Clinical trial NCT03069482
Conditions: Nicotine Addiction Serious Mental Illness
Keywords: Smoking mHealth Serious Mental Illness Acceptance and Commitment Therapy US DHHS Clinical Practice Guidelines
Sponsor: Duke University
Start date: 2017-05-15; Completion date: 2019-01-17
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures.

Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness.

However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population?

Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.

Detailed description:
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to $317 billion expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide reaching technology that could provide individuals with serious mental illness the necessary skills for quitting.

This feasibility trial will test whether a tailored smoking cessation app for people with serious mental illness, Learn to Quit, results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population, NCI QuitGuide. The trial will also demonstrate whether it is possible to (a) feasibly recruit and retain individuals with serious mental illness in an mHealth clinical trial, and (b) successfully gather smoking cessation outcomes. Ninety individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Learn to Quit app. In the comparator condition, participants will use the NCI QuitGuide app. Participants in both conditions will receive Nicotine Replacement Therapy (standard dosing of nicotine patch + 1-week course of 4mg nicotine lozenges) and technical coaching. Study duration will be 4 months, with four follow-up appointments at 1-month, 2-month, 3-month, and 4-months.

Arms: arm 1: A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. arm 2: A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Interventions: intervention 1: Learn to Quit App intervention 2: Nicotine patch intervention 3: Nicotine lozenge intervention 4: Technical Coaching intervention 5: NCI QuitGuide App
Intervention descriptions: intervention 1: A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods. intervention 2: Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines. intervention 3: Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines. intervention 4: Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (\~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance. intervention 5: A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies).

Protocol documents:
Prot_SAP_000.pdf: 
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‘Quit on the Go’ Pilot Trial: Innovative 
Smartphone App for Quitting Smoking for the 
Seriously Mentally Ill 
 
 
 
 
 
 
Pro00075165 
Lead Investigator: Roger Vilardaga, PhD 
October 5, 2018 
Version 4.0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Table of Contents 
Background & Rationale ................................................................................................................................ 3 
Study Purpose ............................................................................................................................................. 4 
Innovation & Significance .......................................................................................................................... 5 
Study Aims ..................................................................................................................................................... 5 
Primary Outcomes ...................................................................................................................................... 5 
Secondary Outcomes .................................................................................................................................. 6 
Design & Methodology: ................................................................................................................................. 6 
Subjects ...................................................................................................................................................... 7 
Selection of Subjects ........................................................................................................................... 7 
Subject Recruitment ............................................................................................................................ 8 
Requirements to Participate ..............................................................................................................10 
Target Population Distributions .........................................................................................................11 
Steps for Withdrawing ........................................................................................................................11 
Sampling Frame .......................................................................................................................................12 
Risks & Benefits .......................................................................................................................................13 
Duration of the Study .............................................................................................................................15 
Study Interventions ........................................................................................................................................16 
Nicotine Replacement Therapy (NRT) ......................................................................................................17 
Study Procedures ...........................................................................................................................................18 
Measures & Assessments ..........................................................................................................................19 
Sequence of Study Activities .....................................................................................................................21 
Recruitment .........................................................................................................................................21 
Consent Session .................................................................................................................................22 
Baseline Session ................................................................................................................................23 
Coaching Sessions .............................................................................................................................24 
Follow-up Sessions ............................................................................................................................24 
Subject Compensation ...............................................................................................................................25 
Adverse Events & Reporting .........................................................................................................................26 
Anticipated Events .....................................................................................................................................27 
Collecting & Recording Adverse Events ...................................................................................................27 
Reporting Adverse Events .........................................................................................................................28 
Data & Safety Monitoring .........................................................................................................................28 
Trial Stopping Rules ........................................................................................................................28 


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Disclosure of any conflict of interest ..........................................................................................29 
Trial feasibility ...................................................................................................................................29 
DSM Plan Administration ...............................................................................................................29 
Data Management & Analysis .......................................................................................................................29 
Data Management Plan ..............................................................................................................................29 
Data Flow .............................................................................................................................................31 
Data Monitoring & Quality Assurance ......................................................................................................32 
Privacy, Data Storage & Confidentiality ...................................................................................................32 
Recording Direct Subject Identifiers .................................................................................................32 
Retaining link between study code numbers and direct identifiers after collection ...................33 
Protecting against data disclosure to the public or non-researchers ..........................................33 
Audio Recordings................................................................................................................................34 
Other Uses of Study Data ..................................................................................................................34 
Data Analysis & Statistical Considerations ...............................................................................................35 
Appendix ......................................................................................................................................................35 
List of Abbreviations .................................................................................................................................35 
References................................................................................................................................................36 
 
 
Background & Rationale 
 
The smoking rate among adults with serious mental illness (SMI), such as schizophrenia 
spectrum, bipolar, and recurring depressive disorders is 3 to 4 times the rate of the 
general population (CDC, 2011). Such high rates of smoking consumption have serious 
health consequences for people with SMI. As a result of smoking, people with SMI have 
higher incidence of cancer (McGinty et al., 2012) and live 25 years less than those who 
don’t (Colton & Manderscheid, 2006). This population is also less likely to use preventive 
medical care (Hackman et al., 2006), receive adequate medical treatments (Wang, 
Demler, & Kessler, 2002), or possess the financial resources to access medication and 
treatment (Kessler et al., 2001). Furthermore, even though research shows that people 
with SMI often want to quit smoking (Irving, Seidner, Burling, Thomas, & Brenner, 1994), 
these individuals are 2 to 8 times more likely to fail smoking cessation treatments 
relative to adults without SMI (de Leon, Gurpegui, & Diaz, 2007). In sum, there is a great 
need for innovative and highly engaging behavioral interventions tailored to this 
population. 
 
Computer technology offers great promise to develop innovative and highly engaging 
behavioral treatments for people with SMI. These technologies can deliver behavioral 
health interventions that are cost-effective, evidence-based, and tailored to each 
individual’s needs. A recent survey among 1592 individuals with a diagnosis of SMI 
reported that 72% of them had a mobile device (Ben-Zeev, Davis, Kaiser, Krzsos, & 


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Drake, 2013). As a result, the Center for Medicare and Medicaid is already expanding 
reimbursement procedures to include technologically-based services. Given that mobile 
technology is already highly adopted in people with SMI, it holds great promise for 
smoking cessation treatments in this population.  
 
In 2 previous usability studies funded by the National Institute of Drug Abuse, we 
examined critical features required by individuals with SMI who use smoking cessation 
apps. In a first study (Vilardaga et al., 2015), 240 hours of field experience using a 
standard smoking cessation app, and 10 hours of recorded interviews and task 
performances revealed that: (a) participants needed guidance to complete critical tasks, 
and experienced high task completion latencies (M = 4.5 minutes), (b) levels of usability 
were below industry standards (SUS = 65). Further, qualitative interviews revealed the 
following themes: (a) the need to simplify data entry and layers’ structure, (b) the need of 
incremental rewards and a focus on the process of cutting down rather than quitting, (c) 
the importance of coaching and assistance, (d) the need of more interactive and 
engagement features (e.g., points, gaming), (e) a request for more elaborate 
psychological skills for quitting and (f) the need for finer-grained cigarette tracking (i.e., 
half cigarettes).  
 
In a second usability study (Vilardaga et al., 2016) we developed a tailored smoking 
cessation prototype app for people with SMI and tested it during 10 hours of qualitative 
interviews. Results indicated that with the tailored app design: (a) users were able to 
complete tasks with minimal guidance, (b) participants had a positive view of the apps’ 
use of points and rewards, (c) participants enjoyed the use of the psychological skills 
proposed, (d) levels of usability were above industry standards (SUS = 74). Users 
comments included: “I wish you guys could send this to me so that I could practice it and 
learn it... (P1)”, “This is very comfortable because the information goes right into your 
mind (P5)”, “Eye catching... this would be kind of fun (P4)”, “Awesome, its inviting [...] the 
cartoons are cute (P3)”, “It was simple, informative, easy to use [...] the points... the most 
exciting (P3)”.The results of these 2 studies laid out the foundation of the Pilot 
Randomized Controlled trial we propose in this application.  
 
Study Purpose 
 
We propose to conduct a Pilot Randomized Controlled trial comparing a novel app 
tailored to people with SMI, Learn to Quit, to an app based on best-practice smoking 
cessation standards (QuitGuide). This study will test the feasibility of implementing a 
novel smoking cessation intervention using a smartphone app in individuals with SMI. 
 
As an adjunct to this feasibility trial we may conduct Single Case Experimental trials in 
which each individual will serve as their own control. Data from each individual will be 
used to iterate on critical user centered design features of the Learn to Quit app. Each 
Single Case Experimental trial will last a maximum of 30 days. We plan to recruit no 
more than 30 patients for these adjunct single case studies.  


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Innovation & Significance 
 
The key innovation will be a new model to enhance the effectiveness and reach of 
smoking cessation interventions in people with SMI. Our intervention will be the first: (1) 
to use smartphones for smoking cessation in people with SMI; (2) ACT for smoking 
cessation intervention in people with SMI; (3) smoking cessation intervention to integrate 
smartphones and pharmacological treatments into ongoing mental health and addiction 
care. 
 
The proposed study meets NIDA’s major programmatic priorities of using innovative 
technologies (e.g., smartphones) and integrating behavioral and pharmacological 
interventions to improve substance use treatment and outcomes (NOT-DA-10-019). The 
proposal addresses a serious problem–high smoking rates in people with SMI—in a high 
priority, high cost population, by delivering ACT, a promising behavioral intervention for 
smoking cessation. Finally, it operates in “real-world” settings using a wide reaching 
technology. If eventually proven effective, the proposed intervention will provide a new 
model for delivering inexpensive, widely available smoking cessation interventions in 
adults with SMI. 
Study Aims 
Primary Outcomes 
The primary objective of this pilot trial is to evaluate the usability and user experience 
(UX) of two smoking cessation smartphone apps – one whose design is tailored to 
people with serious mental illness; another designed for the general population. We are 
investigating whether a tailored smoking cessation app for people with serious mental 
illness results in higher levels of engagement with smoking cessation content as 
compared to an app designed for the general population. 
Engagement with each app 
 
Frequency of daily app openings in each group throughout the study duration 
(i.e., 4 months) 
 
Time of daily app use in each group throughout the study duration (i.e., 4 
months) 
 
Usability of app design 
 
Measured by the System Usability Scale (SUS) 
 
For this pilot trial, we are also looking to test whether smoking cessation mHealth trials 
can be feasibly conducted with this population. To do this we will be evaluating 
recruitment, enrollment, and retention rates relative to our established goals.  


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Recruitment rates 
 
Percentage of subjects enrolled relative to recruitment goal  
Participant retention 
 
Percent of subjects who complete 4-month follow-up assessments 
Feasibility of measurement strategy 
 
Percentage completion of assessment measures 
 
Secondary Outcomes 
 
Number of cigarettes smoked per day 
Biochemically verified abstinence 
 
Percentage of subjects in each group reporting abstinence (determined by self-
report)  
 
<= 6 ppm in carbon monoxide testing 
Point-Prevalence abstinence rates 
 
30-day, 7-day, & 24-hr self-report smoking tobacco usage 
Quit attempts 
Nicotine dependence 
 
Scores on the Fagerstrom Test for Nicotine Dependence 
Cravings and negative affect 
Nicotine Replacement Therapy usage 
Psychiatric symptoms 
 
Scores on the PANSS and BSI 
Design & Methodology:  
 
In a two-arm pilot randomized controlled trial, this study will compare Learn to Quit (n = 
60) to an app based on best-practice smoking cessation standards, QuitGuide (n = 60; 
see Figure below). Both arms will receive Combined Nicotine Replacement Therapy and 
a proof-of-concept smartphone coaching procedure delivered by research staff.  
 
Participants will be given a smartphone with the corresponding app downloaded, and will 
use it over the next 16 weeks, coming in for four follow-up appointments at 1-month, 2-
month, 3-month, and 4-month time points.  
 
During the baseline and follow-up appointments, we will conduct assessments for mental 
status, substance abuse, health status, smoking status, and usability ratings of 
participants. We will be interviewing participants about their experience when using the 
app, and audio recording these sessions to be transcribed. We will also be tracking 
participants’ app usage over the course of the study as they use it in their everyday lives 
using Google Analytics and downloading this onto the Duke Medicine server. 
 


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To balance baseline variables between the two arms, treatment assignment will use an 
automated algorithm stratifying factors known to predict dropout from smoking cessation 
treatments: female (yes/no), ≥20 cigarettes per day (yes/no), a current mood disorder 
(yes/no). Participants will be given a smartphone with the corresponding app downloaded, 
and will use it over the next 16 weeks, coming in for four follow-up appointments at 1-
month, 2-month, 3-month, and 4-month time points. 
 
 
 
Subjects 
Selection of Subjects 
 
The population will be up to 120 participants for the randomized controlled trial (30 for the 
single-case trials). Inclusion/exclusion criteria are:  
 
(1) Currently receiving mental health treatment  
 
(2) Current ICD-10 diagnosis of schizophrenia, schizoaffective, bipolar or 
recurring depressive disorder;  
 
(3) The patient smoking ≥ 5 cigarettes per day over the past 30 days (as 
indicated by self-reported daily smoking), and biochemical verification by a 
carbon monoxide breath test at baseline (cutoff: CM > 6 ppm);  
 
(4) Desire to quit smoking in the next 30 days;  
 
(5) Age 18 and older; 
 
(6) Willing and medically eligible to use Nicotine Replacement Therapy; 
 
(7) Fluent in spoken and written English; 
 
(8) Have a working email, mailing address, or alternative contact person; 
 
(9) Adherence to psychiatric treatment as prescribed by their provider; 


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(10) Have stable housing  
 
Exclusion Criteria 
 
(1) Problematic alcohol or illicit drug use in the last 30 days triangulated from 
substance use disorder diagnosis, self-report, and provider feedback; 
 
(2) Acute psychotic episode, unsafe to participate in the study, or psychiatrically 
unstable determined by self and provider report as well as research staff 
observation;  
 
(3) Being pregnant, breastfeeding, or the intention to become pregnant in the 
next 4 months; 
 
(4) Hearing, comprehension, or visual limitations that preclude study 
participation; 
 
(5) Currently receiving any pharmacological and/or behavioral intervention or 
counseling for smoking cessation; 
 
(6) Using non-cigarette forms of tobacco as the primary source of nicotine (e.g. 
e-cigarettes, chew)  
 
Participants for the single case experimental trials will meet the same eligibility criteria as 
those for recruited for the Randomized Controlled Feasibility trial.  
 
When contacting treatment providers, research team members will ask them to verify if 
they seem to be a good fit for the study per inclusion/exclusion criteria. 
 
The Principal Investigator will ultimately make the determination of whether a participant 
is eligible to participate and document this.  
 
Subject Recruitment 
 
Our research team will recruit subjects using a variety of methods.  
 
For two methods, we will utilize medical records querying systems to identify and pre-
screen possibly eligible subjects. These include the use of medical record query tools to 
identify patients we want to reach and pre-screening them before having their healthcare 
provider send an invitation to participate in the study. Additionally, after a report is 
generated from the medical records of patients meeting our defined criteria, our research 
team will use patient portals to directly invite selected patients to participate in the study. 
 


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In order to access these records, we will obtain a Waiver or Alteration of Consent and 
HIPAA Authorization from our IRB. When using the medical records query tools, 
someone from the research team will notify and ask potential subject’s treatment 
provider about the eligibility of the potential participant. If the provider indicates the 
patient may meet the study’s eligibility, a member of the research team will send a 
recruitment letter to the patient on behalf of the treatment provider, with an option to “opt 
out” of further contact by researchers. For those providers who would prefer to opt out of 
the letter, they may approach their patient about the study during an appointment with 
them. Some clinics may utilize other clinic staff (e.g. nurses, medical assistants) to 
approach patients about the study. We may also utilize alerts and other tools within the 
medical records system to facilitate communication between research staff and 
providers, and providers with their patients.  
 
Unless a patient opts out of further contact, research staff will follow-up with a phone call 
after 10 business days of sending the letter to invite the patient to participate, answer 
study questions, and confirm eligibility criteria. If the patient indicates interest in 
participating, research staff will tentatively schedule a baseline assessment at the 
research lab.  
 
For the use of patient portals, patients will be sent the invitation to participate in the 
study. They can indicate on the portal whether or not to seek more information about the 
study which will send a communication to the research team. Those who indicate 
interest in participating will be contacted by the research team to proceed to the initial 
screening phase. 
 
The research team will approach other clinics in the community that serve our 
population, presenting the study to those clinic providers. Treatment providers then may 
refer their patient to the study if they believe they are possibly eligible.  We may also 
have people who call other research labs interested in participating in a study. If the 
candidate seems to qualify for our study, they may be referred to our research team by 
the research team of the other lab.  
 
Research staff will post flyers with the study contact information at various locations in 
the community (e.g. clinic, library). We may advertise in local newspapers, newsletters, 
internet postings (e.g. craigslist.com, researchmatch.org, dukelist.edu).  Candidates may 
find our study through an advertisement, or web posting. They can call in to the lab, or 
take the web screening survey. The research team may also do public outreach at 
relevant events, handing out study flyers and leaflets, answering questions about the 
study from the public, and providing the chance for people to take the web screening 
survey on a lab-managed electronic tablet or laptop.  
 
Those interested in learning more about the study will call in, and if they are willing, a 
research staff member will go through the screening questions with the candidate. If the 
candidate seems eligible after the phone screen, and they decide they would be 


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interested in enrolling, a research staff member will schedule a time to conduct a 
consent session. 
 
We will also implement a peer referral system which encourages already randomized, 
current research subjects to refer people they think might qualify for the study to us. 
When new subjects are enrolled into the study, research staff will ask if someone 
already in the study had referred them to us. We will then compensate those subjects 
$10 for every enrolled subject they referred.  
 
Approaching Subjects to Participate:  
 
Research staff will approach potential participants by telephone calls in private offices so 
patient information cannot be overheard. However, for those patients pre-screened and 
recruited through the medical records, their’ treatment providers will be the first contact 
(i.e. letter, in-person approach) they have about the study. 
 
During public outreach, research staff will use a “pull strategy” allowing people to come up 
to staff to learn more about the study. 
 
In order to approach candidates for participation, the research team will need to collect 
certain personal information (e.g. names, contact information, psychiatric treatment 
details). Only the research team will have access to this information, which is stored in a 
database hosted on a secured server. 
 
Once described, and if still interested, research staff will ask screening questions to the 
interested patient. Those that decline to participate at any point will have their right to 
refuse participation acknowledged, and be thanked for their time. In order to avoid 
approaching people multiple times, we will track those we approach noting whether they 
refused, screened out, or interested in participating at a later time. 
 
Minimizing Coercion 
  
The research team will stress to candidates that participation is voluntary and that they 
can change their minds or withdraw from the study at any point without penalty. 
 
Research staff will emphasize that the patient’s decision to participate (or not) in the 
study should not affect the services they receive, and that study data will not be shared 
with anyone outside the research team, or those contracted by the team without their 
written permission. 
 
Requirements to Participate 
 
All subjects require their treatment provider’s approval to receive the study interventions. 
In order for the research team to obtain this, we ask all subjects to complete a Release 
of Information (ROI) to talk with primary treatment providers.  


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Subjects are required to complete study visits and use the study app assigned to them. 
We offer both in-person and remote methods for completing these visits. There may be 
some circumstances where a study visit will need to occur in-person. In that case, we 
expect subjects to have transportation to the location of where the study visit is to be 
completed. 
 
Subjects must be the primary possessor of the study phone while actively enrolled in the 
study. They are advised to keep the security settings and to retain the study phone 
passcode programmed for the device set for them at the beginning of the study by 
research staff for the duration of their enrollment.  
 
Subjects need not incur any costs to participate in these studies. 
 
Target Population Distributions 
 
Inclusion of Women: In a previous clinical trial by members of the mentoring team in a 
similar setting, women made up 34% of our sample. We expect a similar distribution.  
 
Inclusion of Minorities: We expect the demographics of participants who participate in this 
project will reflect the overall racial and ethnic characteristics of the Greater Durham area. 
Based on information from the United States Census Bureau, Durham demographics are 
48.3% Caucasian, 40% African American, 4.7% Asian American, 0.2% Native American, 
2.8% Some other race, 3.9% Multi-racial. Fifteen percent are Hispanic. 
 
Steps for Withdrawing 
 
When a subject withdraws from the study, we will be consider them “inactive” in the 
study from their participation “stop date”. After this “stop date”, we will not collect any 
further study data from them. Unless a subject asks us to remove their data, we will 
retain any data the subject has already provided during their participation in the study.  
 
If a subject decides to withdraw from the study, they will need to communicate this to the 
research team. We will count the date of this communication as the subject’s “stop date”. 
As an alternative to full withdrawal, we may ask subjects to continue scheduled 
evaluations without the study intervention(s).  In these cases, their “stop date” will be the 
date of their last study session. 
 
Subjects who initially enroll in the study during the consent session but before 
randomization the research team deems ineligible, we will consider them a “Screen Fail”. 
Once we have determined this for a subject, we will notify them that they are not eligible 
to continue participating in the study. We will consider them inactive in our study and we 
will not initiate any further study procedures. The date of the previous consent session 
will count as the subject’s “stop date”.  
 


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The PI may decide to withdraw a subject if they determine that the study is harmful to 
the subject, that participating is no longer feasible for the subject, or that they are 
inappropriate to continue participating in the study. This “Withdrawal by PI” will be 
applicable after we have randomized the subject to the treatment condition. In this case, 
the subject’s “stop date” will be the day the PI makes this withdrawal determination.  
 
Subjects may be passively withdrawn by becoming “Lost to Follow-Up”. This is when we 
consider the subject inactive in the study if they do not complete certain study sessions 
within a given timeframe. This can happen under two conditions: If they either don’t 
complete their baseline visit 30 days after their initial consent visit (or schedule within 
this timeframe); or if they don’t complete their last follow-up session within 90 days after 
its due date. When a subject becomes “Lost to Follow-Up”, we will no longer initial 
communication with them about completing the study. However, if these subjects initiate 
contact with us and/or provide further study data, we may continue communicating with 
them. The “stop date” for these subjects will be the day of their last completed study 
visit.  
 
Regardless of method, withdrawn subjects will need to return the study phone given to 
them for use while participating in the study. Even if we consider a subject inactive, we 
will continue to contact that subject until the study phone is recovered. In addition, we 
would request that we conduct a final follow-up interview to get any last words on their 
experience with the study app and the trial more generally.  
 
If subjects lose more than one study phone during the course of their participation, we 
may not give out a replacement. However, these subjects may still continue to 
participate in the study without the app intervention by completing non app-related 
outcome measures during study follow-up sessions.  
Sampling Frame 
 
Since this will be a feasibility trial we expect the intervention effect sizes to have notable 
variance (i.e., wide confidence intervals), thus the relevance of the current study is linked 
to its significance and potential impact to the field, and not on its ability to estimate 
parameter estimates in the population. In this scenario, a precision (rather than power) 
approach is especially suited, since calculating confidence intervals is ideal for 
preliminary or pilot investigations, and facilitates that sample size is determined by 
practical rather than formal considerations.  
 
Given that retention is a key issue in smoking cessation studies, we will focus on this 
primary outcome. Prior studies in the general population show 93% 6-month data 
retention for ACT, and 70% for standard of care. Achieving a minimum retention rate of 
75% in each condition with a two-tailed precision of +/-5% will require 76 subjects. 
Ninety participants (45 per arm) will thus provide even higher precision of the retention 
rate estimate. 
 


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Risks & Benefits 
Nature and Degree of Risk 
 
The anticipated physical, psychological, social, or legal risks are all minimal. The 
possible side effects of using Nicotine Replacement Therapy in this study include skin 
irritation at site of patch placement, insomnia, rapid heart rate, dizziness, nausea, and 
diarrhea. As in all studies (including qualitative interviews), there is the possibility of 
unauthorized disclosure of confidential information; discomfort or embarrassment related 
to their ability to use a mobile device. Both the PI and the Research Study Coordinator 
are mental health professionals, and can use their clinical judgment to assess how much 
risk a participant may be put in by doing this interview. 
 
Minimizing risk of harm and protecting subjects’ rights and welfare 
 
To address the possible side effects from Nicotine Replacement Therapy (NRT) 
patches, we will have our study doctor, Dr. Paolo Mannelli to be available to monitor and 
evaluate participants’ use in addition to consulting with the research team. We will also 
emphasize placing the NRT patch in varying locations and replacing the patch every 
morning, to reduce possible skin irritation. The research team will monitor use of the 
NRT as well as reviewing any reported changes in medications by the subject. 
 
Applicants will be screened to eliminate candidates with disorders or conditions that are 
contraindicated (see inclusion/exclusion criteria) or those who are not able to provide 
informed consent. We work to coordinate the subject’s participation in the study with the 
medical/mental health care they are already receiving.  
 
The research team will be sensitive to issues surrounding confidentiality and other forms 
of participant risk, taking steps to maintain confidentiality and reduce the risk of 
unauthorized disclosure of subject data. For instance, we will use a research subject 
identification number (subject ID) as the identifier for research data rather than using 
personally identifiable information (PII).   
 
We will emphasize the confidential nature of the data collected in this, explaining our 
safeguarding procedures study to potential and enrolled research subjects. We will note 
which de-identified data will be shared, and how we work to ensure its security.   
 
If at any time a participant expresses discomfort over any aspect of the study 
procedures, the research team member may discontinue the distressing activity.  
 
Possibility of discovering a subject’s previously unknown condition 
 
We will use a set of safety procedures to ensure safe participation during the research 
trial. The research team has medical personnel on staff nearby (i.e. Duke University 


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Medical Center) that are available to deal with any unforeseen medical complications 
that may arise.  
 
The research team will assess medical and psychiatric safety, treatment compliance, 
and data completion for each subject. We will deal with psychological problems or 
distress should it arise. If needed, research staff can assist participants over to the 
Emergency Department. 
 
Consistent monitoring of participant progress provides one level of safety procedures. 
Another level of safety procedures involves evaluation of data collected (especially items 
related to aggression/suicidality in the BSI) and of verbal reports of suicidal and/or 
homicidal intent to staff members. All reports of suicidal or homicidal ideation will be 
immediately reported to the PI as well as to the patient’s treating clinician. All research 
staff will receive training in identifying suicide/homicide risks and/or signs of dangerous 
intoxication and in following the steps needed to appropriately respond to these signs. 
 
Participants judged by study investigators at any point to be a danger to self or others or 
who are judged to be in grave danger due to continued drug use and/or to 
medical/psychiatric problems will be discontinued from the study but actively connected 
with their treating clinician. 
 
Anticipated benefits of research on individual subjects 
 
Participants might benefit from the study in quitting smoking. We will be providing free 
nicotine patches to participants, and the monitored use of the smoking cessation apps 
may contribute to quitting smoking. 
 
Anticipated benefits of research on society, benefits outweighing risks 
 
Smoking directly causes 480,000 deaths a year in the United States. Sixty to 88% of 
individuals with serious mental illness smoke. Furthermore, half of the cigarettes sold in 
the US are bought by individuals with serious mental illness.  
 
Information derived from the study could help improve the effectiveness and reach of 
smoking cessation treatments for adults with serious mental illness. This may benefit 
society and other clients of treatment programs. Participants in the study may see 
improvement in the physical, psychological, occupational, familial, and economic 
problems associated with their tobacco cessation. 
 
The interviews proposed in this research may guide the development of tools to treat 
tobacco addiction in this population. Given that levels of access to mental health 
providers depends on geographical location, this study may help develop low-cost and 
high-reach smoking cessation tools for individuals with serious mental illness in areas 
where there are few smoking cessation services or are lacking (e.g., rural areas). 


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Therefore, the minimal risks to participants are reasonable in relation to the anticipated 
benefits. 
 
Duration of the Study 
 
The randomized controlled trial will last for 4 months (or 16 weeks). We plan to run this 
study for 18 months from enrolling our first research subject. Once all subjects complete 
their participation in the study, we expect to take another 18 months to complete data 
analysis, publish results of the trial, complete all reporting requirements, and close out 
the study.  
 
 
 
The single-case trials will last for 1 month/4 weeks 


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16 
 
 
Study Interventions 
 
Experimental manipulation: 
 
a. Learn to Quit – a smartphone app developed in collaboration between the research 
team and Smashing Ideas designed for helping those with SMI quit smoking using 
Acceptance and Commitment Therapy (ACT). It incorporates a learning component of 
skills acquisition, gaming feature to keep users engaged, and a tracking component to 
record smoking habits and moods (see Appendix A for screenshots). 
 
b. NCI QuitGuide – a smartphone app developed by the National Cancer Institute which 
uses the similar principles to smokefree.gov. NCI QuitGuide has the following 
intervention components: (a) psycho-education about the impact of smoking in health, 
(b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies). (see 
Appendix B for screenshots) 
 
All participants will receive: 
 
c. Nicotine Replacement Therapy - Standard 8-week course of nicotine replacement 
therapy (see NRT section for more details) All participants will be given nicotine 
replacement therapy lozenges in conjunction with the nicotine patches following 
recommendations contained in the US DHHS Clinical Practice Guideline. They will 
receive about a week’s supply of lozenges for when they come up with a quit date, and 
instructed to use them for the week or so following the quit date. NRT used in this study 
is available as over-the-counter medication. We do not plan to study the NRT itself, nor 
do we plan to submit any data about it to the FDA. The study physician will provide 
oversight of nicotine replacement therapy dispensing and monitoring, and consultation 
as needed with the research team. 
 
d. Smartphone coaching – 4-weeks of coaching on how to use the smartphone apps. 
Research staff will provide the coaching as proof-of-concept of the coaching procedure 
to be ultimately delivered by care providers. The first coaching session will be completed 
by a research staff member trained on the study apps. This session will cover orientation 
to the smartphone and assigned app. Research team members will complete later 


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17 
coaching sessions either over the phone or in-person. These coaching meetings will be 
brief (~15 minutes), done on a weekly basis, and will have a focus on providing technical 
assistance. These sessions will be audio recorded and sent to a Duke-approved 
contracted agency for transcription. 
 
Nicotine Replacement Therapy (NRT) 
 
The study interventions have been described above. However, we’ll explain the dosage 
and administration of the nicotine replacement therapy (NRT) more in-depth. 
 
According to the FDA, the use of these drugs does not constitute "Human Subject 
Research". Although our study involves "human subjects", as our participants will be a 
recipient of the NRT patches, we are not developing information about the NRT patches 
or lozenges for submission to, or inspection by, the FDA. The research team will direct 
subjects to use the study drug (i.e. NRT) according to labelled instructions. We will not 
be using an Investigational Drug Service (IDS), and will conduct all of these activities 
stated below ourselves. We will be asking subjects at follow-up sessions about their use 
of the study NRT or any other NRT they have been using during their participation in the 
study.  
 
If after randomization, a subject’s use of NRT is found by a healthcare professional to be 
detrimental enough to their health we will discontinue use of the NRT for the duration of 
the study. These subjects may continue to be enrolled in study using the smartphone 
smoking cessation app intervention until completing participation.  
 
Nicotine Patch (21mg, 14mg, 7mg) 
 
Subjects enrolled in either study will be given an 8-week course of Nicotine Replacement 
Therapy (NRT) patches. The “standard” 8-week course of NRT (for those who smoke 
over 10 cigarettes a day) includes trans-dermal nicotine patches starting at 21mg/24h for 
4 weeks, and then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the 
last 2 weeks, following recommendations contained in the US DHHS Clinical Practice 
Guidelines. For those who smoke 10 cigarettes or less a day, an “adjusted” 8-week 
course of nicotine patches will be given instead of the “standard” course. This “adjusted” 
course starts at 14mg/24h patches for 6 weeks, and then transitions to the 7mg/24h 
patches for the final 2 weeks. 
 
Participants will be instructed to place the patch on clean, dry, and relatively hairless part 
of the skin between the neck and waist. They will also be taught to replace their patch 
every morning. Overall this would mean per participant: (standard) 28 doses on 21mg, 
14 doses on 14mg, and another 14 doses on 7mg; (adjusted) 42 doses on 14mg, 14 
doses on 7mg 
 


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18 
We will be initially giving participants the first 4-weeks of NRT patches during the 
baseline session. During their first follow-up appointment, participants will be given the 
next 4-week installment of NRT patches. For participants who we anticipate not being 
able to make their first follow-up session in-person, we will give them the full NRT course 
at the baseline session.  
 
Research staff will instruct them on proper sequence of the patches as stated above. We 
will continue to provide oversight during the duration of their participation in the study.  
 
For the Single Case Experimental trials, we will distribute the rest of the NRT patches for 
the 8-week course in the same manner as for the primary study. However, as the study 
is only 4-weeks long, we will not have oversight for the last half of the 8-week course 
with these participants.  
 
Research staff will be dispensing the NRT patches to participants, coaching them on 
how to use it properly. We will be storing the patches in a locked storage space in the 
lab - keys only accessible to research staff. To manage our NRT supplies, we will be 
documenting and tracking how much is given to a participant and have the participant 
report how much they used them. Research staff will document which doses of NRT 
were dispensed and how much of it is given to a subject.   
 
Nicotine Lozenge (4mg) 
 
Each participant enrolled in either study will be given 81, 4mg NRT lozenges to be taken 
orally as nicotine cravings arise (average 10 lozenges per day). We will direct subjects to 
use them for the week or so following their quit date, using no more than once every 1-2 
hours. 
 
Research staff will give participants the full course of NRT lozenges during the baseline 
session. We will be dispensing the NRT lozenges to participants, coaching them on how 
to use it properly. We will be storing the lozenges in a locked storage space in the lab.  
 
We will manage and document our NRT lozenge supplies in the same way as the 
patches.  
Study Procedures 
 
All study sessions are completed either via private phone call, private interview room, or 
through a confidential online survey. Most of the study sessions will take place at the 
offices of the research team. However, in some circumstances we may complete study 
sessions with subjects at outpatient clinic locations and in community settings where 
there is a reasonable expectation of privacy.  


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19 
Measures & Assessments 
 
All measures listed below are entered through REDCap unless noted otherwise. Some 
measures may be completed on their paper versions.  
 
• Tobacco Usage – a short questionnaire assessing current and lifelong smoking habits. 
We will complete these with subjects at the consent session; takes approximately 2 
minutes to complete. 
 
• Breath-Tests –Smokerlyzer®, piCO+™ CO Monitor a breath carbon monoxide monitor, 
will be used to obtain biochemical verification of smoking during baseline and follow-ups 
(cutoff: CM > 6 ppm). The user blows into the handheld monitor, which provides 
feedback about the user’s smoking status and nicotine dependence by displaying carbon 
monoxide (CO) levels in the body. This device is available for the public to purchase, 
though clinicians often use it for their clients to monitor their CO levels over time. We 
have no plans to study the item itself, or submit data about this to the FDA. This 
measure takes approximately 1 minute to complete. 
 
• Drug Abuse Screening Test (DAST-10) – a 10-item screening tool for assessing drug 
use (excluding alcohol and tobacco use) in the past month. It will be used to inform 
whether someone meetings eligibility criteria, and given at the consent session. This 
measure takes approximately 2 minutes to complete. 
 
• Alcohol Use Disorders Identification Test (AUDIT) – a brief assessment of drinking 
behavior and detecting possible alcohol dependence. This measurement will be used to 
inform whether someone meetings eligibility criteria, and given at the consent session. 
This measure takes approximately 2 minutes to complete. 
 
• Demographics – A series of questions assessing common demographic information 
such as sex, race/ethnicity, income, etc. We administer this measure to subjects at the 
consent session only. This measure takes approximately 5 minutes to complete. 
 
• Mini International Neuropsychiatric Interview (MINI) - a brief standardized structured 
interview for the major Axis I psychiatric disorders in the ICD-10 with good reliability and 
validity. We use this measure to assess both substance use and other psychiatric 
diagnoses. Scores on the MINI assist the research team in informing our clinical 
judgment on the subject’s appropriateness to continue participation. This measure takes 
approximately 20 minutes to complete. 
 
• Theory of Mind Picture-Sequencing – This theory of mind task comprises four sets of 4-
card picture stories. Subjects rearrange picture cards to show a logical sequence of 
events, which we then score for accuracy. We administer this measure to subjects at the 
consent session only. This measure takes approximately 20 minutes to complete. 
 


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• Urine Pregnancy Test – To verify that female subjects of child-bearing potential are not 
pregnant, research staff will ask subjects to complete a urine pregnancy test. Unless 
indicated otherwise, this we only request this test from aforementioned subjects at the 
consent session. This test takes approximately 4 minutes to complete. 
 
• Barriers to Study Participation Survey – a brief 16-item survey to assess potential 
barriers that participants may face when participating in research studies. This measure 
will be completed at the end of the consent session on Qualtrics. This measure takes 
approximately 3 minutes to complete. 
 
• Brief Assessment of Cognition (BAC) - Assesses cognitive impairments in a wide 
variety of subject populations.. The measure is created and maintained by NeuroCog 
Trials (NCT). The research team administers it through an iPad app at baseline to get a 
sense of the sample’s range of cognitive functioning. Data will be available to research 
staff and NeuroCog Trials, and saved onto Duke Medicine servers. This measure takes 
approximately 20 minutes to complete. 
 
• Psychiatric Treatment Tracking – a brief survey to assess current psychiatric treatment 
including medications taken and other types of therapies utilized to treat mental health. 
We give this measure at baseline and follow-up sessions. We also use this measure to 
monitor changes in treatment that may require medical and/or psychiatric consultation. 
This measure takes approximately 2 minutes to complete. 
 
• Avoidance and Inflexibility Scale – a scaled 9-item measure of willingness to 
experience and not act on physical urges to smoke (i.e., acceptance). This measure 
assesses theory-based processes of change at baseline and follow-ups. This measure 
takes approximately 4 minutes to complete. 
 
• Fagerström Test for Nicotine Dependence – a scaled 6-item measure for assessing the 
severity of nicotine dependence. We will complete these with subjects at baseline and 
monthly follow-ups. This measure takes approximately 2 minutes to complete. 
 
• Smoking Abstinence – a series of questions to assess smoking status including point-
prevalence and prolonged abstinence from smoking cigarettes. We will also ask about 
any other nicotine consumption and treatment used. We will give this measure at 
baseline and all follow-ups. This measure takes approximately 3 minutes to complete.  
 
• Alcohol/Drug Use Follow-up – a brief measure of substance use adapted from the 
Addiction Severity Index (ASI). We will use this measure during baseline and follow-up 
sessions to track relevant drug and alcohol use during the course of participation. This 
measure takes approximately 2 minutes to complete. 
 
• 12-item Short Form Health Survey (SF-12) – A brief health survey providing indications 
into mental and physical functioning and overall health-related-quality of life. We use this 


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measure to describe the level of medical severity of the sample at baseline. This 
measure takes approximately 3 minutes to complete.  
 
• Brief Symptom Inventory (BSI) - a brief 53 item self-report symptom scale. Assesses 
psychiatric symptoms within the last 7 days, and will be used to track symptoms at 
baseline and follow-ups. This measure takes approximately 5 minutes to complete.  
 
• Internet Access and Use Survey – an 11-item questionnaire assessing technology 
access and use. We will ask about previous experience with smartphones, as well as 
information on smartphone ownership. We will only ask this during the baseline session. 
This measure takes approximately 3 minutes to complete. 
 
• System Usability Scale (SUS) – a 10-item questionnaire, measuring various metrics of 
usability of a design using a 5-point Likert Scale. We complete these with subjects at 
each follow-up. This measure takes approximately 2 minutes to complete.  
 
• User Experience (UX) Interviews – a qualitative interview completed to assess the 
experience of the subject as an app user. Research staff trained on UX interview 
techniques will ask subjects to provide their perspective on the app assigned to them. 
We complete these with subjects at each follow-up. This measure takes approximately 
10 minutes to complete. 
 
• Positive and Negative Syndrome Scale for Schizophrenia (PANSS) – a 30-item 
clinician-rated assessment, measuring positive and negative psychotic symptoms on 
four different scales. Research team members complete the full measurement at 
baseline and follow-ups. This measure takes approximately 15 minutes to complete.  
 
• Research Participant Perception Survey (RPPS) – Questionnaire used to assess the 
research participation experiences of participants to help the research team potentially 
improve the experience of clinical trial research participants. We are using a shortened 
13-item version of the original 77-item measure. Research staff will provide the survey to 
the participant at the end of their study participation. Participants will enter this 
information in directly in order to avoid social desirability effects. This measure takes 
approximately 2 minutes to complete.  
 
• Automated app usage – Access and engagement with the app will be measured with 
data such as number of app openings, duration of app use and app features that were 
used the most. Google Analytics for Mobile Apps will be used to track app usage. The 
developers of both apps (Learn to Quit – Smashing Ideas, QuitGuide – NCI) will have 
access to this data as well as research staff.  
 
Sequence of Study Activities 
Recruitment 
 


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22 
 
We will utilize various recruitment methods in order to meet our recruitment 
targets. We will query medical records to identify a subset of patients who meet specific 
eligibility criteria for the sole purpose of study recruitment. We will approach the primary 
treatment providers for those who meet eligibility criteria on initial screening through the 
medical records. We will ask the providers if they feel the candidates meet eligibility 
requirements, and request they invite their patient to participate in the study. A letter 
briefly explaining the study will be sent to eligible patients from their provider, including 
an option to opt out of further contact by researchers. A research team member will 
follow-up with a phone call to invite participation, explain the study, answer any 
questions, and request permission to move to screening questions. Then, research staff 
will ask eligibility questions and determine the individuals’ eligibility to participate in the 
study. If individuals meet eligibility criteria and are still interested in participating, 
research staff will set up a time to meet individually for a consent session appointment.  
 
The research team will also be reaching out to mental health clinics in the community. 
Treatment providers who are knowledgeable about the study and eligibility criteria may 
provide their patients with study information. Interested patients can contact the research 
team, who will explain the study, answer any questions, and request permission to move 
to screening questions. For those patients who seem to qualify based on the screening 
call, research staff will set up a consent session appointment.  
 
For people who contact the research team, we will briefly explain the study, and give 
room for answering any questions potential participants may have. We will ask 
permission to proceed to the screening questions if they indicate interest in participating.  
Once the screening call is completed, and the person seems to be eligible for the study, 
research staff will set up a consent session appointment  
 
Consent Session 
 
Those who indicated interest in participating in the study will be required to complete a 
consent session. Research staff will give potential subjects a presentation on the study 
purpose, procedures, and what will be expected of them as participants. While going 
through the consent process, the research staff member will be looking to make sure the 
participant understands what is being asked of them if they were to enroll in the study, 
and their rights as participants. The research staff will be evaluating whether the 
potential participant is tracking the conversation, and eliciting understanding of the study 
from the potential participant. If the potential participant is unable to comprehend the 
consent process, the research staff will screen them out of the study.  
 
For those who would like to enroll, we will invite them to sign the consent form and a 
Release of Information (ROI). Research staff will obtain contact information from the 
participant in order to follow-up with them including alternative contacts such as case 
managers, friends, and family. For those who enroll, research staff will complete 


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additional screening measures (e.g., DAST, AUDIT, demographics, MINI, ToM picture-
sequencing task, urine pregnancy test).  
 
Once the consent session is completed, the research team will contact health providers 
listed on the ROI to ask them if they believe their patient would meet study eligibility 
criteria. Once this information is collected, the PI will review the subject’s information to 
confirm whether or not the subject meets study eligibility criteria. If the PI determines a 
subject to be eligible, research staff will schedule a baseline session with the participant. 
 
Baseline Session 
 
The next study session to be completed is the baseline session. This is the session 
where subjects are randomized to treatment conditions (i.e. Learn to Quit or QuitGuide), 
given NRT in preparation for their quit date, and provided an orientation to the study 
smartphone and assigned app. We expect subjects to complete this session on the 
same day. If they are not able to complete the session in one day, we will ask them to 
return as soon as possible to finish it.  
 
The baseline session will need to take place within 30 days after completing the initial 
consent session, unless an appointment is made within the next week following the 30-
day window. Otherwise, the subject will be considered “Lost to Follow-Up” and be 
considered inactive in the study. However, those yet to be randomized and considered 
“Lost to Follow-Up” may become active in the study again. Before we can randomize 
someone who had been “Lost to Follow-Up” between consent and baseline sessions, 
the research team will need to re-verify the subject meets screening criteria and contact 
their treatment providers again to make sure they’re still fine with their patient 
participating in the study. If we have not completed a baseline session with the subject 
two weeks after getting initial approval from their treatment provider, we will need to also 
contact their provider again to ensure the provider approves of their patient participating 
in the study. During the baseline session, we will review consent assessment questions 
with a 30-day timeframe or less to ensure these measures are up-to-date for anyone 
who has had their consent session completed over 30 days.  
 
Before starting the baseline measures, each subject will be verified again by research 
staff (i.e. reviewing screening questions, CO breath test). If the subject does not seem to 
meet eligibility criteria at this time, the staff member will stop the session. Under certain 
circumstances subjects may be able to complete the baseline session at a later point, if 
all the above criteria for starting the study interventions are met.  
 
Research staff will complete baseline measures with the subject. Once these are 
completed, research staff will randomize the subject to either NCI QuitGuide or Learn to 
Quit (50/50 chance of either). We stratify randomization is based on whether the subject 
is diagnosed with a primary mood or psychotic disorder.  
 


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Once the app is assigned, research staff will then conduct the first coaching session 
where they provide the subject with a study smartphone and demonstrate both the app 
assigned to them and the study smartphone functionality. To identify the subject in the 
apps’ user analytics reports, research staff will add a unique tracking ID (similar to the 
subject ID) to the study app. They will be oriented to the coaching available to them, 
provided by research staff over the course of their participation in the study. 
 
We will give subjects Nicotine Replacement Therapy (i.e. patches and lozenges), the 
dosages of which are determined by how much the subject has been smoking during the 
last week. While dispensing the NRT to subjects, research staff will provide instructions 
for their use to them. Research staff will ask subjects to demonstrate understanding of 
proper NRT usage before dispensing them to subjects.   
 
Research staff will set up an appointment for the participant’s in-person follow-up 
interview and for a coaching session the next week. 
 
Coaching Sessions 
 
Participants will communicate with research staff to continue coaching on a weekly basis 
for the first 4-weeks. Coaching sessions will be done over the phone, or in-person at the 
research lab if necessary. These coaching sessions are mainly for working through any 
technical issues with the study smartphone and/or the assigned study app. We also 
assess for any AEs during these sessions. These sessions are audio recorded to help 
improve our coaching procedures with users.   
 
There is a 4-day window to complete coaching visits (2 days before the due date, 2 days 
after the due date). The second coaching session will be due 7 days after the completion 
of the baseline/1st coaching session. Each subsequent coaching session’s due date will 
be an additional 7 days from the previous one.  
 
Once the current coaching session has ended, research staff will schedule their next 
coaching session for the following week. 
 
For subjects enrolled in the single-case trials, during the course of the 4-week period, 
some will shift to a different app intervention. This phase change will be determined prior 
to the beginning of the study and will require participants to meet with research staff to 
conduct a qualitative interview and additional coaching 
 
After the first 4 weeks, participants will no longer have in-person coaching sessions. 
However, they will be able call research staff for more brief consultations over the phone 
until their participation with the study is finished.  
 
Follow-up Sessions 
 


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These sessions are monthly visits completed either in-person, over the phone, or 
completed as an online survey. During the follow-up sessions, research staff will conduct 
further assessments, assess for any AEs, and complete a user experience (UX) 
interview with the subject.  
 
Subjects enrolled in the randomized controlled trial will have four follow-up sessions to 
complete. For subjects in the single-case trials, there will be only one follow-up session.  
 
The first follow-up session is due 30 days after completion of the baseline. Each 
subsequent follow-up session’s due date will be an additional 30 days from the previous 
follow-ups due date (i.e. 60 days after baseline for 2nd follow-up, 90 days for the 3rd 
follow-up, 120 days for the 4th follow-up). There is a 14-day window for completing these 
follow-up sessions (7 days before the due date, 7 days after the due date). 
 
During the first follow-up session, research staff will give participants the second half of 
the 8-week NRT patches (unless we dispensed the entire course to the subject during 
the baseline session). We will ask the subject about what psychiatric treatment they 
have been receiving recently. We will note changes in medications and the PI will 
determine (possibly in consultation with the study physician) whether to contact subject’s 
treatment provider to avoid any contraindications between study interventions and 
current medical care. 
 
The research team will spend the last part of the follow-up session conducting an audio-
recorded UX interview with the subject.  
 
Subject Compensation 
 
Participants can receive a total of $110 for completing all study sessions. We will use 
incremental payments to compensate for those participants who engage in continuous 
engagement through follow-up (See Table below). Those who come in for an in-person 
consent session will be compensated $10 for their time. For those who complete follow-
up study visits over the phone, we will take $5 off of the standard compensation to reflect 
the missing biometric data when these visits are conducted in-person – as well as the 
fact that more effort is required to come in-person for an appointment. All withdrawn 
subjects will be given compensation according to what study sessions they have 
completed.  
 
In addition to monetary compensation, participants will: 1) have access to smartphone 
data and cell phone for a period of 4 months (within the limits of the pre-paid plan used 
for the study, valued ~ $180), and 2) be able retain the study smartphone for personal 
use after study completion (valued ~ $200). 
 
Assessment Time 
Point 
Sessions Completed In-Person 
Sessions Completed Remotely 


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26 
Consent 
$10 
$5 
Baseline 
$10 
$10 (in-person required) 
Follow-up #1 
$15 
$10 
Follow-up #2 
$20 
$15 
Follow-up #3 
$25 
$20 
Follow-up # 4 (final) 
$30 
$25  
Total 
$105 
$85 
Throughout Study 
Compensation 
Smartphone Use 
4-months of data, telephone and text messaging (value ~ $180) 
Smartphone 
Ownership 
Ownership of smartphone at study completion (value ~ $200) 
Peer Referral 
$10 for each referral of a successfully enrolled research subject 
 
Single Case Experimental Trials 
 
Participants will receive a total of $50 (See Table below). Compensation with will follow a 
similar pattern to the randomized controlled trial described above. Although participants 
in this sub-study will have access to Internet, phone, and text messaging on the provided 
smartphone during their time with the study (value ~ $45), participants will need to return 
it once they complete the study.  
 
Assessment Time Point 
Amount in Gift Cards 
Baseline 
$10 
App Switch 
$15 
4-weeks Follow-up 
$25 
Total 
$50 
Throughout Study 
Compensation 
Smartphone Use 
4-weeks of data, telephone and text messaging (value ~ $45) 
Peer Referral 
$10 for each referral of a successfully enrolled research subject 
 
In accordance with guidance for the Duke Primary Care Consortium, we are offering 
compensation to providers and clinic staff for their time and service. The research team 
will compensate clinics and providers based on how much time a provider has spent 
interacting with their patients and the study team (e.g., in-person approaches to patients 
about the study, putting up flyers in clinic space), and not based on referrals to the 
research team. This provider compensation is optional and we only offer it to clinics that 
are capable of or willing to accept it. We will determine the appropriate compensation 
levels on an individual clinic/health system basis, after consulting with them about it.  
 
We will make immediate necessary medical care available to subjects in the event they 
are injured as a result of their participation in this research study. However, there is no 
commitment by the research team and institution to provide monetary compensation or 
free medical care to subjects in the event of a study-related injury.  
Adverse Events & Reporting 
 


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Our research team defines an adverse event (AE) as any harmful event that occurs to a 
research subject while participating in a clinical trial. Any new illness, symptom, sign or 
worsening of a pre-existing condition is considered an AE.  
 
We define serious adverse events (SAEs) as adverse events that: 
 
End in death 
 
Are life-threatening 
 
Require inpatient hospitalization or prolong an existing hospitalization 
 
Result in persistent or significant disability/incapacity 
 
Are a congenital anomaly/birth defect 
 
An event that required intervention in order to prevent one of the above 
outcomes 
Anticipated Events 
Given that many people with serious mental illness and smokers have higher medical 
needs than the general population, we do anticipate subjects will report a higher rate of 
Adverse Events (AEs) to us as an inherent characteristic of this population. These 
include such events as COPD, lung cancer, pneumonia, psychiatric symptoms, 
psychiatric medication side effects, hospitalizations.  
Some anticipated AEs resulting from the study interventions include study drug side 
effects. The study drug (i.e. NRT) does have some common side effects that we expect 
subjects will occasionally report including dizziness, headaches, rapid heart rate, 
increased blood pressure, nausea and diarrhea. For the nicotine patch, some common 
side effects include skin irritation and/or itching where the patch is placed, insomnia, and 
vivid dreaming. Nicotine lozenges may cause hiccups, cough, sore through, or 
heartburn.  
There may be some risks associated with smartphone and app usage. Events that we 
anticipate subjects may report to us around using the study smartphone include sleep 
disturbances (from high frequency use), eye strain (from viewing the screen), and data 
breaches (if subjects enter their personal information in the phone).  
Collecting & Recording Adverse Events 
We will be tracking all adverse events (AEs) and serious adverse events (SAE) that a 
participant may experience once starting the study intervention. We will be doing this 
throughout the study, regardless of whether or not we think they are related to the study. 
We start asking about AEs at the second Coaching session, continuing to assess and 
track them at each subsequent study visits throughout the duration of the study. AEs will 
be documented by research personnel during these visits, or at any other time during the 
clinical trial that they have contact with or about the subject. The PI is responsible for 
oversight on AEs.  


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We will document each AE with details such as: 
 
Start and stop dates (if applicable) 
 
Severity: mild, moderate, severe 
 
Possible relation to study protocol 
 
Outcome: is it ongoing or resolved (e.g. did they get treatment)? 
 
Possible causes 
 
Any other pertinent details  
Collected AEs will be documented and recorded with the information above on AE forms 
On a weekly basis, the PI will review each AE to determine its relation to the study 
procedures; deciding what course of action should be taken to address the AE. The PI 
may consult with the study physician if needed.  
If the participant reports a SAE, the same collection and recording procedures will take 
place as with AEs. However, research staff will alert the PI to the SAE as soon as 
possible (within 24 hours of a reported SAE). The PI will review the reported SAE within 
24 hours of becoming aware of it. SAEs will have a separate form completed for each 
one reported.  
Reporting Adverse Events 
Standard reporting requirements, according to the IRB, will apply for all reportable AEs. 
Expedited reporting (within 24 hours of its occurrence or site’s knowledge of the event) 
for reportable SAEs will be done with the IRB, to the appropriate program officer of the 
National Institute on Drug Abuse (NIDA) and the Food and Drug Administration (FDA). 
This initial report will be followed by a final report that will be sent to the IRB, NIDA, and 
FDA. 
In the case of a reportable SAE we will submit the SAE form, summary, and any other 
relevant documentation along with the follow-up report. We may need to gather more 
information to evaluate the SAE, which may include obtaining hospital discharge reports, 
physician records, autopsy records or any other type of records or information necessary 
to provide a complete and clear picture of the SAE and events preceding and following 
the event.  
Data & Safety Monitoring 
 
Trial Stopping Rules 
The intervention being studied—Learn to Quit—pose minimal safety risks to study 
participants. In the case of a SAE, the study will be stopped and no further enrollment will 
take place until the PI has conducted an investigation of the event. Appropriate 
modification of the protocol will be executed if an association is suspected. If protocol 
modifications to ensure the safety of future study participants cannot be executed, the 
study will be terminated. A decision to stop the study will be determined by the PI and his 


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mentors, in consultation with the National Institute on Drug Abuse, the Institutional Review 
Board.  
 
Disclosure of any conflict of interest 
The researchers involved in this study do not have any known conflict of interest issues in 
this Data and Safety Monitoring Plan. 
 
Trial feasibility 
We will conduct an interim analysis of the feasibility trial after 40 individuals are recruited 
to the study (likely at year 1 of the R00 Phase). Information on trial feasibility will be 
provided to NIDA on a yearly basis after this threshold of recruitment is met.  
 
DSM Plan Administration 
 
Responsibility for Data and Safety Monitoring 
The primary responsibility for monitoring the data and safety of the study will be of the PI 
with the assistance of the research coordinator. 
 
The PI will follow and monitor reportable AEs/SAEs until resolution, stabilization or study 
end. Any serious and study-related AEs will be followed until resolution or stabilization 
(even if beyond the end of the study).  
Frequency of DSM Reviews 
The data will be reviewed annually over the course of the study. 
 
Content of the DSM Report 
The DSM report, to be submitted with the annual progress report, will include information 
organized into the following sections: study description, socio-demographic characteristics 
of the accumulated participants at baseline, data on the status of study participants, quality 
assurance issues, and regulatory issues, data on Adverse Events and Serious Adverse 
Events, and feasibility outcomes. 
 
Data Management & Analysis 
 
Data Management Plan 
 
We will collect data of various types in a variety of ways for this project. Included in the 
data to be collected are quantitative and qualitative types including psychometric (tasks 
and self-report), biometric, observational (automated user analytics from investigational 
apps), and audio recordings of user interviews. Quantitative data collected will be 
formatted into CSV files: Qualitative data will be initially collected using the MP3 format, 
and (.txt) files created from these. We will require around 1 TB of data storage for this 
purpose.  


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Much of the psychometric and biometric data will be collected during study visits with 
subjects, sometimes on paper, but ultimately in electronic data capture systems (i.e. 
REDCap) unless otherwise specified. Research staff will collect biometric data to verify 
smoking status from subjects via a Carbon Monoxide (CO) breath test during study 
appointments. We will collect two types of psychological task data – cognitive functioning 
and Theory of Mind. Trained research staff will administer cognitive tasks on an app via 
an electronic tablet device. The app records the subject’s responses into a third-party 
web portal and downloaded as a CSV file. Research staff will administer and record 
Theory of Mind tasks on pen and paper, then entered into the electronic data capture 
system. Self-report data will either be asked by research staff or provided by the subject 
via survey response, which will be entered into the electronic data capture system. Audio 
recordings will be collected via USB microphones onto study laptops during study visits: 
Transcribers will then translate these recordings into text files. Observational user 
analytic data will be automatically collected via Google Analytics in real-time while 
subjects use the investigational app. With the exception of aggregated data sets from 
the electronic data capture system, all of these data files will be organized by the subject 
level and type. The data files will be labelled with subject ID, date collected (if 
applicable), time point, and randomization assignment. We will maintain version control 
by adding consecutive integers to the end of file names for any new versions beyond the 
original. CSV files will then be imported into a SQL relational database with the primary 
key being subject ID. 
Tracking participants’ app usage will be done automatically and continuously through 
Google Analytics for Mobile Apps. A unique tracking ID will be entered into the app to 
track the individual user as a study subject in the reports obtained from Google 
Analytics. Once the subject completes the study, research staff will remove the tracking 
ID from the study app so as to stop any new data coming in. For Learn to Quit users, the 
app will be deleted from the study phone after they complete the study. The data from 
the apps is stored on Google servers, which are located in various data centers around 
the world, and regularly backed up to prevent data loss. Any data at rest or in transit are 
encrypted. The analytic data will be labeled with their subject ID, and will not contain any 
identifying information other than user time stamps. Subjects will use phones provided to 
them by research staff.  
 
Both the research team and the vendor of the QuitGuilde app (National Cancer Institute) 
will have access to this analytic data. NCI normally collects app usage data on all users 
of QuitGuide. They have agreed to share our participants’ data (using QuitGuide) with 
us.  
 
The developer of Learn to Quit, and its current owner, the University of Washington will 
not have access to our participant’s data.  
 
Data from the Brief Assessment of Cognition (BAC) will be collected through the BAC 
app (cognitive assessment battery mentioned earlier), and accessed through a web 
portal. Subjects are only identified through study ID and time stamp of assessment. Any 


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data collected from the assessment is stored locally in an encrypted database on the 
device. Audio files collected during test administration are stored in an unencrypted 
form, though staff and participants are instructed not to record direct identifiers while 
audio recording. Data is only transmitted to NeuroCog Trials (NCT) when authorized by 
both NCT and the site. These data are transferred over an encrypted HTTPS secure 
internet connection. Data stored at NCT are protected using physical and technical 
security and administrative safeguards. The research team will download  this data to 
our shared drive as well. 
Audio recordings will be collected through lab-owned devices with encryption, and saved 
onto the study’s IRB folder on Duke Medicine’s secured network drive. Any transmission 
of audio files and transcriptions outside of Duke Medicine will be done through Duke’s 
secured internet connection and entrusted to a contracted third-party. The text files 
transcribed from the audio recordings will then be stored on the Duke Medicine servers 
where they will be analyzed. Once the transcriptions are completed, the audio files will 
be deleted from any temporary storage locations (e.g. Duke Box, third-party database).  
The metadata accompanying the study data includes codebooks, the questionnaires and 
measures themselves, along with this study’s protocol. 
Regardless of where data collection originates, all study data will eventually be stored on 
the secured Duke Medicine servers.  
Data Flow 
 


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Data Monitoring & Quality Assurance 
We will maintain quality assurance by reviewing and cleaning study data on a regular 
basis before it is imported into the main database. Duke’s Psychiatry and Behavioral 
Sciences Clinical Research Unit (CRU) will also provide periodic monitoring of the study. 
Data quality will be maintained by entering most measures directly into a REDCap 
database, minimizing errors in data entry. In addition, all data will be double-checked by 
trained research assistants as entered. On a monthly basis the project manager will 
review the study database for the accuracy of data. When data quality issues arise they 
will be immediately addressed. The PI will intermittently observe clinical interviews 
conducted by research staff. Data quality issues will also be reviewed weekly at the 
study team meeting, which will include all research staff. Trained research staff will 
double-check all data before data analysis.  For ensuring accurate and reliable biometric 
carbon monoxide results, we will be calibrating the piCO+ smokerlyzer device per 
package instructions.  
 
Privacy, Data Storage & Confidentiality 
Recording Direct Subject Identifiers 
 
Study iPad
Study Smartphone
Study Laptop
User metrics (e.g. app openings, 
time on app, features used
Statistical Analyses


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Research materials obtained from subject will include personal data and audio-recorded 
data derived from interviews. Research materials obtained from subjects will include 
data shared by them during study visits using REDCap and the Brief Assessment of 
Cognition (BAC) app, app usage data extracted from Google Analytics, and transcripts 
of audio-recorded data derived from interviews. Names and contact information (i.e. 
telephone number, email address, living/mailing address, alternative contacts) are 
needed for subject tracking during the duration of the study in order to solve potential 
technical problems with the mobile device, and scheduling follow-ups and the return of 
the device.  
All forms with information concerning an individual subject will be marked with a unique 
code and not their name. The link between the code and the name will be stored on a 
user managed database that is only accessible by research staff, and our database 
developer (only on a required basis to assist in managing the database). This database 
will contain the subject’s identifiable information and subject ID number.   
Retaining link between study code numbers and direct identifiers after collection 
 
After the study is closed, we will destroy the link between (a) the subject’s name and the 
ID number and (b) the ID number and subject’s contact information.      
Protecting against data disclosure to the public or non-researchers 
 
Records and materials generated by the study will only be available to authorized study 
staff members who have signed a confidentiality agreement with our research lab (with 
the exception of those contracted by the research lab to perform certain tasks – mentioned 
elsewhere in the protocol). Any transmission and storage of electronic data will be done 
as securely as possible, and through encrypted means whenever possible. Paper files will 
be kept in locked filing cabinets located in locked offices on a restricted access suite. 
 
Staff will be trained to be sensitive to issues surrounding confidentiality and other forms 
of participant risk. Agencies, such as the NIH and the Duke University, may request 
access to this data for auditing purposes. 
To the extent possible, any information about a participant will never be released to 
outsiders without his/her explicit written consent, except that, in the event of a medical 
emergency, pertinent medical information will be given to the medical personnel caring 
for the participant, or as required by law. 
Some of the data subjects provide as part of the study will be shared with third-party 
vendors of the apps used in the study. This data will not include subjects’ name, but may 
include other identifiers as indicated below, such as timestamps of app usage activity. All 
vendors are required to comply with HIPAA regulations surrounding the confidentiality of 
the information you provide to us, but this cannot be guaranteed by Duke. 
 
App usage data will be managed through Google servers via Google Analytics and 
saved securely at DUHS. More information on Google’s data security and privacy 


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policies relating to analytics data can be found at 
https://support.google.com/analytics/topic/2919631. The data collected from the apps do 
not contain personally identifiable information other than time stamps of app usage. This 
data will be labeled with a subject ID number. 
 
If a subject is assigned to QuitGuide, the National Cancer Institute (developer of 
QuitGuide) will have access to their app usage data. More information on NCI’s privacy 
policy can be found at https://www.smokefree.gov/privacy-policy as well as in their app 
menu. They collect this data for all users of the app as a common practice, though it is 
possible for the research team to receive a participant’s specific usage data by adding a 
unique code to the app to tag it. We will use a combination of a subject ID and another 
code to identify our study to create this unique code for NCI to retrieve and send us this 
data. By adding this particular code combination identifying a subject in our study as 
such, they consent NCI to share this information with us.  
 
For those using Learn to Quit, neither Smashing Ideas nor the University of Washington 
will have access to this data. The app’s privacy policy and terms of use regarding this 
app are detailed on a sheet given to participants by research staff. It can also be found 
here https://duke.app.box.com/s/n1w3feedyzs8937r5wv31nj72q5nr4sy.   
 
The data from the cognitive assessment performed on the BAC app will be send to the 
developer of the app, NeuroCog Trials (NCT).Subjects’ assessment data will be 
combined with all other users, and will be aggregated and anonymized to understand 
and publish information regarding activities across the various studies using this app. 
This app will not collect any personally identifiable information other than the time stamp 
of the assessment. The privacy policy for NCT can be found at 
http://www.neurocogtrials.com/about/privacy-policy/.  
Audio Recordings 
 
Coaching sessions with participants will be audio-recorded for developing more refined 
protocols, as well as selected interviews for training purposes. Qualitative interviews will 
be audio recorded in order to gain a deeper insight into subject’s experience with the 
smoking cessation app.  
Audio-recordings will be done through encrypted study devices (e.g. laptop, tablet, 
smartphone, etc.). These will be marked with a unique subject ID number and not the 
subject’s name. Audio-recordings will be stored on our Duke Medicine servers, and 
transmitted to our transcribers via Duke’s Box service to be transcribed. Once we 
receive and store the transcription from them (into our Duke Medicine servers), the 
recording will be deleted from the Box.  
Other Uses of Study Data 
 
The research team may use a third party vendor to assist us in managing our study 
databases that contain personal health information (PHI) of participants. Anyone we 


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authorize to have access to our databases will be approved to do so by Duke (via an 
official agreement with ORC), and must agree to abide by all applicable HIPAA and IRB 
regulations when handling participant and patient data. 
Other researchers and the public may have access to this study data, distributed through 
protected digital data repositories (e.g. NIDA Data Share, Duke Digital Repository). Any 
personal information that could identify subjects will be removed or changed to de-
identify them before study files are shared with other researchers or results are made 
public. 
Data Analysis & Statistical Considerations 
 
The current study is a pilot trial with small sample size that may include design 
adjustments to maximize recruitment, retention and assessment quality. As such, we 
cannot test research hypotheses. Instead, the primary focus of study data is to inform 
the development of a fully powered RCT of Learn to Quit. Thorough descriptive statistics 
(e.g., M, SD, proportions) will be used to characterize feasibility outcomes. As a 
secondary analysis, regression models will be used to compare each arm’s primary and 
secondary outcomes. An emphasis will be put on visual analytic strategies and 
hierarchical linear modeling (HLM) for continuous, binary and count data. When 
appropriate, multiple imputation techniques will be used to address data missingness 
 
Qualitative data analysis will be through a thematic analysis of transcripts from the 
audio-recorded interviews. We will extract emerging themes coming out of participants’ 
user experience with the apps and coaching protocol. 
 
Appendix 
List of Abbreviations 
 
PI – Principal Investigator 
CRC – Clinical Research Coordinator 
CRS – Clinical Research Specialist  
DUHS – Duke University Health System 
NAMI – National Alliance on Mental Illness 
NRT – Nicotine Replacement Therapy 
ROI – Release of Information 
SMI – Serious Mental Illnesss 


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UNC – University of North Carolina 
PHI – Protected Health Information 
RPR – Review Preparatory to Research 
CSV – Comma Separated Variables 
HCA – Health Care Administrator 
PCP – Primary Care Provider 
PCRC – Primary Care Research Consortium 
DEDUCE – Duke Enterprise Data Unified Content Explorer 
DISCERN – Duke Integrated Subject Cohort and Enrollment Research Network 
AE – Adverse Event 
SAE – Serious Adverse Event 
IRB – Institutional Review Board 
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