Acceptance and Commitment Therapy for Tobacco Cessation Initiated in a Psychiatric Partial Hospital
Phase: NA
Conditions: Tobacco Smoking, Psychiatric Disorder, Psychiatric Hospitalization
Sponsor: The Miriam Hospital

1 
 
Protocol: Acceptance and Commitment Therapy for Tobacco Cessation Initiated in a Psychiatric Partial 
Hospital 
 
NCT#:  NCT03911960 
 
Version Date: September 4th, 2019 
 
 

2 
 
BACKGROUND 
 
There is a significant disparity in tobacco use among those living with mental illness.  Individuals with  
mental illness are more likely to use tobacco, smoke more cigarettes per day, and experience more difficulty 
quitting than those without mental illness.1-4  Individuals living with serious mental illness (SMI, a mental illness 
meeting DSM criteria and resulting in substantial functional impairment,5 e.g., schizophrenia) die, on average, 
20-25 years earlier than those without; these deaths are, in large part, attributable to smoking related 
diseases.6-8  Despite similar levels of motivation to quit, tobacco use in individuals without mental illness is 
declining while tobacco use in those with mental illness has remained steady.4,9,10  These steady tobacco use 
rates indicate that either existing treatments do not work for smokers with mental illness or that effective 
treatments are not reaching these individuals. 
 
There is a knowledge deficit as to which treatments work for smokers with mental illness.  Individuals 
with SMI are excluded from the majority of clinical trials, so many treatments have not been tested with this 
population.11,12  However, there has been research to support the use of provider intervention, 
pharmacotherapy, and mental health-tailored telephone counseling with smokers with mental illness.13-15  In 
contrast, public health campaigns and other population level interventions aimed at the general population are 
not effective for smokers with mental illness.16 
 
 Mental health providers do not systematically address smoking.  Mental health providers, have among 
the lowest levels of intervention around tobacco use of any healthcare providers.11,14  Among psychiatrists, 
rates of intervention around tobacco use have actually declined over time.17  Treatment models that encourage 
intervention with tobacco use in mental health treatment settings are needed.    
 
Partial hospitalization is an excellent and underused opportunity to engage patients in tobacco 
treatment.  Inpatient hospital systems provide a good setting to initiate intervention with tobacco use because, 
unlike private practice, they provide a closed system of providers who see large numbers of patients. By 
training a few clinicians to intervene and having a system for follow-up, tobacco treatment initiated in this 
setting could reach a large number of patients.  Individuals hospitalized in a psychiatric hospital report high 
levels of motivation to quit.18,19  Two clinical trials of a computerized, stage-based, tobacco cessation treatment 
administered in inpatient psychiatry found that smokers were interested in tobacco treatment (recruitment rates 
69-79%) and that those in the intervention group were more likely to be abstinent following hospitalization than 
usual care.20,21 Post-discharge abstinence rates were low, but increased over time.  No safety concerns were 
found.    
 
Partial hospital programs provide intensive day treatment for individuals in acute psychiatric distress. 
PHPs are prevalent; in 2010, there were over 400 programs nationwide.22  Partial hospitals may be an even 
better place to intervene with tobacco use than inpatient units because: (1) like inpatient psychiatry, there is a 
closed system of providers who can be trained;  (2) patients are accessible;  (3) patients are more stable in 
their illness than inpatients and therefore may be more able to accept and benefit from smoking cessation 
interventions; (4) partial hospital programs provide a context that allows for goal setting and restructuring of 
patients’ home environments; (5) patients spend the day on a smoke free campus which may reduce 
opportunities to smoke and provide practice managing cravings; (6)  patients go home at night and are 
encouraged to practice skills that they have learned in their home environment.   
 
Acceptance and Commitment Therapy (ACT) is a promising treatment strategy for smokers living with 
SMI.  ACT is a third wave cognitive behavioral therapy with two key components: (1) acceptance of unpleasant 
thoughts, feelings or sensations, and (2) commitment to values-guided action despite discomfort.  ACT is a 
general psychotherapeutic approach that has been used successfully to treat a variety of mental health 
diagnoses including anxiety, depression, and psychosis.23,24   
Several pilot studies show promise for ACT as a treatment for tobacco dependence, including one showing 
favorable results compared to traditional cognitive behavioral approaches.25-28   To date, no large scale (fully 
powered) trials have been completed on the use of ACT for tobacco cessation.  
Most of the ACT for smoking cessation studies have included only non-psychiatric populations.  ACT may 
be particularly well-suited for tobacco cessation in patients with psychiatric comorbidities as: (1) ACT 
treatments can also be applied to treat mental health symptoms allowing for a consistent treatment framework 
across diagnosis, (2) the hypothesized mechanism of change (i.e., willingness to experience distress and 
discomfort in order to live a valued life) may be particularly relevant for smokers with psychiatric comorbidities, 
who are more dependent and have more severe withdrawal symptoms (i.e., they will experience more 

3 
 
discomfort than average when quitting).29-32  There have been two, small, uncontrolled, feasibility studies of 
ACT for smoking cessation in patients with mental illness.  These studies found ACT for tobacco cessation to 
be feasible in smokers with bipolar disorder and posttraumatic stress disorder.33,34 There have been no 
controlled trials of ACT for smoking cessation in patients with psychiatric comorbidities.  More work is needed 
to assess the feasibility of applying the ACT treatment approach to tobacco cessation treatment with smokers 
with SMI, particularly among those in acute psychiatric episodes.   
 
SUBJECT RECRUITMENT: Source.  Participants will be recruited from the Rhode Island Hospital (RIH), 
Psychiatric Partial Hospitalization program (PHP; See letter from Dr. Zimmerman, Medical Director of the 
program).  This day treatment program (8AM-2PM) employs the principles of ACT via four group sessions, and 
individual meetings with both a psychologist and a psychiatrist.   
Sample size.  We propose a sample size of 20 smokers per group because the primary aim of the R03 
grant mechanism is to assess initial feasibility.  We will oversample men such that 50% of the sample is male.  
Based on the current census of the PHP, we anticipate 240 smokers will be seen over the 8-month recruitment 
period, making it feasible to recruit 40 smokers. 
Inclusion criteria.  Participants will be male and female, current daily smokers, ≥ age 18, have regular 
telephone access, and are able to read and write English.  
Exclusion criteria will be: current use of tobacco cessation treatment (bupropion prescribed for a psychiatric 
indication will be permitted). In order to participate in the PHP, patients must speak English (as groups are 
offered in English only).  If participants would like the nicotine patch, they must be free of medical 
contraindications to the nicotine patch (unless a medical provider gives approval; contraindications include 
recent (<2 weeks) myocardial infarction, serious underlying arrhythmias, serious or worsening angina pectoris, 
and pregnancy or breastfeeding). 
 
PROCEDURES: 
Recruitment.  Participants will be recruited during PHP treatment.  As standard clinical care, all patients are 
screened for smoking status upon admission.  Current daily smokers will be informed about the study at that 
time and invited to be screened for participation.  All women of childbearing potential who would like the 
nicotine patch will complete a pregnancy test prior to inclusion into the study.  Eligible and interested 
participants will complete an enrollment/pre-quit visit while enrolled in the PHP, which includes a baseline 
assessment, random assignment to a condition, the first counseling session and 4 weeks of nicotine patches 
(to be started on the quit day). The enrollment visit can be on the same day as the first pre-quit visit counseling 
but doesn’t need to be.  Participants will then complete a second pre-quit counseling session (within one week 
of the pre-quit session but before discharge). If the participant is to be discharged before their first or second 
counseling session, the counselor will choose one of the following options in order of preference ((1) complete 
the second counseling session early but not on the same day as the first counseling session,(2)  have the 
patient return to the partial hospital program location for the first or second counseling session, (3) complete 
the counseling session by phone and mail materials distributed during the counseling session). Following the 
second counseling session, participants will continue in their assigned post-discharge intervention consisting of 
up to 5 Quitline or ACT telephone sessions.   
Study outcomes will be assessed at the end of the counseling treatment at an in-person visit 5 weeks after 
their visit 2 date OR 24 hours after the last counseling session by a research staff member, whichever is later.  
As an incentive for completion of the follow-up assessment, those in either group who complete this visit will 
receive $20 compensation and an additional 4 weeks of the nicotine patch. We will try to schedule visits 
around existing appointments in the hospital system to increase compliance.   
Randomization will use block randomization, unknown to the counselor or the participant.  In order to 
balance any benefit of bupropion treatment in combination with the nicotine patch across treatment conditions, 
randomization will be stratified by bupropion use.   
Participant payment.  Participants will be paid $20 for the enrollment/pre-quit visit and $20 for the follow-up 
assessment visit. If the first counseling session happens by phone, participants will be paid for the assessment 
with a mailed gift card with a $20 value, instead of $20 cash.  Participants will be paid $5 per telephone 
counseling session completed.  Payment for the counseling sessions will be paid at the follow-up visit and is 
contingent on follow-up visit attendance. 
 

4 
 
Interventions. 
 
Nicotine patch.  All participants will receive usual psychiatric care plus an offer of the nicotine patch (up 
to 8 weeks), dosed per package instructions.  At the second pre-quit session, participants will be instructed on 
patch use. The first 4 weeks of patch will be distributed at enrollment and the second 4 weeks will be 
distributed at the follow-up visit. 
 
Enhanced Usual Care (EUC).   Participants in the EUC condition will receive one in-person counseling 
sessions during the PHP and a second telephone session the week following: the first session will occur prior 
to the quit day and will focus on establishing a quit plan and instructing the participant on the use of the 
nicotine patch; the second session will occur prior to quit day and will assess for any difficulties using the 
nicotine patch.  After the second session, participants will be electronically referred to the RI state quitline.  
This quitline offers an enrollment call and 5 proactive counseling telephone counseling telephone calls to those 
who enroll. Quitline staff make up to 3 attempts per call to reach users.  Total scheduled counseling time 
offered is 120 minutes.  If the participant is unexpectedly discharged before their first counseling visit, the 
counselor will chose one of the following options in order of preference ((1) complete the second counseling 
session early but not on the same day as the first counseling session,(2)  have the patient return to the partial 
hospital program location for the first counseling session, (3) complete the counseling session by phone and 
mail materials distributed during the counseling session).  
 
ACT Care (AC).  Participants in the AC condition will receive one in-person and 6 telephone contacts 
delivered from an ACT framework.  Sessions will last approximately 30 minutes.  If the participant is 
unexpectedly discharged before their first counseling visit, the counselor will choose one of the following 
options in order of preference ((1) have the patient return to the partial hospital program location for the 
counseling session, (2) complete the counseling session by phone and mail materials distributed during the 
counseling session). This intervention is an adaptation of the in-person and telephone protocols developed by 
consultant Heffner to deliver an ACT-based smoking cessation treatment to patients with bipolar disorder.33  
This treatment was found to be feasible to deliver both in person (80% retention, 40% verified abstinent at end 
of treatment, 90% satisfied with treatment) and by telephone (67% retention, 33% verified abstinence, 100% 
satisfied with treatment).   
The intervention targets the six core processes in ACT: acceptance, cognitive defusion, awareness of the 
present moment, self as context, defining values, and committed action towards values. In ACT, acceptance 
means increasing willingness to fully engage in all aspects of experience, as opposed to avoiding unpleasant 
experiences. Cognitive defusion refers to the separation of oneself from the content of one’s thoughts, 
recognizing that cognition does not 
necessarily have to drive behavior 
(i.e., a patient can notice 
themselves having a thought and 
choose not to act on it).  
Awareness of the present moment 
means being fully in contact with 
the present moment rather than 
dwelling psychologically in the past 
or the future (e.g., rumination about 
past failures or worry about future 
challenges). Self as context refers 
to the awareness that there is a 
self, independent of the content of 
thoughts or experiences that acts 
as an observer of these events.  
Defining values is the process of identifying what is meaningful to individuals.  Finally, committed action means 
making concrete value driven behavior change (as opposed to behavior driven by avoidance).  The 
intervention relies heavily on experiential in-session exercises and metaphors as a means of helping smokers 
learn in vivo to apply ACT principles to the task of quitting smoking.   
Counselor training.  Counselors with previous experience in ACT will be trained by consultant Dr. Heffner in 
the delivery of her ACT for smoking cessation protocol. Dr. Heffner will review mock sessions of the counselors 
delivering the treatment and offer feedback to ensure that the counselors are trained to criterion. Counseling 
Table 2: Measures 
 
 
 
Construct 
Measure 
Enrollment 
EOT 
Feasibility 
% smokers recruited 
X 
 
 
% participants completed follow-up 
 
X 
 
Acceptability  
Safety 
 
Efficacy 
% counseling calls completed 
CSQ 
Rehospitalization 
K6 
Abstinence 
Cigarettes per day 
 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Quit attempts 
 
X 
Treatment Targets 
AIS 
X 
X 
 
CTQ 
X 
X 
Covariates 
Demographics 
X 
 
 
Tobacco History 
X 
 
 
FTCD (Modified) 
X 
 
 
MSW 
X 
X 
 
Cessation treatment utilization 
 
X 

5 
 
sessions will be audiorecorded and we will rate 10% of sessions for fidelity using a fidelity checklist.  Quitline 
counselors are trained Tobacco Treatment Specialists. 
Hennepin Healthcare Research Institute.  Sandra Japuntich, Ph.D., is the MPI of the study.  She will 
continue to be involved in the study at her new institution, Hennepin Healthcare Research Institute (HHRI).  
Her roles will include designing study manuals, protocols and assessments, supervising study counselors, 
listening to audiorecordings of counseling sessions and providing feedback to study counselors and monitoring 
study progress. 
 
Measures. 
Feasibility, acceptability and safety.  Feasibility of recruitment and retention will be measured by the 
proportion of smokers seen in the program during the enrollment period who enroll during the recruitment 
period.  The two existing studies of smoking cessation treatment provided in inpatient psychiatric hospitals 
reported 69-79% recruitment rate (of those meeting inclusion criteria) and 80% retention.21,36  Results in this 
range will be considered feasible.  Feasibility of treatment delivery will be assessed by the number of 
completed visits in the ACT group.  Previous studies of ACT for tobacco cessation have found approximately 
65-67% of calls were completed.26,33  Results in this range will be considered feasible.  Acceptability will be 
measured at end of treatment using the 8-item Client Satisfaction Questionnaire (CSQ), 37 a reliable and valid 
questionnaire developed to test health program acceptability.   Safety.  We will collect information on patient 
re-hospitalization via chart review and using questions from the 2016 National Health Interview Survey about 
visits to the emergency room and to the hospital.38  In addition, we will assess for symptom exacerbation.  In 
addition, we will measure global distress using the K6 scale, a measure of non-specific psychiatric distress that 
has been used in population samples to discriminate between samples with and without mental illness.41   
Efficacy.  Efficacy will be measured by 7-day point-prevalence tobacco abstinence at end of treatment, 
verified by an expired breath CO rating ≤6ppm.42,43  Finally, we will assess number of serious quit attempts 
(>24 hours of intentional abstinence). 
 
ACT treatment targets.  ACT treatment targets will be measured at both in person visits and during the 
follow-up call.  The two overarching constructs of ACT, acceptance, and commitment will be assessed.   
Acceptance, will be measured using the Avoidance Inflexibility Scale (AIS), a 13 item, Likert scale, assessing 
participants’ responses to their internal stimuli, including smoking-related thoughts, feelings and physiological 
sensations.45  Acceptance has been shown to account for the bulk of the treatment effect of ACT for tobacco 
cessation in previous studies.25,26 Commitment will be measured using the 8-item, Commitment to quitting 
scale (CTQ).46   
 
Covariates.  Demographics.  We will collect patient demographics (e.g., psychiatric diagnoses, age, 
race/ethnicity, and age) upon enrollment.  Tobacco use history (e.g., number of cigarettes per day, number of 
years smoking) will be measured at enrollment.  Nicotine dependence will be measured at enrollment via the 
first item of the Fagerstrӧm Test for Cigarette Dependence (FTCD),47,48.   Cigarette withdrawal will be 
measured at each of the in-person visits and at end of treatment using  the Minnesota Nicotine Withdrawal 
Scale (MNWS), a 9-item self-report measure of DSM withdrawal symptoms.49,50  Nicotine patch use will be 
assessed at end of treatment.  We will also assess use of other cessation medications (e.g., prn nicotine 
replacement, bupropion, varenicline) as well as use of tobacco cessation counseling (quitline, group, 
individual) during the trial. 
 
BENEFITS: 
Potential benefits for all participants include free treatment with the potential to increase the likelihood of 
smoking cessation, which could in turn prevent smoking related morbidity and mortality as well as improve the 
effectiveness of psychiatric medications. All participants will be offered the nicotine patch, an FDA-approved 
tobacco cessation pharmacotherapy, for free. By participating in the research, all participants will also benefit 
from knowing they may ultimately be helping others as they will have helped us test an intervention. The costs 
of participating in the research will be minimized through our extensive efforts to maintain confidentiality, 
reduce discomfort or distress, and minimize medical complications. Overall, it is expected that the potential 
benefits to participants in the proposed study will outweigh potential risks. 
 
RISKS: 
Nicotine patch side effects:  All subjects who are ready to quit have no contraindications to the patch will be 
offered an 8-week supply of free nicotine patches. The nicotine patch has been in clinical use for almost 20 

6 
 
years. It is available over the counter and has been judged to be generally safe and efficacious with very few 
contraindications. If the participant has a medical contraindication to the nicotine patch (e.g., recent history of 
MI) he or she must obtain clearance from a medical provider in order to receive the patch from the study team 
(e.g., their PHP psychiatrist or their primary care provider).  Initial dosing will follow package instructions. Study 
counselors will explain the patch’s purpose, application, and side effects. Common side effects of the patch 
include local skin irritation at the site of the patch, nausea if the dose is too large or if the participant continues 
to smoke at a high level while using the patch, and disturbed and vivid dreams. Less common reactions 
include allergic reactions. A comprehensive meta-analysis of 129 studies involving 177,390 individuals 
concluded that there was no significant difference between Nicotine Replacement Therapy and placebo in 
prevalence of severe adverse events (SAEs) including suicidal ideation, heart attack, and mortality.51 Thus, the 
principal investigator of this study, Ernestine Jennings, Ph.D. expects the risk of using the nicotine patch in the 
current study be very minor.  We will obtain a release to inform participants’ psychiatric and primary care 
providers that they have enrolled in a tobacco cessation study and may have been started on the nicotine 
patch.  Participants can call the study PI or their medical provider for information on managing side effects of 
the nicotine patch. 
Nicotine Withdrawal Symptoms After Quitting: There is a strong likelihood that most study participants who 
quit smoking will experience some nicotine withdrawal symptoms, including anxiety, restlessness, anger, 
irritability, sadness, problems concentrating, appetite change and weight gain, insomnia, and decreased heart 
rate. Generally, these reactions are temporary and pose no serious health risks. 
Worsening of psychiatric symptoms and emergent suicidality. Available evidence suggests that quitting 
smoking has not been associated with increases in psychiatric symptoms among those with mental illness and 
may even result in improvement in psychiatric symptoms.20,52  However, this population is at high risk for 
additional acute psychiatric episodes.   
Need for adjustment of psychiatric medication following cessation:  Cessation in some patients on 
psychiatric medications (most notably antipsychotics, benzodiazepines, SSRIs, SNRIs and tricyclic 
antidepressants) can produce increased serum drug levels.53  Medication doses will need to be monitored 
upon cessation to maintain the proper therapeutic dose.   
Confidentiality or loss of privacy. We will collect potentially sensitive information about participants; if 
released inappropriately, participants may experience embarrassment or distress. The seriousness of the 
consequences would depend on the nature of the information revealed and to whom the information was 
revealed. Given the numerous steps we take to protect participant confidentiality, we think the risk of a breach 
of confidentiality is low. 
 
Discomfort or distress when completing assessment and treatment procedures. Some participants may 
feel uncomfortable or distressed answering personal or private questions during assessment or treatment.  In 
our previous studies, when individuals do report discomfort in these situations, it is mild.  Participants will be 
informed at the beginning of each assessment that their participation is voluntary and they may refuse to 
answer any questions that make them uncomfortable or withdraw from the study at any time. 
 
 
1. ADEQUACY OF PROTECTION AGAINST RISK 
 
Recruitment and Informed Consent 
 
Participants who appear to meet inclusion/exclusion criteria, will be informed about the study by partial 
hospital program research assistants. If they express interest, they will be screened for eligibility criteria by the 
research assistants.  At first contact, all participants will first be given a brief verbal overview of the study. If 
participants agree to be screened and pass the screening questions based on inclusion/exclusion criteria they 
will be invited to participate, and will complete a contact information form.  The participant will then be 
scheduled for a baseline assessment visit and counseling session.  Written informed consent (including a 
description of the nature, purpose, risks, and benefits of the study) will be obtained from participants before 
initiating the baseline assessment. The voluntary nature of the study and the participant’s right to withdrawal at 
any time will be stressed during the consent process; this information will be provided to participants in written 
form at the time of consent. As part of the consent process, to ensure comprehension, following the participant 
reading the consent form, we will verbally explain the study to the participant.  All participant questions will be 
answered prior to obtaining written consent.  Research assistants and study counselors will obtain consent.  
 
PROTECTION AGAINST RISK: 

7 
 
 
Minimization of nicotine patch side effects: The nicotine patch is an over the counter medication with 
few serious side effects.  However, participants will be screened for all contraindications to the patch.  If a 
contraindication is present, they must obtain approval from a medical provider before participating.  
Participants will agree to consult with their outpatient medical providers regarding the safety of using the patch 
if their medical status changes after the patch is initially provided. Further, study counselors will explain the 
patch’s purpose, application, and side effects, as well as how to use the patch in a manner that minimizes risk. 
 
To minimize skin reactions, participants will be instructed to move the site of patch placement each day 
and to not repeat site use for at least one week. Patch dose may be adjusted downward if there is significant 
nausea or other reactions. Participants will be instructed to remove the patch before bed if it significantly 
interferes with sleep. Participants with severe side effects will be asked to discontinue patch use and contact 
their primary care provider before resuming. 
Minimization of nicotine withdrawal symptoms after quitting: Participants that decide to use the nicotine 
patch will be told that it will reduce but not entirely eliminate withdrawal symptoms. Participants will be 
instructed to call their outpatient physician or psychiatrist in the case of severe withdrawal reactions. 
Withdrawal symptoms typically abate within 1 to 2 weeks of quitting and are not medically dangerous.  
 Minimization of risk from worsening of depression and emergent suicidality. There is no evidence 
indicating that participation in this trial will worsen depression or cause suicidality. In fact, other studies have 
found that quitting smoking is associated with improvements in psychiatric symptoms.20,52  However, given that 
participants will be enrolled during an acute psychiatric episode, it is likely that some participants will 
experience worsening of depression during this study. A minority may experience episodes of suicidal ideation. 
Thus, we will monitor and respond to these issues in an ethically sensitive manner.  
As part of the Partial Hospital program, all patients are referred to a psychiatrist and a therapist upon 
discharge.  We will obtain a release to inform these mental health providers that their patient is attempting to 
quit smoking and could experience symptom exacerbation.  Participants will be informed that, in the case of 
symptom exacerbation, they should: (1) discuss the symptoms with their psychiatrist, therapist and/or primary 
care provider, (2) page Dr. Jennings, a licensed psychologist (Dr. Langdon, a licensed psychologist, will cover 
if Dr. Jennings is not available); or, if they pose an immediate risk to themselves or someone else, (3) call 911 
or present to the nearest emergency room. 
If a participant reports active suicidality (i.e., any recent suicidal attempts, suicidal gestures, or self-injurious 
behavior; any current plan or intent to engage in suicidal or self-injurious behavior) to any study staff at any 
time, the participant will be assessed by Dr. Jennings or Dr. Langdon, who will respond in an appropriate and 
ethical manner according to the standards of care for suicide prevention (e.g., referral to immediate emergency 
psychiatric care if danger to self is imminent). 
Minimization of risk of inappropriate psychiatric medication dose upon cessation.  Upon enrollment in the 
study, we will inform the patient’s PHP psychiatrist of the patient’s planned cessation attempt.  A benefit of 
stopping smoking while in the PHP is that patients meet with their psychiatrists daily while in the program to 
monitor medication effects and side effects.  In addition, we will obtain a release of information from the 
patients to their outpatient psychiatric provider and primary care provider.  Upon enrollment, we will fax these 
providers a form letter indicating that the patient plans to attempt to stop smoking, their anticipated quit date, 
that they will be using the nicotine patch, and information on potential medication interactions with tobacco 
cessation.   
Minimization of loss of confidentiality/privacy: All data and records will be safeguarded according to the 
strict privacy/confidentiality policies of The Miriam Hospital Institutional Review Board (IRB). Confidentiality will 
be maintained by numerically coding all data, disguising identifying information, and keeping data in secure 
electronic locations or locked in file drawers. All electronic data will be numerically coded and stored on a 
limited access server in a secure research space. All paper forms will be stored in locked file cabinets in a 
locked room. Names of participants will be stored separately. Participant information will be accessible only to 
research staff, who are pledged to confidentiality and complete training in the ethical conduct of research (i.e., 
both HIPAA and CITI trainings). Dr. Jennings will also personally train staff on maintenance of participant 
confidentiality. Identifying information will not be reported in any publication.   
Minimization of discomfort or distress when completing assessment and treatment procedures: We will 
take three specific steps to reduce the possibility of discomfort or distress: 
Study will be clearly explained. A detailed explanation of the study, including what study participation would 
involve, the nature of the questions participants will be asked to answer, the nature of measurements, the 

8 
 
nature of the intervention being tested, and the right to withdraw from the study at any time without penalty, will 
be provided to the participants, both verbally and in writing (through the informed consent form). Participants 
will be encouraged to ask questions about the study. Individuals who are uncomfortable answering these types 
of questions, assessments, or interventions likely will not choose to participate. Those who choose to 
participate but are very uncomfortable with the questions, assessments or interventions will be told that they 
can refuse these assessments or choose to withdrawal from the study. 
Private setting. To help ensure clients’ comfort, they will answer survey questions in a private setting. Thus, 
they should not be concerned that another individual would be able to observe these assessments.  
Staff Training. All staff interacting with participants will be trained by Dr. Jennings to ask questions and 
complete assessments in a sensitive manner and be supportive to any participant experiencing discomfort or 
distress. 
 
INFORMED CONSENT: 
All participants will provide written, informed consent, before engaging in any study procedures.  Participants 
will be given as much time as they need to provide consent, including taking the consent form home to read 
and enrolling at a later date (provided they still enroll while they are a patient in the partial hospital).  The 
consent form will be explained fully by a member of the study staff before signing. 
 
CONFIDENTIALITY OF DATA: 
Data will be kept in locked cabinets in locked rooms and on secure, limited access servers behind The Miriam 
Hospital firewall.  On survey documents and in the survey databases, participants are identified only by only 
numeric IDs, so the identity of participants is protected.  The document connecting participant names to IDs will 
be kept separate from study data.  
 
DATA AND SAFETY MONITORING PLAN: 
 
Given that the proposed research is a single site, pilot RCT, with a very short duration of active 
participant contact and our expectation of a minimal risk designation, the proposed trial does not meet NIH 
criteria requiring establishment of a formal Data and Safety Monitoring Board. However, we have a detailed 
data and safety monitoring plan to ensure the safety of all participants and the validity and integrity of the data.  
 
Monitoring.  
Dr. Jennings (PI) will have primary responsibility for monitoring all participants. Any data or safety 
issues that arise will also be discussed with Dr. Jennifer Tidey, a senior investigator with extensive experience 
conducting tobacco cessation research with patients with mental illness, who will provide consultation. In 
addition, an independent faculty member will be recruited before the start of the study to serve as an 
independent reviewer. Drs. Jennings, Langdon, Tidey, and the independent reviewer will meet quarterly to 
review study progress and the occurrence of adverse events.  
In addition, The Miriam Hospital IRB will initially approve the study. All needed changes or amendments 
to the IRB approved protocol will be submitted to the IRB in a timely manner. There will be no changes in 
protocol enacted until IRB approval of the new protocol is received.   
Dr. Jennings will report all adverse events to The Miriam Hospital IRB within 24 hours. The funding 
institution will be informed in cases when any significant action is taken as a result of an adverse event or by 
direction of the IRB. Any serious adverse event (SAE), whether or not related to study intervention, will be 
reported to both the IRB and the funding institution. A summary of the SAEs that occurred during the previous 
year will be included in the annual progress reports to both the IRB and the funding institution. 
 
Data.  
All data and records will be safeguarded according to the policies of The Miriam Hospital IRB. As 
reviewed above, all participant records and assessment data from this study will be treated as confidential, 
including participant names and the fact they are participating in the study. All electronic data will be stored on 
secure, password protected servers. A file will be maintained that associates the subject’s name with that 
subject's study identification number.  This file will be kept in a secure, password-protected file, separate from 
the actual study data (e.g., screener and survey data). This study will use electronic data collection for all study 
data.  However, consent forms will be paper forms.  They will be stored in locked file cabinets in a locked room. 

9 
 
Long-term storage of these paper files will be at a facility that specializes in the storage of medical/research 
information. The destruction date of these files will be at least 6 years from the termination of the study and will 
be authorized by the PI. 
Only the Principal Investigator, co-Investigator, and study staff will have access to data. The data entry 
system will require login identification and passwords in order to gain access to the data. All data are 
considered part of the subject's confidential record. All staff will receive ethics training and will be trained by Dr. 
Jennings (PI) in strict confidentiality procedures.  
Every effort will be made to ensure that missing data are kept to a minimum. Data entry programs with 
range checking and response validation will be used for any data keypunched.  Where appropriate, validation 
and range rules will be applied to the actual entry fields. Under supervision from the PI, the Data Systems 
Analyst will conduct error checking procedures and preliminary analyses on all data to ensure their accuracy. 
All data designated as primary outcome data will be subject to a 100% cross-referencing. All data files are 
automatically backed-up daily. All audits will be supervised and documented by the PI.   
Only the Principal Investigator will give permission for the release of aggregated study data. No 
identifiable data will be released. Participants in the proposed research will be informed, during consent, that 
completely de-identified data (i.e., data that has been cleaned of all 18 types of HIPAA identifiers) will be 
available to other qualified researchers. Within 18 months of study completion, we will make datasets available 
to interested investigators who submit a written request to the PI. The only contingency on the use of the data 
will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training 
course will have access to the data, the data will be stored securely). The NIH will be notified of transmissions 
of the data to interested investigators. 
 
Education/Training.  
All research personnel connected with this project will participate in mandatory education in human 
research subject protection.  At the core of the self-directed training program is the tutorial provided through 
the Collaborative Institute Training Initiative (CITI) hosted by the University of Miami. All staff must complete 
online training in the protection of human research subjects and units specific to HIPAA regulations and 
compliance.  To be certified, all staff must pass the CITI training every 3 years and the HIPAA unit annually.  
All investigators and staff on the present application have been certified and will maintain certification. 
 
 

10 
 
 
 
References 
 
 
1. 
Cook BL, Wayne GF, Kafali EN, Liu Z, Shu C, Flores M. Trends in smoking among adults with mental illness and 
association between mental health treatment and smoking cessation. JAMA. 2014;311(2):172-182. 
2. 
Bowden JA, Miller CL, Hiller JE. Smoking and mental illness: a population study in South Australia. Aust. N. Z. J. 
Psychiatry. 2011;45(4):325-331. 
3. 
Smith PH, Mazure CM, McKee SA. Smoking and mental illness in the U.S. population. Tob. Control. 
2014;23(e2):e147-153. 
4. 
McClave AK, McKnight-Eily LR, Davis SP, Dube SR. Smoking characteristics of adults with selected lifetime mental 
illnesses: results from the 2007 National Health Interview Survey. Am. J. Public Health. 2010;100(12):2464-2472. 
5. 
Treatment CfSA. Definitions and Terms Relating to Co-Occurring Disorders. COCE Overview Paper 1. Rockville 
(MD): Substance Abuse and Mental Health Services Administration and Center for Mental Health Services; 2006. 
6. 
Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes 
of death among public mental health clients in eight states. Preventing chronic disease. 2006;3(2):A42. 
7. 
Enger C, Weatherby L, Reynolds RF, Glasser DB, Walker AM. Serious cardiovascular events and mortality among 
patients with schizophrenia. The Journal of nervous and mental disease. 2004;192(1):19-27. 
8. 
Chwastiak LA, Rosenheck RA, Kazis LE. Association of psychiatric illness and obesity, physical inactivity, and 
smoking among a national sample of veterans. Psychosomatics. 2011;52(3):230-236. 
9. 
Siru R, Hulse GK, Tait RJ. Assessing motivation to quit smoking in people with mental illness: a review. Addiction. 
2009;104(5):719-733. 
10. 
Steinberg ML, Williams JM, Li Y. Poor Mental Health and Reduced Decline in Smoking Prevalence. Am. J. Prev. 
Med. 2015;49(3):362-369. 
11. 
Prochaska JJ. Failure to treat tobacco use in mental health and addiction treatment settings: a form of harm 
reduction? Drug Alcohol Depend. 2010;110(3):177-182. 
12. 
Hitsman B, Moss TG, Montoya ID, George TP. Treatment of tobacco dependence in mental health and addictive 
disorders. Can. J. Psychiatry. 2009;54(6):368-378. 
13. 
Ong MK, Zhou Q, Sung HY. Primary care providers advising smokers to quit: comparing effectiveness between 
those with and without alcohol, drug, or mental disorders. Nicotine & tobacco research : official journal of the 
Society for Research on Nicotine and Tobacco. 2011;13(12):1193-1201. 
14. 
Rogers ES, Smelson DA, Gillespie CC, et al. Telephone Smoking-Cessation Counseling for Smokers in Mental 
Health Clinics: A Patient-Randomized Controlled Trial. Am J Prev Med. 2016;50(4):518-527. 
15. 
Aubin HJ, Rollema H, Svensson TH, Winterer G. Smoking, quitting, and psychiatric disease: a review. 
Neuroscience and biobehavioral reviews. 2012;36(1):271-284. 
16. 
Ashton M, Rigby A, Galletly C. Do population-wide tobacco control approaches help smokers with mental 
illness? Aust. N. Z. J. Psychiatry. 2014;48(2):121-123. 
17. 
Rogers E, Sherman S. Tobacco use screening and treatment by outpatient psychiatrists before and after release 
of the American Psychiatric Association treatment guidelines for nicotine dependence. Am J Public Health. 
2014;104(1):90-95. 
18. 
Strong DR, Uebelacker L, Fokas K, et al. Utilization of evidence-based smoking cessation treatments by 
psychiatric inpatient smokers with depression. J Addict Med. 2014;8(2):77-83. 
19. 
Walsh R, Schweinfurth L, Dickerson F. Smoking and smoking cessation treatment among hospitalized psychiatric 
patients. Psychiatr Serv. 2015;66(4):442-443. 
20. 
Prochaska JJ, Hall SE, Delucchi K, Hall SM. Efficacy of initiating tobacco dependence treatment in inpatient 
psychiatry: a randomized controlled trial. Am J Public Health. 2014;104(8):1557-1565. 
21. 
Hickman NJ, 3rd, Delucchi KL, Prochaska JJ. Treating Tobacco Dependence at the Intersection of Diversity, 
Poverty, and Mental Illness: A Randomized Feasibility and Replication Trial. Nicotine & tobacco research : official 
journal of the Society for Research on Nicotine and Tobacco. 2015;17(8):1012-1021. 

11 
 
22. 
Beard C, Hearon BA, Lee J, Kopeski LM, Busch AB, Bjorgvinsson T. When Partial Hospitalization Fails: Risk Factors 
for Inpatient Hospitalization. J. Nerv. Ment. Dis. 2016;204(6):431-436. 
23. 
JG AT, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance 
and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 
2015;84(1):30-36. 
24. 
Lee EB, An W, Levin ME, Twohig MP. An initial meta-analysis of Acceptance and Commitment Therapy for 
treating substance use disorders. Drug Alcohol Depend. 2015;155:1-7. 
25. 
Bricker J, Wyszynski C, Comstock B, Heffner JL. Pilot randomized controlled trial of web-based acceptance and 
commitment therapy for smoking cessation. Nicotine & tobacco research : official journal of the Society for 
Research on Nicotine and Tobacco. 2013;15(10):1756-1764. 
26. 
Bricker JB, Bush T, Zbikowski SM, Mercer LD, Heffner JL. Randomized trial of telephone-delivered acceptance 
and commitment therapy versus cognitive behavioral therapy for smoking cessation: a pilot study. Nicotine Tob 
Res. 2014;16(11):1446-1454. 
27. 
Bricker JB, Mull KE, Kientz JA, et al. Randomized, controlled pilot trial of a smartphone app for smoking cessation 
using acceptance and commitment therapy. Drug Alcohol Depend. 2014;143:87-94. 
28. 
Brown RA, Palm KM, Strong DR, et al. Distress tolerance treatment for early-lapse smokers: rationale, program 
description, and preliminary findings. Behav Modif. 2008;32(3):302-332. 
29. 
Tidey JW, Colby SM, Xavier EM. Effects of smoking abstinence on cigarette craving, nicotine withdrawal, and 
nicotine reinforcement in smokers with and without schizophrenia. Nicotine & tobacco research : official journal 
of the Society for Research on Nicotine and Tobacco. 2014;16(3):326-334. 
30. 
Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM, Adolfo AB. Effects of smoking abstinence, smoking cues and 
nicotine replacement in smokers with schizophrenia and controls. Nicotine & tobacco research : official journal 
of the Society for Research on Nicotine and Tobacco. 2008;10(6):1047-1056. 
31. 
Dedert EA, Calhoun PS, Harper LA, Dutton CE, McClernon FJ, Beckham JC. Smoking withdrawal in smokers with 
and without posttraumatic stress disorder. Nicotine & tobacco research : official journal of the Society for 
Research on Nicotine and Tobacco. 2012;14(3):372-376. 
32. 
Schnoll RA, Goren A, Annunziata K, Suaya JA. The prevalence, predictors and associated health outcomes of high 
nicotine dependence using three measures among US smokers. Addiction. 2013;108(11):1989-2000. 
33. 
Heffner JL, McClure JB, Mull KE, Anthenelli RM, Bricker JB. Acceptance and Commitment Therapy and nicotine 
patch for smokers with bipolar disorder: preliminary evaluation of in-person and telephone-delivered treatment. 
Bipolar Disord. 2015;17(5):560-566. 
34. 
Kelly MM, Sido H, Forsyth JP, Ziedonis DM, Kalman D, Cooney JL. Acceptance and commitment therapy smoking 
cessation treatment for veterans with posttraumatic stress disorder: a pilot study. Journal of dual diagnosis. 
2015;11(1):50-55. 
35. 
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of 
patients for the clinician. Journal of psychiatric research. 1975;12(3):189-198. 
36. 
Prochaska JJ, Grana RA. E-cigarette use among smokers with serious mental illness. PLoS One. 
2014;9(11):e113013. 
37. 
Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a 
service evaluation questionnaire. Evaluation and program planning. 1983;6(3-4):299-313. 
38. 
Prevention CfDCa. National Health Interview Survey. 2016; http://www.cdc.gov/nchs/nhis/data-questionnaires-
documentation.htm. 
39. 
Zimmerman M, Chelminski I, McGlinchey JB, Posternak MA. A clinically useful depression outcome scale. 
Comprehensive psychiatry. 2008;49(2):131-140. 
40. 
Zimmerman M, Chelminski I, Young D, Dalrymple K. A clinically useful anxiety outcome scale. The Journal of 
clinical psychiatry. 2010;71(5):534-542. 
41. 
Kessler RC, Green JG, Gruber MJ, et al. Screening for serious mental illness in the general population with the K6 
screening scale: results from the WHO World Mental Health (WMH) survey initiative. International journal of 
methods in psychiatric research. 2010;19 Suppl 1:4-22. 
42. 
Javors MA, Hatch JP, Lamb RJ. Cut-off levels for breath carbon monoxide as a marker for cigarette smoking. 
Addiction. 2005;100(2):159-167. 

12 
 
43. 
Cropsey KL, Trent LR, Clark CB, Stevens EN, Lahti AC, Hendricks PS. How low should you go? Determining the 
optimal cutoff for exhaled carbon monoxide to confirm smoking abstinence when using cotinine as reference. 
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 
2014;16(10):1348-1355. 
44. 
Donny EC, Denlinger RL, Tidey JW, et al. Randomized Trial of Reduced-Nicotine Standards for Cigarettes. N Engl J 
Med. 2015;373(14):1340-1349. 
45. 
Gifford EV, Kohlenberg BS, Hayes SC, et al. Acceptance-based treatment for smoking cessation. Behavior 
Therapy. 2004;35:689-705. 
46. 
Kahler CW, Lachance HR, Strong DR, Ramsey SE, Monti PM, Brown RA. The commitment to quitting smoking 
scale: initial validation in a smoking cessation trial for heavy social drinkers. Addict. Behav. 2007;32(10):2420-
2424. 
47. 
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a 
revision of the Fagerstrom Tolerance Questionnaire. Br. J. Addict. 1991;86(9):1119-1127. 
48. 
Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette 
Dependence. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 
2012;14(1):75-78. 
49. 
Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Archives of general psychiatry. 
1986;43(3):289-294. 
50. 
Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory 
and clinical settings. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and 
Tobacco. 2001;3(1):7-16. 
51. 
Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO. Adverse events associated with nicotine replacement therapy 
(NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies 
involving 177,390 individuals. Tob. Induc. Dis. 2010;8:8. 
52. 
Piper ME, Rodock M, Cook JW, Schlam TR, Fiore MC, Baker TB. Psychiatric diagnoses among quitters versus 
continuing smokers 3 years after their quit day. Drug Alcohol Depend. 2013;128(1-2):148-154. 
53. 
Anderson GD, Chan LN. Pharmacokinetic Drug Interactions with Tobacco, Cannabinoids and Smoking Cessation 
Products. Clin. Pharmacokinet. 2016;55(11):1353-1368.