Conditions: Tobacco Use Tobacco Smoking Tobacco Use Cessation Tobacco Use Disorder Schizophrenia Schizoaffective Disorder
Keywords: tobacco cigarette schizophrenia schizoaffective disorders smoking cessation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 34
Healthy volunteers: no

Brief summary:
Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.

Detailed description:
The investigators will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers with serious mental illness to quit using a therapy approach focused on increasing task persistence.

We will provide free, weekly individual telehealth video counseling sessions for 8 weeks and 10-weeks' worth of the nicotine transdermal patch (an FDA-approved smoking cessation product available over the counter). All sessions will be video recorded for treatment integrity and supervision.

The investigators hypothesize that 1) the PTSC-S intervention will be acceptable to participants, and the study will be feasible to conduct. We will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified \<8ppm).

Arms:
arm 1: Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.

Interventions: intervention 1: Persistence Targeted Smoking Cessation in SMI (PTSC-S) intervention 2: Nicotine patch
Intervention descriptions: intervention 1: All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth intervention 2: All participants will receive 10 weeks of nicotine patch

Protocol document:
Prot_SAP_001.pdf: 
 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
1 
 
 
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IRB Form Version v01022018 
 
STUDY INFORMATION 
 
Title of Project: Persist to Quit: Telehealth Counseling for Smokers with Serious Mental Illness 
 
Principal Investigator: 
 
 
Name: Marc L. Steinberg, Ph.D. 
Division & Department: Psychiatry  
Contact Information:  732-235-4341, marc.steinberg@rutgers.edu  
 
 
PROTOCOL VERSION AND DATE: V22 3/28/2022 
NCT03873337 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
2 
 
 
RESERVED FOR IRB STAMP 
DO NOT MODIFY THIS SPACE 
 
 
 
IRB Form Version v01022018 
 
 
 
 
Table of Contents  
 
1.0 
Research Introduction 
 
 
1.1 
Purpose/Specific Aims 
 
 
1.2 
Research Significance 
 
 
1.3 
Research Design and Methods 
 
 
1.4 
Preliminary Data 
 
 
1.5 
Sample Size Justification 
 
 
1.6 
Study Variables 
 
 
1.7 
Drugs/Devices/Biologics 
 
 
1.8 
Primary Specimen Collection 
 
 
1.9 
Interviews, Focus Groups, or Surveys 
 
 
1.10 
Timetable/Schedule of Events 
 
 
2.0 
Project Management 
 
 
2.1 
Research Staff and Qualifications 
 
 
2.2 
Resources Available 
 
 
2.3 
Research Sites 
 
 
3.0 
Multi-Site Research Communication & Coordination 
 
 
3.1 
Outside Research 
 
 
4.0 
Research Data Source/s 
 
 
4.1 
Primary Data – Subjects and Specimens 
 
 
4.2 
Subject Selection and Enrollment Considerations 
 
 
4.3 
Subject Randomization 
 
 
4.4 
Secondary Subjects 
 
 
4.5 
Number of Subjects 
 
 
4.6 
Consent Procedures 
 
 
4.7 
Special Consent Populations 
 
 
4.8 
Economic Burden and/or Compensation For Subjects 
 
 
4.9 
Risks to Subjects 
 
 
4.10 
Secondary Data – Record/Chart Reviews, Databases, Tissue Banks, Etc. 
 
 
4.11 
Chart/Record Review Selection 
 
 
4.12 
Secondary Specimen Collection 
 
 
5.0 
Special Considerations 
 
 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
 
 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
 
 
5.3 
NJ Access to Medical Research Act 
 
 
5.4 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
 
 
6.0 
Research Data Protection and Reporting 
 
 
6.1 
Data Management and Confidentiality 
 
 
6.2 
Data Security 
 
 
6.3 
Data Safety And Monitoring 
 
 
6.4 
Reporting Results 
 
 
6.5 
Data Sharing 
 
 
7.0 
Data and/or Specimen Banking 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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8.0 
Other Approvals/Authorizations 
 
 
9.0 
Bibliography 
 
 
1.0 Research Introduction 
 
1.1 Purpose/Specific Aims 
This study will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers 
with serious mental illness to quit using a therapy approach focused on increasing task persistence. 
A. Objectives  
We will test the feasibility, acceptability, and initial efficacy of our PTSC-S intervention when delivered via 
telehealth. 
B. Hypotheses / Research Question(s)  
1. We hypothesize that the PTSC-S intervention will be acceptable to participants, and the study 
will be feasible to conduct. 
 
2. As compared to baseline, participants will report greater task persistence as evidenced by 
reduced scores on the Thoughts About Smoking Questionnaire (TASQ).  
 
3. As compared to baseline, participants will report smoking fewer cigarettes per day at 1- and 3-
month follow-up. 
 
 
 
1.2 Research Significance (Briefly describe the following in 500 words or less): 
We created a treatment manual designed to help smokers with serious mental illness to quit smoking, in part, by 
targeting deficits in the tendency to persist in difficult or frustrating tasks (i.e., “task persistence”). While several 
measures of task persistence were not found to be significantly changed in the study, we detected a significant 
change (in the hypothesized direction) on a measure of thoughts likely to dampen task persistence as it relates to. 
Specifically, as hypothesized, scores on the Thoughts About Smoking Questionnaire (TASQ) showed significant 
decreases from baseline to the target quit date, t(16) = 7.753, p < 0.001, and maintained those significant decreases 
from baseline to end-of-treatment, t(19) = 4.537, p < 0.001. 
 
In addition, we found that the intervention was feasible and understandable. Once we began providing 
transportation to our research participants, attendance exceeded our goal of 65% of participants attending at least 
6 of 8 treatment sessions. We also found that in response to the statement, “Overall, this treatment was easy to 
understand,” 68.8% of participants endorsed “7: Totally Agree” with an additional 18.8% endorsing “6: Agree very 
much” for a total of 87.6% endorsing at least a 6 out of 7. In response to the statement, “Overall, this treatment was 
helpful,” 56.3% of participants endorsed “Totally Agree” with an additional 25% endorsing “Agree very much” for a 
total of 81.3% endorsing at least a 6 of 7. 
 
1.3 Research Design and Methods 
Overview: We will evaluate the feasibility and acceptability of our intervention (Persistence Targeted Smoking 
Cessation for Serious Mental Illness; PTSC-S) when delivered via telehealth in a single group, within-subjects design.. 
The purpose of this trial is to test the feasibility, acceptability, and initial efficacy of our PTSC-S intervention. 
A. Participant Recruiting and Screening: The project will take place remotely via telehealth to reduce patient 
burden and travel difficulties. Our Rutgers offices in New Brunswick, NJ, are located in the building next to 
a large University Behavioral Health Care outpatient clinic that serves clients with serious and persistent 
mental illness. We will recruit New Jersey resident smokers from Rutgers University Behavioral Health 
Care, from the community via our website, social media, and local flyers, via Rutgers listservs, local 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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agencies or organizations who serve mental health consumers (i.e. CHOICES; Serv Behavioral Health 
Systems, Inc.; George J. Otlowski, Sr. Center for Mental Health Care, Hunterdon Behavioral Health Care), 
and ElevateU’s  Study Recruitment Platform (more detailed information listed below under “ElevateU 
Recruitment”). We will use IRB approved language from recruitment advertisements for electronic 
communication (i.e. listservs, newsletters, ect.) with approved study sites. Potential participants will call 
our offices for a telephone pre-screen or fill out an interest form on Qualtrics that would be followed by a 
telephone pre-screen. If potentially eligible, they will be offered a more in-depth telehealth phone or video 
assisted screening after providing informed consent. If all inclusion criteria are met, they will be invited to 
participate. This is an urban area with a large low-income population and therefore a greater proportion 
of smokers than the average of 14.8% in the state of New Jersey.  Previous studies have given us the 
necessary experience with Rutgers listservs, websites, Craigslist, and use of flyers and brochures to 
maximize recruitment. 
 
ElevateU. ElevateU is a pilot recruitment platform funded by the National Institute on Drug Abuse. 
The purpose of the online platform is to match individuals with substance use disorders who wish 
to participate in research with researchers doing relevant substance use research. The recruitment 
platform is currently in a pilot phase and there is therefore no fee or contractual agreement related 
to using this National Institute on Drug Abuse funded platform.  
 
Access to ElevateU’s recruitment platform https://moshemu.com/ is provided to researchers at no 
cost. Researchers may register and create an entry describing their research study on the Moshemu 
website for potentially interested individuals to view. ElevateU advertises online, at no cost to the 
research teams for research studies. Potential research participants who see the advertisement 
may choose to click on the advertisement link which will take them to a description of the study. If 
interested in that study, the potential research participant can “sign up” to be contacted by the 
research team via email and/or phone numbers. 
 
ElevateU, as part of this registration process, potential research participants may choose to 
voluntarily provide information related to health behaviors so they can be contacted in the future 
if they match with other relevant research studies. Providing this information is voluntary. The 
ElevateU platform is seen as providing minimal risk to participants who wish to enroll in studies 
because the website and registration/data storage process is similar to methods currently being 
used in people’s day to day lives. For example, people typically register on Facebook, Reddit, and 
online patient communities such as “Patients Like Me,” where they provide information about their 
health either through free text conversations and/or responses to questions. This website will be 
using similar methods and therefore seen as minimal risk to participants.  
 
Furthermore, the primary method of identification will not be through name but through email 
address. Participants have the ability to create a new email address by creating a free email 
through tools such as gmail.com. Overall, we believe these methods involve minimal risk and have 
been used in a variety of IRB-approved studies by our team (e.g., UCLA and UC Irvine researchers) 
in the past. 
 
All information collected via ElevateU’s platform will be stored in an encrypted database. Two 
copies of the encryptions will be created with a passkey for each user (participant on the online 
recruitment platform) and for each study that the user enrolls in. If the user opts into the study, a 
copy of their data becomes encrypted with a passkey of the study. It is therefore will only ever be 
accessible to the user themselves and to the manager of any study they enroll in. 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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Recruitment using ElevateU. ElevateU will advertise, at no cost to us, for the IRB approved study, 
Persist to Quit: Telehealth Counseling for Smokers with Serious Mental Illness. Information about 
our IRB approved study will only be described in language consistent with already IRB approved 
study flyers. As noted above, potential participants who see the advertisement will have the option 
to click the link on the ad, read about the study, and opt-in to being contacted by IRB approved 
research staff if they are interested in participating or learning more about our study. 
 
When a potential participant actively opts-in to being contacted, Dr. Steinberg’s Moshemu account 
will be notified. The research team will then have access to the contact information the potential 
participant chose to provide. Dr. Steinberg’s team will be able to download a CSV file with the 
contact information and Dr. Steinberg will store this file on the secure HIPAA compliant Rutgers 
OneDrive folder. 
 
Study Procedures: A trained research assistant (who will receive weekly and as-needed supervision 
from the principal investigator) will pre-screen potential participants on the phone, followed by a pre-
baseline tutorial regarding the required technology and assist with any troubleshooting needs.  A 
research assistant will meet with participants via telephone or telehealth video platform, obtain 
informed consent via a HIPAA compatible survey platform (i.e., Red Cap or Qualtrics), and administer 
the baseline assessment battery (see Assessment Measures table below). We will divide the baseline 
assessment battery into two sessions to minimize participant fatigue if necessary. Each baseline 
assessment session will last approximately 90 minutes.  
 
The research coordinator (who will receive weekly and as-needed supervision from the principal 
investigator) will screen participants at baseline using the SCID-RV for suicide risk exclusion criteria. If 
any participant indicates high levels of depression or suicidality, we will provide phone numbers and a 
recommendation to contact Rutgers University Behavioral Health Care or the Rutgers RWJMS 
Department of Psychiatry outpatient practice. In case of imminent suicide risk, a research staff member 
will call Acute Psychiatric Services (APS) at 855-515-5700 with the research participant and the principal 
investigator will be contacted immediately. 
 
Questionnaires that are commonly used in tobacco dependence treatment studies will be used in the 
current study. Women of childbearing age will confirm in writing that they are not pregnant or nursing, 
not planning on becoming pregnant in the next three months, and that they are using effective birth 
control if they are sexually active. Carbon monoxide (CO) levels (also commonly collected in tobacco 
dependence treatment studies) will be assessed with a personal carbon monoxide monitor that 
connects to one’s mobile device and CO reading in parts per million (ppm) will be recorded. 
 
Study Intervention: We will provide free, weekly individual telehealth video counseling sessions for 8 
weeks and 10-weeks’ worth of the nicotine transdermal patch (an FDA-approved smoking cessation 
product available over the counter). All sessions will be video recorded for treatment integrity and 
supervision. 
 
HIPAA compatible video platform: We will use Microsoft Teams for all assessment and telehealth 
counseling appointments. If there are any problems connecting to Microsoft Teams, we will use 
Doxy.me or Zoom as a backup. Both Microsoft Teams, Doxy.me, and zoom are HIPAA compatible 
platforms for telehealth services. A trained research assistant will meet with each participant via 
Microsoft Teams (or via telephone) if participant is unable to use the technology without any assistance 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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to review technology, telehealth application, and assist with any technology issues prior to the 
beginning of assessment or counseling.  
 
In the event we are unable to meet with a patient using telehealth video services (e.g. because of 
internet connectivity issues), we will provide counseling using the telephone. There is a strong 
literature supporting tobacco "QuitLines", proactive telephone counseling and we would therefore still 
be providing treatment via an empirically supported format. We expect this will in the best interest of 
the patient as abruptly stopping treatment would be unethical.  
 
Emails: We may create a Google account email with a complex password for each research participant 
using their assigned ID number and short title of our study “ptscs” (i.e. ID#ptscs@gmail.com) if a 
participant does not have an email address to use. We will store this information using the HIPAA 
compliant Microsoft OneDrive cloud storage system and may assist participants with their email as 
needed. No PHI will be transmitted via this email account. This email will be used to set up the 
Smokerlyzer application for the iCO Smokerlyzer device, as the application requires an email to be sent 
to our research team with the results of their breath test. We will ask our participants to not use this 
email account for communication outside of the research study to protect their confidentiality. See 
section 1.7.2 for more on the iCO Smokerlyzer device. 
 
B. Data Points: We will collect data at baseline, at the end of treatment, and at follow up at 3-months post 
quit date. 
 
C. Duration: Participants will be active in the study for approximately 4 months. We anticipate completing 
data collection activities within 32 months. 
 
D. Primary study endpoints include baseline, at the end of treatment, and at follow up at 3-months post quit 
date. We will assess AEs on a rolling basis and report them at DSMB meetings. We will conduct an interim 
analysis after 50% of the target enrollment has completed followup assessment. 
 
1.4 Preliminary Data 
Our pilot study (N=26) examining the PTSC-S intervention demonstrated that we could successfully follow-up this 
population (20 of 26 participants were reached at end-of-treatment). In addition, we demonstrated that our 
intervention engaged our target mechanism (i.e., task persistence). While there was no change in persistence on 
multiple measures, we did find that as hypothesized, scores on the Thoughts About Smoking Questionnaire (TASQ) 
showed significant decreases from baseline to the target quit date, t(16) = 7.753, p < 0.001, and maintained those 
significant decreases from baseline to end-of-treatment, t(19) = 4.537, p < 0.001. These data indicate that our PTSC-
S intervention positively influenced cognitive aspects of our target mechanism, thus meeting milestone 1. More 
specifically, our intervention was able to positively influence cognitions likely to dampen task persistence. 
 
We also found that 57.7% of participants met our target of attending at least 6 of 8 sessions. Importantly, early in 
the study, we noticed that patients were having difficulty with transportation and therefore were missing many 
sessions. We therefore instituted a protocol in which we were able to provide transportation to the participants and 
this has increased participant attendance in treatment. When excluding the first 5 patients from the equation (those 
who did not have the benefit of transportation provided to them), we find that 66.7% of participants attended at 
least 6 of 8 of their PTSC-S treatment sessions. 
 
Finally, participants found the intervention to be easy to understand and helpful. In response to the statement, 
“Overall, this treatment was easy to understand,” 68.8% of participants endorsed “7: Totally Agree” with an 
additional 18.8% endorsing “6: Agree very much” for a total of 87.6% endorsing at least a 6 out of 7In response to 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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the statement, “Overall, this treatment was helpful,” 56.3% of participants endorsed “Totally Agree” with an 
additional  25% endorsing “Agree very much” for a total of  81.3% endorsing at least a 6 of 8. 
 
1.5 Sample Size Justification 
Based on data from the R21 phase of the study, we can expect a large effect (Cohen’s dz = 1.28) of the intervention 
on task persistence as measured by the Thoughts About Smoking Questionnaire (TASQ). We detected a change in 
mean(SD) scores, in the predicted direction, from 4.371(1.0) at baseline to 3.218(1.1) at follow-up. An effect of dz = 
1.28 setting power at 80% and alpha at 0.05 suggests we need N = 6 participants in the within-subjects analysis to 
detect an effect (see Figure 1 below). 
Because effect sizes may be unstable at smaller sample sizes, we will be much more conservative and assume an 
effect size of Cohen’s dz = 0.5 (consistent with a medium, rather than a very large effect size). Given a medium effect 
size, while setting power at 80% and alpha at 0.05, we will require N = 27 participants for this within-subjects design 
(see Figure 2 below). While we will impute baseline data where follow-up data are missing (i.e., assuming no 
improvement), we will also recruit additional participants to account for the possibility of up to 20% loss to follow-
up (i.e., 80% retention rate). We will therefore aim to recruit 34 additional participants to have N = 27 with complete 
data at follow-up after making the protocol changes described within this document. 
 
1.6 Study Variables 
A. Independent Variables, Interventions, or Predictor Variables  
We will provide 8-weeks of free telehealth counseling to participants and 10 weeks of nicotine transdermal 
patch (an FDA-approved, over-the-counter medication).  
 
“Persistence-Targeted Smoking Cessation in those with Serious Mental Illness (PTSC-S)” is an 8-session, 
individual, smoking cessation counseling strategy that focuses heavily on using cognitive behavioral therapy 
targeted at disputing automatic thoughts that may reduce task persistence for smokers with serious mental 
illness. While disputing automatic thoughts will be the focus of each session, skill building and support will 
also be included. Participants will be asked to complete homework assignments between sessions – 
including keeping a daily thought record to monitor automatic thoughts that may put them at risk for 
smoking. A daily thought record is a commonly used cognitive behavioral therapy homework assignment in 
which participants practice identifying and evaluating their thoughts. Participants will also track their daily 
cigarette use and nicotine patch use for homework. 
 
 
We will give participants a 10-week supply of the nicotine transdermal patch (an FDA-approved, over-the-
counter medication) to be used starting two weeks prior to their Quit Date. Although the nicotine patch 
is commercially available without a doctor’s prescription, Co-I Dr. Jill Williams (an addiction 
psychiatrist) will provide medical monitoring during this study. Consistent with the product insert, 
participants will be instructed to use one nicotine patch daily, and to apply it upon awakening at 
about the same time each day. Subjects will be instructed to vary the site of application of the 
patch daily to minimize any skin irritation. They will use the 21mg patch for the first 8-weeks, then 
2-weeks of the 14mg patch. 
 
B. Dependent Variables or Outcome Measures  
Primary Outcome measures 
• 
We will measure prolonged abstinence with a 2-week grace period following the target quit date 
until end-of-treatment and 3-months post quit-date 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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• 
We will measure feasibility using a scale regarding how “useful” the intervention was, how 
acceptable the length of each session was, and how acceptable the number of counseling sessions 
offered was (with higher scores reflecting ratings of more useful and more acceptable).   
• 
Follow-up rates of at least 80% at the 3-month follow-up 
• 
Rates of missing/unusable data will be < 10% of all data collected 
Secondary Outcome measures: 
• 
7-day point prevalence abstinence at end-of-treatment and 3-months post quit-date 
• 
Percent abstinence days between the target quit-date and end-of-treatment and 3-months post 
quit-date. 
• 
Task Persistence 
• 
Treatment attendance 
 
 
1.7 Drugs/Devices/Biologics  
1) Nicotine replacement therapy. The nicotine transdermal patch is an accepted, FDA approved treatment for 
nicotine dependence. Nicotine patches are available over-the-counter (OTC) without a prescription. Study 
participants will be provided with information by a research therapist describing the proper use of the nicotine 
patch, including a description of common side effects.  
 
A. Drug Accountability and Storage Methods 
▪ 
Storage and accountability. We will store any existing nicotine replacement therapy (NRT) in 
original packaging (box containing 2-week supply) in locked cabinets in a room with locked doors 
at 317 George Street; Suite 105; New Brunswick, NJ. We will document temperature of the room 
weekly using a min/max thermometer. All future NRT orders will be directly shipped to 
participants.  
o 
Back Up Storage Site: In the event the storage room reaches a temperature near the 
maximum or minimum allowed temperature range, we will temporarily store the 
medication at the Rutgers RWJMS Research Pharmacy located in the East Tower, 8th 
Floor, 125 Paterson Street in New Brunswick, NJ. We will continue to store the 
medication at the Research Pharmacy until our storage room temperature returns to 
the allowed range. 
 
Any time there is a transfer of medication between the research pharmacy and 
Addiction Psychiatry office, a trained research assistant will contact the pharmacy and 
arrange to drop off/pick up the medication. We will document the transfer in the in the 
medication log. The research assistant will document their name, the date of the 
transfer, and the number of boxes transferred.  
 
If the medication is stored at the pharmacy and the research therapist needs to 
dispense the medication to a research participant, the research therapist will arrange 
with a research assistant to pick up the medication within the same day of the 
appointment and document this in the medication log as described above.  
▪ 
Inventory. A trained research assistant will use an NRT inventory log to document the Lot # and 
Expiration date of each box of NRT. After receiving the nicotine patch shipment, a research 
assistant will meet with the participant using telehealth video platform, asking the patient to 
show each nicotine box’s expiration date and lot number. This information will be documented 
in the inventory log. 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
9 
 
 
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▪ 
Dispensing NRT. We will purchase the 10-week supply and ship the nicotine patches directly to 
each participant. We anticipate directly sending our participants the nicotine patches will reduce 
patient burden and travel difficulties. We will monitor the package tracking number for delivery 
and confirm with participants via phone or telehealth service they have received the package. To 
protect the confidentiality of our participants, there will be no indication on the package that the 
participant is enrolled in a research study. After receiving the nicotine patch shipment, a research 
assistant will meet with the participant using telehealth video platform, asking the patient to 
show each nicotine box’s expiration date and lot number. This information will be documented 
in the dispensing log. The research therapist with meet with the participants who will be 
instructed to store unused nicotine patches at room temperature consistent with the packaging 
instructions. Consistent with the product insert, participants will be instructed to use one 
nicotine patch daily, and to apply it upon awakening at about the same time each day. 
Participants will be instructed to vary the site of application of the patch daily to minimize any 
skin irritation. They will use the 21mg patch for the first 8-weeks, then 2-weeks of the 14mg 
patch. We will not collect unused portions of the NRT because it is not common practice to 
specify a time limit by which participants are required to use the NRT. Patients will receive large 
stickers with the label “21mg” or “14mg”. A research assistant will watch patients put the correct 
sticker over the seal of the appropriate nicotine patch box to minimize chances that patients will 
open the wrong box. 
 
2) Carbon Monoxide Monitor.  We will use the iCO™ Smokerlyzer to measure carbon monoxide (CO). The iCO 
Smokerlyzer has an FDA regulatory classification of a General Wellness Device (GWD) and therefore does not 
have a 510(k) number. The iCO™ Smokerlyzer® allows you to measure your breath CO levels to encourage the 
user to make an informed decision about cutting down or stopping smoking to promote better general health, 
which is in line with the definition and intended use of a General Wellness Device (GWD). 
 
The iCO Smokerlyzer works with iOS or android smartphone or tablet and in conjunction with their 
Smokerlyzer®App (available on Apple App Store & Google Play Store). Each participant will receive an iCO 
Smokerlyzer and a computer tablet with the app loaded to the device. The iCO Smokerlyzer provides 
biofeedback in the form of a personal CO level immediately from a simple breath test.  
 
The patient is asked to hold their breath for a 15 second countdown. This is displayed on the screen of the 
device. At the end of the breath hold, the patient blows gently into the ICO Smokerlyzer expiring as much of the 
breath in their lungs as possible. The reading on the device shall rise until the peak reading is held on the display. 
After completing the breath test, participants will send our research team the results, which are date and time 
stamped, from an email account we set up for them. The data itself are stored on the participants’ own mobile 
device and the data transmitted via email will not contain any PHI. For more information about participant’s 
email accounts please reference 1.3.A.  
  
A. Device Accountability and Storage Methods 
▪ 
Storage and accountability. We will store the iCO Smokerlyzer devices with the study coordinator 
or Principal Investigator. We will document when each iCO Smokerlyzer devices are provided to 
participants. 
▪ 
A research assistant will provide instructions on how to use the iCO Smokerlyzer. The study PI is 
accountable for the devices. 
 
1.8 Primary Specimen Collection 
N/A 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
10 
 
 
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1.9 Interviews, Focus Groups, or Surveys  
We will conduct a semi-structured interview (SCID-RV for DSM 5 - Modules  A, B, C, and D; Suicidal Ideation and 
Suicide Attempt) as part of the baseline assessment. This semi-structured interview is widely recognized as the gold 
standard for determining psychiatric diagnoses. 
 
If any participant indicates high levels of depression or suicidality, we will provide phone numbers and a 
recommendation to contact Rutgers University Behavioral Health Care or the Rutgers RWJMS Department of 
Psychiatry outpatient practice. In case of emergent suicidality a research staff member will call Acute Psychiatric 
Services (APS) at 855-515-5700 with the research participant.  
 
A. Administration 
Participants will meet with a research assistant for a “pre-baseline” appointment technology tutorial for 
assistance with any troubleshooting needs.  Participants will then meet with a research assistant to provide 
electronic informed consent through HIPAA compatible survey platform, RedCap or Qualtrics. Following 
consent, participants will complete a questionnaire battery that does not include PHI online via Qualtrics.  
▪ Timing and Frequency 
We will divide the baseline assessment battery into two sessions to minimize participant fatigue if 
necessary. Each baseline assessment session will last approximately 90 minutes. We will then 
provide free, weekly individual counseling sessions for 8 weeks. Participants will complete an end 
of treatment assessment and a 3-month post quit date assessment, each will last approximately 
60 minutes.  
▪ Location 
Participants will complete questionnaires and counseling sessions using a HIPAA compatible 
telehealth platform (e.g. Microsoft Teams, Doxy.me, or zoom) 
▪ Procedures for Audio and Visual Recording  
Participants will be asked permission to allow study staff to video record their intervention as part 
of the research study, by signing an addendum to the informed consent form. The recording(s) will 
be used for clinical supervision, to validate the integrity of the counseling intervention, and 
potentially to later examine the relationship between what is said during the sessions and various 
clinical outcomes. The recording(s) will include the participant ID number and date of the research 
appointment and will automatically be stored within the Microsoft Teams environment (i.e., 
Microsoft Streams). If we were forced to use Doxy.me or zoom as a backup, recordings would be 
stored on password protected local computers, and the files would then be encrypted and moved 
to a HIPAA compatible network storage.  The files themselves will be password protected and 
encrypted using the Advanced Encryption Standard 256 method (AES-256). Files will be linked with 
each participant’s ID number. Files will be destroyed 6 years after the protocol is closed.        
 
B. Study Instruments 
Concept 
Measure 
B/L 
 
Week 
4 
Week 
8 
3-mo. 
Post 
QD 
Weekly 
DEMOGRAPHICS 
Demographics Questionnaire (includes National Health and Nutrition 
Examination Survey (NHANES) items) 
X 
 
 
 
 
TOBACCO/SUBSTA
NCE USE 
Fagerström Test for Nicotine Dependence (Heatherton et al., 1991) 
X 
 
 
 
 
Timeline Followback (TLFB; Sobell & Sobell, 2000) 
 
 
X 
X 
X 
Current Tobacco Use 
X 
 
X 
X 
X 
Expired Breath Carbon Monoxide (CO) 
X 
 
X 
X 
X 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
11 
 
 
RESERVED FOR IRB STAMP 
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a Participants answering “yes” to any item listed under cardiovascular disorder on the “Medical History Form” will be 
reviewed by an Addiction Psychiatrist for follow-up and approval for the study. The Addiction Psychiatrist will review 
this assessment and will be documented in the patient chart. The addiction psychiatrist will review any other items listed 
as "yes" on the "Medical History Form", determine if follow up is needed, and will be documented in the patient chart. 
 
Online Measures (Qualtrics) 
Smoking History (Allen et al., 2019; NHANES) 
X 
 
X 
X 
 
Medicinal Cannabis 
X 
 
X 
X 
 
AUDIT-C 
X 
 
 
 
 
DAST-10 
X 
 
 
 
 
Brief WISDM (Smith et al., 2010) 
X 
 
 
 
 
CRAVING 
AND 
WITHDRAWAL 
Wisconsin Smoking Withdrawal Scale (Welsch et al., 1999)  
X 
 
X 
X 
 
MOTIVATION 
TO 
QUIT SMOKING 
ICT – Change Measure (includes self-efficacy) (Miller & Johnson, 2008) 
X 
 
X 
 
 
Quitting Fatigue  
 
 
X 
X 
 
Commitment to Quitting Smoking Scale (CQSS) (Kahler et al., 2007) 
X 
 
X 
 
 
TASK 
PERSISTENCE 
 
 
 
 
 
 
Breath-holding 
X 
 
X 
X 
 
Temperament and Character Inventory—Persistence Scale (TCI-P)  
(Cloninger, Przybeck, Svrakic, & Wetzel, 1994) 
X 
 
X 
X 
 
2-item Task Persistence Measure (Steinberg et al., 2007) 
X 
 
X 
X 
 
Distress Tolerance Scale (DTS) (Simons & Gaher, 2005) 
X 
 
X 
X 
 
Discomfort Intolerance Scale (Schmidt, 2006) 
x 
 
x 
x 
 
Thoughts About Smoking Questionnaire 
X 
 
X 
X 
 
 
 
 
 
 
 
MENTAL 
HEALTH 
SYMPTOMS 
Brief Experiential Avoidance Questionnaire 
X 
 
x 
x 
 
Brief Symptom Inventory (BSI) (Derogatis & Melisaratos, 1983) 
X 
 
X 
X 
 
Mental Health and Smoking 
X 
 
X 
 
 
SCID-RV for DSM 5 - Modules  A, B,  C, D, and Suicidal Ideation and 
Behavior (First et al., 2015) 
X 
 
 
 
 
MEDICAL HISTORY 
Medical History Forma 
X 
 
 
 
 
Pregnancy Form 
X 
 
 
 
 
Baseline Medical Problems 
X 
 
 
 
 
ADVERSE EVENTS 
Adverse Event Tracking 
 
 
x 
x 
x 
Adverse Event Specifics Log 
 
 
x 
x 
x 
COVID-19 
COVID-19 Questionnaire 
X 
 
 
 
 
SLEEP 
The Pittsburgh Sleep Quality Index (PSQI; Buysse, 1989).  
X 
 
X 
X 
 
TECHNOLOGY 
Technical Glitches Questionnaire 
 
 
 
 
X 
TELEHEALTH 
Post-counseling questionnaire 
 
 
x 
 
 
FEASIBILITY 
AND 
ACCEPTABILITY  
Working Alliance Inventory – Short Revised (WAI-SR; Munder et al., 2010) 
 
X 
 
 
 
Patient Satisfaction Survey 
 
 
 
 
X 
Final Exit Interview  
 
 
X 
 
 
Weekly Exit Interview 
 
 
 
 
X 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
12 
 
 
RESERVED FOR IRB STAMP 
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IRB Form Version v01022018 
 
Demographics Questionnaire. This questionnaire includes primarily items from the National Health 
and Nutrition Examination Survey (NHANES; (United States Department of Health and Human 
Services & Disease Control and Prevention, 2010) including items about age, race, and income. 
 
Smoking History. This questionnaire includes primarily items from the National Health and 
Nutrition Examination Survey (NHANES; (United States Department of Health and Human Services 
& Disease Control and Prevention, 2010). This self-report asks whether a participant relights 
cigarettes (Yes/No); if subjects responded “Yes,” a follow-up question was asked to 
determine the number of cigarettes that were relit (Allen et al., 2019). 
 
Fagerström Test for Cigarette Dependence (FTCD; Heatherton, Kozlowski, Frecker, & Fagerström, 
1991). The FTCD is a commonly used, 6-item questionnaire designed to measure dependence upon 
cigarettes. 
 
Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM; Smith et al., 2010). The Brief 
WISDM is a 37-item, theoretically derived measure of tobacco dependence measuring a variety of 
smoking motives. Respondents rate each item on a scale ranging from ranging from 1 = Not true 
of me at all to 7 = Extremely true of me. 
 
Wisconsin Smoking Withdrawal Scale (WSWS; (Welsch et al., 1999). The WSWS is a 28-item scale 
developed to contain reliable subscales tapping the major symptom elements of the nicotine 
withdrawal syndrome. There are 7 subscales: anger, anxiety, sadness, concentration, sleep, 
hunger, and craving. Respondents rate each statement on a scale ranging from 0 (strong disagree) 
to 4 (strongly agree). 
 
ICT – Change Measure (Miller & Johnson, 2008). This measure asks participants to rate their 
perception of importance of quitting and confidence in quitting on a 10-point Likert-type scale 
from 0=Definitely Not to 10 = Definitely. 
 
Quitting Fatigue. Quitting fatigue will be measured with a single Likert-scale item ranging from 0 
(Not true of me at all) to 10 (Extremely true of me) in response to the statement, “I am tired of 
trying to quit smoking.” 
 
Commitment to Quitting Smoking Scale (CQSS; Kahler et al., 2007). The CQSS measures motivation, 
or “commitment” to quitting smoking with eight Likert scale items with response options ranging 
from 1 = strongly disagree to 5 = strongly agree. 
 
Thoughts About Smoking Questionnaire. The Thoughts About Smoking Questionnaire is a 14-item 
scale that was developed by the PI to examine cognitions related to smoking that were likely to 
decrease persistence towards the goal of quitting. Respondents rate items from 1-7 (Totally 
Disagree to Totally Agree). 
 
Temperament and Character Inventory—Persistence Scale (TCI-P; Cloninger, Przybeck, Svrakic, & 
Wetzel, 1994). This subscale examines the trait of task persistence in 8 True/False items. 
 
2-item Task Persistence Measure (Steinberg et al., 2007). This 2-item scale measures task 
persistence via a 4-choice Likert scale (Very True to Very Untrue) 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
13 
 
 
RESERVED FOR IRB STAMP 
DO NOT MODIFY THIS SPACE 
 
 
 
IRB Form Version v01022018 
 
Distress Tolerance Scale (DTS; Simons & Gaher, 2005). 15-item scale used to assess 
participants’ perception of their ability to tolerate mental distress. Items (e.g. “I can’t 
handle feeling distressed or upset”) answered on 5-point Likert-type scales ranging from 
(1) strongly agree to (5) strongly disagree evaluate participants’ ability to experience and 
endure negative emotional states and includes scales that assess appraisal, tolerance, 
absorption, and regulation. This scale contains good psychometric properties, including 
high internal consistency. Because six of these items are included in the DII, below, this 
measure will be comprised of nine items. 
 
Distress Intolerance Scale (DIS; Schmidt, 2006). 5-item measure on which participants indicate, on 
a 7-point Likert-type scale (0 = not at all like me to 6 = extremely like me), the degree of agreement 
towards statements related to their tolerance of discomfort 
 
COVID-19 Questionnaire. This questionnaire includes questions from the Coronavirus Stressor 
Survey (McLean & Cloitre, 2020) and relationship between the coronavirus and smoking. 
 
Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983). The BSI is a self-report instrument 
assessing severity of psychiatric symptoms.  
 
Breath-holding. We will document time in seconds that participants can hold their breath as a 
measure of task persistence. Participants will raise their hand when the experience begins to 
become uncomfortable and the total persistence score will be the time (in seconds) bewteen when 
they indicate discomfort and when they release their breath. 
 
Medical History Form. We developed this form to collect brief medical information to assist in 
confirming eligibility for this study. 
 
Inclusion Exclusion Criteria Form. We developed this form to confirm eligibility for this study. Part 
one includes criteria from the initial phone screen. Part two includes risk assessment information 
from the baseline assessment. 
 
Technical Glitches Questionnaire. We developed this form to collect brief feedback about any 
technology issues related to telehealth. This brief questionnaire is completed by therapists, rather 
than participants to assess intervention feasibility. 
 
The Pittsburgh Sleep Quality Index (PSQI; Buysse, 1989). Measure the quality and patterns of 
sleep. It differentiates “poor” from “good” sleep by measuring seven domains: subjective sleep 
quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep 
medication, and daytime dysfunction over the last month. The client self-reports each of these 
seven areas of sleep on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. 
A global sum of “5”or greater indicates a “poor” sleeper.  
 
Post-counseling questionnaire. We developed this form to collect feedback from participants 
based on their experience with telehealth counseling.  
 
Working Alliance Inventory – Short Revised (WAI-SR; Munder et al., 2010).  The Working Alliance 
Inventory‐Short Revised (WAI‐SR) is a 12‐item measure for the assessment of the therapeutic 
alliance 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
14 
 
 
RESERVED FOR IRB STAMP 
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Patient Satisfaction Survey. We developed this form to collect feedback from participants 
regarding satisfaction with the intervention and delivery via telehealth.  
 
Final Exit Interview. We developed this form to collect feedback from participants based on their 
overall experience with this treatment and rating of usefulness.   
  
Weekly Exit Interview. We developed this form to collect feedback from patients from participants 
based on their experience and ratings of usefulness.   
 
Medicinal Cannabis. We developed this form to assess medicinal cannabis use. 
 
Mental Health and Smoking. Indicates patient’s belief about the influence of their mental health 
and quitting smoking. 
 
Alcohol Use Disorders Identification Test, AUDIT-C. 3-item alcohol screen that can help identify 
persons who are hazardous drinkers or have active alcohol use disorders. 
 
Drug Abuse Screen Test, DAST-10. Screen that can help identify persons with problematic 
substance use.  
 
Electronic Measures Forms 
Timeline Followback (TLFB; Sobell & Sobell, 1992). The TLFB method is a strategy for assessing 
substance use requires participants to retrospectively estimate their daily substance and alcohol 
use.  
 
Expired Breath Carbon Monoxide (CO). Participants will provide expired breath carbon monoxide 
by blowing into the iCO smokerlyzer. CO levels will be documented on this form in parts per million 
(ppm). The iCO Smokerlyzer works with iOS or android smartphone or tablet and in conjunction 
with their Smokerlyzer®App (available on Apple App Store & Google Play Store). Each participant 
will receive an ICO Smokerlyzer and a computer tablet with cellular service with the app loaded to 
the device. The iCO Smokerlyzer provides biofeedback in the form of a personal CO level 
immediately from a simple breath test. After completing the breath test, participants will email 
our research team the results, which are date and time stamped, from an email account we set up 
for them. The data itself are stored locally on the mobile device and the data transmitted via email 
will not contain any PHI.  
 
Pregnancy Form. Using this form, women will state in writing that they are not pregnant or nursing, 
not planning on becoming pregnant in the next two months, and that they are using effective birth 
control if sexually active. Although we will request this attestation from all female participants, it 
should be noted that the nicotine patch is available over-the-counter, and although the package 
insert states that “the risks to your child from this medicine are not fully known” observational and 
intervention studies do not find harmful effects on the fetus or on the pregnancy as compared to 
placebo in human studies (Bar‐Zeev et al., 2018).  We therefore expect the risks continue to be 
minimal to our female population and are outweighed by benefits by participation in this study. 
 
SCID-RV for DSM 5 - Modules  A, B, C, D, and Suicidal Ideation and Behavior (First, Williams, Karg, 
& Spitzer, 2015). This semi-structured interview is widely accepted as the gold standard for 
determining psychiatric diagnoses. 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
15 
 
 
RESERVED FOR IRB STAMP 
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Baseline Medical Problems. We developed this form to summarize any medical problems existing 
before the study started to help differentiate pre-existing conditions from new adverse events 
occurring once the participant engages in treatment.  
 
Adverse Event Tracking. We developed this form to monitor adverse events at each weekly 
appointment. 
 
Adverse Event Specifics Log. We developed this form to monitor details for adverse events. 
 
Treatment Form. We developed this form to monitor report weekly carbon monoxide and current 
tobacco use. This form will be used by the research therapists at weekly appointments. This form 
includes a table for research therapists to monitor participant’s dispensed nicotine patch  progress.  
 
 
 
1.10 Timetable/Schedule of Events 
 
2018 
2019 
2020 
2021 
2022 
Rutgers / UBHC 
project meeting 
x 
x 
x 
x 
x 
Train 
study 
therapist 
and 
research asst. 
x 
x 
x 
x 
x 
Recruit 
participants (N=90; 
30/yr; 3/month) 
x 
x 
x 
x 
 
Complete 
follow 
up assessments 
 
x 
x 
x 
x 
Data Analysis 
 
 
 
x 
x 
 
 
2.0 Project Management 
 
2.1 Research Staff and Qualifications 
Marc Steinberg, Ph.D. (PI) is a licensed clinical psychologist, a faculty member in the Rutgers RWJMS Department of 
Psychiatry, and director of the Tobacco Research & Intervention lab. His research focuses on tobacco dependence 
treatment, including tobacco dependence treatment development and tobacco use in vulnerable populations such 
as those with psychiatric comorbidity and lower socioeconomic status. Dr. Steinberg has been PI or Co-I for multiple 
randomized clinical trials of tobacco dependence treatments for high-risk smokers including RCTs of motivational 
interviewing, behavioral therapy, and of nicotine nasal spray for smokers with serious mental illness, of persistence-
targeted smoking cessation in low SES smokers, and of varenicline for smokers not yet ready to quit. 
 
Jill Williams, MD (Co-I) is Professor and Director, Division of Addiction Psychiatry, Rutgers Robert Wood Johnson 
Medical School. Dr. Williams’ research focuses on smokers with mental illness comorbidity and she has extensive 
experience in randomized clinical trials for tobacco dependence treatment with R01 grant support from NIDA and 
NIMH. Dr. Williams and Dr. Steinberg are both housed in the Division of Addiction Psychiatry with one office door 
separating them. They meet regularly to discuss clinical research issues. 
 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
16 
 
 
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Patricia Dooley-Budsock M.A, LPC, NCTTP (Research Therapist). Ms. Dooley has almost 20 years experience in 
working with serious mental illness and cognitive behavioral therapy. 
Shou-En Lu, Ph.D. (Biostatistician) is an Associate Professor in the Department of Biostatics in the Rutgers School of 
Public Health who specializes in multivariate survival analysis, clustered data analysis and cohort case-control and 
case-cohort designs. 
 
Graduate Students: 
Benjamin Billingsley 
Rachel Rosen 
 
Doctoral Psychology Interns and Graduate students have completed coursework and didactics in substance use 
treatment, cognitive behavioral therapy, and motivational interviewing. Students also have prior experience treating 
individuals with psychosocial impairment in the surrounding area. All graduate students have also interfaced with 
members of the community to facilitate completion of research projects focused on nicotine use. This includes, but 
is not limited to, structured clinical interviewing of research subjects and administration of behavioral tasks. 
 
All graduate students have also completed online coursework on ethical research practices (e.g., HIPAA compliance). 
 
 
Undergraduate Students: 
Drashya Shah 
Sara Diras 
Sanjana Thaper 
Daniella Burnett 
 
 
Other research staff: 
Anagha Babu 
 
Undergraduate students have completed coursework in psychology have completed online coursework on ethical 
research practices (e.g., HIPAA compliance).  
 
2.2 Resources Available 
Facilities- Participants will be daily smokers from New Jersey. Participants will attend treatment remotely using an 
online telehealth HIPAA compatible platform. Participants will be in the state of New Jersey during any counseling 
sessions though they may be outside of New Jersey (e.g., if they are traveling) for follow-up research assessment 
appointments. 
 
Medical Or Psychological Resources- Dr. Steinberg is a licensed clinical psychologist in that state of New Jersey and 
will assist in training study staff in the management of crisis intervention. In addition, they will be available 24/7 to 
field any questions/concerns study staff have regarding how to proceed in the event that participants experience 
unanticipated psychiatric distress during the course of the study.  
 
Research Staff Training- All graduate students and research assistants will complete intensive training with Dr. 
Steinberg, including proper administration of each intervention condition and proper administration and 
management of nicotine replacement therapies. All graduate students will also complete weekly supervision with 
Dr. Steinberg. 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
17 
 
 
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2.3 Research Sites 
Research activities will occur remotely or at the offices of Rutgers RWJMS Division of Addiction Psychiatry. We may 
temporarily store nicotine patches at Rutgers RWJMS Research Pharmacy located at the East Tower, 8th Floor, 125 
Paterson Street, New Brunswick, NJ 08901. 
 
 
3.0 Multi-Site Research Communication & Coordination  
N/A 
 
3.1 Outside Research 
N/A 
 
4.0 Research Data Source/s 
 
4.1 Primary Data-Subjects and Specimens 
Research participants will be 61 daily cigarette smokers with schizophrenia, schizoaffective disorder, or bipolar 
disorder. We will collect questionnaire data and expired breath carbon monoxide. We will provide 8-weeks of free 
counseling to participants and 10 weeks of nicotine transdermal patch (an FDA-approved, over-the-counter 
medication).  
 
4.2 Subject Selection and Enrollment Considerations  
A. Recruitment Details 
Research assistants will post flyers at UBHC and will work with staff for help in connecting with potential 
participants. Research assistants will post flyers and place leaflets in local areas. 
 
B. Source of Subjects  
We will recruit smokers from Rutgers University Behavioral Health Care, from the community via our 
website and local flyers, via social media, via Rutgers listservs, local agencies or organizations who serve 
mental health consumers (i.e. CHOICES, SERV Behavioral Health Systems, Inc.; George J. Otlowski, Sr. Center 
for Mental Health Care, Hunterdon Behavioral Health Care), and ElevateU’s Study Recruitment Platform 
(explained above in section 1.3 1.3 Research Design and Methods).  
 
C. Method to Identify Potential Subjects 
Participants responding to flyers or otherwise referred will complete a telephone screen to determine likely 
eligibility. If potentially eligible, they will be offered a more in-depth telehealth appointment screening after 
providing informed consent. If all inclusion criteria are met, they will be invited to participate. 
 
D. Subject Screening 
Interested participants will complete a brief telephone screening where they will be assessed by trained 
study personnel who will determine initial eligibility. 
 
Inclusion Criteria 
• 
Must be between 18 – 70 years old 
• 
Must indicate willingness to make a quit attempt in the next 30 days 
• 
Must report being a daily smoker (including those labeled “little cigars”) for past month 
• 
Must have a diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder on 
SCID-5-RV 
• 
Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, 
and a stable psychotropic medication regimen for 8 weeks 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
18 
 
 
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• 
Must have a smartphone, tablet, or computer with ability to download apps 
• 
Must currently receive mental health treatment 
• 
Must sign release of information for current mental health treatment providers 
  
Exclusion Criteria 
• 
Must not currently (in past 10 days) be taking varenicline (Chantix), 
• 
Must not currently (in past 10 days) be taking bupropion (Zyban/Wellbutrin) to quit 
smoking. 
• 
Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily 
over the last 10 days 
• 
Must not be currently receiving tobacco dependence treatment counseling. 
• 
Must not report myocardial infarction, unstable angina pectoris, or significant cardiac 
arrhythmia (including atrial fibrillation) in the past 30 days. 
• 
Women must not be pregnant, nursing, or planning on becoming pregnant in the next 
three months. Women who can become pregnant may be included if using effective birth 
control. 
• 
Must not have pending legal matters with potential to result in jail time 
• 
Must not be planning on moving outside of New Jersey in next 3-months 
• 
Problematic substance use in the past 3 months (AUDIT-C score ≥5 for men and ≥4 for 
women, DAST-10 score of ≥4) 
• 
Must not have suicidal ideation in the past week with intent, plan, or access to method; 
must not have attempted suicide in the past year (as assessed on the SCID-RV) 
 
 
E. Recruitment Materials  
We will rely upon flyers and consumer letters. We will also give UBHC staff a handout to use for reference 
when making referrals. Please see attachments. We additionally anticipate recruitment of participants via 
word-of-mouth. 
 
F. Lead Site Recruitment Methods 
N/A 
 
4.3 Subject Randomization 
N/A 
 
4.4 Secondary Subjects 
N/A 
 
4.5 Number of Subjects 
A. Total Number of Subjects 
N=120 
 
B. Total Number of Subjects If Multicenter Study 
N/A 
 
C. Require Number of Subjects to Complete Research 
N=61 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
19 
 
 
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D. Feasibility of Recruiting 
We anticipate enrolling 3 participants monthly over the course of 3 years. Based on previous research 
conducted by the principal investigators this should be feasible. This is an urban area with a large low-
income population and therefore a greater proportion of smokers than the average of 14.8% in the state 
of New Jersey.  Previous studies have given us the necessary experience with Rutgers listservs, websites, 
Craigslist, and use of flyers and brochures to maximize recruitment.  
4.6 Consent Procedures 
A. Consent 
▪ Documenting Consent 
All participants will provide electronically signed informed consent using the HIPAA compatible 
survey platform, RedCap or Qualtrics after being given the opportunity to read the consent form 
in full and to ask questions about the research. A research assistant will also electronically sign the 
consent form as a witness. 
▪ Waiver or Alteration of Consent Process  
N/A 
 
B. Consent Process 
▪ Location of Consent Process 
Verbal consent will be obtained for the initial phone screen. The PI or RA will first explain the 
purpose of the phone screen and limits of confidentiality and provide an overview of the study. If 
potential participants remain interested, they must verbally agree to phone screen completion.  
 
During the initial telehealth meeting, study personnel will verbally go over the consent form 
including details regarding the procedure, time commitment, payment, risks/benefits, and option 
to discontinue at any time without penalty, and ask the participant questions to ensure they 
understand.   
▪ Ongoing Consent 
N/A 
▪ Individual Roles for Researchers Involved in Consent 
A trained research assistant (who will receive weekly and as-needed supervision from the principal 
investigator) will pre-screen potential participants on the phone, followed by obtaining informed 
consent and administering the baseline assessment battery. 
 
1. Consent Discussion Duration 
Staff will go over details regarding the procedure, time commitment, payment, 
risks/benefits, and option to discontinue the study at any time without penalty. We 
anticipate that it will take participants 5 minutes to read the consent and up to an addition 
5 for staff to review relevant information.   
 
2. Coercion or Undue Influence 
Potential participants will explicitly be told in the consent form that the study is 
completely voluntary and that they may withdraw without penalty at any time. We will 
inform participants who wish to withdraw, who do not wish to participate, and who do 
not meet inclusion criteria about alternative cessation treatment options. 
 
3. Subject Understanding 
Participants will read a consent form or will have the consent form read to them before 
signing it. Trained research staff will proactively ask participants to describe the research 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
20 
 
 
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study to them in their own words to ensure that participants understand the consent 
form.  If there is any doubt of competence to consent, the individual will not be enrolled. 
In addition to providing written informed consent, participants must verbally indicate that 
they understand the study procedures and that they have no further questions. 
 
4.7 Special Consent/Populations 
N/A 
 
4.8 Economic Burden and/or Compensation for Subjects 
A. Expenses  
N/A 
 
B. Compensation/Incentives 
Participants will be paid $100 through the duration of the study. They will receive $35 at the initial 
assessment, $30 at the post-counseling assessment (after session 8), and $35 at the 3-months post-quit 
date assessment. Participants will be paid via the Rutgers ClinCard system. 
 
 
B.1 We may divide the baseline assessment battery into two sessions to minimize participant 
fatigue if necessary.  
 
C.  Compensation Documentation 
We will maintain a full accounting of funds using the Rutgers ClinCard system.  
  
4.9 Risks to Subjects 
A. Description of Subject Risk 
There is a risk of discomfort associated with nicotine withdrawal for patients who are quitting smoking. The 
nicotine patch (an FDA-approved medication) is well tolerated; however, there are potential side effects 
that may arise when using the patch. Potential side effects include dizziness, headache, nausea, vomiting, 
diarrhea, or redness or swelling at the patch site. Each patient will discuss these side effects with their 
therapist. If questions arise as a result of the patch, one of the study co-investigators is an Addiction 
Psychiatrist who will be available to provide patients with information regarding their side effects. 
 
The overall risk of AEs in this study is expected to be low because both the counseling sessions and the use 
of over-the-counter nicotine replacement products are low risk and similar to established treatments to 
help smokers quit. We will monitor patients for AEs at every session, however, and any AEs that are deemed 
to be moderate to severe will be reviewed by addiction psychiatrist, Dr. Williams and discussed at the 
weekly research meetings. The team will document the recommended actions with input from Dr. Williams. 
AEs will be followed until they resolve or until participant study completion.  The AE Tracking Form and AE 
specifics log will also be completed. 
 
There is a risk that participants’ confidentiality could be violated. To reduce the risk of violating 
confidentiality, several steps will be taken. Only IRB approved members of the research team will have 
access to the data. All computers used by research staff with be password protected with complex 
passwords. The participants google email account will only include their participant ID number and we will 
ask that participants do not use this account for communication outside of the research study to protect 
their confidentiality. Data will only be accessed when coded, entered, or audited. The PI will maintain 
responsibility for safe data storage. All data will be stored in locked cabinets within locked rooms. We will 
use a telehealth platform that is HIPAA compatible (e.g. Microsoft Teams, Doxy.me, or zoom). Based on 
these procedures, we anticipate that the risk to confidentiality is very low. 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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B. Procedures for Risks to Embryo, Fetus, and/or Pregnant Subjects 
N/A 
 
C. Risks to Non-Subjects 
N/A 
 
 
D. Assessment of Social Behavior Considerations 
Study risks are minimal and include a small, temporary increase in distress as a result of the 
assessments; however, the methodologies employed have been utilized in many labs and clinical 
settings with hundreds of participants suffering from a range of psychopathology, and approved by as 
many IRBs. 
 
▪ Reasonably Foreseeable Risks 
Study risks are minimal and include a small, temporary increase in distress as a result of the 
assessments. Participants who quit may experience at least mild nicotine withdrawal 
symptoms even with counseling and nicotine replacement therapy. 
 
▪ Risk Of Imposing An Intervention On Subject With Existing Condition 
N/A 
 
▪ Other Foreseeable Risks 
Our research team employs standard procedures to ensure confidential information about study 
participation is not disclosed. All data are linked to an arbitrary 3-digit study ID unrelated to 
personal information. The file linking participants to their study ID will be stored in a password-
protected file, located within a password-protected database on an encrypted computer. Only 
select trained laboratory personnel will have access to the file. All computer files or printed data 
used for analysis also will be de-identified. Informed consent collected remotely will be stored in 
HIPAA compatible survey platform, RedCap. Physical consent forms and payment forms will be 
stored in a locked file cabinet separate from data in an office that is locked when not occupied. 
Participants’ confidentiality also is protected by never associating a participant’s name with results 
in any published or otherwise publicly presented report. Demographic information, including 
information about participants’ age, ethnicity, education, marital status and employment status, 
will be reported using averages and percentages computed over multiple participants and never 
reported at the level of individual participants. 
 
▪ Observation And Sensitive Information 
N/A 
 
E. Minimizing Risks 
Participants will be instructed to call 911 if they experience a medical emergency and Acute Psychiatric 
Services (APS) at 855-515-5700 if they experience a psychiatric emergency. Patient will be counseled and 
provided with appropriate emergency contact information in the event a research assistant or study 
therapist determines that emergency care is warranted. 
 
Our research team employs standard procedures to ensure confidential information about study 
participation is not disclosed. All data are linked to an arbitrary 3-digit study ID unrelated to personal 
information. The file linking participants to their study ID will be stored in a password-protected file, located 
within a password-protected database on an encrypted computer. Only select trained laboratory personnel 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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RESERVED FOR IRB STAMP 
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IRB Form Version v01022018 
 
will have access to the file. All computer files or printed data used for analysis also will be de-identified. 
Informed consent collected remotely will be stored in HIPAA compatible survey platform, RedCap. Physical 
consent forms and payment forms will be stored in a locked file cabinet separate from data in an office that 
is locked when not occupied. Participants’ confidentiality also is protected by never associating a 
participant’s name with results in any published or otherwise publicly presented report. Demographic 
information, including information about participants’ age, ethnicity, education, marital status and 
employment status, will be reported using averages and percentages computed over multiple participants 
and never reported at the level of individual participants. 
 
All technology platforms handling PHI will be HIPAA compatible and our team is well trained in HIPAA 
compliance. 
 
F. Certificate of Confidentiality 
We have obtained a Certificate of Confidentiality from the National Institutes of Drug Abuse. 
 
 
G. Potential Benefits to Subjects 
The benefits of taking part in this study include access to high-quality, smoking cessation treatment based 
on empirically supported psychosocial approaches. If participants quit smoking, they will experience health 
benefits; however, they may receive no direct benefit from taking part in this study. 
 
H. Provisions to Protect the Privacy Interests of Subjects 
Our research team employs standard procedures to ensure confidential information about study 
participation is not disclosed. All data are linked to an arbitrary 3-digit study ID unrelated to personal 
information. The file linking participants to their study ID will be stored in a password-protected file, located 
within a password-protected database on an encrypted computer. Only select trained laboratory personnel 
will have access to the file. All computer files or printed data used for analysis also will be de-identified. 
Informed consent collected remotely will be stored in HIPAA compatible survey platform, RedCap. Physical 
consent forms and payment forms will be stored in a locked file cabinet separate from data in an office that 
is locked when not occupied. Participants’ confidentiality also is protected by never associating a 
participant’s name with results in any published or otherwise publicly presented report. Demographic 
information, including information about participants’ age, ethnicity, education, marital status and 
employment status, will be reported using averages and percentages computed over multiple participants 
and never reported at the level of individual participants. 
I. Research Team Access to Subject Data 
Only IRB approved staff will have access to participant data. All data will be coded by arbitrary study number 
to ensure confidentiality and will be stored in a locked filing cabinet or stored on the lab server where access 
will be password-protected. Data collected online will be de-identified (e.g., associated with an arbitrary 
study ID number) and only accessible to trained study personnel. Informed consent collected remotely will 
be stored in HIPAA compatible survey platform, RedCap. Physical consent forms with identifying 
information (names) will be filed separately from actual study data in a separate locked filing cabinet. This 
cabinet the office in which it is kept will ensure that it is also double-locked. 
 
 
4.10 Secondary Data – Records/Chart Reviews/Databases/Tissue Banks/etc. 
N/A 


 
 
 
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4.11 Chart/Record Review Selection 
N/A 
 
4.12 Secondary Specimen Collection 
N/A 
 
 
5.0 Special Considerations 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
We will be obtaining and/or disclosing individually identifiable health information associated with a HIPAA-covered 
component or entity. See attachments for release of information and request of information forms.  
 
Informed consent, release of information , and request for information collected remotely will be stored in HIPAA 
compatible survey platform, RedCap. All technology platforms handling PHI will be HIPAA compatible and our team 
is well trained in HIPAA compliance. 
 
5.2 Family Educational Rights and Privacy Act (FERPA) 
N/A 
 
 
5.3 NJ Access to Medical Research Act 
N/A 
 
5.4 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
N/A 
 
 
6.0 Research Data Protection and Reporting 
 
6.1 Data Management and Confidentiality 
 
A. Hypothesis 1: The PTSC-S intervention will be acceptable to participants, and the study will be feasible to 
conduct as evidenced by: 
a. At least 80% of participants will provide at least a 5 on a 1 – 7 scale regarding how “useful” the 
intervention was, how acceptable the length of each session was, and how acceptable the number 
of counseling sessions offered was (with higher scores reflecting ratings of more useful and more 
acceptable). Analysis 1a: Descriptive statistics will be reported. 
b. We will achieve follow-up rates of at least 80% at the 3-month follow-up. Analysis 1b: Descriptive 
statistics will be reported. 
c. 
Rates of missing/unusable data will be < 10% of all data collected. Analysis 1c: Descriptive statistics 
will be reported. 
 
Hypothesis 2: As compared to baseline, participants will report greater task persistence as evidenced by 
reduced scores on the Thoughts About Smoking Questionnaire (TASQ). Analysis 2: One-tailed, paired 
sample t-tests will be used to examine decreases in scores on the TASQ at each timepoint. 
 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
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Hypothesis 3: As compared to baseline, participants will report smoking fewer cigarettes per day at 1- and 
3-month follow-up. Analysis 3: One-tailed, paired sample t-tests will be used to examine decreases in 
cigarettes smoked per day on the TASQ at each timepoint. 
 
B. We determined the sample size based on data from the R21 phase of the study, we can expect a large effect 
(Cohen’s dz = 1.28) of the intervention on task persistence as measured by the Thoughts About Smoking 
Questionnaire (TASQ). We detected a change in mean(SD) scores, in the predicted direction, from 
4.371(1.0) at baseline to 3.218(1.1) at follow-up. An effect of dz = 1.28 setting power at 80% and alpha at 
0.05 suggests we need N = 6 participants in the within-subjects analysis to detect an effect (see Figure 1 
below). 
 
Because effect sizes may be unstable at smaller sample sizes, we will be much more conservative and 
assume an effect size of Cohen’s dz = 0.5 (consistent with a medium, rather than a very large effect size). 
Given a medium effect size, while setting power at 80% and alpha at 0.05, we will require N = 27 participants 
for this within-subjects design (see Figure 2 below). While we will impute baseline data where follow-up 
data are missing (i.e., assuming no improvement), we will also recruit additional participants to account for 
the possibility of up to 20% loss to follow-up (i.e., 80% retention rate). We will therefore aim to recruit 34 
additional participants to have N = 27 with complete data at follow-up after making the protocol changes 
described within this document.  
 
C. Data Handling: Only IRB approved members of the research team will have access to the data. The research 
staff collecting the data will bring the data to the PI within 24 hours of it being collected. Data will only be 
accessed when coded, entered, or audited. The PI will maintain responsibility for safe data storage. All data 
will be stored in locked cabinets within locked rooms. 
 
Data collection: The data will be collected through telehealth video interview using HIPAA compliant 
platform (e.g. Microsoft Teams, Doxy.me, or zoom). If telehealth video appointments are unable to be done 
because of internet connectivity, we will conduct telephone interviews.  Data will be stored at the Division 
of Addiction Psychiatry; 317 George Street; Suite 105; New Brunswick, NJ 08901.  Only the IRB-approved 
research team will have access to the research data. 
 
Data entry, editing and management, including handling of data collection forms, different versions of data, 
and data storage and disposition: Data will only be accessed and handled by IRB approved study personnel 
and kept in password protected databases. Dr. Steinberg is ultimately responsible for the receipt and 
transmission of all data. Informed consent collected remotely will be stored in HIPAA compatible survey 
platform, RedCap. Paper copies of data (e.g., names on consent forms) will be stored immediately in Rutgers 
offices where they will be locked in a cabinet housed behind a locked door (of Division of Addiction 
Psychiatry, 317 George Street, Suite 105, New Brunswick). 
  
All computer files will be kept on computers requiring login and complex passwords for entry, and all files 
with identifying information will have the extra protection of a password to open that individual file.  The 
individual participant’s personal information, including name and contact numbers, will be kept separate 
from their study data and linked only by a study number assigned by the PI. The master link between the 
study number and patient contact information will be destroyed once all data is collected and checked for 
accuracy. The confidential binder containing telephone screen forms will be shredded and properly 
discarded after 12 months of study completion. Participant names will not be used in any publications or 
papers derived from this study. 
 
Additionally, we have obtained a Certificate of Confidentiality from the NIH. 


 
 
 
Version Number: V22 – 3.28.2022 
Protocol Number: Pro2018001696 
PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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D. Qualtrics and Excel databases will be created in such a way as to not allow for out of range data. 
 
E. Data (described in section 1.6 B) will only be accessed and handled by IRB approved study personnel and 
kept in password protected databases. Dr. Steinberg is ultimately responsible for the receipt and 
transmission of all data. Paper copies of data (e.g., names on consent forms) collected at the UBHC will be 
brought immediately to Rutgers offices where they will be locked in a cabinet housed behind a locked door 
(of Division of Addiction Psychiatry, 317 George Street, Suite 105, New Brunswick). 
 
 
6.2 Data Security 
Our research team employs standard procedures to ensure confidential information about study participation is not 
disclosed. All data are linked to an arbitrary 3-digit study ID unrelated to personal information. The file linking 
participants to their study ID will be stored in a password-protected file, located within a password-protected 
database on an encrypted computer. Only select trained laboratory personnel will have access to the file. All 
computer files or printed data used for analysis also will be de-identified. Informed consent collected remotely will 
be stored in HIPAA compatible survey platform, RedCap. Physical consent forms or other forms with identifiable 
information be stored in a locked file cabinet separate from data in an office that is locked when not occupied. 
 
All technology platforms handling PHI will be HIPAA compatible and our team is well trained in HIPAA compliance. 
 
 
6.3 Data and Safety Monitoring  
A. Periodic Data Evaluation 
A Data Safety Monitoring Board will meet quarterly to evaluate safety data and other study issues. 
 
B. Type of Data Evaluated 
Safety data will be reviewed quarterly. Efficacy data will be evaluated after 50% of participants have 
completed follow-up data collection. 
 
C. Collection of Safety Information 
We will use case report forms to document adverse events at each telehealth patient contact. 
 
D. Frequency of Data Collection 
We will document adverse events at each telehealth patient contact. 
 
E. Reviewer of Data 
A Data Safety Monitoring Board will meet quarterly to evaluate safety data and other study issues. The PI 
(Dr. Steinberg) and medical monitor (Co: Dr. Williams) will review safety data as it is collected. 
 
F. Schedule of Review of Cumulative Data 
Safety data will be reviewed every 6-months. 
 
G. Tests for Safety Data 
Independent t-tests will be used to examine differences between treatment groups with respect to number 
of adverse events reported. 
 
H. Suspension of Research 


 
 
 
Version Number: V22 – 3.28.2022 
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PI Name: Marc L. Steinberg, Ph.D. 
Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
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We do not expect any adverse events in this trial that would indicate stopping the trial because 
we are providing established treatments to smokers trying to quit. We will monitor adverse events, 
however, and stop the trial if our DSMB determines that it is warranted in response to adverse 
events. 
 
In addition, we will stop the trial if the DSMB concludes that interim analysis at the halfway point 
of the trial provided overwhelming evidence that PTSC-S intervention was more efficacious than 
the control intervention. 
 
 
6.4 Reporting Results 
A. Sharing of Results with Subjects  
Participants will not be provided with individual study results.   
 
B. Individual Results  
Participants will not be provided with individual study results.   
 
C. Aggregate Results  
Aggregate results such as average number of sessions attended, proportion of participants obtaining 
abstinence from smoking, and cigarettes smoked per day may be reported in peer reviewed scientific 
conference presentations, peer-reviewed scientific publications, or peer-reviewed NIH grant applications. 
 
D. Professional Reporting 
Study results may be presented to the scientific community via peer reviewed manuscripts and 
presentations at scientific conferences.  They will also be included in peer-reviewed NIH grant applications. 
 
E. ClinicalTrials.Gov Registration and Data Reporting 
The trial will be registered with ClinicalTrials.gov within the first three months of receiving the grant funds 
and will reflect the procedures and primary/secondary outcomes outlines in this protocol. 
 
6.5 Data Sharing   
N/A 
 
7.0 Data and/or Specimen Banking 
N/A 
 
8.0 Other Approvals/Authorizations 
N/A 
 
9.0 Bibliography 
1. Allen, S. I., Wasserman, E., Veldheer, S., Yingst, J., Hrabovsky, S., Liao, J., … Foulds, J. (2019). Characteristics 
of Adult Cigarette Smokers Who "Relight" and the Effects of Exposure to Tobacco Smoke 
Constituents. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and 
Tobacco, 21(9), 1206–1212. doi:10.1093/ntr/nty138  
2. Buysse, D.J., Reynolds III, C.F., Monk, T.H., Berman, S.R., & Kupfer, D.J. (1989). The Pittsburgh Sleep 
Quality Index: A new instrument for psychiatric practice and research. Journal of Psychiatric Research, 
28(2), 193-213.  


 
 
 
Version Number: V22 – 3.28.2022 
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Protocol Title: Persist to Quit: Telehealth 
Counseling for Smokers with Serious Mental 
Illness 
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3. Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). (2010). 
National Health and Nutrition Examination Survey Questionnaire (or Examination Protocol, or Laboratory 
Protocol). Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control 
and Prevention, retrieved from: 
https://wwwn.cdc.gov/nchs/nhanes/continuousnhanes/questionnaires.aspx?BeginYear=2009 
4. Cloninger CR, Przybeck TR, Svrakic DM, Wetzel RD. Temperament and Character inventory (TCI): A guide 
to its development and use. Center for Psychobiology of Personality. St. Louis: Washington University; 
1994 
5. Derogatis, L. R., & Melisaratos, N. (1983). The Brief Symptom Inventory: An introductory report. 
Psychological Medicine, 13(3), 595-605. http://dx.doi.org/10.1017/S0033291700048017 
6. 
First MB, Williams JBW, Karg RS, Spitzer RL: Structured Clinical Interview for DSM-5—Research 
Version (SCID-5 for DSM-5, Research Version; SCID-5-RV). Arlington, VA, American Psychiatric 
Association, 2015 
7. Gámez, W., Chmielewski, M., Kotov, R., Ruggero, C., Suzuki, N., & Watson, D. (2014). The 
Brief Experiential Avoidance Questionnaire: Development and initial validation. Psychological 
Assessment, 26(1), 35–45. https://doi.org/10.1037/a0034473 
8. Gard, D. E., Gard, M. G., Kring, A. M., & John, O. P. (2006). Anticipatory and consummatory components of 
the experience of pleasure: a scale development study. Journal of Research in Personality, 40, 1086-1102. 
doi:10.1016/j.jrp.2005.11.001 
9. Heatherton, T. F., Kozlowski, L. T., Frecker, R. C., Fagerstrom, K. O. (1991). The Fagerstrom test for nicotine 
dependence: a revision of the Fagerstrom tolerance questionnaire. British Journal of Addiction, 86, 119–
1127.PMID: 1932883 
10. Kahler, C. W., Lachance, H. R., Strong, D. R., Ramsey, S. E., Monti, P. M., & Brown, R. A. (2007). The 
commitment to quitting smoking scale: initial validation in a smoking cessation trial for heavy social 
drinkers. Addictive behaviors, 32(10), 2420–2424. doi:10.1016/j.addbeh.2007.04.002 
11. Miller, W.R., Johnson, W. R. (2008).  A natural language screening measure for motivation to change. 
Addictive Behaviors, 33, 1177-1182. PMID: 18558466 
12. Munder, T., Wilmers, F., Leonhart, R., Linster, H. W., & Barth, J. (2010). Working Alliance 
Inventory‐Short Revised (WAI‐SR): psychometric properties in outpatients and inpatients. Clinical 
Psychology & Psychotherapy: An International Journal of Theory & Practice, 17(3), 231-239. 
13. Rosner, B. (2010). Fundamentals of Biostatistics. Seventh Edition. Equation 5.15, page 133. Duxbury Press. 
14. Schmidt NB, Richey JA, Fitzpatrick KK. Discomfort intolerance: Development of a construct and 
measure relevant to panic disorder. Journal of Anxiety Disorders. 2006 ;20(3):263-280. DOI: 
10.1016/j.janxdis.2005.02.002. 
15. Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-
report measure. Motivation and Emotion, 29(2), 83-102. 
16. Smith, S., Piper, M., Bolt, D., Fiore, M., Wetter, D., Cinciripini, P., & Baker, T. (2010). Development of the 
Brief Wisconsin Inventory of Smoking Dependence Motives. Nicotine & Tobacco Research, 12(5), 489–499. 
https://doi.org/10.1093/ntr/ntq032 
17. Sobell, L.C., Sobell, M.B. (2000). Alcohol Timeline Followback (TFLB). In American Psychiatric Association 
(Ed.), Handbook of Psychiatric Measures. American Psychiatric Association; Washington, DC. pp. 477-479. 
18. Steinberg, M. L., Williams, J. M., Gandhi, K. K., Foulds, J., Epstein, E. E., & Brandon, T. H. (2012). Task 
persistence predicts smoking cessation in smokers with and without schizophrenia. Psychology of addictive 
behaviors: journal of the Society of Psychologists in Addictive Behaviors, 26(4), 850–858. 
doi:10.1037/a0028375 
19. Velicer, W. F., DiClemente, C. C., Rossi, J. S., & Prochaska, J. O. (1990). Relapse situations and self-efficacy: 
An integrative model. Addictive Behaviors, 15, 271-283. PMID: 2378287 


 
 
 
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20. Welsch, S., Smith, S., Wetter, D., Jorenby, D., Fiore, M., & Baker, T. (1999). Development and Validation of 
the Wisconsin Smoking Withdrawal Scale. Experimental and Clinical Psychopharmacology, 7(4), 354–361. 
https://doi.org/10.1037/1064-1297.7.4.354 
 

ICF_000.pdf: 
Title: Persist to Quit: Telehealth Counseling for Smokers with Serious Mental Illness 
PI: Marc L. Steinberg, Ph.D.
Version #: 2020.11.4
pg. 1
CONSENT TO TAKE PART IN A RESEARCH STUDY
Title Of Study: Persist to Quit: Telehealth Counseling for Smokers with Serious Mental Illness 
Principal Investigator: Marc L. Steinberg, Ph.D.
This form is part of an informed consent process for a research study that will give information 
to help you decide if you wish to volunteer for this research study.  It will help you understand 
what the study is about and what will happen during the study.
If you have questions at any time, you should feel free to ask. We will give you answers that 
you completely understand. After all your questions have been answered, if you still wish to 
take part in the study, you will be asked to sign this informed consent form.
You are not giving up any of your legal rights by volunteering for this research study or by 
signing this consent form.
Who is conducting this research study?
Dr. Marc Steinberg is the Principal Investigator of this research study. A Principal Investigator 
has the overall responsibility for the study. There are other individuals who are also part of 
the research team.
Dr. Steinberg may be reached at 732-235-4341 and/or 317 George Street, Suite 105, New 
Brunswick, NJ 08901 and/or rusmoking@rwjms.rutgers.edu. 
A member of the study team will also be asked to sign this informed consent. You will be 
given a copy of the signed consent form to keep.
This study is sponsored by the National Institute on Drug Abuse.
The principal investigator is being paid to conduct this study according to a budget that will 
cover the costs of the study, including the costs of collecting all of the information required 
by the study.
Why is this study being done?
We want to learn how to best help smokers with serious mental illness to quit smoking. We 
are examining a new counseling approach based on cognitive behavior therapy. Cognitive 
behavioral therapy is a commonly accepted treatment for smoking cessation. 
Why have you been asked to take part in this study?
You have been asked to take part because you are an adult smoker with schizophrenia, 
schizoaffective disorder, or bipolar disorder who is motivated to quit.
Pro2018001696
           6/17/2021
           6/16/2022


Title: Persist to Quit: Telehealth Counseling for Smokers with Serious Mental Illness 
PI: Marc L. Steinberg, Ph.D.
Version #: 2020.11.4
pg. 2
Who may take part in this study?  And who may not?
You may take part in this study if:

You are between 18 and 70 years old

You are willing to make a quit in the next 30 days

You report being a daily cigarette smoker (including those labeled “little cigars”) 

You have a diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder based 
on a semi-structured interview called the SCID-V

You have not been hospitalized for a psychiatric illness in the last 8 weeks

You have been taking the same medications for Schizophrenia, Schizoaffective Disorder, or 
Bipolar Disorder for the past 8 weeks

You have access to a smartphone, tablet, or computer to attend telehealth video 
appointments with ability to download apps

Must be receiving mental health treatment

Must sign release of information for currently mental health treatment providers
You may not take part in this study if you:

Have been taking varenicline (Chantix) daily for the past 10 days

Have been taking bupropion (Zyban/Wellbutrin) to quit smoking daily for the past 10 days

Have been taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over 
the last 10 days

Are currently receiving tobacco dependence treatment counseling

Report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia 
(including atrial fibrillation) in the past 30 days

Report that you are pregnant or nursing, planning on becoming pregnant in the next three 
months, or not using effective birth control if you are sexually active

Have pending legal matters with potential to result in jail time

Are planning on moving outside of New Jersey in next 3-months

Report problematic substance use in the past 3 months (as measured by validated measures, AUDIT-C 
and DAST-10)

Are at risk for suicide based on a semi-structured interview called the SCID-V
How long will the study take and how many subjects will participate?
We expect 61 subjects to participate. This study will take 4-years to complete. Participation 
in this study will last for 4-months and all appointments will be conducted through secure 
video. You will meet with a therapist through secure video for eight (8) weekly individual 
counseling sessions. You will also meet with the research team through secure video for an 
initial assessment, a post-counseling assessment, and a final assessment 3-months after your 
quit date. 
What will you be asked to do if you take part in this research study?

Attend 8 individual smoking cessation counseling sessions (lasting up to 50 minutes)

Attend an initial research assessment (lasting up to 90 minutes)

Attend a post-counseling research assessment (lasting up to 90 minutes)

Attend a final research assessment (lasting up to 90 minutes)
Appointments will be completed using a HIPAA compatible video-conference platform for 
telehealth services (i.e. Microsoft Teams, Doxy.me, or zoom). We will provide you with 
assistance to set up applications used for study appointments. If necessary, we may complete 
assessments over the phone. You must be in the state of New Jersey during your counseling 
appointments.
Our research team may set up a google email account for you if you do not already an email 
that you use. We will not use email to discuss any personally identifying information. The 
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email address itself will only include your research ID number and the letters ptscs. This email 
will be used for communication throughout the research study. We ask that you do not use 
this email address for any communication outside of the research study to protect your 
confidentiality. 
At your initial assessment you will complete standard questionnaires about tobacco use and 
mental and physical health. Women will complete a form indicating they are not currently 
pregnant, are not planning to become pregnant in the next 4-months, and are using birth 
control if sexually active. You will also answer questions about your age, gender, race, and 
other similar information. You will also complete tasks that measure something called 
“persistence,” such as breath-holding endurance at your initial assessment session, after your 
final counseling session, and at the final 3-month assessment.  
Between sessions, we will ask you to record your cigarette use each day. You may be asked 
to provide a carbon monoxide reading prior to appointments. This involves breathing into a 
machine called an “iCO Smokerlyzer” (which we will provide to you at no cost) and sending 
us the results through your email account. 
We will give you nicotine patches for 10 weeks and weekly, individual counseling will last for 
8 weeks. You will begin using the nicotine patches two weeks before your target quit date.
We will videorecord therapy sessions to ensure that counseling is provided as intended.
What are the risks and/or discomforts you might experience if you take part in this 
study?
The Nicotine Transdermal Patch (“the patch”) has few side effects and is sold over the counter 
in the United States. Potential side effects include dizziness, headache, nausea, vomiting, 
diarrhea, or redness or swelling at the patch site. In addition, smokers who have serious 
arrhythmias (a disorder of the heart rate (pulse) or heart rhythm, such as beating too fast, 
too slow, or irregularly) or have chest pains due to coronary artery disease should use the 
patch with caution.
You may experience some nicotine withdrawal when you quit smoking. If symptoms arise, 
they will be addressed as part of your treatment.
There is a risk that your confidentiality could be violated. To reduce the risk of violating 
confidentiality, several steps will be taken. Only IRB approved members of the research team 
will have access to the data. All computers used by research staff with be password protected 
with complex passwords. Data will only be accessed when coded, entered, or audited. The PI 
will maintain responsibility for safe data storage. All data will be stored in locked cabinets 
within locked rooms. The google email account will only be linked to your research ID number 
and ask that you do not use this account for communication outside of the research study to 
protect your confidentiality. Based on these procedures, we anticipate that the risk to 
confidentiality is very low.
There is also a slight risk of feeling distress and frustration when completing our 
questionnaires and participating in counseling sessions; however, this is minimal and can be 
addressed by our addiction psychiatrist or clinical psychologist at any time.
Please call 911 if you have a medical emergency or Acute Psychiatric Services (APS) at 855-
515-5700 if you experience a psychiatric emergency.
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Are there any benefits for you if you choose to take part in this research study?
The benefits of taking part in this study include access to high-quality, evidence-based 
smoking cessation treatment. If you quit smoking you are likely to experience improvements 
in health, social, and economic areas of your life. However, you might receive no direct benefit 
from taking part in this study.
What are your alternatives if you don’t want to take part in this study?
Clinical practice guidelines for smoking cessation recommend getting behavioral support plus 
at least one of the seven FDA approved medications for smoking cessation. If you choose not 
to take part in this study, we will provide you with information regarding other options that 
can help you receive these treatments.
How will you know if new information is learned that may affect whether you are 
willing to stay in this research study?
During the course of the study, you will be updated about any new information that may 
affect whether you are willing to continue with the study. If we learn of information that may 
affect you after the study or your follow-up is completed, you will be contacted.
Will there be any cost to you to take part in this study?
There is no cost to you to take part in this study. 
Will you be paid to take part in this study?
You will receive reimbursement for your time for completing assessment measures of up to 
$100 based on the following schedule:

$35 for the initial research assessment. We may divide the baseline assessment 
battery into two sessions to minimize participant fatigue if necessary. 

$30 for the post-counseling research assessment (after session 8)

$35 at the final research assessment (3-month post-quit date)
How will information about you be kept private or confidential?
All efforts will be made to keep your personal information in your research record confidential, 
but total confidentiality cannot be guaranteed. Only IRB approved members of the research 
team will have access to the data. All data will be stored in locked cabinets within locked 
rooms.
 
All computer files will be kept on computers requiring login and complex passwords for entry. 
Computer files may also be kept stored on the Rutgers Box cloud storage system which 
requires complex passwords for entry. All files with identifying information will have the extra 
protection of a password to open that individual file. Your personal information will be kept 
separate from your study data and linked only by a study number. Your name will not be used 
in any publications or papers derived from this study.
Your participant email address will only include information related to your assigned ID 
number and short title of our study “ptscs”. This email address will not identify your name 
and to protect for confidentiality we ask that you do not use this email for any purpose outside 
of the research study. 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or 
samples that may identify you in any action or suit unless you say it is okay. They also cannot 
provide them as evidence unless you have agreed.  This protection includes federal, state, or 
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local civil, criminal, administrative, legislative, or other proceedings. An example would be a 
court subpoena.
 
There are some important things that you need to know.  The Certificate DOES NOT stop 
reporting that federal, state or local laws require, such as laws that require reporting of child 
or elder abuse, some communicable diseases, and threats to harm yourself or others.  The 
Certificate CANNOT BE USED to stop a sponsoring United States federal or state government 
agency from checking records or evaluating programs. The Certificate DOES NOT stop 
disclosures required by the federal Food and Drug Administration (FDA).  The Certificate also 
DOES NOT prevent your information from being used for other research if allowed by federal 
regulations.
 
Researchers may release information about you when you say it is okay. For example, you 
may give them permission to release information to insurers, medical providers or any other 
persons not connected with the research.  The Certificate of Confidentiality does not stop you 
from willingly releasing information about your involvement in this research. It also does not 
prevent you from having access to your own information.
A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. 
law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time.
What will happen if you do not wish to take part in the study or if you later decide 
not to stay in the study?
Participation in this study is voluntary. You may choose not to participate or you may change 
your mind at any time.
If you do not want to enter the study or decide to stop participating, your relationship with 
the study staff will not change, and you may do so without penalty and without loss of benefits 
to which you are otherwise entitled.
You may also withdraw your consent for the use of your data, but you must do this in writing 
to Dr. Marc L. Steinberg; Division of Addiction Psychiatry; 317 George Street; Suite 105; New 
Brunswick, NJ 08901.
What will happen if I am injured during this study?
Subjects in this study will be exposed to certain risks of personal injury in addition to those 
associated with standard forms of treatment, which can be found above in the section, "What 
are the risks and/or discomforts you might experience if you take part in this study?"
In addition, it is possible that during the course of this study, new adverse effects of the 
nicotine patch that result in personal injury may be discovered. The University will make 
appropriate referrals for medical treatment for subjects who sustain personal injuries or 
illnesses as a direct consequence of participation in the research. The subject’s health 
insurance carrier or other third-party payer will be billed for the cost of this treatment; 
provided that the University shall not submit to federally funded programs, e.g., Medicare, 
Medicaid or CHAMPUS, for reimbursement first if submission to such programs is prohibited 
by law.  No financial compensation will be provided by the University and no other type of 
assistance is available from the University.
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Who can you call if you have any questions?
If you have any questions about taking part in this study or if you feel you may have suffered 
a research related injury, you can call the study principal investigator:
Marc L. Steinberg, Ph.D., Department of Psychiatry, 732-235-4341
If you have any questions about your rights as a research subject, you can call the 
Institutional Review Board (IRB) Director at (732)-235-9806 and Human Subject Protection 
Program at (732)-235-8578.
What are your rights if you decide to take part in this research study?
You have the right to ask questions about any part of the study at any time.  You should not 
sign this form unless you have had a chance to ask questions and have been given answers 
to all of your questions
PERMISSION (Authorization) TO USE OR SHARE HEALTH INFORMATION THAT 
IDENTIFIES YOU FOR A RESEARCH STUDY
Information about you and your health is personal and private, so this information generally 
cannot be used in research without your written permission.  The next few paragraphs tell 
you about how researchers want to use and share your health information in this research 
study. Your information will only be used as described here or as allowed or required by law.  
Ask questions if you do not understand any part of the research or the use of your health 
information. If you sign this consent form, you agree to let the researchers use your 
information in the research and share it with others as described below.
What is the purpose of the research and how will my information be used?
You are being invited to take part in this research study which is described at the beginning 
of this form. The purpose of collecting and using your health information for this study is to 
help researchers answer the questions that are being asked in the research.
What information about me will be used? 

Medical history or treatment

Medications

Psychological testing, surveys or questionnaires
Who may use, share or receive my information?
The research team may use or share your information collected or created for this study with 
the following people and institutions:

Rutgers University researchers involved in the study;

The Rutgers University Institutional Review Board and Compliance Boards

The Office for Human Research Protections in the U.S. Dept. of Health and Human 
Services

A data safety monitoring board (DSMB)

National Institute on Drug Abuse (NIDA)

Federal Drug Administration (FDA)
Those persons or organizations that receive your information may not be required by federal 
privacy laws to protect it and may share your information with others without your permission, 
if permitted by the laws governing them.  
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Will I be able to review my research record while the research is ongoing?
No. We are not able to share information in the research records with you until the study is 
over. To ask for this information, please contact the Principal Investigator, the person in 
charge of this research study.  
Do I have to give my permission?
No. You do not have to permit use of your information. But, if you do not give permission, 
you cannot take part in this research study. (Saying no does not stop you from getting medical 
care or other benefits you are eligible for outside of this study). 
If I say yes now, can I change my mind and take away my permission later?
Yes. You may change your mind and not allow the continued use of your information (and to 
stop taking part in the study) at any time. If you take away permission, your information will 
no longer be used or shared in the study, but we will not be able to take back information 
that has already been used or shared with others. If you say yes now but change your mind 
later for use of your information in the research, you must write to the researcher and tell 
him or her of your decision: Dr. Marc Steinberg, 317 George St., Suite 105, New Brunswick, 
NJ 08901. 
How long will my permission last?
Your permission for the use and sharing of your health information will last until the end of 
the research study.  
Rutgers, The State University of New Jersey IRB
Audio/Videotape Addendum to Consent form
By signing below, you are agreeing to participate in a research study conducted by Marc L. 
Steinberg, Ph.D. We are asking for your permission to allow us to video record your sessions 
as part of that research study. The recording(s) will be used for analysis by the research team 
and for training clinicians. The recording(s) will include your ID number and date of your 
counseling session.
 
Videorecordings will automatically be stored within the Microsoft Teams environment 
(i.e.,Microsoft Streams). If using Doxy.me or zoom as a backup, recordings would be stored 
on password protected local computers, and the files would then be encrypted and moved to 
a HIPAA compatible network storage.  The files themselves will be password protected and 
encrypted using the Advanced Encryption Standard 256 method (AES-256). Files will be linked 
with each participant’s ID number. Files will be destroyed 6 years after the protocol is closed.       
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Your signature on this form grants the investigator named above permission to record you as 
described above during participation in the above-referenced study. The investigator will not 
use the recording(s) for any other reason than that/those stated in the consent form without 
your written permission.
AGREEMENT TO PARTICIPATE
1.  Subject consent:
I have read this entire form, or it has been read to me, and I believe that I understand 
what has been discussed. All of my questions about this form or this study have been 
answered.
Subject Name:
Subject Signature:
 Date:
2.  Signature of Investigator/Individual Obtaining Consent:
To the best of my ability, I have explained and discussed the full contents of the study 
including all of the information contained in this consent form. All questions of the research 
subject and those of his/her parent or legally authorized representative have been 
accurately answered.
Investigator/Person Obtaining Consent (printed name):
Signature:
 Date: 
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