Clinical trial NCT03029819
Conditions: Cigarette Smoking
Sponsor: Georgia State University
Start date: 2017-01-18; Completion date: 2017-10-03
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.

Detailed description:
This study is a pilot investigation of mindfulness-based smoking cessation treatment incorporating between-session text messaging ("iQuit Mindfully"). Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages).

All participants will receive in-person group treatment based on the 8-week MBAT protocol in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco dependence and psychological well-being will be assessed.

Arms: arm 1: Nicotine patch; self-help guide; MBAT arm 2: Nicotine patch; self-help guide; MBAT; text messaging
Interventions: intervention 1: Mindfulness-based Addiction Treatment intervention 2: iQuit Mindfully intervention 3: Self-Help guide intervention 4: Nicotine Patch
Intervention descriptions: intervention 1: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009). intervention 2: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation. intervention 3: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008). intervention 4: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.

Protocol documents:
Prot_SAP_000.pdf: 
1 
 
STUDY PROTOCOL 
 
TITLE OF STUDY:  
iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced 
with Mobile Technology 
 
PRINCIPAL INVESTIGATOR: 
Claire Adams Spears, Ph.D., Assistant Professor 
Division of Health Promotion & Behavior, School of Public Health, Georgia State University 
 
SUPPORTED BY: 
The National Center for Complementary and bv Integrative Health K23 AT008442 (“Using Mobile 
Technology to Understand and Encourage Mindfulness for Smoking Cessation”) 
 
CLINICALTRIALS.GOV NCT NUMBER: NCT03029819 
 
DATE OF PROTOCOL DOCUMENT: 12/15/2016 
 
 
 


2 
 
PRÉCIS 
 
Study Title 
iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced 
with Mobile Technology 
 
Objectives 
The proposed study is a pilot investigation of mindfulness-based smoking cessation incorporating 
between-session text messaging (“iQuit Mindfully”). This will be the first known study to use text 
messaging to enhance mindfulness treatment. 
 
Design and Outcomes 
Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment 
(MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages). Primary 
outcomes for this development and feasibility study are: 1) feasibility (e.g., attrition, engagement, 
participant ratings), 2) determining best practice for implementing and refining the text-messaging 
intervention (e.g., how many texts per day and at what times of day; which types of messages are 
most helpful; ways of increasing adherence), and 3) an estimate of effect size (based on smoking 
cessation in iQuit Mindfully vs. MBAT without text messaging). 
 
Interventions and Duration 
All participants will receive in-person group treatment based on the 8-week MBAT protocol (Wetter et 
al., 2009) in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit 
Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at 
each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. 
 
Sample Size and Population 
Participants will include English-speaking adult smokers (ages 18-65). Recruitment will target a 
racially/ethnically diverse sample of individuals with relatively low income levels. Participants 
(projected N = 70) will be randomly assigned to “iQuit Mindfully” (with text messaging) or MBAT 
(without text messaging). Approximately 10-15 participants will be enrolled per cohort, resulting in 6 
cohorts (3 of each treatment). 


3 
 
1. STUDY OBJECTIVES 
 
Primary outcomes for this development and feasibility study are: 1) feasibility (e.g., attrition, 
engagement, participant ratings; specific definitions of these outcomes are described in section 9), 
2) determining best practice for implementing and refining the text-messaging intervention (e.g., how 
many texts per day and at what times of day; which types of messages are most helpful; ways of 
increasing adherence), and 3) an estimate of effect size (based on smoking cessation in iQuit 
Mindfully vs. MBAT). Effect sizes will be of greater importance than statistical significance, given that 
this is a feasibility study. Secondary analyses will include: 1) effects of treatment conditions on 
average number of cigarettes smoked per day; 2) effects of treatment on weekly mindfulness practice; 
3) effects of treatment on self-reported levels of mindfulness, affect, self-efficacy, coping, 
dependence, and withdrawal symptoms; and 4) associations between number of sessions attended, 
weekly mindfulness practice, and abstinence. 
 
 
2. BACKGROUND AND RATIONALE 
 
Background and Significance 
Tobacco use is the leading cause of preventable morbidity and mortality in the U.S. (CDC, 2008; 
Mokdad, Marks, Stroup, & Gerberding, 2004; USDHHS, 2010). Although most smokers indicate 
interest in quitting, only 6% quit each year (CDC, 2011b). Mindfulness-based interventions show 
promise for improving smoking cessation (Brewer et al., 2011; Davis, Fleming, Bonus, & Baker, 
2007). For example, research suggests that participants receiving mindfulness training are over 5 
times more likely to be abstinent at 17 weeks post-treatment, compared to standard treatment 
(Brewer et al., 2011). However, although between-session mindfulness practice is thought to be 
integral in producing benefits (Grow et al., 2015), participants do not always practice mindfulness in 
daily life (Vettese, Toneatto, Stea, Nguyen, & Wang, 2009). Fortunately, mobile health technology 
presents unique opportunities for mindfulness research and intervention. Between-session text 
messaging might be an effective means to encourage participants to use mindfulness techniques in 
the moments when they need them most, thus enhancing treatment effectiveness. 
Enhancing the effectiveness of smoking cessation treatments is especially critical for underserved 
populations (i.e., members of racial/ethnic minority groups and individuals with low socioeconomic 
status [SES]), who often have greater difficulty quitting smoking and experience profound tobacco- 
related health disparities (CDC, 2011a, 2011b; Fagan, Moolchan, Lawrence, Fernander, & Ponder, 
2007; Honjo, Tsutsumi, Kawachi, & Kawakami, 2006). Mobile technology is revolutionizing healthcare 
and might be used to enhance mindfulness-based interventions for smoking cessation in these 
populations. 
Mindfulness 
Mindfulness is defined as purposeful, present-focused attention with an attitude of acceptance and 
non-judgment (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006; Kabat-Zinn, 1990, 1994). 
Mindfulness is linked to improved mood, less anxiety and stress (Baer et al., 2006; Brown & Ryan, 
2003; Smith et al., 2011), and lower stress reactivity (Bullis, Boe, Asnaani, & Hofmann, 2013). 
Among smokers, mindfulness predicts lower negative affect and perceived stress (Adams et al., 
2015; Waters et al., 2009), higher expectancies regarding ability to regulate emotions without smoking 
(Vidrine et al., 2009), and lower nicotine dependence (Vidrine et al., 2009). Brewer et al. (2011) found 
that in a diverse sample, mindfulness training for smoking cessation produced over 5 times better 
abstinence rates than standard treatment (31% vs. 6% at 17-week follow-up). In another diverse 
sample, Vidrine et al. (2016) found that although mindfulness treatment did not differ from cognitive- 
behavioral therapy (CBT) or usual care in terms of post-treatment abstinence from smoking, 


4 
 
mindfulness was superior in promoting lapse recovery. Among participants who were not abstinent at 
end of treatment, those who received mindfulness were more likely to regain abstinence by 1 week 
post-treatment, and this trend approached significance at 23 weeks. Mindfulness may be effective for 
preventing lapses from transitioning to full-blown relapses. Another study found that African American 
smokers with greater mindfulness were more likely to quit and to recover abstinence after an early 
lapse (Heppner et al., 2016). Tang, Tang, and Posner (2013) found that among current smokers, 2 
weeks of mindfulness meditation produced a 60% reduction in smoking compared to a relaxation 
control. 
 
Mobile Technology to Enhance Mindfulness Intervention Effectiveness. Mindfulness-based 
treatments (e.g., mindfulness-based stress reduction [MBSR] (Kabat-Zinn, 1990, 1994)) encourage 
participants to practice mindfulness between sessions, and consistent home practice appears to be a 
key factor in bringing about therapeutic outcomes (Vettese et al., 2009). However, mastering a new 
skill in treatment does not necessarily mean that it will translate to real-life situations, and a consistent 
barrier to treatment success occurs when individuals fail to practice mindfulness in daily life. In a 
recent trial of mindfulness-based smoking cessation, frequency of between-session mindfulness 
practice was relatively low (Vidrine et al., 2016). In my clinical experience, patients often realize in 
hindsight that using a particular strategy would have been helpful, but the strategy did not come to 
mind in that stressful moment (even with the best of intentions). When participants provide information 
on emotions, smoking urges, and situational circumstances, tailored in-the-moment strategies can be 
provided through text messages. By prompting participants to practice mindfulness in their daily lives, 
text-messaging interventions might increase skill level, self-efficacy, and the likelihood that the skill 
will become part of daily routines (Heron & Smyth, 2010). 
Several researchers have implemented text message-based smoking cessation interventions with 
success, although none have included mindfulness (Abroms et al., 2012; Borland, Balmford, & Benda, 
2013; Free et al., 2011; Obermayer, Riley, Asif, & Jean-Mary, 2004; Riley, Obermayer, & Jean-Mary, 
2008; Rodgers et al., 2005). A recent review concluded that mobile phone interventions for smoking 
cessation nearly doubled the likelihood of quitting up to 6 month follow-up, compared to usual care 
(Whittaker et al., 2012). Research supports text messaging for promoting several health outcomes, 
including weight loss and diabetes management (Cole-Lewis & Kershaw, 2010; Fjeldsoe, Marshall, & 
Miller, 2009; Krishna, Boren, & Balas, 2009). These programs are cost-effective and beneficial across 
age and racial/ethnic groups (Cole-Lewis & Kershaw, 2010; Guerriero et al., 2012). 
Focus on Underserved Populations. Disproportionately high rates of smoking are found in low-SES 
populations (CDC, 2011a). Compared to other racial/ethnic groups, African Americans tend to have 
greater difficulty quitting smoking and higher incidence and mortality rates for diseases associated 
with smoking (CDC, 2011b; Cooper et al., 2000; Fagan et al., 2007; Irvin Vidrine, Reitzel, & Wetter, 
2009). The leading causes of death among Latinos (i.e., cancer, cardiovascular disease) are related 
to smoking (Heron, 2012). The majority of research on mindfulness has focused on higher-SES and 
Caucasian populations. Although mindfulness shows promise with respect to regulating emotion and 
promoting smoking cessation in diverse groups (Brewer et al., 2011; Szanton, Wenzel, Connolly, & 
Piferi, 2011), much work is needed to explore possible benefits and underlying mechanisms in these 
populations. Text messaging may be particularly effective for targeting low-SES and racial/ethnic 
minority populations. Latinos and individuals living in poverty are especially likely to have only 
wireless phones (Blumberg & Luke, 2013). In a Pew Research Center study, mean numbers of texts 
per day for Caucasians, African Americans, and Latinos were 31.2 (median 10), 70.1 (median 20), 
and 48.9 (median 20), respectively. Whereas mean number of texts per day among individuals with > 
college education was 23.8 (median 10), those with < high school education texted 58.7 (median 20) 
times per day (Smith, 2011). Furthermore, text messaging does not require a Smartphone, making it a 
highly feasible mode of intervention in low-income populations. 


5 
 
The proposed study is a pilot investigation of mindfulness-based smoking cessation incorporating 
between-session text messaging (“iQuit Mindfully”). This will be the first known study to use text 
messaging to enhance mindfulness treatment. 
 
3. STUDY DESIGN 
 
In this randomized clinical trial, participants will be randomly assigned to one of two groups: 
Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of 
between-session text messages). 
 
Primary outcomes for this development and feasibility study are: 1) feasibility (e.g., attrition, 
engagement, participant ratings), 2) determining best practice for implementing and refining the text- 
messaging intervention (e.g., how many texts per day and at what times of day; which types of 
messages are most helpful; ways of increasing adherence), and 3) an estimate of effect size (based 
on smoking cessation in iQuit Mindfully vs. MBAT without text messaging). 
 
Secondary analyses will include: 1) effects of treatment conditions on average number of cigarettes 
smoked per day; 2) effects of treatment on weekly mindfulness practice; 3) effects of treatment on 
self-reported levels of mindfulness, affect, self-efficacy, coping, dependence, and withdrawal 
symptoms; and 4) associations between number of sessions attended, weekly mindfulness practice, 
and abstinence. 
 
Participants will include English-speaking adult smokers (ages 18-65). Recruitment will target a 
racially/ethnically diverse sample of individuals with relatively low income levels. Participants 
(projected N = 70) will be randomly assigned to “iQuit Mindfully” (with text messaging) or MBAT 
(without text messaging; see details of interventions in section 5 below). Approximately 10-15 
participants will be enrolled per cohort, resulting in 6 cohorts (3 of each treatment). 
The study will take place at Georgia State University in Atlanta, GA. All participants will receive in- 
person group treatment based on the 8-week MBAT protocol (Wetter et al., 2009) in addition to 
nicotine patch therapy and self-help materials. Assessments will occur at baseline, at each of the 
weekly in-person visits, at end of treatment, and at 1-month follow-up. 
 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS 
 
Participants will include English-speaking adult smokers (ages 18-65). Recruitment will target a 
racially/ethnically diverse sample of individuals with relatively low income levels. 
 
Inclusion Criteria 
 
Inclusion criteria are: 
• 
age 18-65 years 
• 
current smoker with history of >5 cigarettes/day for past year (and CO >6 ppm*; participants 
will not be excluded for use of e-cigarettes) 
• 
motivated to quit within next 30 days 
• 
valid home address in the greater Atlanta area 
• 
functioning telephone number 
• 
own a mobile phone with text messaging capacity 
• 
can speak, read, and write in English 
• 
marginal/adequate health literacy (at least a sixth-grade level as determined by the Rapid 
Estimate of Adult Literacy in Medicine [REALM]; Davis et al., 1991) 


6 
 
 
*Expired carbon monoxide (CO) will be used for biochemical confirmation of smoking status because 
it is a simple and noninvasive method that is commonly used in smoking research. Dr. Spears and/or 
research assistants (who have been trained by Dr. Spears on CO testing procedures) will administer 
CO testing. Participants are asked to take a deep breath in, hold their breath for 15 seconds, and then 
expire into the disposable mouthpiece on the CO monitor. Although some studies have employed 
cutoff values of 8-10 parts per million (ppm), a growing body of research suggests that values of 8- 
10ppm misclassify a large number of smokers as non-smokers (e.g., Javors et al., 2005; Raiff et al., 
2010). A cutoff value of 6 was chosen for the present study because it has been associated with good 
sensitivity and specificity (Middleton & Morice, 2000) and has been used successfully in recent 
research (Vidrine et al., 2016). 
 
Exclusion Criteria 
 
Exclusion criteria are: 
• 
contraindication for nicotine patch 
• 
active substance abuse/dependence 
• 
regular use of tobacco products other than cigarettes 
• 
current use of tobacco cessation medications 
• 
pregnancy or lactation 
• 
household member enrolled in the study 
• 
current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic medications 
• 
Score of >3 on PHQ-2 depression screening instrument (indicating high likelihood of clinically 
significant depressive symptoms) 
 
Study Enrollment Procedures 
Participants will be recruited through flyers (posted at venues including the GSU campus, local 
hospitals/community health centers, near MARTA and bus stops, community centers and shelters, 
etc.) and through print media in local newspapers and on buses and trains. The research team will 
stimulate recruitment by giving presentations, talking with staff, providing study information, and 
supplying flyers at local clinics and community organizations in Atlanta, GA. Dr. Spears and research 
staff will also visit primary care practices and health fairs to provide study information and enhance 
recruitment. Participants will also be recruited through online sources (e.g., Craigslist, listservs) and 
by word of mouth. 
 
Participants (projected N = 70) will be randomly assigned to “iQuit Mindfully” (with text messaging) or 
MBAT (without text messaging). Approximately 10-15 participants will be enrolled per cohort, resulting 
in 6 cohorts (3 of each treatment). 
Randomization. Randomization will take place at the end of the baseline session, after baseline 
assessments have been administered. Block randomization will be used 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 (Hedden, Woolson, & Malcolm, 2006). Thus, in the present study stratified 
permutated block design will be used, and it will be most important to stratify on variables expected to 
interact with the text messaging intervention to predict smoking cessation. Given that younger adults 
typically send and receive more text messages than older adults, age is an important stratification 
factor. Data from the Pew Research Center indicate that mean number of texts sent/received per day 
is 87.7 among people aged 18-29; 27 texts/day among people ages 30-49; 11.4 texts/day among 
those aged 50-64; and 4.7 texts/day among those 65 and older. Thus, stratification will be based on 
ages 18-49 vs. 50-65 (this cutoff is consistent with the Pew Center data and also lines up with data 


7 
 
from Dr. Wetter’s randomized controlled trial of mindfulness-based smoking cessation treatment, in 
which approximately 50% of participants were 49 or younger.) 
 
5. STUDY INTERVENTIONS 
 
In-Person Treatment for all participants will follow the Mindfulness-Based Addiction Treatment 
(MBAT) group protocol (Wetter et al., 2009). MBAT groups will only contain study participants (i.e., 
MBAT groups will not involve existing classes apart from the study). Studies of mindfulness 
treatments have typically utilized a group format (Keng, Smoski, & Robins, 2011; Roemer & Orsillo, 
2003), and the approaches in this study are particularly well suited to a group format. Not only may 
the group format facilitate the acquisition of skills through observational learning and practice, but it 
may also increase participants’ willingness to explore different practices more than they would have 
on their own. Thus, we chose to include group treatment (rather than delivering the entire treatment 
via text-messaging, which would lack important aspects of group treatment). All participants receive 
nicotine replacement therapy (NRT) and self-help materials in addition to MBAT. Participants receive 
nicotine patch therapy because the patch is the most widely used pharmacotherapy for smoking 
cessation and the Treating Tobacco Use and Dependence Clinical Practice Guideline identified the 
patch as a frontline therapy.(Fiore et al., 2000; Fiore et al., 2008) Compared to bupropion and 
varenicline, the patch is safer, better tolerated, and available over-the-counter. 
Therapists. There will be between 1 and 3 therapists (depending on therapist schedules). Minimum 
therapist qualifications are: 1) completion of master’s degree or equivalent in counseling, psychology, 
social work, or related field; 2) daily mindfulness practice; 3) experience teaching stress reduction or 
body-centered awareness disciplines in a group setting; and 4) completion of formal training in 
mindfulness (e.g., the 7-day residential Professional Training Program in Mindfulness-Based Stress 
Reduction or the 5-day Mindfulness-Based Cognitive Therapy professional training). Sessions will be 
audio-recorded in order to allow for assessment of treatment fidelity. After each session, audio 
recordings will be uploaded onto a secure server and deleted from the recorder. The server is 
managed by Georgia State University, password-protected, and available only to research personnel 
who have completed training in research with human subjects. Dr. Spears will randomly select two 
sessions from each group and rate adherence to the protocol using a modified version of the MBCT 
Adherence Scale (Segal, Teasdale, Williams, & Gemar, 2002; reference to depression will be 
replaced with reference to smoking). Each item is rated on a 0 to 2 point scale (0 = no evidence for 
item, 1 = slight evidence, 2 = definite evidence). For any items rated as 0 or 1, Dr. Spears will conduct 
further training with the study therapist. 
 
Nicotine Patch Therapy. Patch therapy (beginning the week before quit day) for participants who 
smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 
week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 
weeks of 14 mg patches and 2 weeks of 7 mg patches. Patch dispensation will occur at weekly visits. 
Participants receive only the number of patches necessary to last until the next study visit plus several 
extra patches should a patch fall off, become torn, or should the visit be delayed. Based on our 
previous research, providing participants with only enough patches to last until the subsequent visit 
improves compliance. 
 
Self-Help Materials. All participants will also be given evidence-based self-help materials for 
smoking cessation (based on the Treating Tobacco Use and Dependence Clinical Practice Guideline 
(Fiore et al., 2008). 
 
MBAT Overview. Group treatment will strictly follow the MBAT protocol developed and used by 
Dr. Wetter. MBAT closely follows Mindfulness-based Cognitive Therapy (MBCT) procedures, but 


8 
 
replaces the depression-related material with nicotine dependence-related material. MBAT consists of 
8 weekly 2-hour sessions (Wetter et al., 2009). The core aims are to help participants: 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. In order to provide additional support 
on the quit date and encourage further mindfulness practice, session 5 (quit date) will be an extended 
4-hour session. 
 
MBAT emphasizes daily practice in several forms: formal sitting meditation, body scan meditation, 
walking meditation, eating meditation, and gentle yoga. Each of these practices shares a focus on 
awareness of the breath. By offering a menu of practices, differing preferences and learning styles 
can be accommodated. The quit day is scheduled for Session 5. Sessions 5-8 focus on continued 
development of awareness of the present, along with expansion of techniques for dealing with 
problematic thoughts, feelings, and situations. The group leader will have: 1) at least a master’s 
degree or equivalent in counseling, psychology, social work, or a related field; 2) a regular personal 
mindfulness practice; 3) experience teaching mindfulness in a group setting; and 4) completion of 
training in teaching mindfulness. 
 
Text Messages. Participants in the iQuit Mindfully condition will receive text messages on each 
day between treatment sessions. These messages are based on the MBAT protocol, the Text2Quit 
program led by Dr. Abroms (Abroms et al., 2012), and the SmokefreeTXT program developed by the 
National Cancer Institute (some of the messages are directly from the SmokeFreeTXT library). The 
content and frequency of messages were revised based on focus groups in low-income, racially 
diverse smokers. Text messages will remind 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). Text messages will also remind participants of 
their personal reasons to quit as well as specific strategies to aid in cessation (e.g., reminders to get 
rid of cues to smoke, reach out for social support, and use cognitive-behavioral strategies taught in 
MBAT). 
Participants will receive approximately 2 messages per day during Week 1, 3/day during Week 
2, 4/day during Week 3, 5/day during Week 4, 6/day during Week 5, 4/day during Week 6, and 3/day 
during Week 7 (these numbers could be revised based on participant feedback). In addition, as in 
Text2Quit and SmokefreeTXT, participants will be able to text specified words to request help. 
Specifically, they may text CRAVE, STRESS, or SLIP at any point to receive additional text message 
support for coping with cravings, stress, or smoking lapses, respectively. Participants will also receive 
a relatively small number of texts (1-3 per week; exact number to be determined based on pilot 
project) during the 1-month follow-up period, and they will also have the opportunity to text keywords 
(CRAVE, STRESS, SLIP) during this time. 
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. Participants will receive text messages and will also have the option of texting 
CRAVE, STRESS, or SLIP. 
Adherence. Adherence is defined as the number of intervention sessions attended and amount of 
mindfulness practice between sessions. Secondary analyses will examine associations between 
these adherence variables and abstinence outcomes. 
Financial Compensation and Retention Procedures. Participants will be compensated for each of 
the 9 in-person visits in which they complete assessments after baseline (8 treatment sessions and 1 
follow-up; $25 for assessments at session 1-4 and 6-7 visits; $40 for session 5 assessment; $50 for 
post-treatment assessment; and $50 for follow-up assessment (assessments on session 5, post- 


9 
 
treatment, and follow-up are longer than other sessions and thus associated with higher 
compensation). Participants will be compensated with $10 for completing at least 7 of the 10 daily 
assessments around the quit date (to be paid at session 6 visit). The maximum compensation per 
participant will be $300. Other procedures to increase adherence include: 1) reminder phone calls and 
letters, 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. Participants who do not attend in-person assessment 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. 
 
6. STUDY PROCEDURES 
 
Screening Evaluation and Consenting Procedure 
 
Telephone Screening. Interested individuals 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. Potential 
participants will then be screened for inclusion/exclusion and answer questions about demographic 
information. 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. 
 
In-Person Baseline Visit and Consent Procedure. Following the phone screen, 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 (REALM; Davis 
et al., 1991), 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; Kroenke, Spitzer, & Williams, 2003; Lowe, Kroenke, & Grafe, 2005) and answer a question 
regarding psychotic disorders in order to screen for clinically significant depressive symptoms and 
psychotic disorders, 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 retention; Goldberg & Kiernan, 2005). 
 
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), 
particularly study procedures; 2) Study personnel will offer an opportunity for participants to ask 


10 
 
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. 
 
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 will indicate when they typically 
wake up and when they typically go to bed. This information will be used so that text messages will 
only be sent during the hours specified by each individual participant. 
 
Individuals who would like to participate and express informed consent will then be asked to complete 
questionnaires. Descriptions of the assessments are provided below: 
 
• 
The Telephone Screening assesses eligibility criteria and demographic characteristics, 
including age, race, ethnicity, education, employment, and income. 
• 
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) 
(Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991): 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 (Kozlowski, Porter, Orleans, Pope, & 
Heatherton, 1994). 
• 
The Rapid Estimate of Adult Literacy in Medicine (REALM)(Davis et al., 1991) is a rapid 
screening instrument that is used to assess health literacy. It takes 2-3 minutes to administer 
and score and is highly correlated with comprehensive literacy diagnostic instruments. 
Individuals are classified as having limited (≤6th grade reading level; REALM=0 to 44), 
marginal (7th- to 8th-grade reading level; REALM=45 to 60), or adequate (≥9th grade reading 
level; REALM=61 to 66) health literacy skills. Participants with scores <44 will be excluded 
from the proposed study. 
• 
In order to assess for current psychotic disorders, participants will be asked, “Do you have a 
current diagnosis of Schizophrenia or Bipolar Disorder or take anti-psychotic medications such 
as Haldol or Thorazine?”. Individuals who answer affirmatively will not be eligible but will be 
provided with appropriate mental health referrals. 
• 
The Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003; Lowe et al., 2005) 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; 
APA, 2013) 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; Kroenke et al., 2003; Lowe et al., 2005) will 
not be eligible but will be provided with appropriate mental health referrals. 
• 
Smoking Status (SRNT) surveys tobacco use, use of other tobacco products, and nicotine 
replacement medications. The questionnaire also collects data on the use of other tobacco 
products and nicotine replacement medications as determined by the participant's time point in 
the protocol (e.g., based upon the date the participant quits smoking) (Hughes et al., 2003). 
Point prevalence abstinence (i.e., no smoking during past week) will be self-reported and 
biochemically confirmed by CO<6ppm. 
• 
The Brief Wisconsin Dependence Motives Questionnaire (Smith, Piper et al., 2011) 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 


11 
 
attachment, loss of control, craving, cue exposure/associative processes, social/environmental 
goals, taste/sensory processes, weight control, tolerance). 
• 
The Wisconsin Smoking Withdrawal Scale (Welsch et al., 1999) includes subscales for anger, 
anxiety, sadness, concentration difficulty, craving, hunger, and sleep. All subscales have 
excellent internal consistency and validity (Wetter et al., 2000). 
• 
The Self-Efficacy Scale assesses confidence for resisting smoking urges in specific types of 
situations (e.g., when feeling stressed, when with friends) (Condiotte & Lichtenstein, 1981) 
Subscales include negative affect, pleasure, social image, social influence, and diet. Scores 
are predictive of relapse (Cinciripini, Cinciripini, Wallfisch, Haque, & Van Vunakis, 1996). 
• 
The Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003) is a 15-item self-report 
measure of dispositional mindfulness that has shown good reliability and validity.(Brown & 
Ryan, 2003) 
• 
The Five-Factor Mindfulness Questionnaire- Short Form (FFMQ-SF; Bohlmeijer, ten Klooster, 
Fledderus, Veehof, & Baer, 2011) 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. 
The FFMQ-SF correlates highly with the 39-item FFMQ and has comparable internal 
consistency and factor structure. 
• 
Participants will fill out a Weekly Mindfulness Practice Log (Vidrine et al., 2016) to indicate how 
frequently they practice each of the mindfulness techniques taught in treatment. 
• 
The Perceived Stress Scale – Short Form (Warttig, Forshaw, South, & White, 2013) is a 4-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 (Watson, Clark, & Tellegen, 1988)) is a 
20-item self-report measure of affective experience yielding two factors (Positive and Negative 
Affect) with strong psychometric properties (Watson et al., 1988). 
• 
Participants in the iQuit Mindfully group will be asked to provide weekly feedback about their 
experiences receiving the text messages (Weekly Text Message Feedback), and both groups 
will complete Final Program Evaluation. Items will assess perceived helpfulness and 
acceptability of the in-person and text messaging portions of treatment and also solicit 
suggestions for improving future programs. 
 
The maximum time between telephone screening and enrollment will be 1 month. The maximum time 
between baseline assessment (as well as randomization, which will occur right after 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). 
 
Daily Surveys around Quit Date. In order to gather more daily data about emotions, smoking, and 
mindfulness surrounding the quit date, all participants will be asked to complete a daily online survey 
for 10 days surrounding the quit date (Days 3, 2, 1 pre-quit, Quit Date, and Days 1-6 post-quit). Each 
morning, participants will be sent a link (via text, and also via email for participants who supply an 
email address) to an online survey including 8 questions about emotions, smoking, and mindfulness 
on the previous day. 


12 
 
 
Follow-Up Visit and Individual Interview. One month following the last treatment session, 
participants will attend an in-person follow-up visit in which they will complete questionnaires, provide 
expired CO samples, and complete an individual interview. Individual interviews will be conducted by 
trained research staff. All participants will be asked for their feedback about and suggestions for 
improving the intervention. In addition, interviews with iQuit Mindfully participants will involve more in- 
depth discussion of what participants liked/did not like about the texts, how they perceived the 
messages to be helpful/unhelpful, and their suggestions for improving the text-based program. 
Interviews will be audio-recorded with a digital voice recorder and transcribed verbatim. 
 
Blinding 
 
The majority of study personnel, including the PI, will be blinded to treatment condition until the 
database is locked. Limited staff will be unblinded to handle randomization codes, administer 
individual interviews (i.e., the graduate research assistant) and delivery of interventions (i.e., the study 
therapist). Once the algorithm for randomization has been prepared, the graduate research assistant 
will execute the randomization scheme. The graduate research assistant (unblinded) will also be 
responsible for preparing reports for data and safety monitoring, as well as conducting individual 
interviews (which requires knowledge of the participants’ treatment conditions). Research personnel 
who are blinded to treatment condition will administer all assessments. For example, in order for 
participants to complete the post-treatment assessment, separate research personnel (who do not 
know the treatment condition) will arrive after the treatment ends and administer the assessments. 
 
 
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 annual report to the mentors, Independent Monitoring 
Committee (IMC), and IRB. The IMC will state that they have reviewed all AE reports in the annual 
report. 
 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be reported to 
the IMC, IRB, and NCCIH 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. 


13 
 
Unexpected fatal or life-threatening SAEs related to the intervention will also be reported to the 
NCCIH Program Officer, mentors, and IMC within 7 days. Other serious and unexpected AEs related 
to the intervention will be reported to the NCCIH Program Official within 15 days. Anticipated or 
unrelated SAEs will be handled in a less urgent manner but will be reported to the Independent 
Monitors, IRB, and NCCIH. In the annual AE summary, the Independent Monitoring Committee 
Report will state that they have reviewed all AE reports. 
 
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. 
 
9. STATISTICAL CONSIDERATIONS AND DATA ANALYSES 
 
Primary outcomes for this development and feasibility study are: 1) feasibility (e.g., attrition, 
engagement, participant ratings), 2) determining best practice for implementing and refining the text- 
messaging intervention (e.g., how many texts per day and at what times of day; which types of 
messages are most helpful; ways of increasing adherence; these variables will be assessed through 
participant feedback in the individual interview and final program evaluation questionnaire), and 3) an 
estimate of effect size (based on smoking cessation in iQuit Mindfully vs. MBAT). 
 
Approximately 35% attrition will be deemed acceptable (based on 34% attrition in Vidrine et al.’s 
(2016) trial of mindfulness-based smoking cessation treatment). Level of engagement will be 
determined based on: 1) the proportion of texts that participants indicate reading (we expect that at 
least 75% will read most or all texts, based on Abroms et al.’s (2012) findings); and 2) responses to 
interactive text messages (we expect that at least 85% of participants will respond to at least one of 
the interactive text messages or use the CRAVE, STRESS, or SLIP keywords at least once, based on 
Heminger et al.’s (2016) findings). In terms of participant ratings, we will focus on ratings of 
helpfulness of the text messages and the extent to which participants would recommend the text 
messaging program to others (rated on 1-10 scales; the minimum acceptable rating is 6). 
Effect sizes will be of greater importance than statistical significance, given that this is a feasibility 
study. Smoking abstinence will be defined as self-reported complete abstinence for 7 days that is 
biochemically confirmed with expired carbon monoxide <6ppm. Chi-square tests and t-tests will be 
used to evaluate group differences. 
Individual interviews will be transcribed verbatim. Transcripts will be managed and coded using QSR 
International’s NVivo 10 software, a qualitative software analysis program that allows researchers to 
associate codes with portions of text, to search within and across codes for patterns, and to construct 
classifications of codes reflecting relationships within the data. Data coding and analysis will follow 
both inductive and deductive approaches. An initial set of codes will be developed from the interview 
topics and the conceptual framework, with additional codes identified from concepts that emerge from 
the data. The objective of the data coding process will be to capture as many concepts as possible 
and then to examine the relationships and patterns of the concepts within and across transcripts to 
identify conceptual linkages or themes (Ayres, Kavanaugh, & Knafl, 2003; Ryan & Bernard, 2003). 
Two independent coders will code the transcripts and then meet to discuss findings, resolve 
inconsistencies, and develop a preliminary coding scheme. Then the remaining transcripts will be 
independently coded (with regular meetings to refine the coding scheme as needed). This method of 
constant comparison will be used to identify themes within the data (Corbin & Strauss, 2008). This 


14 
 
approach involves comparing concepts across categories to identify links, patterns, connections, and 
differences. 
 
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. Participants’ names will not be used in the recorded 
interviews (participants will be asked not to use their names, and the interviewer also will not use their 
names during recorded interviews). These interviews will be transcribed and coded with participant ID 
numbers, and audio files will be deleted within one year after the completion of data collection. 
 
Questionnaire data (both in-person assessments and online surveys surrounding the quit date) 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 
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 


15 
 
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). 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY 
Institutional Review Board (IRB) Review 
This protocol and the informed consent documents and any subsequent modifications will be 
reviewed and approved by the Georgia State University IRB. 
 
Informed Consent Forms 
The consent forms 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, text messages, and interview) 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 separate ely 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. 
 
Although 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), their names will not be connected to any data that is stored in the Mobile 
Commons platform. 
 
By virtue of participating in a treatment group with other people, participants’ verbal responses during 
group 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. 
Participants’ names will not be used in the recorded interviews. These interviews will be transcribed 
and coded with participant ID numbers, and audio files will be deleted within one year after the 


16 
 
completion of data collection. 
Study Discontinuation 
The study may be discontinued at any time by the IRB, NCCIH, or other government agencies as part 
of their duties to ensure that research participants are protected. 
 
12. COMMITTEES 
 
External oversight of participants’ safety will be conducted by the members of the Independent 
Monitoring Committee (IMC): Sarah Bowen, Ph.D., Bradley N. Collins, Ph.D., and Danielle E. 
McCarthy, Ph.D. They are not part of the key personnel involved in this grant. Dr. Bowen, Assistant 
Professor of Psychology at Pacific University, has expertise in designing and conducting randomized 
controlled trials of mindfulness-based treatment for addictions. Dr. Collins, Associate Professor of 
Public Health at Temple University, has expertise in smoking cessation intervention research (with 
particular focus on low-income, racial minority and medically-underserved communities). Dr. 
McCarthy, Associate Director of Research at the University of Wisconsin Center for Tobacco 
Research and Intervention, has expertise in smoking cessation treatment and using mobile 
technology to examine momentary mechanisms underlying behavior change. Together, the IMC 
brings extensive knowledge and experience with regard to mindfulness-based treatments, 
randomized controlled trials, tobacco use and cessation, underserved populations, and mobile 
technology. The IMC will regularly review participant safety and assess study progress (including 
participant confidentiality, recruitment and retention, and data quality and management). 
 
13. 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. 
 
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