Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care
Phase: NA
Conditions: Nicotine Dependence
Sponsor: VA Office of Research and Development

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Adjunctive Mood Management for Telephone-Based 
Smoking Cessation in Primary Care  
“Quit Smoking Tele-health” 
 
 
Principal Investigator:  Jennifer M. Gierisch, PhD, MPH 
Version Date:  February 12, 2018  
 
 
 

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Contents 
Purpose ........................................................................................................................................................................ 4 
Background and Significance .................................................................................................................................... 4 
Design ........................................................................................................................................................................... 5 
Selection of Subjects .................................................................................................................................................. 5 
Study Setting.............................................................................................................................................................. 5 
Eligibility Criteria ...................................................................................................................................................... 5 
Subject Recruitment ................................................................................................................................................... 6 
Consent Process ......................................................................................................................................................... 7 
Study Intervention ....................................................................................................................................................... 7 
Telephone Counseling ............................................................................................................................................... 8 
Smoking cessation counseling (Both Groups): .......................................................................................................... 8 
Mood management enhancement (Mood Management Group): ............................................................................... 8 
Health education control condition (Healthy Lifestyles group): ................................................................................ 9 
Measures.................................................................................................................................................................... 11 
Outcome measures ................................................................................................................................................... 11 
Background Measures  (See Appendix 5 for baseline survey and Table 1 for timing of measures.) ...................... 12 
Mediators of Smoking cessation .............................................................................................................................. 13 
Process measures ..................................................................................................................................................... 13 
Economic Analysis .................................................................................................................................................. 14 
Risk/Benefit Assessment ......................................................................................................................................... 14 
Adverse Events ......................................................................................................................................................... 15 
Costs and Payments to Subjects ............................................................................................................................ 16 
Data ............................................................................................................................................................................. 16 
Information Security ................................................................................................................................................ 16 
Data Destruction ...................................................................................................................................................... 17 
Data Access Termination ......................................................................................................................................... 17 
Incident Reporting ................................................................................................................................................... 17 
Confidentiality and Privacy ...................................................................................................................................... 17 
Safety Monitoring - Handling of Unexpected or Adverse Events ....................................................................... 18 
Data Analysis and Statistical Considerations ....................................................................................................... 19 
Data Summary ......................................................................................................................................................... 19 
Intent-to-Treat Analysis. .......................................................................................................................................... 19 
Analyses .................................................................................................................................................................. 19 
Attachments 
Appendix 1, Patient Abstraction Form 
Appendix 2, Introductory Letter  
Appendix 3, Screen and Consent  
Appendix 4, Assessment Survey 
Appendix 5, Nicotine Replacement Therapy (NRT) Protocol 
Appendix 6, Roadmap to Intervention Sessions 

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Appendix 7, Safety Protocol 
Appendix 8, Follow-up Letters (Manual cover letter, Follow-up call reminder letters, Unable to reach for 
follow-up assessment letter, Intervention call reminder letter, 9-Month Check-in letter, Can’t reach for 
intervention call letter, and Saliva Collection letter) 
Appendix 9, Abbreviated Follow-up Assessment Survey  
 
 

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Purpose 
 
 The overarching aim of the study is to combine the potency of co-delivered mood 
management and the reach of proactive telephone-delivered interventions by testing the 
telephone delivery of behavioral mood management for smoking cessation among smokers with 
current depression and chronic medical illness. 
 
Background and Significance  
Cigarette smoking is the single greatest cause of preventable deaths in the US;1 and 
military service is a risk factor for smoking.2,3 In VA, patients with chronic medical illnesses 
represent an important and prevalent population on which to focus smoking cessation efforts.4 
Smoking cessation among patients with chronic medical illnesses substantially decreases 
morbidity and mortality;5-7 yet, many patients with these illness continue to smoke.6 There is a 
strong interrelationship between depression and chronic medical illness.8,9 Depression can 
derail smoking cessation. Smokers with histories of depression are more likely to relapse after a 
quit attempt; have higher nicotine dependence; suffer negative mood symptoms from 
withdrawal; are less likely to sustain quit attempts and suffer greater smoking-related morbidity 
and mortality than the general smoker population.10-12 Even patients with low levels of 
depressive symptoms, are more likely to relapse from smoking cessation than non-depressed 
smokers or those with a history of depression.13,14   
Despite the barriers they face, smokers with depression are motivated to quit smoking.15 
Smokers with depression may respond better to smoking cessation interventions augmented 
with mood management adjuncts such as mood management counseling than to standard 
cessation counseling.16,17 Yet, the augmentation of smoking cessation with behavioral mood 
management is not yet firmly established. A recent Cochrane review of smoking cessation 
interventions for patients with depression deemed the strength of the evidence as LOW for 
interventions augmented with behavioral mood management. While the overall impact of adding 
behavioral mood management was positive, further study was deemed necessary.17 
Moreover, most of these trials delivered interventions in person, rather than by telephone, 
potentially limiting reach.  
Improving reach of smoking cessation efforts and removing barriers that limit access and 
participation to effective interventions is critical in order to impact cessation rates at the 
population level. While telephone quitlines are accessible to many smokers and can engage 
motivated smokers, proactive recruitment and proactive telephone counseling are essential 
elements of successful evidence-based telephone-delivered interventions.18 Generally, longer 
and more intensive cessation interventions are more efficacious. Persons with depression likely 
require more intensive, longer smoking cessation treatments.19 Current telephone-based 
interventions such as quitlines have proven high reach but are unlikely to have the potency 
needed to cause significant cessation rates in depressed smokers.  
In the study proposed here, we intend to combine the potency of co-delivered mood 
management and the reach of proactive telephone-delivered interventions by testing the 
telephone delivery of behavioral mood-management for smoking cessation among smokers with 
current depression and chronic medical illness. Proposed is a randomized comparative 
effectiveness trial with a two-group design in which 350 Veteran smokers with depression and 
chronic medical illness will be randomized to either: 1) smoking cessation plus adjunctive 
behavioral  mood management (SMK-MM group), an intervention that includes a proactive 
tele-health intervention that combines evidence-based smoking cessation counseling 
augmented with behavioral mood management and a tele-medicine clinic for accessing nicotine 
replacement therapy (NRT), or 2) smoking cessation telephone counseling control  (SMK  
CONTROL), a contact-equivalent control that provides the same smoking cessation telephone 
counseling intervention augmented with health education (instead of mood management) and a 
tele-medicine clinic for accessing NRT. 

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Design 
The proposed study is a randomized trial to compare a 10-session, telephone-delivered 
behavioral mood management adjunct to a state-of-the-science smoking cessation program 
(SMK-MM) to a contact-equivalent smoking cessation and health education control (SMK 
Control) for effects on sustained abstinence from smoking among depressed Veterans with 
chronic disease. Veterans with current tobacco use and chronic disease will be identified from 
patient records at Durham VA Health Care System (Durham VAHCS). Veterans will be sent an 
introductory letter signed by the principal investigator that describes the study and asks for their 
participation. Veterans who do not decline may be called and asked if they currently smoke and 
if they are willing to quit smoking in the next 30 days. They will also be screened for depression. 
Eligible patients will be randomized to one of two arms: SMK Control (N=175) or SMK-MM 
intervention (N=175). Participating patients will be surveyed at 6-month and 12-month post-
randomization. The primary outcome is self-reported prolonged abstinence at the 6-month 
follow-up (Figure 1). 
 
Accordingly, the specific aims of the study are: 
1. To evaluate the impact of adjunctive mood management intervention on cigarette 
abstinence rates among Veterans at the 6- and 12-month follow-ups. 
2. To evaluate the impact of adjunctive mood management on depressive symptoms 
among Veterans at the 6-month and 12-month follow-ups. 
3. Assess whether change in self-efficacy, as well as positive and negative affect mediate 
the impact of adjunctive mood management on smoking cessation in Veterans at 6- and 
12-month follow-ups. 
4. Evaluate the cost and relative cost-effectiveness of the adjunctive mood management 
intervention. 
 
Selection of Subjects 
Study Setting   
Durham VAHCS will be the recruitment site from which patients will be identified. In FY 
2010, 53,661 unique Veterans received care at Durham VAMC. About 30% of these patients 
(approximately 16,100 Veterans) currently smoke cigarettes. Conservatively, 40% of these 
smokers have a history of significant depressive symptoms, yielding approximately 6,500 
Veteran smokers with a lifetime history of depression.20 We will screen and consent individuals 
until we meet the sample size of 350 subjects enrolled.  We anticipate a 22 month recruitment 
period. 
 
Eligibility Criteria  
Patients must meet all of the following inclusion criteria: 
1. Enrolled in the Durham VAHCS and associated Community Based  Outpatient Clinics 
(CBOCs) for ongoing care 
2. Current tobacco smokers willing to quit smoking in the next 30 days 
3. Having received a diagnosis of a qualifying chronic illness (i.e., cancer, cardiovascular 
disease, hypertension, diabetes, COPD) 
Figure 1. Study Flow  

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4. Have significant burden of depressive symptoms (i.e., meets DSM threshold for > 3 of 
the nine MDD criterion symptoms at the threshold of “more than half the days” (one 
symptom must be depressed mood or anhedonia; endorsing “some days” meets criteria 
for self-harm) and endorse functional impairment OR receive a summary score 10 or 
above on PHQ-9. 63,64 
Patients who meet any one of the following exclusion criteria will be excluded:  
1. Active diagnosis of psychosis or dementia or other memory loss condition in their 
medical records 
2. Severely impaired hearing or speech 
3. Lack of telephone access 
4. Enrollment in another research study that might affect the main outcomes of this study 
5. Terminal illness 
6. Behavioral flags  
7. Active suicidal ideation flags  
8. Endorses self-harm and greater than minimal risk of suicide 
 
Subject Recruitment  
 
Patients clinically diagnosed with chronic medical illnesses and receiving care in the 
Durham VAHCS will be identified from CPRS using a data pull for the following health 
conditions using currently available identification codes: 
 
Cardiovascular Disease; e.g. 
Ischemic Heart Disease, Coronary Artery Disease, Peripheral Artery Disease, Carotid Artery 
Disease, Myocardial Infarction, Aortic Valve Disease, Atrial Fibrillation, Congestive Heart 
Failure, Abdominal Aortic Aneurysm, or Stroke (includes Transient Ischemic Attack, 
Cardiovascular Accident, Cerebrovascular Accident). 
 
Cancer; e.g  
Malignant neoplasm of lip, oral cavity, and pharynx, Malignant neoplasm of digestive organs 
and peritoneum, Malignant neoplasm of respiratory and intrathoracic organs, Malignant 
neoplasm of bone, connective tissue, skin, and breast, Malignant neoplasm of genitourinary 
organs, Malignant neoplasm of other and unspecified sites, or Malignant neoplasm of lymphatic 
and hematopoietic tissue. 
 
Diabetes Mellitus 
 
COPD; e.g. 
COPD with acute exacerbation, Chronic airway obstruction, not elsewhere classified, asthma, 
bronchiectasis, bronchitis/with emphysema/decompensated, emphysema, or  
Chronic obstructive asthma. 
 
Hypertension; e.g. 
Essential Hypertension, or Secondary Hypertension. 
 
   
Patients meeting the criteria will be identified to the study team. Medical records for 
these patients will be reviewed; an abstraction form will be completed (See Appendix 1). At the 
time of abstraction, patients will be deemed potentially eligible or ineligible based on disease 

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criteria and smoking status as recorded in CPRS. Potential participants will be sent an 
introductory letter signed by the PI that describes the study and informs them that they may be 
called and asked to complete a telephone survey unless they call a toll-free number to refuse 
participation (See Appendix 2). Approximately five business days after the mailing, patients who 
have not called the toll-free number to decline participation may be called by a research 
assistant (RA) or other trained study team member to request their participation in the research 
study and screen for eligibility. When leaving voice mail or answering machine messages for 
patients, the team member will be discrete and maintain the patient’s privacy by stating only that 
he/she is calling from the Durham VAHCS. No information regarding the patient’s health 
condition or smoking status may be included in the message. For patients who are currently 
abstaining from smoking or aren’t ready to quit, we will ask the patient’s permission to re-contact 
them about study participation in the future.  The study team member will obtain informed 
consent (Appendix 3) as noted in the Consent Process section below. Once subjects are 
consented, the baseline survey (Appendix 4) will be completed over the telephone. Once 
patients have been screened, consented, enrolled, and have completed the baseline survey 
assessment, the call will be either be transferred to or a message left for, depending on 
immediate availability, a non-blinded staff member to notify the patient of which of the 2 
treatment groups they are randomized: SMK Control (N=175) or SMK-MM intervention (N=175). 
The project’s statistical team will perform the entire study randomization before patient 
enrollment begins. Randomization will be stratified by sex and depressive symptoms using 
criterion based PHQ-9 scoring, (≥5 criterion symptoms, consistent with MDD, vs < 5 criterion 
symptoms, consistent with subsyndromal or persistent depressive disorder) and a blocked 
randomization technique will be used to ensure balance between groups.   
 
In addition to direct-recruiting as detailed above, we may employ self-referral or provider 
referral.  Self-referral would involve placing posters and brochures in clinic waiting rooms and 
other common areas, as well as on the closed-circuit television. VA clinicians may also give 
these brochures to patients who may be interested in the study. To facilitate provider referral, 
we may meet with primary care providers to inform them about the study and give study 
information by email and paper forms. We may set up a consult for referring patients to the 
study within the electronic medical record. 
 
 
 
  
 
Consent Process 
The trained study team member will obtain informed consent to participate after 
describing the aspects of the study. Potential participants will be told that their participation is 
voluntary, and they may choose not to answer any questions that they find too sensitive. 
Participants will not sign an informed consent form; rather, this study will operate under a 
Waiver of Documentation of Informed Consent. As part of the consent process, participants will 
provide consent for use of voice recordings so that counseling calls may be monitored for 
intervention fidelity.  Participants may refuse permission to record and still participate in the 
study. 
 
Study Intervention 
 
Patients will receive the following intervention components: 
1. Introductory letter: A letter from Dr. Gierisch to introduce the study and make an appeal to 
the patient to quit smoking.   
 
2. Combination Nicotine replacement Therapy (NRT): United States Public Health Services 
Update of Clinical Practice Guidelines on the Clinical Treatment of Tobacco Use and 

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Dependence (USPHS CPG) recommends the utilization of a combination of a long 
acting nicotine formulation (patch) and a short acting nicotine formulation (gum or 
lozenge, ).21 At the third telephone counseling session, counselors will discuss the types 
of NRT available and the side effects of each type of NRT with patients.  NRT may be 
discussed in earlier counseling calls if initiated by the participant.  Counselors will tailor 
amount and delivery type of NRT based on number of cigarettes smoked per day (using 
an established protocol22). The counselor will enter a research note and the NRT 
prescription in the patient’s electronic medical record.  This note will be reviewed by 
study pharmacist, Dr. Jenny Legge, and the NRT will be provided, as appropriate, by the 
Durham VAMC pharmacy.  In the rare case of a contraindication, the study pharmacist 
will review the patient’s medical record, formulate a plan for NRT distribution, and send a 
CPRS note to the patient’s primary care provider that details the plan.  The primary care 
provider will then have the opportunity to discuss the plan with the study pharmacist 
(See Appendix 5).  The patient’s usual VA prescription co-payments will apply to NRT.  
The subject may decline NRT. 
 
3. Telephone counseling (described below)  
 
Telephone Counseling  
Both groups will receive up to10 sessions of telephone counseling and a participant 
manual.   Counseling session will be completed over about 5 months on an approximately twice 
a month schedule tailored to the individual patient’s needs.  All counseling contact will be 
complete prior to the conduct of the 6-month follow-up survey.  Some participants may not 
complete 10 sessions because they will have timed out of their intervention window. The 
counseling content of each group is described in the following paragraphs and delineated in 
Appendix 6.  
 Smoking cessation counseling (Both Groups):  
Both groups will receive smoking cessation telephone counseling and smoking cessation 
content will be delivered at parallel times. The counseling intervention is based on standard 
techniques that have been shown to be efficacious for smoking cessation, and  is informed by 
behavioral treatment principles,2 Social Cognitive Theory,23 and Motivational Interviewing.24  The 
counseling intervention and participant workbook were adapted from our previous successful 
telephone counseling intervention that targeted chronically ill Veterans (IIR-05-202).25 The 
treatment protocol is consistent with the Public Health Service Clinical Practice Guide26 and was 
tailored to the Veteran population based on principles of evidence and consensus-based clinical 
practices, and our own experience conducting telephone counseling.  
Mood management enhancement (Mood Management Group):  
In the SMK-MM enhanced arm, behavioral mood management will be integrated into the 
evidence-based smoking cessation counseling. We successfully used this integrated approach 
in our pilot; this approach has been used in other smoking studies with depression-history-
positive patients.27,28 The mood-management sessions are informed by Cognitive Behavior 
Therapy (CBT) and emphasize psycho-educational and skills-based approaches to CBT. CBT 
has been used extensively to address mood management. The behavioral mood management 
approach we tested in our pilot was informed by “Cognitive Behavioral Therapy for Depression 
in Veterans and Military Servicemembers”,29 a therapist manual developed by the VA, and a 
self-help guide to controlling depression, which has been evaluated in other depression 
studies.30 Specifically, SMK-MM enhancement includes behavioral activation, cognitive 

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restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., 
activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant 
manual will also include additional worksheets developed for our pilot based on Lewinsohn’s 
self-help guide to controlling depression.30 The main objective of the worksheets will be to 
provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive 
skills thought to facilitate mood management. As is customary in CBT, homework based on the 
worksheets will be discussed during counseling calls. 
 
The Quit Coach will ask at the start of each session if the participant is agreeable to having 
the session recorded. This verbal confirmation that the participant knows and agrees to be 
recorded will be obtained and recorded in Illume at the start of each recorded session. 
 
Recordings will be used for treatment fidelity purposes only.  Drs. Fish and Gierisch will 
monitor all 10 sessions for the first 3 participants assigned to the counselor, and then up to 5 
randomly selected sessions per month for the remaining intervention delivery period to provide 
ongoing training and supervision. They will monitor protocol adherence using checklists of key 
counseling components. 
 
 Health education control condition (Healthy Lifestyles group):  
In the contact-equivalent health education condition, participants will receive parallel 
smoking cessation content on the same schedule as in the MM-enhanced arm; however, health 
education content will supplant the MM content. The educational content will be based on the 
VA National Center on Health Promotion and Disease Prevention’s “Health Living Messages” on 
such topics as being safe, eating wisely, getting recommended immunization and screening 
tests, and being involved with your health care. Participants also will receive chronic-disease-
specific self-management information. 
 
Study Instruments 
1. 
Chart Abstraction: Using an automated data pull of computerized patient medical 
records, we will collect demographic and contact information (name, date of birth, full social 
security number, mailing address, and telephone numbers). The data pull will filter for subjects 
who meet inclusion criteria based on provided ICD-9 or -10 codes for the health conditions listed 
above.  The data pull will exclude for those conditions listed previously.  Prior to contacting 
potential participants, study staff will complete a brief medical chart review to check for any 
exclusion criteria that may have developed since the time of the data pull.  Patients will not be 
eligible to be contacted for study participation if their medical record documents an active 
diagnosis of psychosis, dementia or other memory loss condition, a hearing and/or speech 
impediment that would preclude patients from using a telephone, enrollment in another research 
study that might affect the outcomes of this study, terminal illness, behavioral flags, or active 
suicidal ideation flags. 
2.  Eligibility Screening:  Patient’s will be screened for current smoking, willingness to quit in 30 
days, and depression.  Depression will be measured using the 9-item PHQ.31  Patients who 
score as having major depression will be encouraged to speak with their doctor or a counselor 
and will be provided with Durham VAHCS mental health resources.  For patients who express 
an endorsement of suicidal ideation (endorsement of question #9 on the PHQ-9) and score 
more than minimal risk on the P419 or who show clinical warning signs of elevated risk of self-
harm (e.g., expression of intent to harm self, severe depression, significantly agitated, 
disordered thought, perceived burdensomeness on others) the RA will engage the Safety 

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Protocol. (See Appendix 7 for details.)  Those qualifying and interested will be consented via 
telephone.   
3.  Baseline Survey: Patients who consent to participate will complete the baseline survey that 
assesses demographics, smoking history and current smoking including e-cigarettes, use of 
other tobacco or nicotine-based products, nicotine dependence, self-efficacy to quit smoking, 
contraindication for NRT, health care provider advice for quitting, attitudes lung cancer 
screening, pain, and depression severity. Participants will be asked to respond to three 
questions (four for women under the age of 50 years) to determine if they are contraindicated to 
receive NRT (i.e. high blood pressure not controlled by medication, chest pain, and wear 
dentures or have jaw problems).  For women under the age of 50 years old, they will be asked if 
they are planning to get pregnant in the next 6 months. If the participant responds YES to high 
blood pressure not controlled by medication and recent chest pain, then the participant must 
receive physician approval prior to receiving NRT (as detailed on the Study Intervention 
section).  
4.  Six (6) and 12 Month Surveys: 
Two follow-up surveys will be administered by phone by a 
study team member blinded to randomization.  One survey will be administered approximately 6 
months after enrolling. There will be another follow up survey about 12 months after enrolling. 
The follow-up surveys will include assessments similar to those used in the baseline and will 
also include measures assessing smoking status, use of intervention materials (e.g., NRT, 
worksheets), and, at the 6-month follow-up, intervention acceptability (e.g., intervention 
appropriateness, suitability, effectiveness, and convenience).   
 
Should the participant be unavailable to complete the full set of follow-up questions, we 
will offer an abbreviated survey version including only questions relating to our primary and 
secondary outcomes as well as cigarettes smoked per day for a reduced incentive payment.  
This abbreviated version is comprised of approximately 14 questions taking about 5 minutes.  
Either we may complete this abbreviated follow-up survey by phone or mail, prioritizing phone 
efforts as it would allow us the opportunity to answer participant questions or address concerns.  
Should staff be unable to contact the participant to complete either the full or the abbreviated set 
of questions by phone by week 3 of a 4-week window of opportunity, we will mail a no-contact 
letter to the participant.  In the letter, we will ask the participant to call in to complete the full set 
of follow-up questions for the full incentive payment by the closing date.  To increase the 
response rate, we will offer to these non-responders the option to complete an enclosed mail-in 
abbreviated follow-up survey for a reduced incentive payment.  On the mail-in version, we will 
replace the PHQ-9 with the PHQ-8 as the measure for depression.  As we have not been able 
to reach these participants by phone, we anticipate being unlikely to reach non-responsive 
subjects for appropriate follow-up should they indicate thoughts of self-harm.  We will include 
the phone number for the Veteran’s Crisis Line on the letter accompanying the abbreviated 
survey.  Despite mailing the survey at three of 4 weeks, we will continue attempts to reach 
participants by phone until the window closes to make every effort to complete the full set of 
follow-up questions.  Should the participant return or complete the abbreviated survey, we will 
enter the responses into the survey software and label the remaining questions as “missing” 
data handling as such.  Should we either successfully reach a participant who mailed in an 
abbreviated survey or a participant changes their mind about wishing to complete the full set of 
questions within the window of opportunity, we will complete the full questionnaire with them by 
phone.  In this case, we will set aside the previously submitted abbreviated survey responses 
for that time point and distribute the full incentive payment.    
 
Surveys for this protocol are administered by study staff using the standard Durham, NC 
HSR&D survey tool “Illume”. Running on top of Microsoft IIS, Illume is a commercial web 
application configured to use https addresses. The application uses a Microsoft SQL server 
database to store both survey questions, and the answers provided to them. The servers are 
operated under the auspices of VA OI&T personnel, who patch, back up, monitor, and update 

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the servers, their supporting operating system instances, and their virtual machine instances, in 
accordance with established VA research policies and OI&T practices, including having the 
physical servers in a secured server room with restricted access, a UPS infrastructure, and 
adequate cooling. HSR&D has a software maintenance contract for Illume to ensure access to 
patches/fixes from the providing corporation, DatStat. The “Illume” application has been 
evaluated by VISN6, whose personnel have run an “AppScan” on the application, and approved 
its use at HSR&D.  Mail-in follow-up surveys will be entered into the survey tool as soon as 
possible by blinded study staff. 
 
Measures 
Medical data, including diagnosis, will be collected from the patient’s medical record.  
 
Outcome measures  
 
Primary outcome  
Prolonged abstinence: In keeping with the Society for Research on Nicotine and Tobacco 
recommendations for measuring abstinence, we use prolonged abstinence as our main 
outcome and allow for a grace period around quit date. During the 6- and 12-month follow-ups, 
patients will be asked about prolonged abstinence, “Since [date of randomization plus 90 days] 
have you ever smoked at least a part of a cigarette on each of 7 consecutive days, that is 7 
days in a row?” and “Since [date of randomization plus 90 days] have you smoked any in each 
of 2 consecutive week, that is 2 week in a row?”32     
 
We also will assess prolonged abstinence via another established single-item measure to 
assess if a more simplified manner of assessing prolonged smoking abstinence yields similar 
resutls.66   This item is, “Have you smoked at all since (date of randomization plus 90 days)?” 
with responses of: a. No, not at all; b. 1-5 cigarette; or c. More than 5 cigarettes.  Answering “a” 
or “b” would categorize a respondent as achieving prolonged abstinence.   
 
  
Secondary outcomes  
Point prevalent abstinence: At each follow-up (6-and 12-month), patients will be asked whether 
they have smoked a cigarette, even a puff, in the past 7 days and, if no, will be asked whether 
they have smoked a cigarette, even a puff, in the past 30 days.  
 
Biochemical Verification 
Saliva samples will be collected from participants who report not smoking in the last 7 days to 
biochemically validate self-report smoking status. Samples will be collected by mail within a 2-
week window following the telephone interview.33 Participants are sent instructions, saliva vials, 
a brief tobacco use assessment (that includes the use of nicotine replacement therapies in the 
prior week), and a postage-paid, padded envelope for returning the sample to the Durham VA 
Medical Center project coordinator so that receipt of samples can be tracked for participant 
payments. Participants self-reporting non-smoking who mailed in a follow-up survey will have 
the saliva sample kit express mailed to them in an attempt to reduce the turnaround time 
between self-report and sample collection.  A reminder call will be made by the Project 
Coordinator to participants mailed a sample kit inquiring about kit receipt, inviting questions, 
reinforcing return by the deadline, reminding about including the completed questionnaire and 
the incentive payment upon receipt.  Samples will be stored in a secure VA research freezer at 
the medical center. Next, samples will be sent to an independent laboratory for analysis.  Saliva 
samples will be analyzed for the presence of cotinine using a standard cut point of 16 ng/ml to 
determine abstinence. This method of analysis has been used in many of our prior smoking 

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cessation studies and yields response rates that are comparable to in-person collection 
methods (i.e., 70%).81   A blind sample of 5% will be run again to assure test accuracy of saliva 
samples. Tubes will be re-labeled prior to shipment with a unique barcode, not the participant’s 
study ID. Following sample analysis, the independent laboratory will be responsible for 
destroying the samples.  The project coordinator will maintain the crosswalk between the two 
codes. Coded samples will be sent by trained study team members in accordance with the 
standards of practice outlined in Research Transporting and Shipping Biological Specimens, 
SRS SOP 202.  Results of the saliva samples will be returned to study staff via a password 
protected Excel spreadsheet attached to an encrypted email sent from the laboratory to the 
study coordinator.    
Participants will receive $20 incentive for returning the saliva sample. 
 
PHQ-9 Patient Depression Questionnaire:  
Patients will be asked the frequency with which they experienced symptoms indicative of 
depression in the past two weeks. This measure can be used to assess DSM criterion 
symptoms for MDD, assess depression severity, and assess suicidal ideations.31 The PHQ-9 
performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of 
administration (e.g., patient self-report).34  For participants responding using the abbreviated 
mail-in follow-up survey, they will be administered the PHQ-8.   
 
Background Measures  
(See Appendix 4 for all assessment survey items and Table 1 for timing of measures.) 
Demographics: Age, race, gender, education, marital status, finance, and employment status 
will be assessed. 
Smoking history/Current smoking: Patients will be asked number of cigarettes currently smoked  
per day on average, number of serious quit attempts (quitting for at least 24 hours) in the last six 
months and use of e-cigarettes. 
Use of Other Tobacco & Nicotine Products: We will also ask if and how often they use the 
following tobacco or nicotine products: smokeless tobacco (e.g., snuff, dip), cigars, regular pipe, 
and electronic cigarettes.  
Nicotine dependence: We will use the 6-item Fagerstrom Test for Nicotine Dependence.35   
Health Care Provider Advice for Quitting:  Patients will be asked if they’ve seen a health care 
provider in the past 12 months.  If yes, they will be asked if they were advised to quitting 
smoking. 
Perceived Stress and Coping: The Rhode Island Stress and Coping Index (RISCI) is a 12-item 
measure with two subscales: perceived stress and perceived coping.36 The RISCI measures 
general stress and coping responses rather that situation-specific responses, and has been 
widely used in smoking cessation studies. A sample stress item reads “I felt there was not 
enough time to complete my daily tasks” and a sample coping item reads “I successfully solved 
problems that came up” (1=never to 5=most of the time).Quality of life: Patients will be asked 
the Euro-Qol (EQ-5D-5L) to rate 5 symptoms (e.g., mobility, self-care ) on a 5-point scale (1=not 
at all to 4=very much). 37  
Contraindications to NRT:  Participants will be asked to respond to 3 questions (4 for women 
under the age of 50 years) to determine if the patient is contraindicated to receive NRT. The 
study pharmacist will review all NRT requests for contraindications and formulate an appropriate 
plan based on revealed contraindications.  
Body Mass Index (BMI):  We will collect from the electronic medical record participant’s weight 
and height measures to calculate BMI. 
 

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Additional Psychosocial Measures  
Self-efficacy - Global self-efficacy to quit smoking: 
A single item will assess “How confident are you 
that you will be able to quit smoking?” (1=Not at all 
confident to 4= Very confident).38 The use of a 
global measure is supported by previous studies in 
which multiple-item SE questionnaires formed a 
unifactorial construct.39 
Situational Self-efficacy:  A 12-item measuring 
situations that tempt people to smoke.40  
Participants will be asked, “Please indicate 
whether you are sure that you could refrain from 
smoking in each situation”. Response options are:  
Not at all sure, Not very sure, More or less sure, 
Fairly sure, and Absolutely sure.” 
Desire to quit: Patients will  be asked four 
questions about their desire and determination to 
change smoking behavior (α= .81).41 
Smoker Identity: We will use two items to assess 
the degree to which a participant considers 
themselves a smoker over the course of the 
intervention.61, 62 
Positive and Negative Affect Scale (20-item 
PANAS): Participants will be asked to report 
positive and negative affect. Items will be 
introduced by the stem “I’d like to know how you 
feel right at this moment. Your answer choices 
range from Not at All to Extremely. I’ll read you a 
list of words, and for each one, please tell me to 
what extent you feel that way right now (0= not at 
all to 4=extremely). 42 
Confusion, Hubbub, and Order Scale (CHAOS): A 
6-item scale designed to address consistency of 
daily routine, ability to plan, and anticipate future 
activities, and being on time.67, 68  
Use of other mood or smoking cessation aids:  
Patients will be asked if they used other mood 
(antidepressants use and type, psychotherapy use and dose) or smoking cessation counseling 
outside study. 
Abrupt Versus Gradual Cessation: A single item will assess the nature of smoking cessation 
behavior.65  
Process measures 
Use of smoking cessation self-help materials and counseling:  Patients will be asked how much 
of the self-help manual they read, and how useful the self-help manual was in helping them to 
try to quit smoking. 
Use of intervention materials:  Patients will be asked how useful the counseling calls were in 
helping them to try to quit smoking and if they would recommend the program to a friend who 
was trying to quit smoking. They will be asked if they used NRT and, if so, what type and what 
their level of adherence was with NRT.  

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Economic Analysis  
Cost assessment: Cost assessment will be conducted from an implementation perspective, 
meaning only costs that will be incurred if the intervention were to be implemented throughout 
the VA are considered.  
 
Direct costs: Cost assessment consists of three components: training, telephone counseling 
labor input, and cost of NRT. We will collect both the trainer and trainee time needed to train the 
counselor to conduct the smoking cessation counseling calls. The counselor will log the total 
time needed for each counseling call including pre-call preparation and post-call tasks, like 
making patient notes. We will track time for unsuccessful call attempts and re-attempts. 
Aggregate time data will be multiplied by the counselor’s per-minute wage and further inflated 
by 30% to account for fringe benefits to derive direct telephone counseling cost. We will obtain 
unit cost of NRT from the Durham VA Pharmacy and apply this cost for the patients prescribed 
NRT in each study arm. 
  
Indirect costs: The VA also incurs costs such as administrative costs, custodial costs, utilities, 
etc., that cannot be attributed to specific health services (i.e. indirect cost). The VA’s Health 
Economics Resource Center recommends allocating indirect costs as a percentage of direct 
cost.44 In previous research, we used administrative data from the VA Decision Support System 
to obtain direct and indirect cost for telephone-based services provided at the Durham VAHCS. 
We used these cost figures to calculate a direct-to-indirect cost ratio of 0.59.45 We will apply this 
multiplier to the direct cost to derive total counseling time cost. Total costs will be divided by 
number of patients in the intervention and control arms to derive average counseling cost per 
patient. 
  
Cost-effectiveness: Two cost-effectiveness ratios commonly calculated in the smoking 
cessation economics literature are cost per quitter and the gold standard of cost per life-year 
saved or quality-adjusted life years (QALY) saved.46 We, too, will calculate cost per quit and 
cost per QALY for this study. To derive cost per quit we will take the total intervention cost and 
divide it by the 6-month and 12-month quit rates observed in each arm. An often used approach 
to derive effectiveness in smoking cessation cost-effectiveness analysis is to extrapolate quit 
rates to increases in life expectancy or QALYs.46 We will use the increase in QALYs due to 
smoking cessation provided by Fiscella and Franks47, stratified by sex and age at quitting, to 
extrapolate QALYS from quit rates in our study. Fiscella and Franks’ estimates mees cost-
effectiveness guidelines established by the US Preventive Services Task Force because they 
provide quality-adjusted life expectancy, and because an annual discount rate of 3% is applied. 
The total cost derived for each arm will be divided by the total gain in QALYs extrapolated for 
each treatment arm to derive the cost-effectiveness ratio for both arms.  
 
Sensitivity Analyses: We will conduct sensitivity analyses to assess robustness of cost-
effectiveness results by distributions of labor rate and counseling time costs, NRT cost, and 
potential QALY gains from quitting. 
 
Risk/Benefit Assessment 
The study is completely voluntary; participants are informed that they are free to refuse 
to answer any items on the questionnaires or questions form the interview that they do not wish 
to answer.  They are also informed that they are free to decline participation in any procedure 
and can withdraw from the study at any time. 

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There are no known psychological hazards or risks associated with completing 
questionnaires, but it is possible that some distress or discomfort may be caused by answering 
study questions.  There is a potential risk associated with the loss of confidentiality of study 
data.  Risks also include discomfort related to quitting smoking. Quitting smoking will cause 
nicotine withdrawal that may lead to headaches, nausea, irritability, weight gain, difficulty 
concentrating, poor sleep, increased appetite increased anxious or depressed mood, and 
craving for cigarettes.   
Participants may choose nicotine replacement therapy (NRT). There are risks 
associated with the use of NRT. Minimal risks associated with wearing a nicotine patch include 
skin irritation, dizziness, lightheadedness, increased heart rate or blood pressure, nausea or 
vomiting.  Participants must get VA physician authorization prior to receiving NRT if they have 
uncontrolled high blood pressure or taking medication for depression. 
 
 While participants may benefit from quitting smoking, there are no guaranteed benefits 
to the individual participant and no immediate benefits of the proposed research to others. 
There are potential benefits to others from the information generated that potentially will be 
helpful in increasing reach of smoking cessation strategies and developing more effective 
treatment interventions for smoking cessation for Veteran smokers. In our opinion, the 
anticipated benefits of this study outweigh the potential risks. 
 
 
Adverse Events 
 
Quitting smoking should enhance rather than jeopardize health status, and potential 
serious adverse events (SAE) for participants in this project are not expected. Regardless, we 
will minimize potential risk by careful screening of potential participants. Those with 
contraindications for NRT will be reviewed and cleared by the study pharmacist prior to 
issuance of appropriate NRT.   
The PI and project manager will oversee monitoring activities. There will be several 
ongoing mechanisms for monitoring and reporting of adverse events: 1) ongoing participant 
contact via study personnel, 2) a toll-free number provided to participants to report concerns 
related to study participation; 3) regular meetings between the PIs and study personnel. 
Prior to initiation of any smoking cessation aid, participants will be informed again of the 
potential risks and side-effects associated with NRT or other medication. Participants also will 
be able to call directly via the study toll-free number to report AEs. This toll-free number, 
directed to the project coordinator’s phone, will be provided to all participants upon entry into the 
study.  
All adverse events will be reviewed and patients evaluated as necessary by the Study 
Physician to determine whether the AE is study related. In addition, study staff will provide 
patients with any applicable referral numbers. This and other instructions will be provided at the 
beginning of the study. The project manager will follow up with participants in a timely manner to 
ensure that the event has been resolved and document actions taken.  
The PIs will meet regularly with study personnel to discuss participants’ reactions to the 
intervention, proper delivery of the intervention, and any adverse events. Monthly meetings 
between the investigators and the project manager will allow for ongoing progress reports, 
including the number of participants currently involved in the study groups, attrition rates, and 
scheduled data collection from participants, as well as notification and review of any AEs. The 
investigative team will classify AEs as "health threatening" or "non-health threatening" events 
and "possibly attributable" or "non-attributable" to the intervention.  Some subjects may not 
complete all scheduled phone calls or follow-up surveys.  This is expected and will not be 
considered an AE. 
Current VA policy regarding reporting of AEs will be followed.   
 

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Costs and Payments to Subjects 
Patients in this study may be paid up to $100. Patient will receive $30 for completing 
each follow-up survey and for those reporting not smoking, $20 for submitting saliva samples to 
confirm smoking status. For subject’s completing an abbreviated version of the follow-up survey, 
they will be compensated $5 for their time.  The patient’s usual VA prescription co-payments will 
apply to NRT. 
Compensation is for the time and effort the patient invests to 1) complete the follow-up 
surveys and 2) where applicable, obtain a saliva sample, package and return it to the study 
team.  Without compensation, patients may not complete these two outcome measures for the 
study.  Patient’s may choose to decline payment. 
 
Data  
All patient information collected in the context of this research study, and even the fact 
than an individual is participating in the study, will be considered confidential. The following 
steps will be taken to ensure confidentiality and safe handling of all data: 
1. Access to all participant data and information will be restricted to authorized personnel. 
2. Participants will not be identified by name in any reports or publications, nor will data be 
presented in such a way that the identity of individual participants can be inferred. 
3. Each participant will be assigned an anonymous study ID which will be used on all study 
forms and within the study database. 
4. All study personnel will maintain certification with the Durham VAHCS IRB that they 
have completed training in research ethics and confidentiality. 
 
With respect to paper based records: 
1. All study records that contain participant information will be kept in secured, locked 
areas when not in use. 
2. Such materials, when in use, will be kept safe from public scrutiny 
3. Materials that need to be discarded will be destroyed. 
 
Information Security  
Actual access is accomplished by adding the individuals’ domain IDs to study specific, 
and often directory or database specific, or role specific, security groups within the Active 
Directory.  For this research study, HSR&D COIN OIT support personnel policy is to accept 
requests for access to data from principle investigators or their delegated project coordinators. 
The requests are captured in the VA’s instance of service Desk Manager from Computer 
Associates. The names for those for whom access is requested must be on a copy of the 
appropriate study’s IRB-approved staff listing on file with the center’s Program Specialist before 
access is granted. 
 
Data will be maintained in a secured server room within the Durham VA Medical Center, 
room FG104, Building 1.  Data are backed up directly to tape. Most backups run daily, Monday 
through Friday.  Most tapes are retained indefinitely pending resolution of some questions 
around VA Research data retention policy. Tapes created at the NC Mutual building, via 
Symantec Backup exec, are moved from the server room to a separate room, also equipped 
with an intrusion alarm, keypad, and PIV card access. From there, the tapes are moved to an 
Iron Mountain storage facility, after being locked in purpose-made tape cartridge carriers. Future 
backups may involve data backed up to near-line storage, at the Durham VAMC using EMC 
Networker software and associated hardware, which is then replicated to Richmond, Virginia, at 
another Region 3 data center then backed up to tape which is again sent to an Iron Mountain 
facility. 

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Primary survey data will be gathered and entered by study staff using the commercial 
product “Illume” from the DatStat Corporation. Access to the data collected is through various 
tools provided by DatStat.  Illume provides additional levels or granularity of restriction to the 
data, beyond what is provided via Active Directory groups. “Illume”, running on top of Microsoft 
IIS, is a commercial web application configured to use https addresses. The application uses 
the Microsoft SQL server database previously mentioned, to store both survey questions, and 
the answers provided to them. The “Illume” application has been evaluated by VISN6, whose 
personnel have run an “AppScan” on the application, and approved its use at HSR&D. 
Individual workstations, desktop PCs or laptops, are patched using the VA standard, 
SCCM from Microsoft. Laptops and desktop PCs are encrypted using the VA standard tool 
Symantec’s SEE. Workstations are equipped with anti-virus and firewall software. 
Data Destruction 
Records will be retained in accordance with the VA records control schedule. 
Data Access Termination 
OI&T personnel remove personnel’s IDs from the groups at the direction of the project 
coordinators and principal investigators. Termination of access will be requested when someone 
departs the project team. 
Incident Reporting 
Any suspected or confirmed loss of VA information will be reported to the Durham 
VAHCS R&D, Privacy Officer, and Information Security Officer within 1 hour of awareness of the 
issue and done so using the VHADUR Research Events Report e-mail group:  
VHADURResearchEventReport@va.gov.  In addition, the study PI and Bradley Dokter, HSR&D 
Computer Scientist will be notified of suspected or confirmed loss of VA information. 
 
Confidentiality and Privacy  
 
Of primary importance in all study activities will be the security and protection of patients’ 
private health information (PHI).  The responsibility of protecting this information begins the 
moment a member of the study team accesses information about a patient and does not 
ultimately end until project data sets are destroyed and/or anonymized in accordance with the 
VA records control requirements.   
 
All information will be kept confidential as provided by law. Confidentiality is maintained 
by numerically coding data.  Data connecting the numerical code with identifying patient 
information will be stored in password-protected databases and will be accessible only to 
pertinent research staff.  All databases will reside on the secure VA network.   
All hard copies of identifying information will be kept in a secure file cabinet in a locked 
office on VHA property.  Identifiers will be destroyed at study end in accordance with the VA 
records control schedule.  All data will be entered and saved directly to a password protected 
database.  Research data, including access to the study database, will be limited to current 
research staff.  Removal of access to the research study data will be accomplished for study 
personnel when they are no longer a part of the research team. 
 
All interviews and intervention contacts will be conducted by trained study staff, and data 
will be directly entered into a VA computer located on VA property. In case of unforeseen 
computer or network failure, staff will complete hard copies of surveys. The staff member will 
enter the survey data once computer or network connectivity is achieved. Hard copies of the 
survey will be filed. Counseling sessions will be digitally recorded and saved to a secure 
network. The recordings of the sessions will be kept in accordance with VA records and control 
schedule, and only study staff will listen to the recordings.   

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Saliva specimen tubes will be labeled with the unique study ID number only.  Specimens 
will be returned to the project coordinator.  Bulk samples will be hand carried by the project 
coordinator or research assistant to the Duke University Nicotine Research Program.  Results 
from the cotinine test will be transferred from Duke to the VA statistician by way of a FIPS 140.2 
compliant encrypted thumb drive that will be hand carried both ways by either the project 
coordinator or research assistant.   A Data Use Agreement is in effect between the Durham 
VAMC, HSR&D and the Duke University Nicotine Research Program.                                                                   
 
  
 
Safety Monitoring - Handling of Unexpected or Adverse Events 
 
The individuals responsible for safety monitoring will be the PI, the project manager, and 
the Study Physician. The Study Physician for this trial is John Williams, Jr., M.D.  As Study 
Physician, Dr. Williams will ensure participants are medically cleared to participate in this trial 
and review all reports of adverse events sent by the study coordinator and evaluate the patient 
as necessary to determine whether corrective action is needed.  
Interviewers and counselors will be trained and instructed to contact the study 
coordinator immediately if the participant informs them of the occurrence of an adverse event. 
The study coordinator will inform the principal investigator, and a report of all adverse events will 
be included in progress reports submitted to the IRB. Serious adverse events for participants 
will be reported according to current VA policy. Additionally, theft or loss of data, unauthorized 
access of sensitive data or storage devices, or non-compliance with security controls will be 
handled promptly in accordance with current VA policy. 
 
The risks to participants in this study are minimal. Risks may include psychological 
distress after quitting smoking, and skin irritation or headaches resulting from use of the nicotine 
patch for those patients who opt to use NRT. In the event that a participant experiences 
problems due to NRT, he/she will be instructed to contact his/her primary care physician.  This 
and other instructions regarding use of nicotine replacement and side effects associated with 
use of NRT will be provided to the subject.   
 
It is also possible that the interviews with participants will increase their psychological 
and emotional distress. A toll-free number will be provided to participants to report concerns 
related to study participation, to ask questions, or to withdraw consent. If a participant 
experiences extreme distress while on the telephone with study staff, the counselor or 
interviewer will provide them with appropriate referral numbers. The study measure of 
depression, the Patient Health Questionnaire (PHQ-9), will be administered at screening and 
follow-up. For patients who express an endorsement of suicidal ideation (endorsement of 
question #9 on the PHQ-9) and are greater than minimal risk on the P4 or have who show 
clinical warning signs of elevated risk of self-harm (e.g., expression of intent to harm self, severe 
depression, significantly agitated, disordered thought, perceived burdensomeness on others) 
the RA will arrange a warm transfer to the Veteran Crisis Line. (See Appendix 7 for details.)  
 
There will be several ongoing mechanisms for monitoring non-medical adverse events 
(e.g., anxiety related to the smoking cessation intervention, depression). This monitoring will be 
facilitated by:  1) a toll-free number provided to participants to report concerns related to study 
participation; 2) ongoing patient contact via interviewers and telephone counselors; and 3) 
monthly meetings between the investigators, including study physician, and project team in 
which progress reports are reviewed. The PI or qualified Co-Investigator will conduct regular 
supervision meetings with the counselors to discuss participants’ reactions to the intervention, 
any adverse events, and proper delivery of the intervention.  

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Data Analysis and Statistical Considerations 
Data Summary  
Descriptive statistics, including graphical displays, will be used to summarize all study 
variables, both overall and by intervention group. Evidence of imbalance in baseline 
characteristics will be noted and discussed as to whether they are clinically significant. As 
recommended by CPMP guidelines71, we will consider sensitivity analyses adjusting for these 
baseline characteristics to ensure that an observed intervention effect is not due to this baseline 
imbalance. We will construct individual and mean trajectory plots of the longitudinal outcome 
variables (e.g., PHQ) to understand their general trends over the study period. In addition, we 
will explore the variability and correlation structure of the longitudinal outcome variables. All 
statistical analyses will be performed using the SAS software package; the Durham HSR&D 
Center of Innovation maintains the current SAS release on our system. 
Intent-to-Treat Analysis.  
All primary and secondary analyses focus on the effect of SMK-MM as compared to 
control. We, therefore, plan to use the intent-to-treat assumption for all analyses; participants 
will be analyzed as part of the group to which they are randomized, regardless of intervention 
adherence. 
Analyses 
Hypothesis 1.1: Prolonged abstinence rates will be significantly higher among Veterans in the 
SMK-MM group as compared to those in the control group. 
Hypothesis 1.2: The 7-day point prevalence abstinence rates will be significantly higher among 
Veterans in the SMK-MM group as compared to those in the control group. 
 
As described in Section E.10.1, rates of cigarettes abstinence (prolonged abstinence) 
will be assessed at 6- and 12-month follow-ups. Abstinence will be measured as a dichotomous 
variable that indicates whether patients have been abstinent or not. The same analysis 
approach will be used to test both prolonged and 7-day point prevalence abstinence rates. Self-
report of abstinence will be validated with cotinine saliva testing.  
 
We will use logistic regression48 to test for a between-group difference in abstinence 
rates at 6 months.  This logistic regression model can be written as: Logit(pi) = β0 + SMK-MMi*β1 
, where pi represents the probability that patient i has abstained from smoking  at the 6-month 
follow-up. In this model, SMK-MMi is the intervention group indicator; therefore, β1 represents 
the log-odds ratio of smoking abstinence in the SMK-MM group as compared to the control 
group. For each of the abstinence outcomes, we will formally evaluate the intervention effect by 
testing that β1 differs from zero and report the odds ratio (exp(β1)) and 95% CI of the odds ratio. 
An odds ratio significantly greater than 1.0 provides evidence that SMK-MM group patients have 
higher prolonged abstinence rates. The model will also include stratification variables (gender, 
number of depression symptoms)  as recommended in the Committee for Proprietary Medicinal 
Products guidelines.49   
  
Sustainability, or longer term effects of the intervention, will be examined by comparing 
abstinence rates between groups at 12 months. We will model change in abstinence rates at 
baseline, 6, and 12 months using generalized linear models with a logit link fit with GEE 
(Generalized Estimating Equations).50  The regression coefficients from this model have 
essentially the same interpretation as those from a cross-sectional regression analysis (e.g. 
logistic regression) but are more appropriate as they properly incorporate the within-subject 
correlation that is inherent in the longitudinal structure of the data. The model will be fit using the 
SAS procedure GENMOD (SAS Institute, Cary, NC). 

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Hypothesis 2.1: Veterans in the SMK-MM group will experience significantly less negative 
effects on depressive symptoms post cessation attempt as compared to the control group. 
 
A general linear mixed model will be used to estimate changes in PHQ scores over time 
and test the secondary hypothesis. Because of the small number of time points, we will apply an 
unstructured covariance matrix to take into account the within-patient correlation between 
repeated measures over time. The predictors in the model will include a dummy coded time 
effect and an indicator variable for the intervention interacting with the time effect. The model 
will have the form: Y = β0 + β1*(month6) + β2*(month12) + β3*(SMK-MM*month6) + β4*(SMK-
MM*month12). This model assumes the groups have equal baseline means, which is 
appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA 
model.51 Additionally, the model will include the stratification variables. We plan to estimate the 
parameters in the model using the SAS procedure MIXED (SAS Version 9.2, Cary, NC).  
 
Hypothesis 3.1: The relationship between adjunctive mood-management intervention and 
smoking cessation will be mediated by self-efficacy, and positive and negative affect 
 If there is a significant intervention effect on smoking cessation (i.e., if β1 is significantly 
different from zero in the first model above in Hypothesis 1.1), then we also plan to examine 
whether change in self-efficacy and affect mediate the impact of the intervention. This aim can 
be addressed under the general framework of mediation. We propose to conduct this mediation 
analysis using the MacArthur approach, a modification of the traditional Baron & Kenny criteria, 
developed for use specifically in randomized clinical trials.52,53 By the MacArthur definition, the 
potential mediator must be evident during or post-treatment; therefore, for example, the change 
in patient self-efficacy measures between baseline and 6-months will be considered as potential 
mediators. The outcome will be patients’ abstinence at 12-months. We will first fit a model to 
examine the correlation between the mediator (C) and the SMK-MM group: C = γ0 + γ1*SMK-
MM. We also fit a model that examines the relationship between the mediator and the 
probability of abstinence (p): logit(p) = β0 + SMK-MM*β1 + C*β2 + C*SMK-MM*β3. Improvements 
in patient self-efficacy and affect will be considered to account for improvements in abstinence 
rates if there is evidence that γ1 is not equal to zero, and if either β2 or β2 are not equal to zero. 
 
Missing Data. Because main predictors of interest are collected at baseline, we do not 
anticipate much missing data in these variables. We do, however, anticipate missing values in 
the longitudinal outcomes owing to dropout, death, inability to reach patient, or item non-
response. If the missing values are related to other measured patient factors, such as age, 
gender, or employment status, then multiple imputation provides a framework for incorporating 
information from these auxiliary variables while still preserving a parsimonious main treatment 
effect mode54: the Panel on Handling Missing Data in Clinical Trials recommends this 
framework.55 We will follow multiple imputation methods presented in Hedeker et al for missing 
abstinence outcomes.56 Depending on type and scope of missing data for other longitudinal 
variables, multiple imputation will be conducted with SAS procedure PROC MI57 or the SAS 
macro IVEware.  In the unique situation of paper-based collection of the PHQ-8 at follow-up, we 
will conduct a sensitivity analysis where the missing ninth item is imputed with the follow-up 
sample mean. 
  
Sample Size Considerations:  
The sample size estimate is based on the primary hypothesis of the trial, which is that 
prolonged abstinence rates at the 6-month follow-up will be significantly higher among Veterans 
in the SMK-MM group as compared to the control group. The sample-size estimate is based on 
a Z-test for the difference in proportions, assuming a two-sided type I error rate of 5% and 
power of 80%. While we did have 20% quit rates in IIR 05-202 for the total study population, the 

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7-day point prevalence rate for those with clinically meaningful depression was only 17%. These 
quits rates are higher than those reported in the literature, 29,31 raising concern that they may be 
somewhat anomalous. Thus, we derived quit rates for the proposed study from the broader 
smoking cessation literature. In a recent Cochrane review of smoking cessation interventions 
among those with depression, abstinence rates ranged from 0-24%, with an average of 9.7%. 
As a second approach, we tried to derive an estimate more specific to the Veteran population. 
The largest trial to date of Veteran smokers (not selected for depression) exposed to telephone 
counseling and NRT yielded 14% prolonged abstinence rates.58 We then searched the literature 
for a correction factor that would convert this 14% prolonged abstinence rates into a cessation 
rate among depressed patients. A meta-analysis of quit rates among smokers with a history of 
depression demonstrated a 34% lower odds of long-term abstinence compared to non-
depressed patients (OR=0.66; 95% CI 0.53, 0.82).11 If we extrapolate a 34% correction factor to 
the 14% prolonged abstinence rate, we get an expected rate of 9.7% prolonged abstinence for 
our depressed control group. In our meta-analysis, the mean differences between mood-
enhanced intervention and non-mood enhanced comparator was 10%; this differences jumped 
approximately 15% when NRT was used.16 
Based on results these studies, we estimate the 6-month prolonged abstinence rate to be 
approximately 10% in the contact-equivalent control condition, and 22% in the SMK-MM 
group. With 146 Veterans in each group, we will have 80% power to detect this difference (12%) 
in prolonged abstinence rates. We anticipate a drop-out rate of 15% by 6 months; therefore, we 
plan to enroll 175 Veterans in each group to achieve adequate power. Because 7-day point 
prevalence rates are generally ~ 25% higher than prolonged abstinence rates,59 we estimate the 
6-month, 7-day point prevalence abstinence rate to be approximately 13% in the control group 
(10% x 1.25=13%). With 175 Veterans randomized to each group, we will have 80% power to 
detect a difference of 13% in 7-day point prevalence rates at 6 months.     
 
Given our planned sample size, we also examine the power and detectable difference 
for Hypothesis 2.1 (depressive symptoms) evaluated at the 6-month follow-up using methods 
from Borm et al.60 Using data from our previous studies, we estimate common baseline 
standard deviation of 6.7, and correlation between baseline and 6 months of 0.7. With 175 
Veterans randomized to each group and a type-I error of 0.05, we will have 80% power to detect 
a differential improvement of 1.6 in depression severity, corresponding to an effect size of 0.24.  
 
  
 

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Brown DW. Smoking prevalence among US veterans. Journal of general internal 
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Klevens RM, Giovino GA, Peddicord JP, Nelson DE, Mowery P, Grummer-Strawn L. The 
association between veteran status and cigarette-smoking behaviors. Am J Prev Med. 
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Yu W, Ravelo A, Wagner TH, et al. Prevalence and costs of chronic conditions in the VA 
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Critchley J, Capewell S. Smoking cessation for the secondary prevention of coronary 
heart disease. The Cochrane database of systematic reviews. 2004(1):CD003041. 
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Critchley JA, Capewell S. Mortality risk reduction associated with smoking cessation in 
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Appendix 4, Assessments Survey 
ASSESSMENTS SURVEY 
[If participant is unable to commit to completing the full set of assessment questions, ask, "Whether 
you've quit smoking or not, would you be willing to answer just a few questions to help us out? It 
would take about 5 minutes and we'd be happy to send you a $5 thank-you payment for your time to 
express our gratitude."] 
R) Point Prevalence Abstinence (6- and 12-MONTH ONL V)
First, I'd like to start by asking you some questions about your smoking habits right now.
Rl. Have you had a cigarette, even a puff, in the past 7 days? 
1 = VES 
O= NO
777=DK 
888=REF 
R2. [If no to Rl] Have you had a cigarette, even a puff, in the past 30 days? 
1 =YES 
0= NO
777=DK 
888=REF 
S) Prolonged Abstinence, Hughes (6- and 12-MONTH ONLY)
Sl. Since [DATE OF RANDOMIZATION+ 90 days] have you smoked at least part of a cigarette on each of 
7 consecutive days, that is 7 days in a row? 
1 =Yes 
O= No 
777 = DK 
888 = REF 
S2. Since (DATE OF RANDOMIZATION+ 90 days) have you smoked any in each of 2 consecutive weeks, 
that is 2 weeks in a row? 
1 =Yes 
0 = No 
777 = DK 
888 = REF 
T) Prolonged Abstinence, Russell (6- and 12-month ONLY)
Tl. Have you smoked at all since (DATE OF RANDOMIZATION+ 90 days):
A) No, not at all
B) 1-5 cigarette
C) More than 5 cigarettes?
Appendix 4, Assessments Survey, v8, 2017-10-25 
IRBAppfO 
OVAMC / 
Date ,,,_/17 · 

(If no to Rl) Congratulations on quitting smoking. As we mentioned at the beginning of the study, we 
would like to get a sample of your saliva. We will use the saliva to test how much nicotine you have 
been exposed to. Giving a saliva sample is voluntary. If you return the sample, we will send you $20 as 
a thank-you for your time and effort. I'll tell you more about that toward the end of our call. 
A) Smoking History (BASELINE ONLY, except as noted) 
[BASELINE: Now I am going to ask you some questions about your smoking history.] 
(6- and 12-MONTH: Now I'm going to ask you some questions about your smoking in the last 6 months.] 
Al. 
[Ask at all time points] [Baseline: "Have you ever ... "; 6- and 12-months: "In the last 6 months 
have you ... "] made a serious quit attempt and stayed off cigarettes for at least 24 hours? 
1 = YES 
0 = NO [Jump to A3] 
777=DK [Jump to A3] 
888=REF [Jump to A3] 
999=Missing 
A2. 
[Ask at all time points] How many serious quit attempts of at least 24 hours have you made in 
the past [Baseline: " ... year"; 6- and 12-months: " ... 6 months"]? 
Specify: ____ _ 
777=DK 
888=REF 
999=Missing 
V) Cigarettes per Day 
[Baseline: Always ask; 6- and 12-month follow-up, ONLY ask if participant indicated recent smoking from 
Rl, R2, Sl, OR S2.] 
[Baseline: "I just asked about how many cigarettes you smoke per day. Now I'd like to get a little more 
specific and get an exact number''] 
Vl. On average, how many cigarettes do you smoke each day? (For RA: If they state a range or it varies, 
clarify by saying "on your heaviest day".) 
W) Current Depression (PHQ 9) (6- and 12-MONTH FOLLOW-UP ONLY) 
The next questions are about your emotional health. Some questions may be difficult to think about. 
That's okay as there aren't any "right" or "wrong" answers. Be as honest as you can. 
I'm going to read to you a list of statements. Over the last 2 weeks, how often have you been bothered 
by any of the following problems? 
Appendix 4, Assessments Survey, v8, 2017-10-25 
2 

(Instructions to RA: Read statements. If they say no, code as "not at all." If they say yes, ask, "How 
often? Several days, more than half the days, nearly every day?" 
1. 
Had little interest or pleasure in 
doing things? 
2. 
Felt down, depressed, or 
hopeless? 
3. 
Had trouble falling or staying 
asleep, or sleeping too much? 
4. 
Felt tired or had little energy? 
5. 
Had a poor appetite or overate? 
6. 
Felt bad about yourself-or that 
you are a failure or have let 
yourself or your family down? 
7. 
Had trouble concentrating on 
things, such as reading the 
newspaper or watching 
television? 
8. 
Moved or spoke so slowly that 
other people could have 
noticed? Or the opposite -
being so fidgety or restless that 
you have been moving around a 
lot more than usual? 
9. 
Had thoughts that you would be 
better off dead or of hurting 
yourself in some ways? 
Appendix 4, Assessments Survey, v8, 2017-10-25 
Not 
at All 
0 
Several 
Days 
1 
More 
than 
Half the 
Days 
2 
Nearly 
Every 
Day 
3 
DK 
777 
REF 
888 
3 
Missing 
999 

10. {If any of the above PHQ-9 questions were answered with "several days" or more frequently, ask ... ) 
How difficult have these problems made if for you to do your work, take care of things at home or 
get along with other people? 
0 = Not difficult at all 
1 = Somewhat difficult 
2 = Very difficult 
3 = Extremely difficult 
777 = Don't Know 
888 = Ref used 
999 = Missing 
IF THE PARTICIPANT ENDORSES QUESTION #W9 (ANSWERING SEVERAL DAYS OR MORE), YOU 
WILL ASK THE P4 SCREENER ASSESSING RISK OF SELF-HARM AT THE END OF THE SURVEY. FOR 
NOW ... 
"It sounds like things have been hard for you lately. I'd like to come back to that later to get 
some additional information to make sure you are safe." 
[If participant is only completing the previous questions (abbreviated survey version), ask, 
"Thank you for taking the time with those questions. Would you be willing to hang in there to 
complete the rest of the questions? It would take about 25 more minutes and we'd send you 
a total of $30 for your time." 
If yes, "Thank you. We appreciate your help." Proceed with the remaining questions. 
If no, skip to the abbreviated survey closing language or the P4 Screener to assess for the risk 
of self-harm if indicated by their responses on the PHQ-9 above.] 
Pack years: 
The next couple of questions I'm getting ready to ask is about your overall smoking history. 
A3. Keeping in mind that you may have stopped and started several times, overall how many years have 
you smoked? 
__ years 
777=DK 
888=REF 
999=Missing 
A4. During all the time that you smoked, how many cigarettes did you smoke per day on average? If you 
did not smoke every day, you may answer with the number of cigarettes per week, per month 
or per year 
Day __ 
Week __ 
Month __ 
Year __ 
Appendix 4, Assessments Survey, v8, 2017-10-25 
4 

777=DK 
888=REF 
999=Missing 
AS. 
[Ask at 6- and 12-month follow-up and ONLY if Al=yes,] 
In the last 6 months, what was the longest period of time you were able to stay off cigarettes? 
__ Days 
__ Weeks 
__ Months 
777=Don't Know, 888=Refused, 999=Missing 
U) Gradual Versus Abrupt Smoking Cessation (6- and 12-MONTH ONLY) 
Ul. On your most recent quit attempt, did you stop smoking suddenly or did you gradually cut down on 
the number of cigarettes you smoked?" 
1 = stopped suddenly 
2 = cut down gradually 
Q) Other Tobacco/Nicotine Products 
The next set of questions is about your use of other tobacco products. 
Everyday 
Somedays 
Rarely 
Not at all 
Do you now use chewing tobacco, 
snuff, dip, or snus every day, some 
1 
2 
3 
4 
days, rarely, or not at all? 
Do you now smoke a regular pipe 
filled with tobacco every day, 
1 
2 
3 
4 
some days, rarely, or not at all? 
Do you now smoke cigars, 
cigarillos, or little filtered cigars 
1 
2 
3 
4 
every day, some days, rarely, or 
not at all? 
B) E-Cigarettes 
Bl. Now let's talk about electronic cigarettes. Do you use an electronic cigarette every day, some 
days, rarely, or not at all? 
l=Every day 
2=Some days 
3=Rarely 
4=Not at all 
777=DK 
888=REF 
999=Missing 
Appendix 4, Assessments Survey, v8, 2017-10-25 
5 

C) Nicotine Dependence - Fagerstrom Test for Nicotine Dependence (BASELINE ONLY) 
The next question is about your smoking habits right now. 
Cl. 
How soon after you wake up do you smoke your first cigarette? 
3 = WITHIN 5 MINUTES 
2 = 6-30 MINUTES 
1 = 31-60 MINUTES 
0 = AFTER 60 MINUTES 
777=DK 
888=REF 
999=Missing 
C2. Do you find it difficult to refrain from smoking in places where it is forbidden (e.g. in church, at the 
library, cinema, etc.)? 
1- Yes 
0-No 
777=DK 
888=REF 
999=Missing 
C3. Which cigarette would you hate to give up? 
1 - The first one in the morning 
0 -All others 
777=DK 
888=REF 
999=Missing 
C4. How many cigarettes a day do you smoke? 
0- 10 or less 
1- 11-20 
2 - 21-30 
3 - 31 or more 
777=DK 
888=REF 
999=Missing 
CS. Do you smoke more frequently during the first hours after waking than during the rest of the day? 
1- Yes 
0-No 
777=DK 
888=REF 
999=Missing 
CG. Do you smoke if you are so ill that you are in bed most of the day? 
1- Yes 
0-No 
777=DK 
888=REF 
999=Missing 
Appendix 4, Assessments Survey, v8, 2017-10-25 
6 

D) HCP Advice for Quitting (BASELINE ONLY) 
Ok, thank you. Now let's touch briefly on doctor's appointments. 
Dl. 
In the PAST 12 MONTHS have you SEEN a medical doctor? 
l=Yes 
2= No, [skip question D2 and go to E] 
777=DK 
888=REF 
999=Missing 
D2. During the PAST 12 MONTHS, did any medical doctor ADVISE you to stop smoking? 
1= Yes 
2= No 
777=DK 
888=REF 
999=Missing 
E) Smoker Identity 
On a scale from 1 to 10 where 1 means completely disagree and 10 means completely agree, how much 
do you agree with the follow statements? 
El. 
I consider myself a smoker. 
E2. 
If someone were to casually ask if I were a smoker, I would say yes. 
F) Desire to Quit (BASELINE ONLY) 
Let's take a moment to discuss how much you would like to quit smoking. 
Fl. At present, how much do you want to cut down the number of cigarettes you smoke'? 
l=Not at all 
2=A little 
3=Some 
4=Very much 
777=DK 
888=REF 
999=Missing 
F2. How determined are you to cut down? 
l=Not at all determined 
2=A little determined 
3=Somewhat determined 
4=Very determined 
777=DK 
888=REF 
Appendix 4, Assessments Survey, v8, 2017-10-25 
7 

999=Missing 
F3. How much do you want to quit smoking? 
l=Not at all 
2=A little 
3=Some 
4=Very much 
777=DK 
888=REF 
999=Missing 
F4. If you plan to quit smoking, how determined are you to quit? 
l=Not at all determined 
2=A little determined 
3=Somewhat determined 
4=Very determined 
777=DK 
888=REF 
999=Missing 
G) Global Self-efficacy 
Now that we are done with that, let's move on to the next question. 
Gl. 
On a scale from 1 to 7, where 1 is "not at all confident," and 7 is "very confident", how confident 
are you that you will be [BASELINE: "able to quit"; 6- and 12-MONTH: "able to quit or stay quit"] 
smoking completely in the next 6 months? 
NOT AT ALL 
CONFIDENT 
,1 
2 
I 
So you would say 
3 
you're not confident 
4 
5 
H) Situational Self-efficacy (Etter Measure) 
COMPLETELY 
CONFIDENT 
I 6 
7 
I 
So you would say 
you're completely confident 
999=Missing 
777=DK 888=REF 
The following are some situations in which certain people might be tempted to smoke. Please 
indicate whether you could refrain from smoking in each situation. 
Response options are: 
Not at all sure 
Not very sure 
More or less sure 
Fairly sure 
Absolutely sure. 
Appendix 4, Assessments Survey, v8, 2017-10-25 
8 

For RA use if needed: 
777=DK 
888=REF 
999=Missing 
Internal stimuli 
Hl. 
When you feel nervous 
H2. 
When you feel depressed 
H3. 
When you are angry 
H4. 
When you feel very anxious 
HS. 
When you want to think about a difficult problem 
HG. 
When you feel the urge to smoke 
External stimuli 
H7. 
When having a drink with friends 
HS. 
When celebrating something 
H9. 
When drinking beer, wine or other spirits 
HlO. 
When you are with smokers 
Hll. 
After a meal 
Hl2. 
When having coffee or tea 
I} Euro-Qol (EQ-5D-SL) 
Let's move on to talking about your health. For the next group of questions, please select the 
statements that best describe your health TODAY. 
11. 
Let's start by talking about Mobility. Would you say: 
1= You have no problems in walking about 
2= You have slight problems in walking about 
3=You have moderate problems in walking about 
4=You have severe problems in walking about 
5= You are unable to walk about 
777=DK 
888=REF 
999=Missing 
12. 
The next statement is about Self-Care. Would you say: 
1= You have no problems washing or dressing yourself 
2= You have slight problems washing or dressing yourself 
3=You have moderate problems washing or dressing yourself 
4=You have severe problems washing or dressing yourself 
5= You are unable to wash or dress yourself 
777=DK 
888=REF 
999=Missing 
Appendix 4. Assessments Survey, v8, 2017-10-25 
9 

13. 
The next statement is about Usual Activities (e.g. work, study, housework, family or leisure 
activities). Would you say: 
l=You have no problems doing your usual activities 
2=You have slight problems doing your usual activities 
3=You have moderate problems doing your usual activities 
4=You have severe problems doing your usual activities 
S=You are unable to do your usual activities 
777=DK 
888=REF 
999=Missing 
14. 
The next statement is about Pain/Discomfort. Would you say: 
l=You have no pain or discomfort 
2=You have slight pain or discomfort 
3=You have moderate pain or discomfort 
4=You have severe pain or discomfort 
S=You have extreme pain or discomfort 
777=DK 
888=REF 
999=Missing 
15. 
The next statement is about Anxiety/Depression. Would you say: 
l=You are not anxious or depressed 
2=You are slightly anxious or depressed 
3=You are moderately anxious or depressed 
4=You are severely anxious or depressed 
S=You are extremely anxious or depressed 
777=DK 
888=REF 
999=Missing 
J. Positive and Negative Affect Scale 
I'm now going to ask you about some words that describe different feelings and emotions. Please 
indicate YES or NO if you felt this way during the past few weeks. 
[If NO, code 1 = Very slightly or not at all] 
[If YES, "To what extent did you feel this way? 
2 = A little 
3 = Moderately 
4 = Quite a bit 
5 = Extremely] 
Appendix 4, Assessments Survey, v8, 2017-10-25 
10 

How often in 
Very 
the past few 
slightly 
weeks did you 
or not 
I 
Quite a 
Don't 
feel... 
at all 
A little 
Moderately 
bit 
Extremely 
Know 
Refused 
Missing 
lnter¢sted 
1 
2 
3 
4 
5 
777 
888 
999 
Distrbsed 
1 
2 
3 
4 
5 
777 
888 
999 
• 
I 
Exc1t¢d 
1 
2 
3 
4 
5 
777 
888 
999 
Upset 
1 
2 
3 
4 
5 
777 
888 
999 
Strong 
1 
2 
3 
4 
5 
777 
888 
999 
Guilty 
1 
2 
3 
4 
5 
777 
888 
999 
Scar¢d 
1 
2 
3 
4 
5 
777 
888 
999 
Hostile 
1 
2 
3 
4 
5 
777 
888 
999 
Enthusiastic 
1 
2 
3 
4 
5 
777 
888 
999 
Proud 
1 
2 
3 
4 
5 
777 
888 
999 
lrritc1ble 
1 
2 
3 
4 
5 
777 
888 
999 
Alert 
1 
2 
3 
4 
5 
777 
888 
999 
Ashamed 
1 
2 
3 
4 
5 
777 
888 
999 
Inspired 
1 
2 
3 
4 
5 
777 
888 
999 
Nervous 
1 
2 
3 
4 
5 
777 
888 
999 
Determined 
1 
2 
3 
4 
5 
777 
888 
999 
Attentive 
1 
2 
3 
4 
5 
777 
888 
999 
. 
: 
Jittery 
1 
2 
3 
4 
5 
777 
888 
999 
: 
Active 
1 
2 
3 
4 
5 
777 
888 
999 
Afrajd 
1 
2 
3 
4 
5 
777 
888 
999 
K) Pain Measures 
Kl. 
Thank you for working through that last series of questions. Let's take a moment to discuss pain 
you may be experiencing. 
On a scale from 0-10 where 0 is no pain and 10 is pain as bad as you can 
imagine, please rate your pain when it was at its worst in the last week. 
PAIN AS BAD AS 
NO PAIN 
YOU CAN IMAGINE 
DK REF 
I o-------1-------2-------3--t----4-------s-------6---t7-------8 ------9--------10 I 777 888 
So you would say 
you've had little pain 
this past week 
Appendix 4, Assessments Survey, v8, 2017-10-25 
So you would say 
you've had a fair amount 
of pain this past week 
11 

L) Stress & Coping {RISCI) 
I'm now going to read to you a set of statements about how things have been going for you lately. 
Please respond either never, seldom, occasionally, often or most of the time. 
In the lqst month . .. 
1. How often 
have you felt 
there was not 
enough time 
to complete 
your daily 
taisks. 
2 ... H~w,~n. 
hi ,ve you felt 
. 
ti at yp~ t\ad .\ [; 
111iore stress 
·. 
,tf an UWat It . 
3. Hpw often 
h~veyou 
taken on 
more than 
you could 
handle. 
4, .t-owoften 
' . ·. ~ ~ve'yClU f~lt ; 
c ~rwJlelmeq. 
5. How often 
have you 
were 
pressured by 
others. 
6 I owoften. • ·· .. 
,;.,: .. >" 
'.>>. .... ··,. 
< 
'. 
-:,,·,, 
' 
I ave you felt · 
: ~ 1,e$$ed bY ---
,. 
I> , , nexpected i 
: 
. l veffts., . . i 
:2~ I "OW·bften; 
'< 
' i avt,~u~g;: 
1olimeto 
.··.·. 1elax. 
1 
2 
2 
1 
2 
2 
1 
2 
1 
2 .; 
1·.:· .. 
'·,\' 
2 
. 
Appendix 4, Assessments Survey, v8, 2017-10-25 
OccasionallV 
Often 
Most of 
REF 
DNK 
Missing 
the time 
3 
4 
5 
777 
888 
999 
3 
4 
5 
777 
888 
999 
3 
4 
5 
777 
888 
999 
3 
4 
s 
777 
888 
999 
3 
4 
5 
777 
888 
999 
3 
4 
5 
777 
888 
999 
3 
4 
5 
777 
888 
999 
12 

2 
4 
5 
777 
888 
999 
9. 
Hc>w often 
1 
2 
3 
4 
5 
777 
888 
999 
have were 
you able to 
cope with 
un6xpected 
problems. 
2 
3 
4 
s 
777 
888 
999 
ha ewere 
y 
ableto, 
With 
ult 
1 
2 
3 
4 
5 
777 
888 
999 
h~ve you felt 
able to meet 
demands. 
1 
.. 2' 
3 
4 
5 
777 
888 
999 
Z) Measure of Life CHAOS 
We'd like to better understand your lifestyle. Please tell us how true or false the following statements 
are for you. 
Very 
slightly 
or not at 
Quite a 
DK/Ref/ 
all 
A little 
Moderately 
bit 
Extremely 
Missing 
My life is organized 
1 
2 
3 
4 
5 
999 
My life is unstable 
1 
2 
3 
4 
5 
999 
My routine is the same 
from week to week 
1 
2 
3 
4 
5 
999 
My daily activities from 
week to week are 
unpredictable 
1 
2 
3 
4 
5 
999 
Appendix 4. Assessments Survey. v8. 2017-10-25 
13 

Keepirg a schedule is 
difficult for me 
1 
2 
3 
I don't like to make 
appoihtmetns too far in 
advance because I don't 
know/what might come up 
1 
2 
3 
X) NRT Use and Adherence (6- and 12-month follow-up ONLY) 
Thank you. Moving on. 
4 
5 
999 
4 
5 
999 
Xl. Over the last 6 months, have you used any of the following to help you quit smoking or stay quit? 
Nicotine Patch (If yes, ask questions 2 and 3) 
Nicotine Lozenge {If yes, ask questions 4 and 5) 
Nicotine Gum {If yes, ask questions 4 and 5) 
X2. [If PATCH used] In the last 6 months how many days have you used the patch? 
X3. [If PATCH used] On average, on the days that you used the patch, how long did you wear the patch 
each day? 
24 hours/all day 
Took it off only to sleep 
Other (please specify) 
N/A {NOT USING PATCH 
Don't Know 
Refused 
Missing 
X4. [If GUM or LOZENGE used] In the last 6 months, how many days have you used the NRT gum or 
lozenge? 
XS. [If GUM or LOZENGE used] On average, on the days that you used the NRT gum or lozenge, how 
many lozenges have you used or pieces of gum have you chewed? 
Appendix 4, Assessments Survey, v8, 2017-10-25 
14 

M) Other Non-NRT Counseling and Medications Use 
The next few questions are about any help you may have received with quitting smoking or your mood 
in the past. [6- and 12-months ONLY: "Please note we are interested in help you may have received 
outside of the Quit Smoking Tele-Health program."] 
Ml. [BASELINE: In the past 3 months ... ] [6-MONTH or 12-MONTH: Not including calls with your Quit 
Smoking Tele-Health Coach {insert name}, in the past 6 months ... ], have you had any visits to a 
counselor, therapist, or other health provider for help with quitting smoking? 
1 = YES 
0= NO 
777=DK 
888=REF 
999=Missing 
MS. (6- and 12-MONTH ONLY) Not including calls with the Quit Smoking Tele-Health Quit Coach, have 
you used a Quit Line for help with quitting smoking? 
1 = YES 
0= NO 
777 = DK 
888 = REF 
999 = MISSING 
M6. {6- and 12-MONTH ONLY) In the last 6 months, have you used a text or email quit smoking support 
service such as Text 2Quit or QuitVet? 
1 = YES 
O= NO 
777 = DK 
888 = REF 
999 = MISSING 
M2. [BASELINE: "Are you taking ... "] [6- and 12-MONTHS: "Not including the patches, gum, or lozenge 
nicotine replacement medications you may have received through the Quit Smoking Tele-Health Quit 
Coach, in the last 6 months, have you used ... "] any prescription medication to help with quitting 
smoking? 
1 = YES 
0= NO 
777=DK 
888=REF 
999=Missing 
M7. {If yes, to M2) What medication did you use? 
Chantix 
Xyban/bupropion 
Patch from a source other than Quit Smoking Telehealth 
Gum or lozenge from a source Quit Smoking Telehealth 
Nicotine inhaler 
Appendix 4, Assessments Survey, v8, 2017-10-25 
15 

M3. [BASELINE: "Are you seeing ... "] (6- and 12-MONTHS: "Not including the calls with your Quit 
Smoking Tele-Health Coach {insert name}, in the last 6 months, did you see ... ") a counselor, therapist, 
psychotherapist, or other mental health provider to help with mood or depression? 
1 = YES 
0= NO 
777=DK 
888=REF 
999=Missing 
M4. [BASELINE: "Are you taking ... "] (6- and 12-MONTH: "In the last 6 months have you taken ... "] any 
prescription medication to help with mood or depression?? 
1 = YES 
0= NO 
777=DK 
888=REF 
999=Missing 
N) Demographics (BASELINE ONLY) 
Now, I would like to get some background information about you. 
Nl. 
What is your date of birth? 
N2. 
What is your sex? 
l=Male 
N3. 
N4. 
2=Female 
777=DK 
888=REF 
999=Missing 
Which one or more of the following would you say is your race? {Check all that apply) 
l=American Indian or Alaskan Native 
2=Asian 
3=Black or African American 
4=Native Hawaiian or other Pacific Islander 
5=White 
6=Other: Please list 
777=DK 
888=REF 
999=Missing 
Are you Hispanic, Latino/a, or Spanish origin? 
0=No, not Hispanic, Latino/a or Spanish 
l=Yes, I consider myself to be Hispanic, Latino/a or Spanish 
777=DK 
888=REF 
999=Missing 
Appendix 4, Assessments Survey, v8, 2017-10-25 
16 

l I 
1 
·· 1 l i I 
, . 
, ; 
NS. 
What is your current marital status? 
l=Married or Living as married 
2=Divorced 
3=Separated 
4=Widowed 
S=Single, never married 
777=DK 
888=REF 
999=Missing 
N6. 
Without giving exact dollars, how would you describe your household's financial situation right 
now? Would you say that: 
1=After paying the bills, you still have enough money for special things that you want. 
2=You have enough money to pay the bills, but little spare money to buy extra or special things. 
3=You have money to pay the bills, but only because you have cut back on things. 
4=You are having difficulty paying the bills, no matter what you do. 
777=DK 
888=REF 
999=Missing 
N7. 
Which one of the following best describes your current work status? 
1=Working Full Time 
N8. 
2=Working Part-Time 
3=Unemployed, searching for work 
4=Unemployed, not searching for work 
S=Homemaker 
6=Retired 
7=Disabled 
8=Student 
777=DK 
888=REF 
999=Missing 
What is the highest level of education that you have completed? 
1=Grade school/junior high 
2=Some high school 
3=High school graduate or equivalent (GED) 
4= Trade/tech n ica I/vocation a I schoo I 
S=Some college credit but no degree 
6=Associate's degree (AA or AS) 
7=Bachelor's degree (BA or BS) 
8=Post graduate work or graduate degree 
777=DK 
888=REF 
999=Missing 
Appendix 4. Assessments Survey. v8. 2017-10-25 
17 

O. Contraindications to nicotine replacement therapy (BASELINE ONLY) 
I only have a few questions left. As part of the Quit Smoking Tele health program, we are offering the 
nicotine patch and other forms of nicotine replacement products to participants who are seriously 
thinking about quitting smoking. For this reason, I need to ask you some questions about your health. 
01. 
Do you have high blood pressure that is not controlled by medication? 
1 = YES 
0= NO 
777=DK 
888=REF 
999=Missing 
02. 
Have you had any recent instances of chest pain or heart attack? 
1 = YES 
O= NO 
777=DK 
888=REF 
999=Missing 
03. 
Do you currently wear dentures or have jaw problems? 
= YES 
0= NO 
777=DK 
888=REF 
999=Missing 
04. 
For women less than 50 years of age, "Are you pregnant or plan to become pregnant in the next 
6 months?" [Question shown if female and< SO years of age] 
1 = YES 
O= NO 
777=DK 
888=REF 
999=Missing 
P) Lung cancer screening (BASELINE ONLY) 
"The next few questions are about a new test for lung cancer. Lung cancer screening, using a yearly CT 
scan, is recommended for some, but not all, adult smokers. The CT has the potential for both benefits 
and harm. Medical experts recommend that patients who are eligible for lung cancer screening have a 
discussion to see if lung cancer screening is the right choice for them. I would like to find out your 
opinions on lung cancer screening. There are no right or wrong answers. " 
Pl. Of the following people, which people would you be willing to discuss lung cancer screening with? 
[Ask all three options and mark Yes or No] 
Appendix 4, Assessments Survey, v8, 2017-10-25 
18 

Physician 
l=Yes 0=No 
777=DK888=REF 
999=Missing 
Nurse 
l=Yes 0=No 
777=DK888=REF 
999=Missing 
Non-medical person who is trained to answer questions about lung cancer screening 
l=Yes 
0=No 
777=DK888=REF 
999=Missing 
Other: Please specify ___________ _ 
P2. Now imagine a typical visit with your primary care physician, scheduled to address your ongoing 
medical problems. Your doctor often addresses preventive care at these scheduled visits, including 
vaccinations and cancer screening. Lung cancer screening is one of the topics that needs to be 
discussed during this visit. It will need to be covered along with all the other concerns, exams and the 
like that happen during a typical visit with your primary care doctor. 
Now imagine a visit with a non-medical person who is specially trained to address any concerns you 
may have about lung cancer screening. This person is able to devote 10-15 minutes to talk to you just 
about this one screening test. He/she can talk about what the procedure is like and the potential 
benefits and harms. If the lung cancer screening test is abnormal and the next steps to follow-up on 
these findings. This discussion could be done on the same day as another medical appointment and 
wouldn't require and extra trip to the doctor. 
a) Which of these two scenarios do you prefer? 
Talking about lung cancer screening with your primary care physician during a typical visit 
Talking about lung cancer screening with a non-medical person with special training in lung 
cancer screening 
777=DK 
888=REF 
999=Missing 
b) What is you main reason for selecting that scenario? 
P3. At our medical center, we are considering a number of options to deliver information about lung 
cancer screening to patients. Of the following options, which ways would you like to learn about lung 
cancer screening? [Ask all options and mark Yes or No] 
In a group with other patients who are considering lung cancer screening l=Yes 2=No 
777=DK 
888=REF 
999=Missing 
In person 1-on-1 l=Yes 0=No 
777=DK888=REF 
Educational materials you can access at home l=Yes 
999=Missing 
999=Missing 
0=No 
777=DK888=REF 
Other, please specify: ____________ _ 
P4. Of the following options, what types of visual aids would you find helpful to learn more about the 
benefits and harms of lung cancer screening? [Ask all options and mark Yes or No] 
Print communications 
l=Yes 0=No 
777=DK888=REF 
999=Missing 
Video 
l=Yes 0=No 
777=DK888=REF 
999=Missing 
Interactive computer interface 
l=Yes 0=No 
777=DK888=REF 
999=Missing 
Other: Please specify ___________ _ 
Appendix 4. Assessments Survey. v8, 2017-10-25 
19 

Y) Process Measures: Intervention (6-MONTH ONLY) 
We would like to hear about your recent experiences with Quit Smoking Telehealth smoking cessation 
program. You received up to ten telephone counseling sessions where you talked with a quit coach 
about smoking. These next questions are about your experience with those telephone calls. Please 
keep in mind that there is no right or wrong answer. 
Yl. Do you remember receiving the telephone calls from the Quit Smoking Telehealth Coach? 
1 =YES 
0 = NO (SKIP REMAINING PROCESS QUESTIONS) 
Y2. On a scale from Oto 4 where (0) is not at all helpful and (4) is very helpful, how helpful was 
the Quit Smoking Telehealth program in helping you quit smoking? 
0 
1 
2 
3 
4 
777=DK 888=REF 
l. 
I 
y 
So you would 
'-..... ____ 
_,) 
y 
So you would 
say not at all 
say very much 
Y3. On a scale from Oto 4 where (0) is not at all and (4) is very much, how much did the Quit 
Smoking Telehealth program fit your lifestyle. 
0 
1 
2 
3 
4 
777=DK 888=REF 
'-
V 
j 
\....___ _ _ 
_,) 
V 
So you would 
So you would 
say not at all 
say very much 
Y4. On a scale from Oto 4 where (0) is not at all and (4) is very much, how useful were the skills 
you learned in the Quit Smoking Telehealth program. 
0 
1 
2 
3 
4 
777=DK 888=REF 
V 
So you would 
j 
, ___ ___ 
) 
V 
So you would 
say not at all 
say very much 
Y5. On a scale from Oto 4 where (0) is definitely not recommend and (4) is definitely 
recommend, how much would you recommend the Quit Smoking Telehealth program to 
veterans who are trying to quit smoking. 
0 
1 
2 
3 
4 
777=DK 888=REF 
... _______ _,; 
V 
So you would 
say not at all 
... _______ ; 
y 
So you would 
say very much 
Y6. What did you think about the number of sessions or telephone calls you received from the 
Quit Smoking T elehealth Coach? 
1 =Way too few 
2=A little too few 
3=Just about right 
4=A little too many 
Appendix 4, Assessments Survey, v8, 2017-10-25 
20 

5=Way too many 
REF/DK 
Y7. What did you think about the length of the sessions with the Quit Smoking Telehealth 
coach? 
1 =Way too short 
2=A little too short 
3=Just about right 
4=A little too long 
5=Waytoolong 
REF/DK 
At the beginning of the coach calls, we sent you a participant booklet. 
Y8. Do you recall receiving the booklet? 
1 = YES 
0 = NO (SKIP REMAINING BOOKLET QUESTIONS) 
DK/REF (SKEP REMAINING BOOKLET QUESTIONS) 
Y9. How often did you use the participant booklet during the coaching calls? 
0 = Never 
1 = Seldom 
2 = Occasionally 
4 = Often 
5 = Most of the time 
(If never, skip next question.) 
Y10. On a scale from 0-4, where 0 means not at all useful and 4 means very useful, how useful 
were the materials in the booklet during the coaching calls? 
0 
1 
2 
3 
4 
777=DK 888=REF 
\. 
j 
V 
So you would 
, ___ _____ 1 
y 
So you would 
say not at all 
say very much 
Y11. How often did you use the participant booklet between coaching calls? 
0 = Never 
1 = Seldom 
2 = Occasionally 
4 = Often 
5 = Most of the time 
(If never, skip next question.) 
Y12. On a scale from Oto 4, where 0 means not at all useful and 4 means very useful, how 
useful were the materials in the booklet between coaching calls? 
0 
1 
2 
3 
4 
777=DK 888=REF 
\. ______ 
) 
V 
So you would 
say not at all 
Appendix 4. Assessments Survey, v8, 2017-10-25 
'----- __ 
1 
y 
So you would 
say very much 
21 

Y13. Did you show the booklet to anyone else? 
1 =YES 
0=NO 
REF/DK 
(MOOD MANAGEMENT PARTICIPANTS ONLY) 
I am going to name skills that were covered during the program and ask about your experiences 
with learning and practicing each of these skills 
Me time Doin fun activities for ourself) 
Progressive muscle relaxation {The relaxation exercises in which you tensed and relaxed 
different areas of our bod 
Mini practices (Quick way to relax and calm yourself, a smaller version of Progressive Muscle 
Relaxation 
Examining your thoughts (In which you gave some consideration to how you might look at 
thin s different! ) 
Identifying and using rewards (Giving yourself a well-deserved pat on the back for reaching 
our oals 
Y14. On average, how often have you used or practiced this skill? 
Not;rtall* 
Once or twice 
Once a month 
Once a week 
Every Day 
Me time 
0 .... 
I 
2 
3 
4 
Progressive muscle 
.•·• 'O 
I 
2 
3 
4 
relaxation 
:}. 
Mini practices 
' 
,:.o" 
1 
2 
3 
4 
Examining your 
. 
0 
I 
2 
3 
4 
thoughts 
,, 
Three good things 
. ' '\) 
.. 
I 
2 
3 
4 
Identifying and using 
:<o. 
1 
2 
3 
4 
rewards 
*Ifresponse is "not at all" skip the next two questions for that skill (select ''not applicable" response) 
Y15. On a scale from Oto 4 where 0 is not at all useful and 4 is very useful, how useful was this 
skill in helping you quit smoking? 
Not at all 
Very useful 
Not 
DK/Ref 
useful 
aoolicable 
Me time 
0 
I 
2 
3 
4 
666 
999 
Progressive 
0 
1 
2 
3 
4 
666 
999 
muscle relaxation 
Mini practices 
0 
I 
2 
3 
4 
666 
999 
Examining your 
0 
I 
2 
3 
4 
666 
999 
thoughts 
Three good 
0 
I 
2 
3 
4 
666 
999 
things 
Identifying and 
0 
I 
2 
3 
4 
666 
999 
using rewards 
Appendix 4. Assessments Survey, v8. 2017-10-25 
22 

Y16. On a scale from Oto 4 where 0 is not at all useful and 4 is very useful, how useful was this 
skill in helping you manage your mood? 
Not at all 
Very useful 
Not 
DK/Ref 
useful 
annlicable 
Me time 
0 
I 
2 
3 
4 
666 
999 
Progressive 
0 
I 
2 
,., 
4 
666 
999 
.) 
muscle relaxation 
Mini practices 
0 
I 
2 
,., 
4 
666 
999 
.) 
Examining your 
0 
I 
2 
,., 
4 
666 
999 
.) 
thoughts 
Three good 
0 
I 
2 
3 
4 
666 
999 
things 
Identifying and 
0 
I 
2 
3 
4 
666 
999 
using rewards 
(ALL PARTICIPANTS) 
We'd like to hear a bit more about your experiences with the Quit Smoking Telehealth 
program. 
Y17. Please tell me what you found helpful about the program? 
Y18. In particular, what most helpful? 
Y19. What was least helpful? 
Y20. Were there other things that we could have added to the program to make it more helpful 
for you? 
Probe: Were there any topics that we did not cover that would have been useful to you? 
Y21. Is there any other feedback you have for use about the Quit Smoking Telehealth 
Program? 
P4 Screener 
Have you had thoughts of actually hurting yourself? 
NO 
YES 
(.._F_o_u_r _s_cr_e_e_n_in_g_a_u_e_s_ti_o_ns __ ..J) • 
1. 
Have you ever attempted to harm yourself in the past? 
NO 
YES 
2. 
Have you thought about how you might actually hurt yourself? 
Appendix 4, Assessments Survey, v8. 2017-10-25 
23 

! I 
1 
NO 
Vii$ 7[How? ______ 
___, 
3. 
There's a big difference between having a thought and acting on a 
thought. How likely do you think it is that you will act on these thoughts about hurting 
yourself or ending your life some time over the next month?" 
a. Not at all likely 
b. Somewhattikely 
c. Very likely 
4. 
Is there anything that would prevent or keep you from harming 
yourself? 
NO 
YES '7 [What? ______ 
___, 
Risk Category 
Shaded {"Risk"} Response 
Items 1 and 2 
Items 3 and 4 
Minimal 
Neither is shaded 
Neither is shaded 
Lower 
At least one item is shaded 
Neither is shaded 
Higher 
At least one item is shaded 
[For participants scoring in the "lower" and "higher" risk categories, engage the study safety 
protocol.] 
[For participants scoring in the "minimal" risk category: "It sounds like things have been hard for 
you lately. Thoughts of harming yourself are nothing to be ashamed of AND should be taken 
seriously. If you ever want to talk with someone who is SPECIALLY trained to help veterans 
with thoughts of self-harm, you may talk to your doctor, counselor, or call the VA crisis line at 
any time, day or night. The VA crisis line number is 1-800-273-8255. Press 1 when 
prompted. Would you like a moment to write that number down?"] 
Exit {6- and 12-MONTH) 
(If sending a saliva sample kit} Again, congratulations on quitting smoking. We will send you a saliva 
sample kit. You can expect to see the package containing the sample kit within a week or so. While there 
are instructions in the package, do not hesitate to call if you have questions. The phone number will be 
with the instruction page. Providing the sample is, again, completely voluntary. If you return it, we will 
send you a $20 thank-you for taking the time to collect the sample and mail it back to us. 
[IF COMPLETED FULL SURVEY] We'd like to send you a $30 thank-you for taking the time today to talk with 
me. May I confirm your mailing address? (Compare to tracking.) Expect that check to arrive within the 
next 4-6 weeks if you do not have direct deposit set up with the VA. 
Appendix 4. Assessments Survey. v8. 2017-10-25 
24 

[IF COMPLETED ABBREVIATED SURVEY] We'd like to send you a $5 thank-you for taking the time today to 
talk with me. May I confirm your mailing address? (Compare to tracking.) Expect that check to arrive 
within the next 4-6 weeks if you do not have direct deposit set up with the VA. 
(6-Month ONLY) We will be contacting you again in 6 months to complete another set of questions similar 
to those you did today. May I confirm the phone number(s) I have for you are up to date? (Compare 
against tracking.) You will again receive a $30 thank-you payment for completing those questions. 
Thank you again for your time today and thank you for participating in this research study. Do you have 
any questions for me? ANSWER PATIENT'S QUESTIONS. 
Exit (BASELINE) 
Thank you so much for taking the time to talk with me. Do you have any questions for me? ANSWER 
PATIENT'S QUESTIONS. 
You will be getting a package in the mail from the Quit Smoking Telehealth project in the next week or so. 
I would like to confirm that the address we have for you is correct. Is your address: CONFIRM ADDRESS 
[Update tracking database if necessary] 
What are other phone numbers we can use to reach you if we cannot reach you at (confirm current 
number)? [Update tracking database if necessary] 
Home number: ____ _ 
Cell phone number: ____ _ 
Work phone number: _____ _ 
What is your preferred time and day to be called? 
Is there alternate contact information in case we are unable to reach you? [Document name and 
telephone number in tracking database]. 
Name: 
Phone: ___ 
_ 
At some point, someone from the study may need to call you back to clarify some of your answers. Would 
that be okay? 
l=YES 
0=NO 
777=DK 
888=REF 
That is all the questions I have. Let me transfer your call to [Jennifer Chapman, Project Manager, OR 
Margaret Falkovic, Interventionist, depending upon availability], so she can tell you what group to which 
you've been randomized. If we get her voicemail, I'll leave a message and she will call you back as soon as 
possible. She'll also arrange for your first coaching call. If for some reason we get disconnected, please 
feel free to call me back at (919) 286-0411 extension (provide your extension) or the Project Manager, 
Appendix 4, Assessments Survey, v8, 2017-10-25 
25 

Jennifer Chapman, at the local number or 1-888-878-6890 ext. 5648. [Confirm patient has the correct 
contact information] 
I also want to mention that if you have any questions or problems during the study, please contact 
Jennifer Chapman. 
Thank you again for talking with me today. I am going to transfer your call to [Jennifer or Margaret]. 
[TRANSFER CALL] 
Appendix 4, Assessments Survey, v8, 2017-10-25 
26