators of associations between treatment and abstinence outcomes, we will test more fine-
grained day-to-day associations using electronic daily diaries.  
We will test moderated mediation using a model proposed by Preacher, Rucker, and Hayes49 that 
fits the hypothesized model (Figure 3), as the independent variable (mindfulness training) also 
functions as a moderator. Kline50 termed this “second-stage moderation,” as the second path of the 
indirect effect of the predictor on the dependent variable depends on the moderator. Conditional 
mediation and moderation effects will be tested using bootstrapping methods.49 GzLMM provides an 
ideal method for assessing the proximal relation between negative affect/craving at a given 
assessment and smoking at the next assessment (using both questionnaire and daily diary data). For 
example, using daily diary assessments, we will examine whether the association between negative 
affect on a given day and next-day smoking is weaker among MBAT vs. UC participants.  
Missing Data. Although there is no complete, comprehensive method for handling missing data 
for generalized linear mixed models, there are several different approaches that we can draw upon to 
address this issue.44  We will use multiple imputation of missing data whereby missing observations 
for individuals are estimated based on baseline responses and other study covariates, and perform 
additional sensitivity analyses regarding various missing data assumptions for smoking outcomes.51  
 
Power and Sample Size Determination. Sample size was estimated based on the number of 
participants needed to detect meaningful treatment effects of the iQuit Mindfully and MBAT 
interventions. We obtained effect sizes (converted to Cohen’s d for comparability across measures) 
from relevant meta-analyses and used the Optimal Design program to estimate sample size for 
GzLMM models.52 Smoking abstinence in MBIs vs. UC was quantified as d=0.35 in a meta-analysis,53 
and a Cochrane review of primarily text messaging-based interventions for smoking cessation54 
concluded an effect size of d=0.33. Assuming 80% power, level of significance of .05, two-tailed 
statistical tests, error variance of 1.0, coefficient variance of 2.0, and oversampling to account for 20% 
attrition, this results in 145 participants in each treatment group. An unequal allocation ratio was used 
to allocate fewer participants to usual care (n=50),55,56 for an overall sample size of 485 participants 
(145 per treatment group and 50 in usual care). We expect this sample size to adequately allow for 
mediational testing (Aim 2) at the 80% power level. Fritz and MacKinnon57 offer a guide regarding 
sample size required to detect mediated effects and report that 79.9% of studies in their literature 
review applied mediational testing with less than 400 subjects, suggesting our study plan with 485 
subjects will be ample for achieving all study aims. 
 
 

23 
 
 
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
 
During this study, psychosocial assessments and biochemical confirmation of smoking will be 
conducted at baseline and at regular intervals. All of the materials collected are for research purposes 
only, and data will be kept in strict confidence. Confidentiality will be ensured by use of identification 
codes. All data will be identified with a randomly generated identification code unique to the 
participant. The master list containing participant numbers and participants’ names will be kept in a 
locked file, accessible to study staff only. Although participants will sign informed consent documents, 
these forms will be kept in a separate locked file and will never be connected to the study data. No 
names will ever be recorded on the questionnaires, which will be stored in a locked file cabinet and 
available only to the research personnel.   
The online screener will be conducted using the GSU-hosted Qualtrics platform. The qualtricsxm 
Security Statement (January 31, 2020) reads: “Qualtrics’ most important concern is the protection and 
reliability of customer data. Our servers are protected by high-end firewall systems and scans are 
performed regularly to ensure that any vulnerabilities are quickly found and patched. Application 
penetration tests are performed annually by an independent third-party. All services have quick 
failover points and redundant hardware, with backups performed daily. Access to systems is restricted 
to specific individuals who have a need-to-know such information and who are bound by 
confidentiality obligations. Access is monitored and audited for compliance. Qualtrics uses Transport 
Layer Security (TLS) encryption (also known as HTTPS) for all transmitted data. Surveys may be 
protected with passwords. Our services are hosted by trusted data centers that are independently 
audited using the industry standard SSAE-18 method.” 
Questionnaire data will be collected using the REDCap (Research Electronic Data Capture) system 
available at Georgia State University. This will provide a secure way to collect and manage data, while 
avoiding potential issues with manual data entry. Georgia State University belongs to a consortium of 
institutional partners that work to maintain a software toolset and workflow methodology for electronic 
collection and management of research data. REDCap data collection projects rely on a study-specific 
data dictionary defined by the research team. REDCap also contains a Survey tool for building and 
managing online surveys. The research team can create and design surveys in a web browser and 
engage potential respondents using a variety of notification methods. Both REDCap and REDCap 
Survey systems provide secure, web-based applications that are flexible enough to be used for a 
variety of types of research, provide an intuitive interface for users to enter data and have real time 
validation rules (with automated data type and range checks) at the time of entry. These systems offer 
easy data manipulation with audit trails and reporting for monitoring, reporting, and querying patient 
records, and an automated export mechanism to common statistical packages (SPSS, SAS, Stata, 
R/S-Plus). REDCap application is securely housed in Amazon AWS and managed by the Research 
Solutions department at Georgia State University. All web-based information transmission is 
encrypted and the data is encrypted at rest. Amazon AWS’s data centers are state of the art 
nondescript and secured facilities. Data will be downloaded from REDCap into a secure server that is 
managed by Georgia State University, password-protected, and available only to research personnel 
who have completed training in research with human subjects. 
Additional safeguards will include appropriate password protection and physical security for all 
computer systems and physical data. Personal names will not be stored in electronic data files. 
Physical data will be stored in a locked file cabinet and available only to the research personnel. The 
master list containing participant numbers and participants’ names will be kept in a separate locked 
file, also accessible to study staff only.    
The Mobile Commons platform maintains a high level of security control for sending and receiving text 
messages. The Mobile Commons HIPAA and Text Messaging Security White Paper indicates: “All 

24 
 
 
 
Mobile Commons systems that transmit or store sensitive client information are housed in a secure 
data center facility that maintains a high standard of physical security controls…. The Mobile 
Commons information security program includes comprehensive technical security measures geared 
towards protecting the confidentiality, integrity, and availability of sensitive client data…. 
Authentication controls are in place for access to all systems and applications that deal with sensitive 
client data. All activity regarding access to, and transmission of, this data is logged. Sessions are 
configured to timeout after a period of inactivity. All sensitive data, including PHI and authentication 
credentials for system and application access, are transmitted via encrypted protocols (SSL or 
SSHv2) when traversing public or untrusted networks. Strong encryption is used for sensitive data 
stored on Mobile Commons systems. Multiple layers of procedures and technical controls are in place 
to verify the identity of any person or entity seeking access to any sensitive client information” 
(https://www.mobilecommons.com/wp/wp-content/uploads/2014/07/Mobile-Commons-HIPAA-Text-
Messaging-Security-White-Paper1.pdf).  
 
 

25 
 
 
 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
 
Institutional Review Board (IRB) Review  
This protocol and the informed consent documents (see Appendix) and any subsequent modifications 
will be reviewed and approved by the Georgia State University IRB.  
 
Informed Consent Forms 
The consent forms (see Appendix) describe the purpose of the study, the procedures to be followed, 
and the risks and benefits of participation.  
 
The informed consent process will include:  
1) A thorough review of the Informed Consent Forms (ICF), particularly study procedures; 2) Study 
personnel will offer an opportunity for participants to ask questions and have them answered; 3) The 
ICF will be signed and dated by the participant and staff member; and 4) A copy of the ICF will be 
given to the participants. (For the consent process prior to telephone screening, the research staff will 
document participants’ verbal consent after reviewing the ICF).  
 
Participant Confidentiality  
Participants will be assured that the information gathered from the study (including responses to 
questionnaires, diary assessments and text messages) will be kept confidential to the extent of the 
law, and that the findings of the study may be published, but that participants will not be identified. 
Upon enrollment, participants will receive an ID number. Assessment data will be linked to this 
number. Personal/identifying information, including consent forms, will be maintained separately from 
study assessment data. Although participants will sign informed consent documents, these forms will 
be kept in a separate locked file and will never be connected to the study data. Data will be stored on 
a secure server to protect the data and to prevent unauthorized access. Databases will be accessed 
only by members of the research staff who have met the IRB’s requirements for training in Human 
Subjects’ Protection.  
 
Participants’ first names will be used in the text messages that participants receive (in efforts to 
increase the personalization of the text messaging, as suggested by our qualitative research to inform 
this intervention). However, their full names will never be entered into the Mobile Commons platform. 
First names will be deleted from the data when downloaded from the Mobile Commons platform.  
 
By virtue of participating in a treatment group with other people, participants’ verbal responses during 
MBAT treatment will be known to others in the group. Thus, we will request (in the consent form and 
verbally at the start of the group) that participants keep what they hear confidential. Of course, we 
cannot guarantee that the other members of the treatment group will maintain confidentiality of 
responses, and this is made clear in the consent form.  
Study Discontinuation  
The study may be discontinued at any time by the IRB, NCI, or other government agencies as part of 
their duties to ensure that research participants are protected.  
 
 
12. PUBLICATION OF RESEARCH FINDINGS  
In accordance with NIH public access policy, final peer-reviewed journal manuscripts that arise from 
this study will be deposited to PubMed Central immediately upon acceptance for publication. 
 
 

26 
 
 
 
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