Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
Phase: NA
Conditions: Copd, Smoking Cessation, Nicotine Dependence, Tobacco Use, Cigarette Smoking
Sponsor: Rush University Medical Center

PROTOCOL TITLE: Fresh Start Study 
 
 
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PROTOCOL TITLE: 
 
 
Addressing Psychological Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start 
Study 
 
PRINCIPAL INVESTIGATOR: 
 
Amanda R. Mathew, PhD 
Department of Preventive Medicine 
(312) 563-1273 
Amanda_Mathew@Rush.edu 
 
VERSION DATE: 
 
8/27/20 
 
 
 

PROTOCOL TITLE: Fresh Start Study 
 
 
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1.0 Purpose of the Study:  
 
 
Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation 
is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue 
to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions – nicotine 
dependence, depression, and anxiety – which serve as barriers to quitting. The proposed research will develop 
and pilot test a behavioral intervention designed to target the common psychological factors underlying these 
co-occurring conditions and foster smoking cessation among COPD patients. Specific aims are: 
 
Aim 1: Refine behavioral treatment components. We will conduct a series of semi-structured qualitative 
interviews with COPD providers (pulmonologists, nurses, and respiratory therapists) that will elicit feedback on 
key elements of treatment design (components, methods, and milestones) and implementation (safety, 
tolerability, and acceptability) to guide treatment tailoring and foster engagement. 
 
Aim 2: Develop a multi-component behavioral treatment to address psychological risk factors among 
COPD patients. We will conduct a component analysis using single case design experiments with 15 
participants to a) examine the contribution of each treatment component to the behavioral target of smoking for 
affect regulation, and b) establish proof-of-concept on the clinical endpoint of initial cessation (>24 hours 
abstinence). Hypothesis: Behavioral treatment components will produce a) clinically significant reductions in 
smoking for affect regulation (> 30%), and b) achievement of initial cessation in > 60% of participants.  
 
Aim 3: Examine effects of psychological risk factor reduction on smoking outcome. Informed by Aim 2, we 
will conduct a pilot trial in which 62 participants are randomized to the multi-component behavioral treatment 
(9 weekly sessions) or self-guided treatment (mailing of printed self-help materials). Each participant will make 
a quit attempt at week 4. The primary outcome is number of days abstinent for 2 weeks post-quit (range = 0-14 
days); secondary outcomes are smoking status at 3 months post-quit, COPD functioning, activity avoidance, 
and depression and anxiety symptoms. Hypothesis: Participants in the behavioral treatment vs. self-guided 
treatment will demonstrate a) greater number of abstinent days, and b) longer latency to smoke during the quit 
attempt.  
 
2.0 Background / Literature Review / Rationale for the study: 
 
 
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death in the United States, 
responsible for 135,000 deaths each year.1,2 COPD is caused primarily by smoking and approximately 47% of 
those with COPD are current smokers.3 
 
Smoking cessation is imperative for COPD patients. Quitting smoking is the most effective and cost-
effective therapy for COPD4,5. As compared to smokers in the general population, COPD patients are equally 
motivated to quit6 and 
attempt to quit at equal 
rates,3,7 but are less 
responsive to smoking 
cessation treatment,8,9 with 
only 12% abstinent at 12 
months.10 COPD patients 
commonly have co-
occurring conditions – high 
nicotine dependence,11,12 
depression, and anxiety13,14 

PROTOCOL TITLE: Fresh Start Study 
 
 
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– that maintain smoking for negative reinforcement (i.e., reduction of withdrawal-related distress).15 To 
improve upon stagnant quit rates among COPD patients, novel, targeted treatment strategies are needed.  
Psychological factors are a promising treatment target. Guided by recent systematic reviews16,17 and 
our preliminary, human laboratory-based work, we propose three core psychological factors that commonly 
underlie nicotine dependence, depression, and anxiety: distress intolerance (DI; inability to withstand 
distressing states), anxiety sensitivity (AS; fear of anxiety-related sensations), and anhedonia (Anh; diminished 
sense of pleasure or interest). As shown in Figure 1, we propose that each of these factors interacts with clinical 
symptoms specific to COPD to drive smoking persistence. First, DI promotes smoking for distress termination 
(i.e., during frequent bouts of acute withdrawal caused by high nicotine dependence) and results in exacerbation 
of COPD-specific symptoms. Second, AS promotes smoking for anxiety reduction especially when COPD 
patients experience distressing symptoms such as shortness of breath18 and leads to avoidance of activities that 
may increase these symptoms (i.e., physical exercise, engagement in pulmonary rehabilitation). Third, as 
activity avoidance cuts off contact with natural rewards in the environment, Anh promotes smoking for pleasure 
enhancement. Lastly, all three factors contribute to smoking persistence and perpetuate depression and anxiety 
symptoms, creating a cycle which serves as a powerful barrier to quit even among highly motivated individuals. 
In summary, these psychological factors index an individual’s tendency to smoke to regulate affect (i.e., to 
enhance pleasure or reduce distress) in response to COPD-specific states and underlie smoking persistence 
among COPD patients.  
 
Behavioral treatment can address psychological factors and promote cessation. Cognitive-
behavioral treatment strategies have been shown to effectively reduce these psychological factors among a 
general population of cigarette smokers19,20 as well as individuals with chronic illness,21 elevated depressive 
symptoms,22 and substance use disorders.22-25 These treatment strategies reduce reliance on smoking for affect 
regulation26,27 and improve cessation rates.26,28,29 Ours will be the first study to adapt a behavioral treatment to 
specifically target these psychological factors among COPD patients.  Effectively addressing psychological 
conditions is also shown to increase COPD patients’ exercise tolerance, engagement in pulmonary 
rehabilitation, and quality of life.30,31 Thus, this intervention has potential to obviate a large number of health 
burdens among COPD patients. 
 
3.0  Inclusion and exclusion criteria: 
 
 
For COPD patients in Phases 2-3, study eligibility will be determined as follows: Inclusion criteria: 
Eligible participants will be males and females who are 1) diagnosed with COPD (as documented in electronic 
health record [EHR]), 2) daily cigarette smokers (> 5 cigarettes per day over past 30 days), 3) intend to quit 
smoking within the next 60 days, 4) report at least moderate level of smoking for affective regulation (SMQ-
R32,33 coping subscale score >30), 5) have access to a smartphone, tablet, or computer, and 6) are able to 
communicate fluently in English. Exclusion criteria: We will exclude based on presence of any concurrent 
medical or psychiatric condition which would preclude ability to provide informed consent or perform study 
procedures (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia), as determined by the 
treating physician or study PI. 
 
We will not include adults unable to consent, pregnant women, prisoners, or individuals under the age of 
18. Socioeconomically disadvantaged persons will be included in this study, but not targeted for recruitment. It 
is possible that Rush University employees or students may choose to participate. However, status of 
participation in the study will be independent of the participant’s work or school activities. 
 
4.0  Procedures Involved: 
 
Overall Study Design 
 
The project includes a total of three phases that will each recruit an independent sample of participants, 
as shown in Table 1 below. A total of 97 participants will be recruited for the current study. First, Phase 1 will 

PROTOCOL TITLE: Fresh Start Study 
 
 
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involve qualitative interviews with COPD healthcare providers (N=20). In Phase 2, we will conduct a series of 
single case design experiments in which COPD patients (N=15) will complete behavioral treatment components 
before an attempt to quit smoking. Lastly, Phase 3 consists of a pilot randomized, controlled trial comparing the 
behavioral intervention to minimally-enhanced usual care (N=62).  
 
  
Phase 2: Single Case Design Experiments  
 
Procedure. Single case 
design experiments offer a rigorous 
and methodologically-sound 
procedure to test within-subject 
change across conditions (i.e., 
baseline to active treatment) in a 
replication context to efficiently 
evaluate interventions.34,35 
Specifically, we will conduct a 
component analysis using a series 
of 15 single-case design experiments. As shown in Figure 2, a non-concurrent multiple baseline design (1-3 
weeks in length) will be used across participants to observe if change in the behavioral target occurs when, and 
only when, a treatment module is introduced, thus controlling for the effects of extraneous factors.34 The overall 
goal of Phase 2 is to examine whether each treatment component in isolation follows the hypothesized pathway 
in Figure 3.  
 
Length of Study Participation. As shown in Figure 2, participants who are randomized to the short 
baseline condition will be enrolled in the study for approximately 35 days; participants randomized to the long 
baseline condition will be in the study for approximately 50 days. 
 
Pre-Screening and Baseline Session. Participants will complete an initial pre-screening questionnaire 
administered by telephone or computer, using surveys developed in REDCap software, version 6. Eligible 
participants will be scheduled for an in-person baseline session approximately 1.5 hours in length. The 
following procedures will be completed at the baseline session: 
1. Informed consent/HIPAA forms will be reviewed with participants, during which they will hear a 
description of all study procedures, risks, benefits, and information about the study medication. Participants’ 
questions will be answered. Following this discussion, the combined informed consent and HIPAA form 
will be completed. 
2. A carbon monoxide (CO) breath assessment will be used to measure recent tobacco exposure. The handheld 
device uses a disposable mouthpiece, reports CO in parts per million (ppm), and takes about three minutes 
to administer.  
3. Participants will complete questionnaire measures of smoking-related variables, psychological factors, and 
COPD-related variables, as described below. 
4. Following a randomization scheme programmed in REDCap, participants will be randomized to baseline 
length (long or short) and treatment condition (Mindfulness, Interoceptive Exposure, or Behavioral 
Activation, described below). 
5. Lastly, participants will be provided with instructions on electronic diary completion. The study team 
member will provide each participant with written instructions on how to complete the REDCap 
questionnaires via smartphone, tablet, or computer. All participants will be provided with contact 
information for the research team should they have any questions about the electronic diary questionnaires.  
 
 Electronic Diary (ED) Assessment. ED assessments have demonstrated high compliance rates (>80%) 
among older adults, including those with chronic illness.36,37 Thus, we believe these methods are feasible for the 
current study. Participants will be prompted to complete nightly ED assessments via REDCap each evening 
(between 7:00 and 10:00 pm) during both baseline phase and treatment phase of the study. This will yield up to 
approximately 29 assessment timepoints for participants in the short baseline condition and 43 assessment 
timepoints for participants in the long baseline condition. In order to allow for the five-week treatment session 

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window described below, we will provide compensation for up to 36 assessment timepoints in the short baseline 
condition and up to 50 assessment timepoints in the long baseline condition.    
 
Treatment Sessions. Each treatment component consists of 4 weekly in-person, individual sessions of 
45-60 minutes each with a trained study therapist. We will attempt to schedule treatment sessions on the same 
day of each week, but will allow for a five-week window to complete all four sessions, to accommodate some 
rescheduling of sessions if needed. Session content is described in the Behavioral Treatment Components 
subsection below. 
 
Target Quit Date. Each participant will set a target quit date on the day following the final treatment 
session. They will be instructed not to smoke starting at midnight (12:00 am) on their designated quit date.   
 
Remote CO Assessment. At the final treatment session, participants will be provided with a carbon 
monoxide (CO) monitor and trained to submit a breath CO sample via REDCap at 24-hours post-QA (i.e., upon 
waking on Day 30 for the short baseline condition or Day 44 for the long baseline condition). This procedure 
will be used to conduct remote bioverification of smoking status. Developed by Dr. Dallery, a study 
collaborator at the University of Florida,38-43 this method has demonstrated feasibility among a variety of 
populations, including older adults.44 We will provide each participant with written instructions and contact 
information for the research team should they have any questions about the CO monitor.  
 
End-of-Treatment Session. Participants will return for an end-of-treatment (EOT) study assessment 
approximately one week following their target quit date. At this assessment, participants will complete a final 
set of questionnaire measures on smoking-related variables, treatment implementation variables, and the 
behavioral target of smoking for affect regulation, described below. Participants will also return the CO monitor 
device and receive compensation for all completed ED assessments.  
 
Behavioral Treatment Components. Treatment components are cognitive-behavioral strategies 
adapted from the Unified 
Protocol (UP) for the 
Transdiagnostic Treatment 
of Emotional Disorders45. 
For the current study, we 
will evaluate only the three 
modules that have been 
shown to reduce reliance 
on smoking for affect 
regulation before a QA26,27 
and provide skills to cope with acute nicotine withdrawal after quitting:26,28,29 Mindfulness, Interoceptive 
Exposure, and Behavioral Activation (described below).  
Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service 
guidelines46, are incorporated in each treatment module. All participants will be provided with the American 
Lung Association Freedom from Smoking guide to aid in their quit attempt. 
Component 1: Mindfulness. This module introduces mindfulness training skills, with the goal of 
cultivating nonjudgmental, present-focused experience of emotions, thoughts, and physical sensations related to 
cigarette smoking. By progressing though a series of experiential exercises (e.g., awareness of the breath, 
anchoring in the present), this module seeks to reduce maladaptive attempts to control negative emotions and 
facilitate tolerance of the physical and emotional symptoms of nicotine withdrawal. 
Component 2: Interoceptive Exposure (Practice Quitting). This module introduces interoceptive 
exposure, a technique in which participants purposefully and systematically complete exercises to evoke 
physical sensations typically associated with anxiety and distress, in order to reduce fear and avoidance of these 
sensations. Interoceptive exercises will focus on a gradual exposure to nicotine withdrawal symptoms, through a 
series of ‘practice quit attempts’ (i.e., brief periods of smoking abstinence without intention to permanently 
quit). 
 
Component 3: Behavioral Activation (Countering Emotional Behaviors). Lastly, this module introduces 
behavioral activation, which seeks to increase positive emotions by systematically introducing greater 

PROTOCOL TITLE: Fresh Start Study 
 
 
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engagement with natural rewards. Treatment sessions focus on the identification of avoidance strategies, 
including cigarette smoking as a coping strategy for negative emotions. The goal of this treatment module is to 
replace smoking with adaptive coping strategies to facilitate contact with and enjoyment of reinforcing activities 
that are incompatible with smoking.   
 
Treatment Fidelity. All treatment sessions will be delivered by trained study counselors, supervised by 
the PI, a licensed clinical psychologist.  Dr. Mathew has extensive experience in cognitive-behavioral therapy 
for mood and anxiety disorders, as well as behavioral counseling for smoking cessation. She obtained 
specialized training in delivery of the proposed intervention at the Unified Protocol Institute at Boston 
University in October, 2017. Sessions will be audio recorded, with 20% of sessions reviewed by an independent 
evaluator using standardized fidelity ratings for each UP module. 
 
Measures.  
 
Psychological Factors. Anhedonia will be assessed with the Environmental Reward Observation Scale 
(EROS),47 which measures amount of pleasure experienced from daily activities. Anxiety sensitivity will be 
assessed with the Anxiety Sensitivity Index (ASI-3),48 a measure of tendency to fear body sensations. Distress 
intolerance will be assessed with the Distress Tolerance Scale (DTS),49 which assesses perceived tolerance of 
negative physical or emotional states.  
 
Smoking-Related Variables. We will administer a Smoking History Questionnaire to assess baseline 
smoking characteristics. We will administer validated PROMIS measures of nicotine dependence50 and smoking 
coping expectancies.51 We will administer the Cessation Fatigue Scale,52 a measure of perceived tiredness of 
trying to quit smoking. Smoking 
status will be assessed with timeline 
follow-back methods, and will be 
supplemented with an assessment of 
expired carbon monoxide (CO) at in-
person assessment sessions to 
provide bioverification of smoking 
status. Lastly, an outside-study 
treatment review will be conducted to 
identify any pharmacotherapy or 
behavioral therapy for smoking 
cessation received outside of the 
study. 
 
COPD-Related Variables. We 
will conduct a chart review to 
identify participants’ most recent six-
minute walk test53 and spirometry 
(FEV1) values prior to COPD 
hospitalization. The chart review will 
also be used to supplement 
participants’ self-report of any 
hospitalization for COPD at the time 
of the 3-month follow-up assessment. 
COPD symptom impact will be 
assessed with the COPD assessment 
test (CAT),54 an 8-item questionnaire 
measuring the global impact of 
dyspnea on health status. PROMIS 
measures will be used to assess task 
avoidance and emotional response to 
dyspnea symptoms.   
Table 2. Phase 2 Study Measures 
Timepoint Assessed 
Baseline 
Treatment 
Sessions 
End-of-
treatment 
Demographic Questionnaire 
X 
 
 
Contact Form 
X 
 
 
Psychological Factors 
 
 
 
Anxiety Sensitivity Index 
X 
 
X 
Environmental Reward Observation Scale  
X 
 
X 
Distress Tolerance Scale  
X 
 
X 
Smoking-Related Measures 
 
 
 
Smoking Motives Questionnaire-Revised  
X 
 
 
Smoking History Questionnaire 
X 
 
 
PROMIS-Nicotine Dependence 
X 
 
X 
PROMIS-Coping Expectancies 
X 
 
X 
Cessation Fatigue Scale 
X 
 
X 
Smoking timeline follow-back 
X 
 
X 
CO assessment 
X 
X 
X 
Outside-study treatment review 
X 
X 
X 
COPD-Related Measures 
 
 
 
Six-minute walk test  
X 
 
 
Spirometry (FEV1) 
X 
 
 
Charlson Comorbidity Index 
X 
 
 
COPD Assessment Test 
X 
 
X 
PROMIS- Dyspnea Task Avoidance 
X 
 
X 
PROMIS- Dyspnea Emotional Response 
X 
 
X 
Depression and Anxiety Measures 
 
 
 
PROMIS- Depression short form 
X 
 
X 
PROMIS- Anxiety short form 
X 
 
X 
Treatment-Related Measures 
 
 
 
Freiberg Mindfulness Inventory 
X 
X 
X 
Avoidance and Inflexibility Scale 
X 
X 
X 
Behavioral Activation for Depression 
Scale 
X 
X 
X 

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Depression and Anxiety Symptoms. PROMIS short forms will be used to assess past-7 day depression 
and anxiety symptoms.55,56 
 
 
Treatment Implementation. To assess treatment implementation, participants will complete process 
measures at each treatment session assessing skill acquisition specific to each module (i.e., Freiberg 
Mindfulness Inventory,57 Avoidance and Inflexibility Scale,58 and Behavioral Activation for Depression Scale,59 
respectively).   
 
Behavioral Target. The behavioral target will be smoking for affect regulation, as measured by 13 items 
from the Smoking Motives Questionnaire-Revised (SMQ-R).33,60 Items are adapted from a measure of drinking 
motives and have been validated to assess coping motives across classes of substance use.32,60,61 SMQ-R items 
can be modified to assess within-subject, state-like motives for use via ecological momentary assessment62 and 
have demonstrated good internal consistency.63 Further, these items are sensitive to treatment-related change 
(i.e., reduced as a function of a brief behavioral intervention)64,65 and specifically related to reductions in 
substance use and associated problems, above and beyond non-affective motives.64,65 Responses are scored 
from 0 (not at all) to 100 (extremely) and averaged to index the overall tendency to smoke for affect regulation. 
Threshold of clinically-significant change is set at > 30%, as this change magnitude was associated with 
substance use outcomes in prior studies.64,65 Specific items which index smoking for distress termination (e.g., 
“To turn off negative thoughts about myself”), anxiety reduction (e.g., “Because it helped me when I was 
feeling nervous”), and pleasure enhancement motives (e.g., “To help me feel more positive about things in my 
life”) will be examined separately in follow-up exploratory analyses.  
 
Clinical Endpoint. The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-
treatment, as verified by CO < 5 ppm,66,67 for at least 60% of participants (i.e., 3 of the 5 participants receiving 
each module), as this is consistent with rates of initial abstinence achieved by established smoking cessation 
treatments.68,69 We chose this endpoint because it is highly sensitive to treatment effects,70 strongly predictive of 
long-term abstinence,69,71 and especially relevant for smokers with elevated psychological risk factors who are 
vulnerable to early lapse.72,73 
 
Procedures to Minimize Risk 
 
Throughout the study phases, we will implement procedures to minimize risk to participants. First, the 
risk of participant distress will be minimized through ongoing training and supervision of study staff to maintain 
a good working relationship with participants, thoroughly explain all procedures and address participant 
questions, and consult with the PI, a licensed clinical psychologist, as needed. The PI will respond to all 
situations of participant distress or worsening of mental health symptoms, and will provide appropriate 
psychiatric referrals.  
 
Second, participants will be thoroughly debriefed on common symptoms of nicotine withdrawal. In 
Phases 2-3, these symptoms will be monitored throughout the active treatment phase and coping with nicotine 
withdrawal symptoms will be addressed in treatment (either through behavioral counseling or provision of self-
help smoking cessation materials).  
 
Third, the risk of potential loss of confidentiality will be minimized through supervision of study staff, 
storage of all private health information on a secure network drive and the use of numeric code identifiers.  
Only the study staff will have access to the master list of participants’ names and codes. Dr. Mathew will 
provide oversight of the maintenance of patient confidentiality and will report any breaches of confidentiality to 
the IRB. All staff with access to the data with have completed Rush University requirements for the responsible 
conduct of research including Collaborative Institutional Training Initiative (CITI) training. 
 
5.0 Multiple sites:  
 
 
N/A 
 
6.0  Incomplete Disclosure or Deception: 

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N/A 
 
7.0  Recruitment: 
 
 
Participants will be recruited from the Departments of Internal Medicine and Pulmonary Medicine at 
Rush University Medical Center, under the supervision of study co-investigator Dr. Zimmermann. The 
Department of Internal Medicine provides approximately 87,000 primary care visits per year at 10 sites in the 
medical center and community-based clinics in the Chicago area. The department sponsors more than 50 active 
clinical trials and interfaces with the Electronic Data Warehouse to facilitate clinic-based recruitment. We 
expect that 40% of patients with COPD identified through clinic-based recruitment are current cigarette 
smokers.3,74  
Trained study personnel will identify potential participants through reviewing Epic data requests, 
screening outpatient clinic schedules, and provider referral. Potentially eligible patients who are identified 
through chart review process will be mailed a recruitment letter to describe the research study and inform them 
that study staff will be calling them within the next week. Patients will have the opportunity to ‘opt out’ by 
calling the study team if they are not interested in being contacted.  
Study recruitment will also be supplemented by partnerships with Rush University organizations such as 
the Tobacco Oversight Committee and Rush Lung Institute, and community organizations, including the 
Respiratory Health Association (RHA) and American Lung Association (ALA). Dr. Mathew will share IRB-
approved recruitment materials with these organizations through multiple communication channels (i.e., 
newsletters, e-newsletters, website postings) to reach potentially eligible COPD patients and providers. She and 
other study team members will also attend events and meetings hosted by these organizations and post sign-up 
sheets where interested individuals may provide their contact information. The study team will call and/ or 
email these individuals to describe the study and assess interest in participating and eligibility, if applicable.  
 
8.0  Consent Process:  
 
 
We will obtain electronic informed consent via the REDCap e-consent template. After 
completing the phone screener, those who remain interested and eligible for the study will be 
immediately emailed or texted a link to the appropriate IRB-approved online consent form in REDCap. 
Study staff will discuss the consent form while on the phone with the participant following the screening 
process. If the participant does not have time for this discussion, a second phone call will be arranged. 
We will attempt to conduct the signature process in one continuous session with the participant. If this is 
not possible (e.g., the participant uses a cell phone as their only connected device, and is unable to 
simultaneously talk on the phone and view the REDCap e-consent), study staff will follow the consent 
process below to obtain verbal consent. Study staff will then follow up with the participant by email/ 
text to obtain an electronically signed copy of the consent form as soon as possible after the phone call 
has ended.  
 
Consenting procedures will follow Rush IRB guidance for the use of electronic informed consent 
to ensure best practices are followed in remotely obtaining informed consent. Study staff will first verify 
that: 1) the form the participant received is the currently approved version, 2) all pages of the consent 
were received, and 3) the participant can read all pages of the consent. Study staff will verify the identity 
of the participant by asking their date of birth. Study staff will then review all information in the consent 
form, similarly to how this discussion would be conducted in an in-person format. Participants will be 
provided with ample time to review the consent and ask any questions they may have. Those who 
remain interested will provide an online signature on the REDCap consent form.  A PDF version of the 
consents will be emailed or texted to the participant. Informed consent will be obtained prior to any data 
collection or study procedures. There is no waiting period between informing the prospective subject of 

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their eligibility and obtaining the consent. Non-English speaking individuals, individuals under the age 
of 18, cognitively-impaired adults, and adults unable to consent will not be included in the current study.  
 
9.0  Process to Document Consent:  
 
 
Documentation of the consent process will occur within the REDCap e-consent project (i.e., eConsent 
form with electronic signature for each study participant, Consent Collection Form, and Consent Process 
Documentation Form). 
 
10.0  Risks to Participants: 
 
 
First, participants will be asked to report on their smoking, COPD symptoms, and symptoms of 
psychological disorders. As a result, they may experience discomfort or distress from providing self-report of 
private, potentially embarrassing information. Second, participants may experience nicotine withdrawal-related 
distress as a result of smoking cessation in Phases 2 and 3. Third, while we will make every effort to protect 
privacy and keep data confidential, a risk of potential for loss of confidentiality also exists.  
 
11.0  Potential Benefits to Participants:  
 
 
Participants may not directly benefit from the proposed research, but will contribute to the research 
literature on improving smoking cessation treatment for individuals with COPD. The risk/benefit ratio is seen as 
highly favorable, as the potential benefits of quitting smoking for improving COPD functioning and preventing 
the development of other smoking-related illnesses greatly outweigh the potential of temporary withdrawal 
discomfort and frustration associated with quitting. 
 
12.0  Financial Compensation: 
 
 
Participants will be provided with financial compensation for completing study assessments, as shown in 
table below. They will be paid $10 to offset travel costs for each in-person study visit. Participants are only 
eligible for payment if all study procedures at a given assessment are completed. For Study Phase 3, payments 
will be provided in the form of a mailed check or reloadable debit card (Greenphire ClinCard). Participants will 
not be responsible for any costs associated with participating in the research. 
 
Table 4. Financial Compensation per Participant by Study Phase 
 
Visit 
Compensation 
Travel 
Compensation 
Total 
Phase 2 
 
 
 
   Baseline assessment 
$20 
$10 
$30 
   Electronic diary assessment  
$2 x up to 50 
total 
N/A 
Up to $100 
   Treatment sessions 
N/A 
$10 x 4 total 
$40 
   CO assessment 
$10 
N/A 
$10 
   End-of-treatment assessment 
$20 
$10 
$30 
   TOTAL 
 
 
Up to $210 
 
13.0  Provisions to Protect the Privacy Interests of Participants: 
 

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The risk of potential loss of confidentiality will be minimized through training and ongoing supervision 
of study staff as well as storage of all private health information on a secure network drive (detailed in section 
14.0 below).  
 
14.0  Confidentiality and Data Management: 
 
Data Management 
 
Sources of data include a) consent forms, b) self-report questionnaires, c) expired CO values, d) digital 
audio recordings, and e) chart review variables. Data will be stored for a minimum of 7 years after study 
completion on a secure Rush University network drive and in a double-locked office suite within the 
Department of Preventive Medicine. At the conclusion of the study, all data will be stripped of identifiers and 
archived for future analysis.  
 
Procedures to secure the data include training and ongoing supervision of study staff; use of an 
encrypted, digital recording device; storage of all private health information on a secure network drive; and the 
use of numeric code identifiers. Digital audio recordings will be identified by numeric code only, and submitted 
to the transcription service via their secure, cloud-based Exavault server. Dr. Mathew will be responsible for 
data and safety monitoring activities. She will provide oversight of the maintenance of patient confidentiality 
and will report any breaches of confidentiality to the IRB. She will report any changes to the study's risk/benefit 
ratio to the IRB. Only the study investigators will have access to the master list of participants’ names and 
codes. All co-investigators and study personnel have completed CITI training in human subjects research. 
 
All questionnaire measures will be completed using REDCap data management software, which allows 
real-time data quality control measures (e.g., requiring fields to be completed, restricting ranges of acceptable 
values). We will also complete data quality checks by automatically setting each form status to ‘Unverified’ 
upon initial entry. Study staff will click on each unverified record, check for data quality and completeness, and 
select either ‘Complete’ or ‘Incomplete.’ They will then lock the form to prevent further changes, with 
administrative privileges set to unlock forms only for the study investigators. REDCap data will be downloaded 
and backed up on the secure Rush University network drive on an ongoing, monthly basis. 
 
Data Analyses 
 
Phase 2 Data Analyses. We will examine change scores in the behavioral target over the course of 
treatment (i.e., with visual interpretation and calculation of non-overlapping parameters) and rates of achieving 
24-hour abstinence by treatment module. Only those treatment components that demonstrate effects as specified 
in the hypothesized pathway on both milestones across participants will be included in a finalized treatment 
manual for use in Phase 3. We will secondarily examine magnitude of effect size for each treatment component 
on the behavioral target, relative to baseline, with Shadish’s d,75 a measure of effect size specifically for single-
case designs and equivalent to Cohen’s d. If all effect sizes are medium or greater (> 0.5), we will include all 3 
components in the multi-component treatment in Phase 3; otherwise, we will select the two components with 
the highest effect sizes. 
 
15.0  Data Monitoring Plan to Ensure the Safety of Participants: 
 
 
In collaboration with Dr. Hitsman and co-mentors, Dr. Mathew has developed a data safety and 
monitoring plan for this project that is commensurate with the with the risks, nature, size, and complexity of the 
study. The proposed study has been designated as a minimal risk study by the Rush University IRB, consists of 
a behavioral intervention only (no medication), and will occur at a single site. Further, pilot trial procedures 
have been updated to be conducted on a fully remote basis, with all study contacts occurring via phone or online 
assessment, to facilitate social distancing. Given these study characteristics, a Data Safety Monitoring Board 
will not be convened. As detailed below, data and safety monitoring for the pilot trial (i.e., Study 3 of the 
current project) will consist of oversight by the PI, in coordination with the Rush University Institutional 

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Review Board (IRB). The PI will be assisted by study Co-Investigator, Dr. Laura Zimmermann, a board-
certified Internal Medicine physician and Medical Director of the Rush University Prevention Center.   
 
Data Acquisition and Maintenance 
 
Data will be collected using REDCap (Research Electronic Data Capture) electronic data capture tools 
hosted at Rush University. REDCap is a secure, web-based software platform designed to support data capture 
for research studies. REDCap provides 1) an intuitive interface for validated data capture; 2) audit trails for 
tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads 
to common statistical packages; and 4) procedures for data integration and interoperability with external 
sources. 
The PI will be responsible for maintaining the security of the data stored both in REDCap and on the 
secure network server. Data will only be identified with the study ID of the participant. The codes that link the 
name of the participant and the study ID will be kept confidential by the PI on a secure network drive, with 
permissions set on an as needed basis. All data will be stored on the Department of Preventive Medicine’s MS 
SQL server relational database. Rush data network security and availability on DMC servers is supported by 
Rush Information Services servers. Rush University has two data centers on our Chicago campus at 1700 W. 
Van Buren St. and 711 S. Paulina St. All servers are located in the locked data centers, with access limited to 
authorized personnel via a biometrics access system. Data centers each have Sinorix™ 227 and Ecaro-25™ 
Clean Agent Chemical Fire Suppression Systems, redundant backup diesel generator and uninterruptible power 
supply (UPS) systems, and redundant chillers for cooling. 
The Rush data network is segmented and protected from the internet by a Palo Alto Networks® firewall. 
Access to the network from the internet requires multi-factor authentication. All network users are required to 
have a unique login and password. The passwords must be changed every 180 days and must be complex (i.e., 
must have: a capital letter, small letter, number, special character, and be at least 8 characters in length). Change 
management policies and procedures are in place to protect the integrity of the systems. A Change Management 
Review Board meets once each week to review all proposed software and hardware changes. Systems are 
backed-up nightly and the data is duplicated and sent to an offsite storage facility.  
 
Monitoring of Data Quality 
 
We will embed data validation checks within each questionnaire (i.e., required items, allowable ranges 
of response values) to ensure valid data is entered by participants at the time of data collection. 
Study staff 
will complete a verification process for each questionnaire record before ‘locking’ the record to prevent further 
changes. Only the PI will have administrative privileges to unlock completed records. Our study database will 
also include a scheduling program that tracks when research contacts occur and when visits or calls need to be 
scheduled based on the participants’ condition. 
 
Monitoring of Safety Data 
 
Overall framework. The PI will be responsible for monitoring the safety and efficacy of the project, 
executing the Data and Safety Monitoring (DSM) plan, and complying with the reporting requirements. She 
will be assisted by Dr. Laura Zimmermann (study Co-Investigator), a board-certified Internal Medicine 
physician and Medical Director of the Rush University Prevention Center.  The PI will provide a summary of 
the DSM report to NHLBI on an annual basis as part of the progress report. The DSM report will include the 
participants’ sociodemographic characteristics, expected versus actual recruitment rates, retention rates across 
all study assessments, any quality assurance or regulatory issues that occurred during the past year, summary of 
Adverse Events (AEs) and Serious Adverse Events (SAEs), and any actions or changes with respect to the 
protocol. The DSM report to NHLBI will also include, when available, the results of any data analyses 
conducted. No interim analyses of the data are planned. 
 
The PI will ensure the project is conducted according to the protocol. She will oversee data quality 
checks on a regular basis to ensure completeness and accuracy of ongoing data collection. Through weekly 
meetings with project staff, the PI will discuss issues related to progression of the project and factors that may 

PROTOCOL TITLE: Fresh Start Study 
 
 
Page 12 of 17 
affect outcome including review of data quality and security, recruitment, and retention. The PI will be 
available for meetings with project staff outside the weekly allotted time to discuss any issues that may arise, 
including AEs or unanticipated problems. The PI will ensure all project staff have completed research ethics 
training as required by the IRB and are thoroughly trained on study procedures.  
 
Adverse events. Adverse events are defined as any untoward or unfavorable medical occurrence in a 
human subject, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or 
disease, temporally associated with the subject’s participation in the research, whether or not considered related 
to the subject’s participation in the research. At all assessment points (i.e., Days 0, 28, 42, 56, and 120), we will 
monitor participant reports of adverse events related to: 1) nicotine withdrawal symptoms; 2) COPD symptoms, 
including COPD exacerbation, defined as an acute worsening of symptoms of COPD requiring new or increased 
doses of systemic corticosteroids, antibiotics, and/or emergency treatment or hospitalization; 3) utilization of 
outside study treatment (e.g., smoking cessation, mental health services, pulmonary rehabilitation, and 
medication use); and 4) any other symptoms participants believe may be related to study participation. 
Procedures for identifying and reviewing adverse events, including SAEs, are as follows: The research assistant 
will review each assessment to identify symptoms of moderate or greater severity, indicated by 1) Minnesota 
Tobacco Withdrawal Scale score > 24, 2) COPD Assessment Test score > 20, 3) any report of acute COPD 
exacerbation since the prior assessment, and/ or 4) any other symptom identified by participants to be of 
moderate or greater severity. In all cases of an assessment indicating symptoms of moderate or greater severity, 
an assessment summary will be emailed to the PI and study Co-I Dr. Zimmermann within 24 hours. Drs. 
Mathew and Zimmermann will review the assessment summary and respond within 24 hours to advise on 
appropriate actions to be taken. Actions may include continuing to monitor symptoms, contacting the 
participant for further assessment, advising that the participant contacts his or her healthcare provider, or 
advising that the participant presents to the Emergency Room.   
 
Serious adverse events. A serious adverse event is defined as follows: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
disability/incapacity, a congenital anomaly/birth defect, or a medically significant event that may require 
medical or surgical intervention. Risks of participation will be continually monitored and appropriate measures 
implemented in cases of unforeseen adverse events. If a serious adverse event occurs, the study PI will notify 
the IRB and the appropriate NHLBI program official. These events will be reported regardless of whether they 
appear to be related to study procedures. A summary of the SAEs that occurred during the previous year will be 
included in the annual progress report to NHLBI and the IRB Continuing Review. 
Unanticipated problems. All unanticipated problems will be reported to the PI and study Co-I Dr. 
Zimmermann within 24 hours by research staff. The PI will notify the Rush University IRB and the appropriate 
NHLBI program official within five (5) business days of discovering any unanticipated problems involving 
risks to participants and others. 
 
Trial Registration.  
 
This project includes an applicable trial which requires registration on ClinicalTrials.gov. The PI will be 
responsible for compliance of registration and reporting of trial outcomes.  
 
16.0  Data and if applicable, Specimen Banking:  
 
 
N/A 
 
17.0  Qualifications to Conduct Research and Resources Available: 
 
 
The primary investigator, Dr. Mathew, is a licensed clinical psychologist with expertise in human 
laboratory-based and clinical research within the field of smoking cessation. All study staff will be directly 
supervised by Dr. Mathew and have been trained in human subjects research and current study procedures.  

PROTOCOL TITLE: Fresh Start Study 
 
 
Page 13 of 17 
            Ms. Chelsea Cox, study counselor, is an advanced graduate student in the Clinical Psychology Program 
at the University of Illinois-Chicago. She will conduct all study-related activities as a Rush University 
Independent Contractor. Ms. Cox has received training in cognitive-behavioral therapy, and will be trained and 
supervised by Dr. Mathew to deliver the study intervention. 
 
Dr. Laura Zimmermann, study co-investigator, is a board-certified internal medicine physician (PCP) 
and medical director of the Rush University Prevention Center. Dr. Zimmermann will primarily assist the study 
PI with eligibility determination and medical oversight of study participants.  
 
 
 
 

PROTOCOL TITLE: Fresh Start Study 
 
 
Page 14 of 17 
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