A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website
Phase: NA
Conditions: Tobacco Use, Smoking Cessation, Smoking, Tobacco, Tobacco Smoking, Guided Imagery
Sponsor: University of Arizona

Study Product Guidelines and Considerations 
1 of 38 
Version 1.0 
 
 
29 MAR 2012 
A Guided Imagery Tobacco Cessation Intervention Delivered 
by a Quitline and Website 
Principal Investigator  
Judith Gordon, Ph.D, Professor and Vice Chair for Research, Department 
of Community and Family Medicine, University of Arizona  
Supported by:  
The National Center for Complementary and Integrative Health  
Application Number: 1 R34 AT008947-01 
Study Intervention Provided by:  
The Study Team in collaboration with the Arizona Smokers’ Help Line 
(ASHLine) 
Sponsor of IND (IDE):  
Not Applicable 
 

Study Product Guidelines and Considerations 
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Version 1.0 
 
 
29 MAR 2012 
Tool Revision History 
Version Number:   8.0 
 
Version Date:    November 6, 2018 
 
Summary of Revisions Made:  
 
 
 
- 
Remove 8-week cotinine assay. 
 
- 
Change 6-month cotinine assay collection procedure. 
 
- 
Increase feasibility enrollment from 100 to up to 120 subjects, which will increase total 
enrollment to up to 178.  This changes the number of subjects assigned to control group 
from 50 to up to 60, and the number of subjects assigned to the intervention group from 
50 to up to 60. 
 
- 
Remove two staff people who are no longer with the project. 
 
 
 
 
 
 

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TABLE OF CONTENTS 
Page 
FULL PROTOCOL TITLE ......................................................................................................... 1 
Tool Revision History ................................................................................................................. 2 
TABLE OF CONTENTS ............................................................................................................. 3 
STUDY TEAM ROSTER........................................................................................................... 6 
PARTICIPATING STUDY SITES ............................................................................................ 6 
PRÉCIS ....................................................................................................................................... 7 
1. STUDY OBJECTIVES ............................................................................................................. 8 
1.1 
Primary Objective ........................................................................................................... 8 
1.2 
Secondary Objectives...................................................................................................... 9 
2. BACKGROUND AND RATIONALE .................................................................................... 9 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 9 
2.2 
Study Rationale ............................................................................................................... 9 
3. STUDY DESIGN ..................................................................................................................... 10 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 16 
4.1 
Inclusion Criteria .......................................................................................................... 17 
4.2 
Exclusion Criteria ......................................................................................................... 17 
4.3 
Study Enrollment Procedures ....................................................................................... 18 
5. STUDY INTERVENTIONS .................................................................................................. 18 
5.1 
Interventions, Administration, and Duration ................................................................ 18 
5.2 
Handling of Study Interventions ................................................................................... 18 
5.3 
Concomitant Interventions ............................................................................................ 20 
5.3.1 Allowed Interventions ............................................................................................... 16 
5.3.2 Required Interventions .............................................................................................. 16 
5.3.3 Prohibited Interventions ............................................................................................ 16 
5.4 
Adherence Assessment ................................................................................................. 16 
6. STUDY PROCEDURES ........................................................................................................ 17 
6.1 
Schedule of Evaluations ................................................................................................ 18 
6.2 
Description of Evaluations ............................................................................................ 19 

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6.2.1 Screening Evaluation ................................................................................................ 19 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 20 
6.2.3 Blinding..................................................................................................................... 26 
6.2.4 Followup Visits ......................................................................................................... 26 
6.2.5 Completion/Final Evaluation .................................................................................... 26 
7. SAFETY ASSESSMENTS ..................................................................................................... 27 
7.1 
Specification of Safety Parameters ............................................................................... 27 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 27 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 27 
7.4 
Reporting Procedures .................................................................................................... 28 
7.5 
Followup for Adverse Events ....................................................................................... 28 
7.6 
Safety Monitoring ......................................................................................................... 28 
8. INTERVENTION DISCONTINUATION ........................................................................... 29 
9. STATISTICAL CONSIDERATIONS .................................................................................. 25 
9.1 
General Design Issues ................................................................................................... 25 
9.2 
Sample Size and Randomization .................................................................................. 30 
 9.22 Treatment Assignment Procedures ................................................................................... 26 
9.3  
Definition of Populations .............................................................................................. 26 
9.4 
Interim Analyses and Stopping Rules ........................................................................... 26 
9.5 
Outcomes ...................................................................................................................... 26 
9.5.1 Primary Outcome ...................................................................................................... 26 
9.5.2 Secondary Outcomes ................................................................................................ 26 
9.6 
Data Analyses ............................................................................................................... 27 
10. DATA COLLECTION AND QUALITY ASSURANCE .................................................. 28 
10.1 
Data Collection Forms .................................................................................................. 28 
10.2 
Data Management ......................................................................................................... 28 
10.3 
Quality Assurance ......................................................................................................... 30 
10.3.1 
Training ................................................................................................................. 35 
10.3.2 
Quality Control Committee................................................................................... 35 
10.3.3 
Metrics .................................................................................................................. 35 
10.3.4 
Protocol Deviations ............................................................................................... 35 
10.3.5 
Monitoring ............................................................................................................ 36 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................... 36 
11.1 
Institutional Review Board (IRB) Review .................................................................... 36 
11.2 
Informed Consent Forms .............................................................................................. 36 

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11.3 
Participant Confidentiality ............................................................................................ 36 
11.4 
Study Discontinuation ................................................................................................... 36 
12. COMMITTEES..................................................................................................................... 36 
13. PUBLICATION OF RESEARCH FINDINGS .................................................................. 37 
14. REFERENCES ...................................................................................................................... 37 
15. SUPPLEMENTS/APPENDICES ........................................................................................ 38 
 
 
 

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STUDY TEAM ROSTER  
Judith Gordon, Ph.D. 
University of Arizona 
College of Nursing 
1305 N. Martin Ave., #410 
Tucson, AZ 85721 
Phone - 520-626-4970 
Fax – 520-626-2211 
judithg@email.arizona.edu 
 
Peter Giacobbi, Ph.D. 
West Virginia University 
375 Birch Street 
Morgantown, WV 26506-6116 
Phone - 304-293-5970 
Peter.Giacobbi@mail.wvu.edu 
 
Melanie Bell, PhD 
University of Arizona 
PO Box 210202 
Tucson, AZ 85719 
Phone - 520-626-2795 
melaniebell@email.arizona.edu  
 
Julie Armin, PhD 
University of Arizona 
1450 Cherry Avenue 
Tucson, AZ 85719 
Phone - 520-626-4166 
Fax – 520-626-6134 
jarmin@email.arizona.edu 
 
Uma S. Nair, Ph.D 
Assistant Director, Arizona Smokers’ Helpline (ASHLine) 
The University of Arizona 
3950 S. Country Club Road, Ste. 3210 
Tucson, AZ 85714 
Phone: 520-621-2233 
 
 
 

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Hagan Franks 
Biocomputing Facility - Arizona Research Laboratories Business Office 
University of Arizona 
Tucson, AZ 85721 
(520)626-4811 
franks@email.arizona.edu 
 
Emilia Yessenya Barraza 
Behavioral Measurement and Interventions Shared Resource 
Research Assistant  
3950 S. Country Club Rd. Suite 330 
Tucson, AZ 85714 
(520) 445-2232 
 
Gayle Povis, MS 
The University of Arizona Collaboratory  
3950 S. Country Club Road, Ste. 3310 
Tucson, AZ 85714 
(520) 626-7168  
gpovis@email.arizona.edu 
 
Kristina Souders, Intervention Coach 
The University of Arizona Collaboratory  
3950 S. Country Club Road, Ste. 3310 
Tucson, AZ 85714 
520-626-6112 
ksounders@email.arizona.edu 
 
Crista Meinke, Control Condition Coach 
The University of Arizona Collaboratory  
3950 S. Country Club Road, Ste. 3310 
Tucson, AZ 85714 
cristameinke@email.arizona.edu 
 
PARTICIPATING STUDY SITES 
University of Arizona 
Department of Family and Community Medicine 
College of Public Health 
 
West Virginia University 
Department of Sports Sciences, Department of Epidemiology 
 
 
 

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PRÉCIS  
Study Title: A Guided Imagery Tobacco Cessation Intervention Delivered by a Quitline and 
Website 
Objectives: This clinical protocol has the following three objectives: 1) Develop a theory-based, 
guided mental imagery tobacco cessation intervention for quitline callers with input from expert 
consultants in health disparities and a Community Advisory Board representing diverse 
populations and tobacco control stakeholders, 2) Develop training and competency standards for, 
and train, two imagery coaches in the implementation of the guided imagery intervention, and 
two behavioral strategy coaches for implementation of control condition, 3) Conduct a feasibility 
and acceptability trial (N= up to 120) to gather preliminary data on the effects of the guided 
imagery intervention on quitline callers’ tobacco abstinence, number of quit attempts, number of 
cigarettes smoked, and self-efficacy to quit smoking.  
Design and Outcomes   
The study consists of two phases: 1) Developmental; and 2) Randomized Feasibility Trial.  
Phase 1: As shown in Table 1 below, the development of the intervention will occur iteratively 
and include the following 7 stages: 1) the development of protocols for the guided imagery 
intervention and control conditions for use in a telephone-based coaching model; 2) a website 
containing instructions,  and testimonials regarding the use of guided imagery and control 
conditions; 3) focus group testing of materials and the website (N=48); 4) the development of a 
training program for the study coaches; 5) Programming of the website and internal quality 
assurance/quality control (QA/QC) testing; 6) Usability testing of the study website; and 7) 
Modification of the ASHLine’s 2.0 electronic data system to gather and transfer study 
information, and development of  a REDCap system for protocol implementation, participant 
management and data storage.  
Phase 2: Prior to beginning the trial, we will user test all recruitment and data collection systems 
with up to 10 user test participants to identify and correct any problems. We will randomize up to 
10 user-test participants to test the ASHLine 2.0/REDCap systems and correct any errors 
identified. Once any identified errors are corrected, we will begin the feasibility trial. The 
Feasibility Trial will employ a two-group randomized controlled design. While developing the 
intervention, we will also develop an attention-control condition that will control for treatment 
length and contact time of the intervention. The trial will enroll up to 120 smokers (males and 
females age 18 and older) who will be randomly allocated to either the Imagery Intervention 
(IIC) or control condition (CC). Participants will be recruited and screened for eligibility by 
ASHLine staff and study staff. Informed consents and surveys will be obtained by ASHLine and 
study staff at baseline. Study staff will collect follow-up surveys at 8-weeks and 6-months post-
enrollment, including demographics, tobacco use, self-efficacy for quitting, cravings, and 
imagery expectancies for both groups. Participants will also complete measures of their imagery 
experiences, system usability, and other evaluations of their experiences with the website and 
study protocol.  All participants who report abstinence at  the 6-month assessment will be asked 
to perform a biochemical test using a saliva test kit to validate self-reported smoking abstinence. 
Participants meeting this criteria will be mailed a saliva kit in the mail and then join a video chat 
with staff who will instruct the participant and monitor the collection of saliva and reading of the 
test strip. Participants will be offered $25 for completing the saliva assessment.  
 
Commented [PG-(1]: Define abstinence:  e.g. 7 day (not 30 
day) 

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Total participants to be enrolled for Phase 1 equal 48.  Total participants to be enrolled in Phase 
2 will be up to 10 user-test participants, and up to 120 feasibility trial participants.  Total 
enrollment for all phases of this study will be up to 178. 
The remainder of this protocol will describe procedures for the randomized feasibility trial. 
 
Table 1.  Project Timeline 
QLI Project Time Line 
2016 
2017 
2018 2019 
Activities OctNov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep 

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Form IMC, hire 
project staff, set 
up accounts, set 
up subawards 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop 
Protocols for 
each study 
conditions   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Form Advisory 
Board 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop session 
content for each 
study condition 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop 
Training--Design 
training manual 
& competency 
standards 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obtain feedback 
on session 
content from AB 
and revise 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Finalize study 
measures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Get feedback 
from AB and 
revise measures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Identify all data 
items and 
collection points 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop 
Website--
Functional 
specs, content, 
user interface, 
storyboards 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obtain feedback 
from AB and 
revise 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct Focus 
Testing–Recruit 
& conduct 
groups & revise 
website 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Program 
Website--
Content & data 
transfer, & 
internal QA/QC 
testing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct 
Usability 
Testing--Recruit 
& conduct 
testing, final 
revisions to 
website 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Customize 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Interventions and Duration  
For the feasibility trial, we will randomize up to 120 participants to either the Imagery Intervention 
(IIC) or Control (CC) condition. We anticipate that participants will receive 6 sessions.  All 
sessions will be approximately 20-50 minutes long. All participants will be instructed to log into 
the project website, which will contain a repository of study and intervention information tailored 
to condition.  
 
Participants will be assessed at 8-weeks post-enrollment, and at 6 months post-enrollment via 
online survey (or phone for non-responders) by project personnel. All  participants who report 
abstinence at  the 6-month assessment will be asked to perform a biochemical test using a saliva 
test kit to validate self-reported smoking abstinence. Participants meeting these criteria will be 
invited to receive a saliva kit in the mail and then join a video chat with staff who will instruct the 
participant and monitor the collection of saliva and reading of the test strip.  Participants will be 
offered $25 for completing the saliva assessment. 
 
ASHLine 
Software—
Participant 
management, 
program 
management, 
data collection, 
data transfer  
Obtain feedback 
from QL 
coaches and 
revise 
 
 
Conduct 
usability testing 
and make final 
revisions 
 
 
Conduct 
Feasibility Trial 
 
 
Hire GI 
coaches 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Train all 
coaches 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Recruit 
participants, 
conduct user 
test 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruit 
participants, 
collect baseline 
data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collect data 8-
week and 6-
month data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analyze data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Publications, 
presentations, 
finalize MOP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Sample Size and Population  
The target population for the feasibility intervention will be a racially and ethnically diverse 
sample of male and female smokers (N= up to 120) who will be randomized to the IIC or CC.  
1. STUDY OBJECTIVES 
1.1 
Primary Objective 
The primary outcome will be self-reported tobacco abstinence. We will measure 7-
day point prevalence, 30-day point prevalence and prolonged abstinence at the 6-
month follow-up assessment. All participants who report abstinence at  the 6 month 
assessment and agree to perform a saliva test will be biochemically validated. We 
hypothesize that participants in the Imagery Intervention Condition will report equal 
or higher rates of cessation than those in the Control Condition.  
Our feasibility outcomes include: at least 50% of participants will complete the 6-
session intervention program; 50% Of the IIC participants will report listening to the 
guided imagery audio files at least 5 times per week; 50% will visit the website at 
least one time; and 75% of participants will complete both follow-up assessments.   
1.2 
Secondary Objectives 
Secondary outcomes will include reduced tobacco use (for non-quitters), increased 
self-efficacy for quitting, and reduced nicotine cravings. We hypothesize that 
participants in the Imagery Intervention Condition will report equal or lower levels of 
tobacco use and cravings, and equal or higher levels of self-efficacy for quitting. 
 
In addition, we will explore the demographics of study participants to assess how they 
may differ from the general population of ASHLine callers.  
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Tobacco use continues to be a leading preventable cause of death in the United States 
accounting for about 480,000 deaths each year (USDHHS, 2014). For every death 
related to smoking-related diseases there are 30 people who suffer from serious 
illnesses directly related to smoking that include stroke, chronic obstructive pulmonary 
disease, heart disease, and lung cancer. According to a recent report by the Surgeon 
General, the total economic cost of tobacco use in the United States was $289 to $332 
billion from 2009-2014.  
2.2 
Study Rationale 
Several meta-analytic reviews have shown that proactive telephone-based tobacco 
cessation services are an effective way to reduce cravings for and use of tobacco (Fiore 
et al., 2008; Hopkins et al., 2001; Lichtenstein et al., 2010). Telephone Quitlines (QLs) 
are an efficient, centralized, and highly scalable way to help individuals quit their use 
of tobacco that are available in all fifty states plus the District of Columbia. The North 

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American Quitline Consortium reported that 515,000 users, or 1.2% of all smokers, 
contacted QLs in 2009: this represents an increase of 129.7% since 2005. In Arizona, 
the Arizona Smokers’ Help Line (ASHLine) is run through the University of Arizona, 
Mel and Enid Zuckerman College of Public Health, and is funded by the State of 
Arizona, Department of Health. The ASHLine, where the proposed study will be 
implemented, enrolled 10,824 individuals from July 2013 to June 2014, which 
represented a 7% increase from the previous year. Of these, about 73% were Caucasian, 
57% were female, 17% were Hispanic, 8% were African American, and 2% were 
American Indian. The ASHLine uses a “Coaching Model,” and reported an average of 
3.9 calls per enrollee--two calls for medication only enrollees, and nine calls per 
coaching enrollees.  
 
Researchers have also demonstrated the cost-effectiveness of telephone QLs in the 
United States and Europe over the past 25 years (Cromwell, Bartosch, Fiore, 
Hasselblad, & Baker, 1997; Fiore et al., 2008; Kahende, Loomis, Adhikari, & Marshall, 
2009; Lichtenstein et al., 2010). Despite these findings, many state agencies that 
oversee the implementation of QLs are cutting funds at a time when there is record 
utilization of services (NAQC, 2010). This situation has prompted many state sponsors 
to try to improve their effectiveness by focusing recruitment on under-represented 
groups and reducing human capital with increased web-based services: approximately 
1/3 of US QLs include some type of internet service to supplement counseling. 
Theoretically-based website services and alternative intervention approaches that are 
more appealing to diverse groups may increase the reach, engagement, and 
effectiveness of QLs.  
 
Guided imagery is a mind-body technique that involves the visualization of mental 
images and is similar to mindfulness meditation (MM). Both mindfulness meditation 
and mental imagery can create awareness and direct attention to one’s thoughts, 
feelings, and health behaviors. Guided imagery and other mindfulness interventions 
can effectively assist tobacco users to quit (Brewer et al., 2011; Wynd, 2005; Zernig et 
al., 2008). One randomized controlled trial with 779 adult smokers compared the use 
of bupropion with brief psychotherapy that was taught to participants over 2 days 
lasting 8 hours (Zernig et al., 2008). The latter condition consisted of exposure to 
guided imagery intended to enhance self-management, decidedness, assertiveness, self-
determination, and self-assurance. Intent-to-treat analysis showed 12-month abstinence 
rates of 39.1% and 12.3% for the psychotherapy and bupropion groups, respectively. 
These rates were 39.9% (psychotherapy) and 22.5% (bupropion) for those who 
completed the study. In another four week randomized controlled trial, 33 adults were 
taught mindfulness and encouraged to practice at home (Elwafi et al., 2013). Results 
showed that home practice predicted reduced cigarette use, and informal mindfulness 
practice moderated the relationship between craving and cigarette use (Elwafi et al., 
2013). Another smaller trial compared those receiving education and counseling with 
education/counseling plus imagery training (Wynd, 2005).  Results of that study 
indicated abstinence rates of 12% and 26%, respectively (Wynd, 2005). These studies 
support the efficacy of guided mental imagery for smoking cessation.  
 

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However, these studies employed in-person interventions that are prohibitively 
expensive and limit larger scale implementation and overall reach. Combining the use 
of guided imagery with tobacco QL services offer a highly scalable, innovative, and a 
cost-effective strategy for delivering a guided imagery intervention. We will develop, 
using input from expert consultants, a community advisory board, and our target 
population, a guided imagery intervention, attention-control condition, and recruitment 
strategies. The intervention has little potential risk and may increase the use of 
telephone-based tobacco cessation counseling by male and racially-/ethnically-diverse 
smokers. 
3. STUDY DESIGN 
 
As shown in Figure 1, we will use a two-group randomized control design. Participants will 
be recruited through IRB-approved flyers and advertising, and the ASHLine, screened for 
eligibility by ASHLine or study staff, consented by ASHLine or study staff, administered the 
baseline survey by ASHLine or study staff, and automatically randomized by the REDCap 
system (using a randomization algorithm) to either the Imagery Intervention (IIC) or Control 
(CC) Condition. We will enroll and randomize up to 120 feasibility trial participants 
(approximately equal numbers per condition).  
 
Participants in both conditions will receive a screening call and 6 telephone coaching 
sessions delivered over 6 weeks by trained ASHLine or project staff. The screening call will 
be conducted by ASHLine or study staff to assess study eligibility, collect consent for study 
participation, and collect baseline survey items. The coaching sessions will be approximately 
20-50 minutes long. We will develop baseline survey items to be administered to participants 
during the screening call. We will develop content for each coaching call for each study 
condition, including instructions for using the study website. The IIC sessions 1-4 will 
include an introduction to guided imagery, setting a quit date, setting a guided imagery 
schedule, and helping the participant develop a guided imagery script which the coach will 
record as an audio file and send to the participant to listen to. Sessions 5-6 will focus on 
quitting issues and relapse prevention. The CC sessions 1-4 will include an introduction to 
cognitive behavioral telephone coaching, setting a quit date, an introduction to the quitting 
booklet [in development], and setting a schedule for using the booklet, and assistance in 
developing the first part of the quit plan. Sessions 5-6 will focus on quitting issues and 
relapse prevention strategies. Sessions 2 – 4 will review progress and build skills according 
to study condition, culminating in a quit day at approximately 4 weeks post-enrollment. 
Sessions 5-6 will reinforce quitting smoking or help participant recommit to quit.  Between 
sessions, participants in both conditions will receive occasional text messages (e.g. 
motivational messages, call reminders). During the enrollment process participants are asked 
for a phone number at which they can receive texts.  By providing the number they are 
agreeing to receive occasional texts.  During the coaching sessions, the coach asks the 
participant if they wish to receive more messages (e.g., motivational messages, tips for 
quitting, etc.).   
 
Participants in both conditions who request it will receive up to 4 weeks of Nicotine 
Replacement Therapy (NRT), either nicotine patches or lozenges based on level of nicotine 

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dependence. All participants requesting NRT will be screened by trained project staff for 
contraindications for use, assessed for level of dependence, and informed of potential side 
effects (AEs and SAEs) of using NRT. The screening, assessment, and informational scripts 
are under development and will be submitted to the IRB for approval prior to these activities 
occurring with participants.   
 
Participants will be assessed by project staff at 8-weeks and 6-months post-enrollment. Self-
report surveys will be administered online or by phone. All participants who report 
abstinence at  the 6-month assessment will be asked to perform a biochemical validation. 
Biochemical validation will be performed via saliva test kit sent to the participant’s home and 
a video chat with  University of Arizona  project staff.  
 
The primary outcome will be self-reported tobacco abstinence. We will measure 7-day point 
prevalence, 30-day point prevalence and prolonged abstinence at each follow-up assessment. 
We hypothesize that participants in the Imagery Intervention Condition will report equal or 
higher rates of cessation than those in the Control Condition.  
 
Our feasibility outcomes include: at least 50% of participants will complete the 6-session 
intervention program; 50% will report listening to the guided imagery audio files at least 5 
times per week; and 50% will use the website at least one time; and 75% of participants will 
complete both follow-up assessments.  
  
Secondary outcomes will include increased number of quit attempts, reduced tobacco use 
(for non-quitters) and increased self-efficacy for quitting. We hypothesize that participants in 
the Imagery Intervention Condition will report equal or lower levels of tobacco use, and 
equal or higher levels of quit attempts and self-efficacy for quitting. 
 
 
In addition, we will explore the demographics of study participants to assess how they may 
differ from the general population of ASHLine callers. Our goal is to increase the diversity of 
ASHLine callers. 
 

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Figure 1. Study Flow Diagram  - Minimum Number of Participants Noted, Up to 120 (60 Per 
Condition) Will be Randomized 
 
4.    SELECTION AND ENROLLMENT OF PARTICIPANTS  
Participants will be male and female smokers over the age of 18 who are interested in 
quitting and call the ASHLine or respond to flyers or advertising. During the study period, 
we will actively recruit underrepresented smokers to call the ASHLine. The ASHLine has 
agreed to display tailored recruitment information on their website (as developed by our 
consultants and community advisory board [CAB]), and we will employ additional 
recruitment strategies (e.g., swap meets, churches, medical providers, identified by the CAB 
and consultants) to attract diverse potential participants. Additional participant recruitment 
may occur through the Arizona ASHLine using special features on their study website (see 
Figure 2). ASHLine staff  may embed a link about the research study that will be tailored for 
racially- and ethnically-diverse audiences and feature content about the use of guided 
imagery.  
 
8 
N=16,000 quitline callers per 9-month 
recruitment period plus direct contacts 

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4.1 
Inclusion Criteria 
Participants must meet all of the inclusion criteria to participate in this study.  
Inclusion Criteria: 
• Current smokers or those whose primary tobacco product is cigarettes 
(e.g., dual cigarette and smokeless tobacco users). 
• Current callers and former callers who have not enrolled in the ASHLine 
for the previous 12 months  
• At least 18 years of age 
• Have email access  
• Speak English 
• Ability to understand study procedures and to comply with them for the 
entire length of the study. 
• Contraception is not necessary or required. 
4.2      Exclusion Criteria 
All candidates meeting any of the exclusion criteria at baseline will be excluded 
from study participation. 
Exclusion Criteria: 
• Individuals with serious mental illness 
• Tobacco users who have used the ASHLine in the past 12 months 
• Tobacco users who are currently receiving any form of tobacco cessation 
treatment 
• Refusal to be randomized to one of the study conditions.  

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4.3 
Study Enrollment Procedures  
The REDCap system will be used to document information during all phases of the 
study. The REDCap system will track the name and contact information of the 
participants, date of contact with ASHLine or study staff, the staff person who took 
their telephone call, eligibility/screening information, consent, baseline survey, and 
randomization information. Informed consent will occur over the telephone with 
ASHLine or study staff reading an IRB-approved abbreviated version of the consent 
document to participants. Participants will provide verbal consent and be  emailed a 
copy of the full-length consent form for their records. Upon completion of informed 
consent, ASHLine or study staff will administer the baseline survey via the phone. 
Upon completion of the baseline survey, the data from ASHLine 2.0 will be 
transferred to the REDCap system. Study staff will then call the participant and 
confirm consent.  The REDCap system will be used to randomize the participant to 
either the IIC or CC. The REDCap system will automatically assign the participant to 
condition using a randomization algorithm. Following randomization, study staff will 
assign the participant to an appropriate study coach. The coach will then schedule the 
first session with the participant. 
5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
The Imagery Intervention will consist of 6 weekly telephone coaching sessions 
delivered by trained project staff plus a companion website containing study 
materials. As shown in Table 2, the first session will include an overview of guided 
imagery, setting a quit date, setting a guided imagery schedule, description of the 
Intervention website and instructions for using the website. Sessions 2-4 will include 
follow-up and review of progress and use of the imagery files. Session 5 will include 
instructions  using / modifying the guided imagery script. Session 6 will review 
progress and creating a plan for continued use of guided imagery for relapse 
prevention and/or cessation.  
 
Week 1-Imagery Intervention Condition 
Theme:  Intro and planning 
Goal:  Set quit date, define GI, determine 
reasons/benefits of quitting, create script and set times 
to practice script. 
Content:  Basic definition of GI, intro to breathing, 
relaxation.  Draft one GI sentence for each 
reason/benefit. 
Week 1-Control Condition 
Theme:  Intro and planning 
Goal:  Set quit date, determine reasons/benefits of 
quitting and set time to do portion of booklet. 
Content:  Define and discuss behavioral treatment.  
Discuss previous quit attempts.   
Week 2-IIC 
Theme:  Triggers 
Goal:  Develop GI strategies to address triggers. 
Week 2-CC 
Theme:  Triggers 
Goal:  Develop behavioral strategies to address 
triggers. 
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Content:  Identify participant’s primary trigger and 
coping strategy; develop script.  Practice previous 
script and this one together. 
Content:  Review triggers and coping strategies 
participant identified in booklet.  Recommend 
practicing new coping strategy in the trigger setting 
each day. 
Week 3-IIC 
Theme:  Cravings and Withdrawal 
Goal:  Have client understand 2 types of urges 
(habitual and physiological reaction).  Develop 
strategies to address cravings and withdrawal. Discuss 
NRT. 
Content:  Create script to manage cravings and 
withdrawal.  Make listening to GI a new habit. 
Week 3-CC 
Theme:  Cravings and Withdrawal 
Goal:  Have client understand 2 types of urges 
(habitual and physiological reaction). Develop 
strategies to address cravings and withdrawal. Discuss 
NRT. 
Content:  Identify replacement behaviors for cravings 
and withdrawal issues. 
Week 4-IIC    (On or slightly before quit date) 
Theme:  Handling withdrawal and preparing to quit 
Goal:  Determine strategies to handle withdrawals, 
discuss use of NRT and quit preparation. 
Content:  Make edits or additions to script if 
necessary.  Practice entire script throughout week, or 
just a portion if too long. 
Week 4-CC   (On or slightly before quit date) 
Theme:  Handling withdrawal and preparing to quit 
Goal:  Determine strategies to handle withdrawals, 
discuss use of NRT and quit preparation. 
Content:  Review strategies previously identified and 
any new ones, as needed. 
 
Week 5-IIC 
Theme:  Relapse prevention/recommit to quit 
Goal:  Support quitting among those who quit and 
encourage quitting among those who didn’t or who 
relapsed.   
Content:  Check whether participant wants any 
changes to the script.  If so, identify changes and re-
record. 
Week 5-CC 
Theme: Relapse prevention/recommit to quit 
Goal:  Support quitting among those who quit and 
encourage quitting among those who didn’t or who 
relapsed.   
Content:  Revise behavioral strategies as needed to 
cope with anything that came up during the week. 
 
Week 6-IIC 
Theme:  Relapse prevention/recommit to quit 
Goal:  Prepare participants to be successful on their 
own.  Give post-quit resources. 
Content:  Revise script if necessary.  Provide GI and 
relaxation resources. 
Week 6-CC 
Theme: Relapse prevention/recommit to quit 
Goal:  Prepare participants to be successful on their 
own.  Give post-quit resources. 
Content:  Revise behavioral strategies if needed.   
8 Week Follow-up Survey 
Assess for 7 day and 30 day point prevalence. 
 
8 Week Follow-up Survey 
Assess for 7 day and 30 day point prevalence. 
6 Month Follow-up Survey 
Assess for 7 day and 30 day point prevalence as well 
as prolonged abstinence. 
6 Month Follow-up Survey 
Assess for 7 day and 30 day point prevalence as well 
as prolonged abstinence.  
 
Participants are also eligible to use nicotine replacement therapy as per study 
guidelines. The study will provide nicotine lozenge or patch for up to 4 weeks if the 
participant has no medical contraindications for use.   
Participants can opt in to receive text messages from the quit coaches throughout the 
quitting process. Quit coaches will ask participants during the coaching sessions if 

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they wish to receive additional, optional text messages (e.g., motivational messages, 
quitting tips, etc.).  
5.2 
Handling of Study Interventions  
For a description of the intervention protocol, see section 5.1. As part of the R34 we 
will develop a Manual of Procedures to document all study-related policies, 
procedures, measures and materials. In addition, we will work with the Arizona 
Research Labs (ARL) to modify the ASHLine 2.0 system to collect study-related 
information, and contract with BMISR to create a REDCap data and participant 
management system that will be integrated with the ASHLine 2.0 system and the 
project website. ARL is responsible for programming and maintaining the ASHLine 
2.0 system and the project website. Therefore, these systems will be integrated and 
maintained by ARL. 
As this is a behavioral intervention, it is not possible to employ masking procedures 
with participants or study coaches. However, ASHLine staff and project staff who 
obtain informed consent and conduct baseline assessments and confirm consent will 
not know participants’ study assignment prior to obtaining consent or baseline 
assessments. 
5.3 
Concomitant Interventions  
Those calling the ASHLine who request only medications will be excluded (see 
above).  
 
We will provide NRT to all study participants who request it, and have no medical 
contraindications for use. We will screen all participants for contraindications for use 
of NRT, and assess level of dependence to determine whether participants should use 
nicotine patches or lozenges.  We will offer up to 4 weeks of NRT.  
 
 
5.3.1 Allowed Interventions 
Participants are allowed to take nicotine replacement medication as per study 
policies and any other medication prescribed by their physician. 
5.3.2 Required Interventions 
The participants must agree to be randomized to one of the two study 
conditions and to participate in 6 weekly sessions, and use the project website.  
5.3.3 Prohibited Interventions 
Participants may not be currently enrolled in the ASHLine or any other 
tobacco cessation treatment program or have been enrolled in the ASHLine in 
the past 12 months. 

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5.4 
Adherence Assessment  
Adherence will include: 1) Coach collected participant attendance of coaching 
sessions; 2) Participant self-reported listening to guided imagery audio files (IIC 
only); 3) Participant self-reported use of cognitive-behavioral techniques (CC only); 
and 4) Automatically collected use of the study website.  
 Adherence  feasibility outcomes will be measured as: at least 50% of participants 
will complete the 6-session intervention program; 50% of IIC participants will report 
listening to the guided imagery audio files at least 5 times per week; and 50% will use 
the  website at least one time.   
6. STUDY PROCEDURES  
The study procedures are outlined below. See also Figure 1 and Table 3.  
1. Potential participants will call the ASHLine or study staff.  
2. ASHLine or study staff will describe the study and screen callers for eligibility.  
3. Eligible participants will be consented by the ASHLine or study staff, who will also 
administer the baseline survey. If participants are consented by ASHLine, study staff will 
call participants and confirm consent. 
4. Participants who complete the survey will be enrolled in the study and automatically 
randomized by the REDCap system to one of the two study conditions.  
5. Participants will be assigned to a study coach depending on condition.  
6. The study coach will schedule the first and subsequent telephone coaching visits.  
7. All visits will be conducted via phone at the initiation of the study coach.  
8. All follow-up assessments will be scheduled and conducted by project assessment staff 
(not study coaches). 
9. Study staff will administer the follow-up assessments at 8-weeks and 6-months post-
enrollment. 
10. A link to a REDCap or Qualtrics online questionnaires will be sent by email at 8 weeks 
and 6 months post-enrollment and participants will be instructed to complete the surveys. 
11. Participants who have not completed a survey after one week will receive a reminder 
email.  
12. Participants who have not completed a survey after two weeks will receive a phone 
reminder and offered the opportunity to complete the survey by phone or online. 
13. Participants who have not completed a survey after three weeks will receive a phone 
reminder to complete the survey. 
14. All participants who report abstinence on the 6-month survey will be asked to perform a 
biochemical validation using saliva.   
15. Participants who have not completed a survey at four weeks will be considered lost to 
follow-up but retained in analyses. 
 
 
 

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Table 3. Schedule of Evaluations
Assessment 
Screening, 
Consent, 
Baseline, 
Randomization 
Visit 0 
Treatment 
Visit 1 
(W1) 
Treatment 
Visit 2 
(W2) 
Treatment 
Visit 3 
(W3) 
Treatment 
Visit 4 
(W4) 
Treatment 
Visit 5 
(W5) 
Treatment 
Visit 6 
(W6) 
Followup 
(W6) 
Followup 
(W24) 
Informed Consent Form   
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
Criteria  
X 
 
 
 
 
 
 
 
 
Enrollment/Randomization 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Tobacco Use 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dependence 
X 
 
 
 
 
 
 
X 
X 
Cravings 
X 
 
 
 
 
 
 
X 
X 
Self-Efficacy 
X 
 
 
 
 
 
 
X 
X 
Expectancy/Credibility 
X 
 
 
 
 
 
 
X 
X 
Biochemical Validation 
 
 
 
 
 
 
 
X 
X 
Website Use 
 
 
 
 
 
 
 
X 
X 
Imagery File Use 
 
 
 
 
 
 
 
X 
X 
Imagery Vividness 
 
 
 
 
 
 
 
X 
X 
Consumer Satisfaction 
 
 
 
 
 
 
 
X 
X 
Treatment Administration 
Form  
 
X 
X 
X 
X 
X 
X 
 
 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events  
 
X 
X 
X 
X 
X 
X 
 
 

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6.2 
Description of Evaluations  
All activities in this study (except for biochemical validation) will occur online or via 
telephone. The ASHLine 2.0 system and/or REDCap data base will be used to 
automate, deliver and track all study-related activities. The ASHLine 2.0 system or 
REDCap will provide the prompts and scripts for ASHLine or study staff to describe 
the study, screen for eligibility, read the abbreviated informed consent document, 
obtain and document informed consent, obtain and document the baseline assessment 
and confirm and document consent. The REDCap system will perform and track 
randomization, assign participant to study coach, and track all follow-up assessments. 
Table 3 above shows the schedule of assessments. Baseline assessments will be 
administered by ASHLine or study staff via phone as per “Visit 0”. All participants 
will be administered the Treatment Administration Form which will document their 
participation in the telephone coaching calls during Visits 1 to 6. Use of the websites 
will be collected automatically. Eight-week and 6-month assessments will be 
conducted by study staff. Links to online surveys will be sent via email, with 
reminder calls and emails for up to four weeks. Surveys can be completed online or 
via phone with study staff. Biochemical validation will be done on all participants 
who report abstinence on the 6-month assessment and agree to perform a saliva test 
monitored via video chat by study staff. 
 
6.2.1 Screening Evaluation 
Smokers who express interest in our study will eligible if they: 
• Have smoked any cigarettes in the past 30 days. 
• Are willing to quit smoking within 30 days.  
• Want help / information about quitting. 
 
• Are not currently receiving any type of tobacco cessation treatment. 
• Are at least 18 years of age. 
• Have not enrolled and participated in Quitline services in the past 12 months. 
• Have never been diagnosed with schizophrenia by a health care professional. 
• Have current valid email address. 
• Are willing to receive occasional text messages from us. 
Consenting Procedure 
The potential participants who are eligible to participate in the study will be read the 
abbreviated informed consent document verbatim by ASHLine or study staff.  The 
abbreviated and full informed consent documents and the study were reviewed and 
approved by the University of Arizona IRB prior to recruitment. 
Participants are called by study staff to confirm consent and are then emailed the full 

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informed consent and are told that if after reading the full consent they decide not to 
participate to inform study staff. 
All ASHLine and study staff are trained in Human Subjects Protection and the 
Responsible Conduct of Research. ASHLine staff are employed by the College of 
Public Health and regularly participate in recruitment for research studies. The PI will 
train the ASHLine and study staff in the procedures for the study and ensure that all 
staff demonstrate understanding before they begin enrolling participants.  
All procedures and systems will be thoroughly tested prior to implementation. 
ASHLine and study staff will be instructed to inform the PI or Dr. Nair if they 
experience problems using the informed consent document or the ASHLine 2.0 and 
REDCap systems. If any study procedures affecting participants change, appropriate 
changes will be made to the informed consent document and resubmitted to the 
University of Arizona IRB for approval. 
ASHLine or study staff will read the abbreviated informed consent document as many 
times as requested by the caller. The caller will provide verbal consent which will be 
documented in the ASHLine 2.0 or REDCap system. Study staff will send an email of 
the full-length informed consent document to each participant for their records.  
Screening 
All screening will be performed at the time of the first call to the ASHLine (Visit 0). 
Participants will be eligible if they: 
• Have smoked any cigarettes in the past 30 days. 
• Are willing to quit smoking within 30 days.  
• Want help / information about quitting. 
 
• Are not currently receiving any type of tobacco cessation treatment. 
• Are at least 18 years of age. 
• Have not enrolled and participated in Quitline services in the past 12 months. 
• Have never been diagnosed with schizophrenia by a health care professional. 
• Have current valid email address. 
• Are willing to receive occasional text messages from us. 
At any time, if the caller is not eligible, staff will inform the caller that they are not 
eligible to participate in the study and will offer standard ASHLine coaching. 
 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
Enrollment in the study will occur upon completion of the informed consent 
document, the baseline assessment, confirmation of consent and randomization to one 

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of the study conditions. All screening, consent, assessment and randomization 
activities will be prompted and tracked by the ASHLine 2.0 system and REDCap data 
base. 
Assessments 
All of the measures proposed for use in this study have been used successfully in our 
previous work. All baseline assessments will be administered by ASHLine or study 
staff.  See Table 4. 
 
 
 
Measures for All Participants 
Demographics. At baseline, we will collect gender, 
age, race/ethnicity, level of education, insurance, 
prior use of tobacco cessation resources (including 
quitline and medication) and guided mental 
imagery experience. 
Tobacco use. At baseline, at every session, 8-
weeks and 6-months post-enrollment, we will 
collect tobacco use status using a series of 
questions that have been standardized and 
employed in previous studies (Severson, Gordon, 
et al., 2008, Gordon et al., 2007; Severson et al., 
2000), and level of dependence using the the 
Fagerström Tolerance Nicotine Dependence scale 
(Fagerstrom & Schneider, 1989). We will conduct 
biochemical validation  using a saliva test kit on all participants who report abstinence 
at the 6-month assessment and agree to perform a saliva test. Participants meeting these 
criteria will be mailed a saliva kit in the mail and then join a video chat with staff who 
will instruct the participant and monitor the collection of saliva and reading of the test 
strip.  Participants will be offered $25 for completing the saliva assessment. As all 
participants will be current smokers, there is no need for biochemical testing at 
baseline. 
Self-efficacy for quitting. We will measure self-efficacy for quitting smoking with 
items from the 15-item version of the Condiotte & Lichtenstein Confidence 
Questionnaire (Condiotte & Lichtenstein, 1981).  
Cravings. All participants will be asked to rate their experience with withdrawal 
symptoms and cravings using items from the 5-item Shiffman rating scale (Shiffman, 
2004) at each baseline and each follow-up assessment.  
Imagery expectancies and credibility. We will include items adapted from the Borokov 
and Nau (1972) Treatment Credibility Scale, and used in our on-going guided imagery 
mobile app study, to measure expectancies and perceived credibility of guided imagery 
for smoking cessation.  
Consumer satisfaction measure. At both follow-ups, participants will complete a 
consumer satisfaction survey that we have used in our previous research (Gordon et al., 
2013; Severson, Gordon, et al., 2008) consisting of 8 items (using a 5-point Likert 
scale), measuring overall satisfaction with the program, perceived usefulness and 
relevance of the information, likeability, level of interest, ease of use, and whether they 
Table 4. Measures  
Both Conditions 
T0 
T1 T2 
Demographics 
 
 
 
Tobacco Use 
 
  
Dependence 
 
  
Cravings 
 
  
Self-Efficacy 
 
  
Expectancy/Credibility 
 
  
Biochemical Validation 
 
 
 
Consumer Satisfaction 
 
 
 
Website Use 
 
Dai ly 
Intervention Only 
Daily T1 T2 
 
 
 
Imagery File Use 
 
 
 
Imagery Mastery 
 
 
 
 
 
 
Commented [PG-(2]: Note that the checkmark for T1 has been 
removed. 

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would recommend the program to others. 
Website use. We collect usage data and can analyze use of all components of the site. 
Data most likely related to outcome will include, but not be limited to: (a) the length of 
time participants interact with the site; (b) the number of pages they visit within the 
site, and (c) the number of links they click on while using the site.  
System usability. At both follow-up assessments, we will use Tullis and Stetson’s 
(2008) 10-item adaptation of Brooke’s widely used System Usability Scale (Brooke, 
1996) to rate the usability of our website.  
 
 
Measures for Only Imagery Intervention Condition Participants 
Imagery files use. We will collect number of times imagery files were listened to , and 
if the participant modified or created their own file.  
Imagery mastery. Ratings of imagery vividness and controllability will be measured 
weekly via the coach in order to verify compliance with the protocol (Marks, 1973).  
Randomization 
Eligible participants who are consented and complete the baseline assessment will be 
automatically randomized immediately by the REDCap system using a randomization 
algorithm. The assignment will be documented and tracked in the REDCap system, 
and the participant will be assigned to a study coach. 
6.2.3 Blinding 
 Due to the nature of the study with two different behavioral interventions it 
would not be possible to blind participants or study coaches.  
6.2.4 Follow-up Visits 
All measures by follow-up are listed in Table 3. There will be two follow-up 
assessments: 1) 8 weeks post-enrollment; and 2) 6 months post-enrollment. 
All items will be asked at each follow-up assessment of every participant. In 
addition, biochemical validation of self-reported tobacco use will be 
conducted   on all participants  who report abstinence at  the 6-month 
assessment and agree to perform a saliva test. Participants meeting these 
criteria will be mailed a saliva kit in the mail and then join a video chat with 
staff who will instruct the participant and monitor the collection of saliva and 
reading of the test strip.  Participants will be offered $25 for each sample. 
6.2.5 Completion/Final Evaluation 
The items assessed at the final follow-up assessment are listed in Table 3. If a 
participant does not complete a follow-up assessment within 4 weeks of their 
initial reminder, they will be considered lost to follow up. However, their data 
will be retained and will be used in intent-to-treat analyses. We will make 
every effort to track and determine reasons for participant dropout including 
the unlikely possibility of an adverse event related to participation in this 
study.   

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7. SAFETY ASSESSMENTS  
This is an extremely low risk study. However, participant safety will be monitored throughout 
the study by project staff. During Visits 1-6, study coaches will monitor participants 
withdrawal symptoms (if the participant quits tobacco), and provide assistance or referral to 
the patient’s primary care physician.  
 
7.1 
Specification of Safety Parameters 
The primary safety risk is the loss of privacy. However, all data will be stored on the 
secured ASHLine 2.0 and REDCap systems. We will be collecting usage data on the 
website, and participants could be concerned about the related lack of privacy.  
 
If the participant quits smoking, s/he could experience withdrawal symptoms from 
nicotine cravings such as hunger, anxiety, restlessness, or sleep disturbance. 
Individuals who quit their addiction to tobacco products commonly experience these 
symptoms. Project coaches will be prepared to assist participants in handling these 
symptoms. 
 
If a participant experiences adverse events as a result of using NRT, the coaches will 
be prepared to assist participants in handling these symptoms. In the event of an SAE, 
participants will be instructed to call 911 or schedule an appointment with their 
primary care provider. All AEs will be documented by project staff. Serious AEs will 
be reported to the University of Arizona IRB and the NCCIH Program Officer.  
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
Methods to assess, record, and analyze safety parameters will be ongoing throughout 
the study by study staff. The PI will be responsible for ongoing evaluation of the 
procedures used by the study coaches. 
7.3 
Adverse Events and Serious Adverse Events  
An adverse event (AE) is generally defined as any unfavorable and unintended 
diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or 
disease which either occurs during the study, having been absent at baseline, or if 
present at baseline, appears to worsen. Adverse events are to be recorded regardless 
of their relationship to the study intervention.   
A serious adverse event (SAE) is generally defined as any untoward medical 
occurrence that results in death, is life threatening, requires inpatient hospitalization 
or prolongation of existing hospitalization, results in persistent or significant 
disability/incapacity, or is a congenital anomaly. 
It is possible that some questions about personal behaviors (e.g. smoking) might 
cause emotional discomfort to participants.  Care will be taken to ensure that all 
participants understand that they may choose not to answer any question. Quitting 
smoking may result in physical symptoms (e.g., sleep disturbance) and changes in 
mood (e.g., irritability).  

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Participants who use NRT may experience adverse events. Most adverse events are 
rare. The most common adverse events are skin irritation and itching (nicotine patch), 
and mouth/throat soreness or ulcers (nicotine lozenges), vivid dreams and insomnia. 
Rarer, more serious adverse events include dizziness, headache, rapid heartbeat, and 
nausea. Participants will be screened for contraindications for use of NRT (e.g., 
recent heart attack, uncontrolled high blood pressure). Participants using NRT will be 
queried about AEs at each phone contact by coaches. Participants reporting AEs will 
be advised how to minimize side effects. Participants reporting SAEs will be advised 
to stop using the NRT and call 911 or their primary care physician. All participants 
will be given a study telephone number to contact the study staff if they have any 
concerns about an untoward medical event.  
 
SSL and TLS security protocols will be used to protect all communications between 
the website and/or mobile devices and the project database. These protocols use 
certificate-based authentication to ensure that the user is communicating with the 
correct server. In addition, the protocols validate data and use public-key 
cryptography to guard against eavesdropping. Users will also be required to be 
authenticated by logging into the application with both their user name and password. 
This authentication data, as well as all other communications, will be transmitted 
securely using the SSL or TLS protocols. 
7.4 
Reporting Procedures 
It is highly unlikely that any of the study procedures will cause an AE or SAE.  
Should an AE or SAE occur, ASHLine personnel and research study staff are trained 
to immediately report AEs connected to implementation of the intervention to Dr. 
Nair (co-I) or Dr. Gordon (PI).  Dr. Nair will report AEs to Dr. Gordon who will keep 
a log of AEs and SAEs. In the event of an SAE, we will file a report with the 
University of Arizona (UA) IRB. As part of this process the UA IRB will determine if 
the event is directly related to  project procedures, so that It can be determined if 
project procedures should be modified.  
7.5 
Followup for Adverse Events 
Dr. Gordon will monitor all AEs until resolved or considered stable up to the end of 
the study. Information about all AEs and SAEs will be provided in annual progress 
reports to UA IRB and NCI.   
7.6 
Safety Monitoring  
The NCCIH requires that all Human Subjects research studies undergo independent 
monitoring, and NCCIH Program Officials will provide specific guidelines to the PI 
for the study.   
Once approved by the UA IRB, the following aspects of the study and study conduct 
are monitored: all procedures to ensure conformity with the approved study protocol; 
unforeseen circumstance that might arise and affect participant safety; all reports of 
serious adverse events and defined in 38 CFR 46 (death, new or prolonged 
hospitalization, persistent or significant disability or incapacity; congenital anomaly 

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or birth defect); Other significant adverse events that lead to participant dropout, 
participant termination by the principal investigators, or termination of participation 
in the intervention. 
8. INTERVENTION DISCONTINUATION  
Participation in the study is voluntary. Participants may withdraw from the study at any time 
without penalty. Participants will continue to be followed with their permission if study 
intervention is discontinued (i.e., if they do not participate in all the coaching calls or use the 
website). Participants who wish to withdraw from all study activity will not be assessed at 
follow-up. 
Possible reasons for participant withdrawal may include, but are not limited to, dissatisfaction 
with the intervention or study coaches/staff, lack of desire to quit smoking, or lack of time. No 
modifications to the study protocol will be permitted in terms of time spent with coaches, and 
the use of the study websites and audio files will be monitored.  
Participants will be informed that: “You may refuse to participate in this study.  If you 
decide to take part in the study, you may leave the study at any time.  No matter what decision 
you make, there will be no penalty to you and you will not lose any of your usual benefits.  
Your decision will not affect your future relationship with the University of Arizona or the 
Arizona Smokers Help Line (ASHLine).  If you are a student or employee at the University of 
Arizona, your decision will not affect your grades or employment status. If you are a patient at 
Banner University Medical Center, your decision will not affect your healthcare.” 
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
This is a feasibility study using a two arm parallel randomized controlled design. We 
chose this design in order to run the definitive trial in miniature, so that we can 
reliably address the aim of our feasibility study, which is to give assurance that we 
can do the future study. Expanding upon this, we aim to answer: will we be able to 
recruit, randomize and retain participants?; are the trial procedures working?; are we 
using the correct measures?; what are the relevant variance components in order to 
design the future study; and is there any preliminary evidence that the intervention is 
effective? 
We have defined feasibility outcomes as % completing the 6-session intervention 
program; % listening to the guided imagery audio files at least 5 times per week, % 
using the other website functions at least one time. 
Our primary efficacy outcome is tobacco use. We hypothesize that the participants in 
the intervention group will have lower rates of tobacco use than in the control arm. 
Our secondary outcomes are dependence, cravings and self-efficacy. We hypothesize 
that the intervention group will have lower scores for dependence, cravings and 
higher score for self-efficacy, in comparison to the control arm.  
Tobacco use. At baseline, and 8-weeks and 6-months post-enrollment follow-ups, we 
will collect tobacco use status using a series of questions that have been standardized 

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and employed in previous studies (Severson, Gordon, et al., 2008, Gordon et al., 
2007; Severson et al., 2000), and level of dependence using the the Fagerström 
Tolerance Nicotine Dependence scale (Fagerstrom & Schneider, 1989). At each visit, 
we will ask for participants’ current tobacco use status.  We will conduct biochemical 
validation using  saliva test kit on all participants who report abstinence at  the 6-
month assessment and agree to perform a saliva test.  Participants meeting these 
criteria will be mailed a saliva kit in the mail and then join a video chat with staff who 
will instruct the participant and monitor the collection of saliva and reading of the test 
strip.  Participants will be offered $25 for each sample. 
Self-efficacy for quitting. We will measure self-efficacy for quitting smoking with 
items from the 15-item version of the Condiotte & Lichtenstein Confidence 
Questionnaire (Condiotte & Lichtenstein, 1981).  
Cravings. All participants will be asked to rate their experience with withdrawal 
symptoms and cravings using items from the 5-item Shiffman rating scale (Shiffman, 
2010) at baseline and each follow-up assessment.  
9.2 
Sample Size and Randomization 
 
9.2.1 Sample size 
Because this is a feasibility study, our primary objective is to assess feasibility. 
A minimum sample size of 50 participants per group will yield a margin of 
error (95% confidence interval half-width) of no more than 1% for all binary 
outcomes, such as feasibility outcomes (% completing the 6-session 
intervention program; % listening to the guided imagery audio files at least 5 
times per week, % using the other website functions at least one time), 
smoking prevalence, and dropout rates. This sample size is large enough to 
reasonably estimate, in conjunction with sensitivity analysis, relevant variance 
components, recruitment, and dropout rates for use in a future definitive trial 
(Julious, 2005).  This sample size will also help us to assess the potential 
efficacy of the intervention, by giving 80% power to detect large effects for 
continuous outcomes (standard effect size 0.7) assuming a type I error rate of 
0.05, a dropout rate of 20%, and a two sample t-test. We will use clinically 
meaningful effect sizes (not pilot effect sizes) to estimate the future R01 
sample size. 
9.2.2 Treatment Assignment Procedures 
Randomization will be performed by REDCap using a randomization table 
created by a biostatistician who will have no contact with the participants.  The 
allocation sequence will be automated, unpredictable, and concealed from 
study staff.    
9.3  
Definition of Populations 
We will be using maximum likelihood based mixed models for all outcomes 
measured over time, using all available data. Mixed models are consistent with an 
intention to treat analysis due to their implicit imputation of missing data. 

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(Molenberghs et al., 2004). The per protocol population is defined as users who 
complete the 6-session intervention session. 
 
9.4 
Interim Analyses and Stopping Rules 
No interim analyses or stopping rules are planned, as there are no potential safety 
issues, and because this is a feasibility study. 
9.5 
Outcomes  
9.5.1 Primary Outcome   
The primary efficacy outcome is tobacco cessation at 6 months. 
The primary feasibility outcomes will be 50% of participants completing the 
6-session intervention program; 50% of IIC participants listening to the 
guided imagery audio files at least 5 times per week, and 50% of participants 
using the website at least one time; and 75% of participants completed both 
follow-up assessments. 
 
9.5.2 Secondary Outcomes   
Secondary outcomes include number of quit attempts, number of cigarettes 
smoked, tobacco dependence, self-efficacy for quitting, and cravings.  We will 
also explore the demographics of participants in the study compared to those 
of ASHLine callers in general.  
 
9.5.3  Process and Exploratory Outcomes (Intervention Condition Participants) 
All Participants 
Website use. We collect usage data and can analyze use of all components of 
the site. Data most likely related to outcome will include, but not be limited to: 
(a) the length of time participants interact with the site; (b) the number of pages 
they visit within the site, and (c) the number of links they click on while using 
the site.  
 
System usability. At both follow-up assessments, we will use Tullis and 
Stetson’s (2008) 10-item adaptation of Brooke’s widely used System Usability 
Scale (Brooke, 1996) to rate the usability of our website.  
Imagery files use. These data will be collected automatically by the website. 
We will collect number of times and which imagery files were listened to 
completely, and if the participant created their own file.  
Website use. We collect usage data and can analyze use of all components of 
the site. Data most likely related to outcome will include, but not be limited to: 
(a) the length of time participants interact with the site; (b) the number of pages 
they visit within the site, and (c) the number of links they click on while using 

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the site.  
Imagery Intervention Condition Participants Only 
Imagery files use. We will collect number of times and which imagery files 
were listened to completely, and if the participant modified and/or created their 
own file.  
Imagery mastery. Ratings of imagery vividness and controllability will be 
measured weekly via the website in order to verify compliance with the 
protocol (Marks, 1973).  
9.6 
Data Analyses  
Feasibility outcomes, including recruitment and dropout, will be described using 
frequencies and percentages, and 95% confidence intervals. Questionnaires will be 
scored according to developer instructions. Tobacco use outcome measures will use 
appropriate mixed models (linear for continuous outcomes and generalized linear 
with a logistic link for binary) using time categorically. Comparisons between the 
intervention and control group at 8 weeks and 6 months will be carried out using 
contrasts within these models. Mixed models are robust to missing outcome data 
(including dropout) and model misspecification, and are consistent with an intention 
to treat analysis (Bell and Fairclough, 2014; Mallinckrodt et al., 2004; Molenberghs 
et al., 2004). Mixed models will also be used to model self-efficacy, cravings, and 
consumer satisfaction, and to estimate intervention effects. Outcomes measured in the 
intervention group (e.g., imagery file use, website use), appropriate descriptive 
statistics will be computed, including means, standard deviations, ranges and 
frequencies/proportions. Linear regression and chi-square tests of trend will be used 
to assess the stability of the system usability and website/file use over time. We are 
underpowered to detect any subgroup analyses, but will conduct exploratory analyses 
in anticipation of the larger trial by including appropriate interactions within the 
mixed models. We will compare guided imagery use with tobacco outcome measures 
using linear regression in order to investigate a “dose-response” effect of the 
intervention.  Demographics will be described with means, standard deviations, 
ranges and frequencies/ proportions and will be explored as correlates for successful 
tobacco outcomes. 
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
All baseline data collection will take place over the telephone by ASHLine staff who 
will be blinded to the participants’ allocation to the intervention or control groups or 
by study staff. All data will be collected within the ASHLine 2.0 system and/or the 
REDCap system, which follows HIPAA standards for privacy and security.  The 
study website will be integrated with the ASHLine 2.0 system and will also be 
HIPAA compliant. Follow-up assessments will be collected online and stored via 
REDCap on our secure servers. Data from follow-up assessments conducted on the 

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phone by study staff will be entered directly into the REDCap system on our secure 
server. 
10.2 Data Management  
Data and Safety Monitoring Plan 
Based upon the NIH definitions of clinical trials, this is not a Phase III clinical trial, 
therefore, no data and safety monitoring board is required.  Only a data and safety 
monitoring plan is required. 
 
Entities conducting monitoring of the study: 
The Human Subjects Committee (institutional Review Board [IRB]) at the University 
of Arizona (UA) will review and provide oversight for the proposed research.  
 
What is monitored: 
Once approved by the UA IRB, the following aspects of the study and study conduct 
are monitored: all procedures to ensure conformity with the approved study protocol; 
unforeseen circumstance that might arise and affect participant safety; all reports of 
serious adverse events and defined in 38 CFR 46 (death, new or prolonged 
hospitalization, persistent or significant disability or incapacity; congenital anomaly 
or birth defect); Other significant adverse events that lead to participant dropout, 
participant termination by the principal investigators, or termination of participation 
in the intervention. 
 
Data Monitoring 
Data handling and quality 
Assessments will be administered to study participants as described in E1.  
All aspects of data collection and data storage will be carefully monitored to ensure 
rapid detection or errors, inconsistencies or other problems. Study personnel involved 
in data collection will follow a strict written protocol that describes study measures 
for protecting data privacy, clearly explains to study participant that she has the right 
to refuse to participate or refuse to answer any individual question that she wishes to 
not answer, and emphasizes reporting as accurately and truthfully as possible.  The 
Principal Investigator and co-Investigators are experienced in training study staff in 
handling sensitive and confidential data, and in the storage and processing of such 
data. 
 
No survey data resides on the website. It is used solely as a collection and submission 
device through a broadband internet connection to the University of Arizona 
Computer Science data center. The transmission of survey data between the web and 
database server where it is stored, is encrypted via a 128-bit SSL certificate. 
  
Physical access to the data center is restricted to authorized personnel. All servers are 
housed in a locked rack and secured from the Internet and other university 
departments through the use of a hardware-based firewall and virtual LAN. A host-
based firewall is installed and configured on each server as a secondary level of 
defense from outside intrusion. All servers and computer systems on the network are 

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configured with domain-managed accounts and password controls with audit logs. 
Access to server resources such as project data are restricted to authorized users only 
as approved by the project's Principal Investigator. 
  
All servers and data are backed up daily to disc and tape with secure offsite storage at 
the University of Arizona's Computer Center. 
 
Safety monitoring plan 
Population: The proposed study involves smokers who want to quit tobacco.  Since 
the study intervention is empirically based, and all participants are interested in 
quitting, it is unlikely that completing assessments or interacting with the website will 
cause an “adverse event” among the study populations.  However, quitting smoking 
can cause discomfort, with physical symptoms and changes in mood. 
 
Adverse events: We will use the definition of adverse events in the NIH OHRP 
document “Guidance on Reviewing and Reporting Unanticipated Problems Involving 
Risks to Subjects or Others and Adverse Events.” 
 
Adverse event (AE): Any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 
participation in the research, whether or not considered related to the subject’s 
participation in the research 
 
Serious adverse event: Any adverse event that: (1) results in death; (2) is life-
threatening (places the subject at immediate risk of death from the event as it 
occurred); (3) results in inpatient hospitalization or prolongation of existing 
hospitalization;(4) results in a persistent or significant disability/incapacity; (5) results 
in a congenital anomaly/birth defect; or (6) based upon appropriate medical judgment, 
may jeopardize the subject’s health and may require medical or surgical intervention 
to prevent one of the other outcomes listed in this definition.  
 
It is possible that some questions about personal behaviors (e.g. smoking) might 
cause emotional discomfort to participants.  Care will be taken to ensure that all 
participants understand that they may choose not to answer any question. Quitting 
smoking may result in physical symptoms (e.g., sleep disturbance) and changes in 
mood (e.g., irritability). Participants will be queried about AEs at each phone contact 
by coaches, and participants will be given a study telephone number to contact the 
study staff if they have any concerns about an untoward medical event.  
 
Reporting: It is highly unlikely that any of the study procedures will cause an AE or 
SAE.  Should an AE or SAE occur, ASHLine personnel and research study staff are 
trained to immediately report AEs connected to implementation of the intervention to 
Dr. Nair (co-I) or Dr. Gordon (PI) who will keep a log of AEs and SAEs. In the event 
of an SAE, we will file a report with the University of Arizona (UA) IRB. As part of 
this process the UA IRB will determine if the event is directly related to  project 

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procedures, so that It can be determined if project procedures should be modified. 
Information about all AEs and SAEs will be provided in annual progress reports to 
UA IRB and NCI.   
10.3 Quality Assurance  
10.3.1 Training 
All ASHLine and study staff will complete CITI training in the protection of 
human subjects and responsible conduct of research prior to engaging in any 
study-related activities. ASHLine personnel who will describe the study, 
screen, and enroll participants will be trained by Dr. Gordon and Dr. Nair, 
who will ensure that these staff demonstrate understanding and proficiency in 
all tasks prior to implementation. Project coaches will be trained by Drs. 
Gordon and Giacobbi on the use and administration of either the guided 
imagery intervention or the attention-control protocol. Dr. Giacobbi has 
previously developed and applied theory-based principles for training 
individuals to use and train others to administer guided imagery for behavior 
change. This included readings about the use of guided imagery and role 
playing exercise. These training sessions will occur in person and over 
ongoing/weekly telephone conversations prior to the implementation of the 
feasibility trial. Similar training (e.g., method, duration, etc.) will occur for 
coaches in both conditions.  
10.3.2 Quality Control Committee  
There will be no quality control committee. However, randomly selected 
telephone conversations will be audio-recorded and coaches in both 
conditions will be given immediate corrective feedback about the 
implementation of the protocols.   
10.3.3 Metrics 
A rating scale similar to the one shown below will be used to assess coaches’ 
protocol adherence (1 = poor compliance; 5 = excellent). A rating system 
similar to the one proposed has been used by Dr. Giacobbi in previous studies 
and by  Dr. Nair to monitor adherence to ASHLine protocols. 
Scoring Criteria 
1  
2 
3 
4 
5 
Meeting day/time (record keeping and reliability) 
 
 
 
 
 
Follow protocol (followed reminder list) 
 
 
 
 
 
Application of guided imagery 
 
 
 
 
 
Use of open-ended questions that stimulate vivid 
images 
 
 
 
 
 
 
10.3.4 Protocol Deviations 
When deviations of the protocol are observed, these deviations will be 
documented in the REDCap system, and coaches will be given immediate 
corrective feedback by Drs. Gordon, Nair or Giacobbi. These coaches will be 
monitored until adherence to the protocol is achieved, or will be replaced with 
coaches who can achieve adherence. 

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10.3.5 Monitoring 
We will perform ongoing oversight of data capture by reviewing the project 
databases. All data will be collected and housed at the University of Arizona. 
Dr. Gordon will be responsible for ongoing oversight of project databases. 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
This protocol and the informed consent documents (See Appendix for the Informed 
Consent Forms) and any subsequent modifications will be reviewed and approved by 
the University of Arizona IRB, which will be the IRB of record for this study. The 
consent forms will be separate from the protocol document.  
11.2 Informed Consent Forms 
All participants must be able to speak English and demonstrate understanding of the 
consent process. All participants will provide verbal consent on the telephone.  The 
consent form will describe the purpose of the study, the procedures to be followed, 
and the risks and benefits of participation. A copy will be mailed to each participant 
and this fact will be documented in the participant’s record in the ASHLine 2.0 and/or 
REDCap system.  
11.3 Participant Confidentiality  
Efforts will be made to keep study-related information confidential.  However, there 
may be circumstances where this information must be released.  For example, 
personal information regarding your participation in this study may be disclosed if 
required by state law.   
Also, all study records may be reviewed by the following groups: 
o Office for Human Research Protections or other federal, state, or 
international regulatory agencies 
o The University of Arizona Institutional Review Board  
o The sponsor supporting the study, their agents or study monitor.  
o If the results of this study are published, your identity will remain 
confidential. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the 
FDA, or other government agencies as part of their duties to ensure that research 
participants are protected.  
12. COMMITTEES 
A community advisory board will be formed to guide our overall efforts, help us recruit 
racially and ethnically diverse participants, and tailor the intervention.   

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13. PUBLICATION OF RESEARCH FINDINGS  
Efforts will be made to present our findings to all stakeholders (e.g., ASHLine, community 
advisory board, etc.), academic conferences, and publish the results in high impact journal 
outlets.  
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15. SUPPLEMENTS/APPENDICES 
See Appendices for the Informed Consent Forms, measures, and other supplemental 
documents.