Development of an Internet-based Behavioral Pain Management Intervention
Phase: NA
Conditions: Chronic Low Back Pain
Sponsor: VA Office of Research and Development

Ver. 7/25/2016 1 
 
 
 
Title: 
Development of an Internet-based Behavioral Pain Management Intervention 
 
Protocol Approval by VA Connecticut Healthcare System:  
7/25/2016  
 
NCT number: NCT01918189 
 

Ver. 7/25/2016 2 
 
 
RESEARCH PROTOCOL PROJECT DESCRIPTION 
 
1. Principal Investigator: Alicia Heapy, Ph.D.*  
Co-Principal Investigator: Diana Higgins, Ph.D.* 
 
Co-Investigators: 
Joseph Goulet, Ph.D.* - VA Connecticut Healthcare System 
Marc Rosen, M.D. – VA Connecticut Healthcare System 
Cynthia Brandt, M.D.*– VA Connecticut Healthcare System 
William Becker, M.D. – VA Connecticut Healthcare System 
Woody Levin* – VA Connecticut Healthcare System 
 
Co-Investigators not at VACHS 
David Williams, Ph.D. – University of Michigan 
Matthew Bair, M.D. – Richard L. Roudebush VA Medical Center, Indianapolis, Indiana 
Sarah Krein, Ph.D. – VA Ann Arbor Healthcare System 
Kenneth Weingardt, Ph.D. – Web Services, Office of Mental Health Services, Washington DC 
Haseena Rajeevan, Ph.D. – Yale University 
Robert Kerns, PhD – Yale University 
 
 
Study Staff: 
TBD* – VA Connecticut Healthcare System 
TBD* – VA Connecticut Healthcare System 
*Access to PHI 
 
Title: Development of an Internet-based Behavioral Pain Management Intervention 
 
2.  Purpose:  
The proposed study includes development, evaluation of preliminary efficacy, and usability testing of a 
behavioral self-management program (the VPMRC) involving cognitive-behavioral and progressive 
physical activity components for CLBP delivered via the Internet. The intervention will be developed and 
tested during 2 phases: (1) Development (Phase 1) and (2) Pilot Feasibility Trial of the VPMRC (Phase 
2). 
 
Phase 1: Development  
The primary aim of this phase of the project is to develop an integrated, Internet-based behavioral pain 
self-management intervention called the Veteran Pain Management Resource Center (VPMRC).  The first 
phase of the project will involve development of the VPMRC based on materials previously developed by 
our group in the context of several prior projects. During this phase, an Expert Panel (EP) of clinician 
investigators, including several with specific expertise and experience in developing and testing e-health 
interventions, will assist the PIs in preparing the initial content for the VPMRC. The EP will provide regular 
feedback that will be used to modify the VPMRC over a 14-month development period. This phase of the 
project also involves obtaining feedback from 15 Veterans with chronic low back pain (CLBP) to assess 
usability of the VPMRC, ease of navigation of the website, functionality of the website, and overall 
participant satisfaction with the VPMRC program. 
 
Phase II:  Pilot Feasibility Trial of the VPMRC  
The primary aim of this phase of the project is to execute a pilot feasibility trial to evaluate the preliminary 
efficacy of, usability of, and satisfaction with the VPMRC.  
The primary hypothesis is that a clinically meaningful reduction in pain interference with functioning post-
exposure to the VPMRC will be observed compared to baseline ratings.  
The secondary hypothesis is that Veterans who participate in the VPMRC will report a clinically 
meaningful reduction in pain intensity and statistically significant improvements on other important 

Ver. 7/25/2016 3 
 
problems commonly associated with CLBP including fatigue, sleep problems, depressive symptoms and 
negative mood, relative to baseline.  
The tertiary hypothesis is that participants will report high levels of interest (credibility), use, and 
satisfaction with the VPMRC. 
 
3.  Background:  
Limitations of current interventions for CLBP  
For years, the practice of pain medicine has over-emphasized expensive and modestly effective 
treatments for CLBP, while under-utilizing inexpensive evidence-based behaviorally-oriented approaches 
that have demonstrated comparable or superior effect.1,2,3,4,5 Non-pharmacological treatments such as 
education, exercise, and behaviorally-based therapies have been demonstrated to be efficacious and 
effective,  but are rarely used in routine clinical practice. Optimal care should combine both 
pharmacological and non-pharmacological behavioral interventions – but again, this is rarely done. 
Patients have historically considered behavioral interventions to be “mental health” resulting in reluctance 
to accept the need for a “psychological” treatment for their pain. It is imperative that a viable delivery 
platform be developed to facilitate Veteran access to efficacious non-pharmacological interventions. Such 
integrated delivery has become the “gold standard” of care for other chronic medical conditions such as 
diabetes, congestive heart failure, and asthma.  The development of the Veterans Pain Management 
Resource Center (VPMRC) represents a necessary “first step” in providing comparable evidence-based 
disease management for CLBP – a long anticipated transformation in how clinical pain medicine is 
practiced.  
 
Behavioral interventions for pain self-management 
Cognitive-behavioral therapy 
Psychological interventions  such as cognitive behavioral therapy (CBT) have demonstrated efficacy 
for reducing pain and improving function in persons with a broad spectrum of pain-related conditions and 
have become the most commonly cited alternatives to traditional medical and rehabilitation approaches to 
chronic pain management.6,7,8 CBT is informed by a theory of chronic pain that suggests that patients' 
beliefs, attitudes, and coping resources play a central role in determining their experiences of pain.8 The 
overarching goal of CBT for chronic pain is to assist patients in the development of an adaptive self-
management approach to pain management based upon a conceptualization of pain as controllable and 
a personal attitude of self-efficacy and self-control. An important aspect of CBT is its foundation in a 
biopsychosocial and multidimensional perspective of chronic pain and the fact that it is specifically 
designed to simultaneously target reductions in pain and associated disability, emotional distress, and 
improve overall quality of life. CBT is a structured, time-limited, and goal-oriented therapeutic approach 
that can be delivered in either small groups or individual outpatient sessions. Therapy usually involves six 
to twelve outpatient treatment sessions during which a range of cognitive (e.g., attention diversion, 
development of coping self-statements) and behavioral (e.g., activity pacing, mental relaxation and other 
stress reduction) pain coping skills are taught. Progress toward individually-tailored goals for treatment 
and pain coping skill practice are encouraged through the collaborative development of intersession 
homework assignments. Kerns and colleagues published a meta-analysis of psychological interventions 
for chronic back pain and documented moderate to large effects of psychological interventions, including 
CBT, in reducing pain and pain-related interference relative to waiting list control conditions.6 A similar 
Cochrane type review led to nearly identical conclusions.7  
Exercise  
Exercise or progressive physical activity programs also have a demonstrated role in helping to 
control pain. Of particular importance, physical activity helps to maintain function among persons with 
chronic pain conditions. 9-11 While pain severity shares an imperfect relationship with function, the 
presence of chronic pain can result in decreased activity levels and self-protective behaviors such as 
guarding and avoidance of physical activity due to fear of pain exacerbation or potential re-injury.9,10 Over 
time, such behaviors can lead to reduced muscle tone, increased pain, and functional disability – a 
vicious cycle that perpetuates the persistence of pain and low levels of functioning.9 It has been 
hypothesized that interventions that specifically target increasing physical activity and functioning may 
serve to disrupt this downward spiral. Research shows that physical activity can help prevent recurrence 

Ver. 7/25/2016 4 
 
or reduce pain, improve functional status, and decrease sick leave and disability for patients with chronic 
pain.5, 11-14 It has been suggested that the most effective strategy for improving pain includes a 
supervised, yet individually designed home-based exercise program, consisting of high-dose intensity 
exercise (defined by the amount of time spent exercising). However, studies also suggest that a variety of 
exercise programs or interventions including yoga as well as aerobic (e.g., walking) and strengthening 
exercises result in both clinically and statistically significant improvements in outcomes for patients with 
CLBP.5,11,13 Despite the importance of exercise in managing chronic pain, efficient and effective strategies 
for promoting exercise therapy among patients with CLBP are not widely available, and the use of 
exercise as a management strategy among patients with CLBP remains relatively low.15-17  
Internet as a delivery platform for behavioral interventions  
Internet-based Interventions in Veterans    
While new technology, such as telemedicine, has been introduced with success for chronically ill 
Veterans,18 few Internet-based interventions have focused on US Veteran populations. McMahon and 
colleagues examined a web-based intervention compared to usual care for management of blood 
pressure and glucose among Veterans with diabetes.19 Participants in the web-based condition 
demonstrated lower and clinically meaningful hemoglobin A1c (HbA1c) values and systolic blood 
pressure over 12 months post-intervention compared with control participants. Using the same sample of 
participants cited by McMahon,19 Fonda and colleagues compared “diabetes distress” in Veterans 
receiving usual care for diabetes to those receiving an Internet-based care management program for 
diabetes.20  Results indicated that participants (mean age 61 years) in both conditions demonstrated a 
decrease in diabetes distress; however, those with sustained usage of the Internet-based program 
showed significantly greater decreases in diabetes distress compared to non-users. In addition, glycemic 
control was positively correlated with a measure of diabetes-related distress, such that reductions in 
HbA1c were associated with reductions in distress. These results suggest the promise of an Internet-
based program, even among older Veterans.   
Internet-based interventions for chronic pain 
 
To date, few published studies have evaluated Internet-based interventions for chronic pain.  A 
recently published meta-analysis included 11 studies of Internet-based interventions that included pain 
intensity as an outcome.21 Studies involved persons with back pain, osteoarthritis, headache, 
fibromyalgia, and rheumatoid arthritis. The nature of the interventions varied considerably across the 
studies and included delivery of email, discussion groups, live chat groups, information promoting 
exercise or relaxation therapy, and more comprehensive psychoeducational approaches based on 
principles of CBT and pain self-management.  Across all studies, an overall small effect of the Internet-
based interventions on reports of pain intensity relative to control conditions was noted. In the sole study 
of persons with CLBP with an intervention similar to that proposed in this study, participants were 
randomized to waiting list or to receive access for six weeks to an Internet-based intervention comprised 
of education, cognitive skills acquisition, behavioral rehearsal, and generalization and maintenance.22 
Statistically significant improvements on measures of pain catastrophizing, control over pain, and “ability 
to reduce pain” were reported.  None of the reported studies were noted to include Veterans. The authors 
concluded that, although only small improvements in pain were noted across the studies, greater 
improvement in pain-related disability was noted in studies that examined this variable, and that the 
efficacy of cognitive behavioral interventions was particularly supported. 
4.  Significance:   
VHA has recognized numerous challenges in achieving its Pain Management Strategy objectives.  
Of particular relevance to the current proposal, VHA has specifically recognized the need to develop 
systems of care that promote equitable access to specialty healthcare services for Veterans regardless of 
geography and socioeconomic barriers. Pain management has been identified by the PACT leadership as 
the top priority area for this initiative. 
The short term objective of this project is to conduct a pilot feasibility trial of an Internet-based self-
management program, the VPMRC, for Veterans with CLBP that is compatible with VA IT architecture 
and MHV. The evaluation will examine preliminary efficacy of the VMPRC for reducing pain-related 
interference, pain severity, and related problems commonly associated with CLBP, and will also test the 
usability of and satisfaction related to the VPMRC. If successful, the long term objective is to migrate the 

Ver. 7/25/2016 5 
 
VPMRC to the MHV platform to provide widespread and easy access for Veterans across VHA regardless 
of geography or other access barriers.  
 
5. Research Plan:   
The proposed study includes development, evaluation of preliminary efficacy, and usability testing of 
a behavioral self-management program (the VPMRC) involving cognitive-behavioral and progressive 
physical activity components for CLBP delivered via the Internet. The intervention will be developed and 
tested during 2 phases: Development (Phase 1) and Pilot Feasibility Trial of the VPMRC (Phase 2). 
Because the proposed study includes 2 phases, each phase will be described separately.   
Phase 1: Development  
The primary aim of this phase of the project is to develop an integrated, Internet-based behavioral 
pain self-management intervention called the Veteran Pain Management Resource Center (VPMRC).  
The first phase of the project will involve development of the VPMRC based on materials previously 
developed by our group in the context of several prior projects. Five specific studies from our investigative 
team provide additional background for the development of the VPMRC and for informing this phase of 
the project. : A Clinical Science R&D Service Merit Award to Dr. Kerns titled “Efficacy of tailored cognitive 
behavior therapy for chronic back pain”, HSR&D funded Short Term Project, “Piloting Interactive Voice 
Response Modules for Chronic Pain Treatment”, an efficacious web-based behavioral self-management 
program (WEB-SM) known as “Living Well with Fibromyalgia.”, an Internet-mediated exercise intervention 
for Veterans with CLBP that was tested at the Ann Arbor VA Medical Center, and a RR&D study 
examining a motivational interviewing intervention for Veterans with mental health conditions applying for 
VA disability benefits that has recently been translated for delivery via the Internet at VACHS.  
During this phase, an Expert Panel (EP) of clinician investigators, including several with specific expertise 
and experience in developing and testing e-health interventions, will assist the PIs in preparing the initial 
content for the VPMRC. The EP will provide regular feedback that will be used to modify the VPMRC over 
a 14-month development period.  
Process:  Development of the VPMRC will follow an iterative process between the informatics experts 
and the Expert Panel (EP; described below). The initial content will be developed based upon the 
Veteran-centered materials for self-management of CLBP described above. A prototype web site with a 
single module (i.e., Introduction Module) will be developed in conjunction with the informatics expert and 
programmer (Dr. Haseena Rajeevan) and a graphic designer incorporating User-Centered Design 
processes. Once a draft of the first module is completed, the EP will be convened by teleconference (with 
LiveMeeting capability) to review the content and prototype navigation for the site. Draft materials for 
each of the remaining modules will be developed iteratively by the writing team and Dr. Rajeevan and 
added to the VPMRC prototype. On a monthly basis, the EP will be asked to review and comment on new 
content. Once all modules are completed and reviewed, an initial version of the entire VPMRC will be 
evaluated by the EP and by 15 Veterans (see below for further detail) to assess usability, ease of 
navigation, and functionality. Based upon feedback from this round of review, modifications will be made 
to the beta version of the VPMRC program followed by a second review by the EP. Final modifications to 
the VPMRC program will be made prior to releasing it into the production environment for the Phase II 
pilot feasibility trial.  
Compatibility with VA WebOps Standards: Compatibility with VA WebOps Standards and VA IT 
architecture requirements is ensured by the close involvement of three additional co-investigators. Dr. 
Kenneth Weingardt is National Director of Web Services for the Office of Mental Health Services. Dr. 
Cynthia Brandt is Director of the Informatics Core of the PRIME Center and is a member of the eHealth 
QUERI project. Dr. Rajeevan will work with the EP and with Drs. Weingardt and Brandt to develop the 
VPMRC using guidelines provided by VHA (i.e., WebOps standards) to ensure that the VPMRC is 
compatible with the VHA’s web environment and can ultimately be integrated into the MHV platform. 
Initially, the VPMRC will be hosted on a Yale University server and will not be tied to the VHA’s Intranet. 
TheWebOps standards specify software and server compatibility (i.e., Dr. Rajeevan will build the VPMRC 
using Microsoft tools to ensure compatibility), security and privacy (i.e., no PHI will be collected in the 
VPMRC), accessibility (e.g., section 508 guidelines), compatibility with web browsers, space quotas, and 
file type restrictions. Attention will also be given to representation of VHA using correct decals, symbols, 
and disclaimers about content while in development phases, although the interface design may be 

Ver. 7/25/2016 6 
 
somewhat flexible because MHV has a templated interface. Dr. Rajeevan will also build the VPMRC with 
knowledge of the “Clinic in Hand” chronic pain mobile application for smartphones to ensure compatibility.   
Composition of the VPMRC 
As currently envisioned, the VPMRC program will contain two components, a participant home page 
and several behavioral and cognitive pain coping skill modules containing evidence-supported methods of 
managing CLBP.   
Home Page: The home page will contain a number of features including (a) the ability to log in and 
be recognized by the program (which will be required to access features of the program), (b) a self-
assessment survey to guide users to the modules of most relevance based upon problem areas (e.g., low 
scores on measures of adaptive coping such as exercise, pacing, mental relaxation), readiness to make 
behavioral changes, and preferences, (c) a site map indicating utilization and progress within skill 
modules, (d) a link to summary information associated with self-monitoring or activities tied to each 
module, and (e) optional customization applications such as daily tips, pain news, links to resources, and 
similar functionality. 
Pain Coping Skill Modules:  Table 1 provides an overview of the preliminary modules to be 
adapted for the VPMRC program.  Each module will adhere to a common structure composed of the 
following: (1) a video lecture on the specific skill topic by a subject matter expert, (2) an opportunity for 
self-assessment regarding the content covered in the video lecture followed by automated feedback 
comparing the participant’s current behavior with known or recommended standards, (3) a demonstration 
video or animation modeling how skills can be used to modify the behaviors associated with the content 
of each module, and (4) a tool for setting goals and for developing an action plan for achieving desired 
behavioral changes. This behavioral action plan can also be shared with family or clinicians. In addition, 
each module will include tools for identifying and overcoming barriers to change, and supporting resource 
materials specific to each module (e.g., self-monitoring forms, information about the skill that can be 
shared with a physician).   
Table 1.  Introduction to Intervention and Pain Coping Skill Modules 
Module 
Coping Skill 
Description 
Introduction to VPMRC 
 
Present rationale for treatment, explain pain 
cycle, introduce goal setting 
1. 
Progressive Physical 
Activity 
Walking 
Instructions for walking and benefits of increased 
activity; goal setting (increase distance walked by 
10%/week) 
 
2. 
Physical Activity 
Stretching/Body Mechanics 
Instructions for stretching and body mechanics 
benefits; goal setting (perform stretching 
exercises once/ day) 
  
3. 
Relaxation 
Diaphragmatic Breathing 
Instructions for diaphragmatic breathing and 
benefits; goal setting (practice 20 minutes/day) 
 
4. 
Relaxation 
Progressive Muscle 
Relaxation 
Instructions for progressive muscle relaxation and 
benefits; goal setting (practice 20 minutes/day) 
 
5. 
Adaptive stress 
response 
Identifying negative thoughts 
Influence of negative thoughts on pain, activity, 
and mood; self-monitoring negative thoughts 
(maintain daily diary) 
6. 
Adaptive stress 
response 
Using positive coping 
statements 
Countering negative thoughts with coping 
statements; self-monitoring (maintain daily diary) 
  
7. 
Pacing 
Activity pacing  
Pace activities based on time rather than pain 
level; goal setting (set daily goals and maintain 
daily diary) 
8. 
Pacing 
Pleasant activity scheduling 
Using pleasant activity scheduling to increase 
activity and enhance mood; goal setting (select 
daily goals and maintain daily diary) 
9. 
Addressing pain 
flares 
Skill consolidation and 
relapse prevention 
Planning for relapse and pain flares; goal setting 
for sustaining improvements 

Ver. 7/25/2016 7 
 
 
Expert Panel   
The EP will be comprised of several co-investigators and led by Drs. Higgins, Kerns, and Williams.  
Members of the EP have expertise in pain management and clinical, rehabilitation, and health services 
pain research, conduct of clinical trials using behavioral interventions, and adaptation of therapy materials 
for Internet delivery. Table 2 includes a list of the EP members, their disciplines, and a brief description of 
their areas of particularly relevant expertise. 
Table 2. Expert Panel Membership 
Expert Panel Clinician 
Study Role 
Expertise 
Diana Higgins, Ph.D. 
(Clinical Psychologist) 
EP lead; Project Coordinator; 
oversee production of 
VPMRC (content and patient 
interface) 
• 
Adapting behavioral interventions for delivery via 
the Internet for Veterans 
• 
Psychologist therapist in clinical trials of cognitive 
behavioral interventions for chronic pain 
Robert Kerns, Ph.D. 
(Clinical Psychologist) 
EP lead; oversee content of 
VPMRC; dissemination lead 
• 
National Program Director for Pain Management 
• 
Director, PRIME Center 
• 
Pioneered development and evaluation of CBT for 
chronic pain, psychosocial pain assessment 
instruments, and a model of readiness to adopt 
behavioral changes for pain management 
David Williams, Ph.D. 
(Clinical Psychologist) 
EP lead; development of 
VPMRC; translation of face-
to-face treatment for Internet 
delivery 
• 
Leading contributor to development of pain coping 
construct and its measurement  
• 
Lead author of cognitive behavioral intervention in 
prior Gulf War Veteran Illness VA Cooperative 
Studies Project 
• 
Developed Internet-based interventions for pain 
including “Living-well with FM”  
Alicia Heapy, Ph.D. 
(Clinical Psychologist) 
 Development of VPMRC; 
translation of face-to-face 
treatment for Internet delivery 
for Veterans 
• 
Associate Director, PRIME Center 
• 
Developing/implementing clinical trials using IVR to 
disseminate CBT for Veterans with chronic pain 
who have limited access to specialized care 
Marc Rosen, M.D. 
(Psychiatrist) 
Development of VPMRC; 
translation of face-to-face 
treatment for Internet delivery 
for Veterans 
• 
Adapting a behavioral intervention for Veterans 
with mental health conditions who are applying for 
VA benefits for Internet delivery 
Matthew Bair, M.D.,M.S. 
(Primary Care 
Physician) 
Development and content 
expert; implementing VPMRC 
into primary care setting 
• 
Investigator at the Center of Excellence on 
Implementing Evidence-Based Practice 
• 
HSR&D Career Development Awardee, focus on 
pain management in VA primary care settings 
William Becker, MD 
(Primary Care 
Physician) 
Development and content 
expert; implementing VPMRC 
into primary care setting 
• 
Investigator at the PRIME Center 
• 
HSR&D Career Development Awardee, focus on 
pain management in VA primary care settings 
Sarah Krein, Ph.D., RN 
(Doctoral-level Nurse) 
Development of VPMRC; 
translation of face-to-face 
treatment for Internet delivery 
for Veterans; content expert 
for progressive physical 
activity  modules 
• 
Investigator at the VA Center for Clinical 
Management Research 
• 
Utilizing the Internet as a delivery platform for 
exercise interventions 
Pre-pilot testing 
 
Once a complete initial version of the VPMRC is developed, the intervention will be piloted with a 
small sample of Veterans (N=15) to determine usability, ease of navigation, and functionality. Based on 
suggested sample sizes for qualitative research, which recommend using at least 6 participants23,24for a 
phenomenologic approach (i.e., designed to capture the essence of the experience25 to obtain thematic 
saturation), we opted to enroll 15 participants to achieve thematic saturation and to reduce the likelihood 

Ver. 7/25/2016 8 
 
that we will obtain bimodal opinions of the program. This phase is designed to solicit feedback from 
participants to further develop and modify the VPMRC program. 
Procedure:  Eligible participants (N=15) will be asked to participate in two, 2.5 hour visits during 
which they will complete informed consent, complete the tailoring self-assessment, and review the 
modules using a computer at VACHS while the Research Assistant (RA) prompts the participant for 
feedback and records his/her feedback.  During the first visit, participants will be asked to complete the 
informed consent, review the program’s homepage, complete the tailoring self-assessment, and review 
the first 3 treatment modules while providing verbal, audio-recorded feedback (e.g., using the “Think 
Aloud” method).  Participants will be given a homework assignment to login to their account on 2 separate 
occasions to revisit the modules they have reviewed and choose one skill to practice during the week 
following the first study visit. This will provide information about the ease of logging in, sufficient speed of 
Internet connection, and so forth, in addition to ensuring that they are able to provide a thorough 
evaluation of their experience with the VPMRC. During the second visit, participants will be asked to 
provide brief feedback regarding their experience with the homework assignment and will review the final 
6 treatment modules, again while providing verbal feedback.  At the end of the second visit, participants 
will be asked to complete the Post-intervention Measure to obtain quantitative feedback.  Table 3 
describes study visits, assessment measures, and qualitative and quantitative data collection for Phase I.   
Table 3: Phase I Visits and Assessments 
Visit 
Visit description 
Assessments 
Consent, 
Self-
Assessment 
& 
First 3 
Modules 
• Consent 
 • Issue userID and temporary      
    password 
 • Review first 3 treatment    
    modules  
• Informed Consent 
• Participant will provide verbal feedback about his/her    
  experience with the homepage, self-assessment, and    
  first 3 modules which will be recorded by the RA (Think  
  Aloud Method) 
Final 6 
Modules 
& 
Data 
Collection 
 • Report experience accessing  
    modules at home 
 • Review final 6 treatment  
    modules      
 • Post-intervention assessment 
 
• Participant will provide verbal feedback about his/her  
  experience with the final 6 modules which will be  
  recorded by the RA (Think Aloud Method) 
• Post-intervention questionnaire assessing participants’  
  experience with the intervention 
Feedback from Veterans will be reviewed with the EP which will subsequently make 
recommendations to the VPMRC developers for further modifications to the program.  As the refinements 
are made, the EP will continue to interact with the developers to ensure that the feedback from the 
Veterans is adequately addressed and incorporated in the final version of the VPMRC. 
Assessments: The primary focus of assessment during Phase I is to gather qualitative and 
quantitative feedback during and after completion of the intervention regarding the layout of the website, 
ease of navigation and use, relevance of the materials presented, appeal of the program, understanding 
of key concepts, appropriateness of the graphics and multimedia interface, problems encountered, 
amount of material presented, and general likes, dislikes, overall functionality of the program, and 
recommendations for change.  
Intra-intervention Assessment: Qualitative information will be collected through a “Think Aloud” 
process in which the participants provide unstructured verbal feedback while engaging in the computer 
task.  This feedback is recorded by a member of the study staff who will be present in the room with the 
participant.  Think Aloud is a popular method for testing usability and for revision of novel applications that 
involves a participant providing verbal feedback about an application to a “listener” (i.e., a research 
assistant [RA]) that is recorded and then transcribed for coding and analysis.26  
Post-intervention Measure: Participants will be administered an investigator-created measure 
designed to assess the layout of the website, ease of navigation, relevance of the materials presented, 
appeal of the program, understanding of key concepts, appropriateness of the graphics and multimedia 
interface, ease of use, problems encountered, amount of material presented, and general likes, dislikes. 
These data will be used to guide modification of the VPMRC. 
Phase II:  Pilot Feasibility Trial of the VPMRC  
Design 

Ver. 7/25/2016 9 
 
The primary aim of this phase of the project is to execute a pilot feasibility trial to evaluate the 
preliminary efficacy of, usability of, and satisfaction with the VPMRC. A single treatment condition (Usual 
Care [UC] plus VPMRC) X two evaluation periods (baseline and 10 weeks post-baseline) design with 
multiple dependent measures will be employed. Participants in the study will be 55 Veterans with CLBP. 
Participants will continue to receive care as usual from their primary care providers (PCPs) and other 
healthcare providers.  
 
Recruitment   
VistA Search: We will identify potential Veterans for inclusion from available electronic medical 
record (EMR) data in VistA. All Veterans 18 years or older from VACHS (Station 689) with low back pain 
defined using the International Classification of Diseases, Ninth Revision diagnostic codes related to low 
back pain (724, 7240x, 7241x, 7242x, 7243x, 7244x, 7245x, 7246x, 7247x, 8460x, and 8472x) will be 
considered eligible. We will attempt to oversample OEF/OIF/OND, female, and minority Veterans, as 
these Veterans have high prevalence rates of chronic musculoskeletal pain conditions and are of 
particular interest in the context of the proposed study. We will then identify Veterans in this group to 
exclude psychiatric hospital admissions in the previous 30 days, suicide flag in the Electronic Medical 
Record (EMR), or behavioral alert flag in the EMR.   
 
A letter will be sent to the identified Veterans from their PCPs informing them about the study and 
inviting them to participate. Veterans will be provided with information about the voluntary nature of the 
study and the option to “opt out” from further contact with study staff by notifying us of their lack of interest 
by phone, email or letter.  Veterans who do not contact us will be called by the study RA to be further 
informed about the study and, if interested, to be screened for participation. Screening will include several 
of the key eligibility criteria for the study (e.g., confirmation of presence of CLBP, readiness to engage in 
self-management for pain, interest in Internet-based pain care, and absence of medical and psychiatric 
comorbidities). If screening suggests potential eligibility, and if the Veteran is interested, an in-person 
appointment for obtaining written informed consent and baseline assessment data will be scheduled. 
Solicitation letters will be mailed in waves in order to prevent overwhelming our capacity to offer 
participation in a timely manner.  
We also will post the already approved flyer in the following venues: 1) patient care waiting areas, 2) 
flat screen informational televisions around the hospital, 3) Good Morning VA Connecticut 4) VA 
Connecticut’s Facebook page, 5) vet centers (after securing their permission) and 6) at the Pain 
Education table.  We also will provide advertisement language in “The Prime Times”, a PRIME Center 
community newsletter. 
 
Procedures 
Veterans meeting eligibility criteria based on screening (e.g., by phone) will be scheduled to meet in 
person with the RA to obtain written informed consent and to complete all baseline study measures. 
Immediately upon completing the measures, the participant will meet separately with the study 
coordinator to receive instructions for accessing the VPMRC, and additional logistical details related to 
their participation in the study. Participants will be provided with a userID and temporary password for 
accessing the VPMRC program.   
Questionnaires and inventories that comprise the principle outcome measures will be reassessed at 
10 weeks post-baseline, online using a secure, encrypted Internet-based interface called TrialDB. TrialDB 
allows participants to complete the self-report questionnaires via their home computer without the need to 
travel to VACHS. This system has been successfully used to collect data in the HSR&D funded “Women 
Veterans Cohort Study” (WVCS; PI: C. Brandt). The RA and TrialDB data manager will check the TrialDB 
reports for accurate and timely completion. The RA will contact participants by phone or email at 10 
weeks post-baseline to prompt them to complete post-baseline measures online. If participants are 
unable to complete the assessments online using TrialDB, alternative arrangements for data collection 
will be made, such as administering the measures to the participant in person or mailing the measures to 
the participant with a postage-paid return envelope. The 10 weeks post-baseline timeframe was chosen 
to allow sufficient time to complete the tailored skills modules and will serve as the post-intervention 
assessment. Table 4 outlines specific assessment measures to be collected at each assessment point. 
Participants will be paid $75 for their participation in each of the two assessments. 
Table 4. Phase II Assessment Schedule 

Ver. 7/25/2016 10 
 
 
 
Baseline 
in-person 
Weekly 
Telephone 
10 weeks Post-
baseline TrialDB 
Regular computer/Internet access 
X 
 
 
Readiness to Change Checklist 
X 
 
 
Interest in Internet-based pain self-
management 
X 
 
 
Can walk one block? 
X 
 
 
Consent Form 
X 
 
 
Chart/Medication Review 
X 
 
X 
WHYMPI-Interference Scale  
X 
 
X 
Numeric Rating Scale of Pain 
Intensity (0-10) 
X 
 
X 
Profile of Mood States 
X 
 
X 
Beck Depression Inventory 
X 
 
X 
Multidimensional Fatigue Scale 
X 
 
X 
MOS Sleep Scale 
X 
 
X 
Behavioral Goal Adherence 
 
X 
X 
Patient Treatment Satisfaction Scale 
 
 
X 
Treatment Credibility Scale 
 
 
X 
Module(s) completed 
 
X 
 
Usability of Module 
 
X 
 
Time and content accessed  
 
X 
 
Post-intervention Measure 
 
 
X 
In addition to completing assessments at baseline and 10-weeks post-baseline, participants will be 
contacted by the study staff via telephone on a weekly basis beginning 1 week post-baseline and ending 
at 10 weeks post-baseline. The brief phone contacts will serve to confirm continued Internet access to the 
VPMRC and to remind participants to continue to complete the VPMRC modules. Qualitative and 
quantitative feedback will be obtained. Questions will be asked on the following dimensions: goal 
adherence for previous week’s goals (using a 0-10 Likert scale, where 0 indicates no adherence to 
completing the goal and 10 indicates complete adherence), feedback regarding usability of the previous 
week’s module(s), and specific indication of modules most recently completed. The study staff member 
will also solicit questions about the content of the VPMRC and provide clarifying answers to these 
questions. Strict limits will be placed on the nature of the responses and length of time of the calls (i.e., no 
greater than 10 minutes).     
Intervention Description (UC+VPMRC) 
Usual Care (UC):  All participants will continue to receive whatever pain care they have been 
receiving. There will be no attempt by study personnel to influence ongoing pain care. Although it is 
beyond the scope of this project to influence pain care at VACHS, it may be important to know that 
VACHS continues to work to implement the VHA’s stepped care model and to ensure that accepted 
standards for pain assessment and treatment are met for all Veterans. Within the primary care setting, a 
Primary Care Pain Workgroup works to promote system improvements related to pain care. Facility 
performance improvement data document a high rate of adherence to performance criteria related to 
documentation of pain assessments, treatment plans, and reassessment of the effectiveness of the 
interventions. Participants in this study will be encouraged to discuss pain concerns with their PCP. 
Results from the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) trial conducted 
in both VHA and non-VHA settings and involving a collaborative care intervention for improving pain 
outcomes indicated that spill-over for pain outcomes are likewise minimal.27 Whatever minor spillover 
does occur, results in a conservative estimate of the intervention’s efficacy. 
Veteran Pain Management Resource Center (VPMRC):  Participants will continue to receive UC 
as described above, in addition to receiving access and being encouraged to complete the VPMRC 
program. The VPMRC will be accessed via the Internet at the participant’s home or other regular access 
point. The VPMRC will guide participants in initially completing a self-assessment screening tool for 
module selection and in setting personally-relevant goals, in addition to assisting them with tracking 
progress made toward goal accomplishment. The skill modules identified by the self-assessment will be 
listed and available to the patient to access, learn, and practice through written text, guided narration, 
video demonstration, and interactive printable action plans to assist patients in learning and practicing 

Ver. 7/25/2016 11 
 
pain self-management skills. Participants will be encouraged to complete the skill modules at their own 
pace. Participants will also be able to access other modules not identified by the self-assessment if they 
are interested in completing them. Participants will be provided with a pedometer at the baseline 
assessment to facilitate completion of the exercise/walking module, which requires patients to track the 
number of steps walked each day. 
Attrition 
The RA and study coordinator will monitor the study for attrition and follow-up with participants when 
they appear at risk for withdrawal or report the intent to withdraw. If a participant contacts the study 
coordinator to withdraw, s/he will first ask if there is a problem that s/he can address that would allow 
them to stay in the study. If not, s/he will ask subjects who wish to withdraw from treatment if they will 
consider continuing to complete the follow-up assessments. To keep losses-to-follow-up at a minimum, 
every effort, including reminder e-mails and follow-up phone calls, will be made to collect post-baseline 
data. We will also prospectively collect the reasons for missing data such as “patient refusal due to 
difficulty completing skill modules” or “patient moved away”. Reasons for missing data will be evaluated 
during data analysis. 
Outcome Measures  
Standardized and reliable interview and questionnaire measures will be used to assess outcome and 
process variables. These outcome measures are similar to those we have used in prior CBT efficacy 
studies and are consistent with CONSORT and IMMPACT guidelines. In addition to these outcomes we 
also propose to examine treatment satisfaction, treatment credibility, and goal accomplishment. 
Primary Outcome:   
Pain Interference: The 9-item Interference subscale of the West Haven-Yale Multidimensional Pain 
Inventory (WHYMPI) assesses pain-related interference in social, work and household functioning and 
has demonstrated good internal consistency (0.86) and stability (0.85 over 2 weeks).28 The WHYMPI-
Interference Scale was recommended by IMMPACT as a core outcome measure for this domain.29  A 
reduction in WHYMPI-Interference Scale scores of 0.6 or greater has been identified as an indicator of 
meaningful improvement in physical functioning and will be employed in this study.30   
 
Secondary Outcomes:  
Pain intensity:  Self-report of pain is recognized as the gold standard for pain assessment given the 
inherently subjective nature of pain.  Although the numeric rating scale (NRS), verbal rating scale (VRS), 
and the visual analogue scale (VAS) are all reliable and valid measures of pain, there are differences that 
led to the IMMPACT recommendation and our selection of the NRS as the primary measure of pain. Of 
particular note is the fact that the NRS is the accepted measure for screening for the presence and 
intensity of pain for the VHA, and it is quite familiar to Veterans. Data from several studies suggest that 
use of this measure, relative to the VRS and VAS,  yields fewer missing observations and is preferred by 
more participants, especially among older persons and among those prescribed opioids.31 The NRS can 
be easily administered by either a research assistant, via the telephone, or online as is proposed for this 
study.  In this trial, participants will be asked, “Please rate your pain by indicating the number that best 
describes your average pain in the last 24 hours on a 0 (no pain) to 10 (pain as bad as you can imagine) 
scale”.32  A clinically-meaningful reduction in pain intensity will be defined as a reduction in pain of 30% on 
the NRS relative to baseline NRS.  This threshold is also consistent with IMMPACT recommendations 
based on an analysis of ten studies that examine changes in absolute ratings of pain intensity and 
independent ratings of treatment satisfaction.33 
Emotional functioning: Overall functioning will be assessed using the 65-item Profile of Mood States 
(POMS), a multidimensional measure of emotional functioning designed to assess six dimensions of 
mood and can be used in non-psychiatric or physically ill populations.34 Internal consistency (0.84 to 0.95, 
depending on subscale) and test-retest reliability (0.65 to 0.74, depending on subscale) is good. 
Depressive symptom severity will be assessed using the 21-item Beck Depression Inventory (BDI) a 
widely used self-report measure with excellent internal consistency (.92) and stability (.80-.90).35 Both 
measures were recommended by IMMPACT.26 
Fatigue:  Clinical fatigue will be assessed using the Multidimensional Fatigue Inventory (MFI).36 The 
MFI can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced 
motivation, and reduced activity.  

Ver. 7/25/2016 12 
 
Sleep Problems: Sleep problems will be assessed using the MOS Sleep Scale. The MOS is 
segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, awaken 
short of breath or with headache, adequacy of sleep, somnolence, a problems index 1 and a problems 
index 2).  An additional single item assesses quantity of sleep.37 
Behavioral Goal Adherence: Goal adherence for previous week’s goals will be assessed via 
telephone on a weekly basis for 10 weeks post-baseline using a 0-10 Likert scale, where 0 indicates no 
adherence to completing the goal and 10 indicates complete adherence. 
Tertiary outcomes: 
Module completion:  Participants will be asked during weekly (for 10 weeks) phone calls placed by 
the study staff about completion of modules (i.e., how many modules completed, which modules) during 
the previous week. In addition, the web developer will build a database to track time spent on each 
module, which modules were accessed, and number of times each participant accessed the program. 
This database will be linked only to userID and will not be linked with PHI. 
Module usability: Participants will be asked during weekly phone calls about usability of modules.  
Specifically, they will be asked to rate each completed module on a 0-10 scale where 0= very difficult and 
10=very easy, in terms of accessing information presented, understanding information presented, setting 
a module goal, navigating the module. 
Treatment credibility: Participants’ judgments of treatment credibility will be assessed at the post-
baseline assessment interval using a questionnaire adapted from Borkovec and Nau.38 This measure has 
been shown to have an internal consistency of .85 and test-retest reliability of .83.  
Patient satisfaction:  Patient satisfaction will be assessed by the Pain Treatment Satisfaction Scale 
which is a 5-item satisfaction survey designed to assess patient satisfaction with 5 domains of pain 
care.39 This measure shows good internal consistency (.83-.90 across two samples) and significant 
associations to follow-up treatment satisfaction and staff and patient ratings of patient improvement.  
VPMRC program-specific feedback: Participants will be administered an investigator-created 
measure designed to assess the layout of the website, ease of navigation, relevance of the materials 
presented, appeal of the program, understanding of key concepts, appropriateness of the graphics and 
multimedia interface, ease of use, problems encountered, amount of material presented, and general 
likes and dislikes  
Sociodemographic status and pain-relevant variables: Participants’ age, sex, education level, 
racial/ethnic background, and marital status will be assessed at the time of the baseline examination. 
Pain-specific factors such as pain duration, number and location of pain sites, past and current pain 
treatments, cause of pain, and presence of radicular symptoms, will also be assessed at baseline. 
Pain medication: At baseline, medication use will be assessed by the study coordinator through 
participant interview and VACHS computer pharmacy records. Medications will be coded into several 
categories, namely non-steroidal anti-inflammatory, non-opioid analgesics, opioid analgesics, and 
benzodiazepines and other sedative/hypnotics using a recording sheet used in our prior studies. The 
specific medication used, its dose, and schedule of administration will be recorded. At 10 weeks post-
baseline, this information will again be collected via patient self-report using Trial DB, and participants’ 
medical records will be independently reviewed for changes in medication regimen from baseline by the 
RA for corroboration. 
Analytic Plan 
Because the overall goal of the project is to develop a pain self-management resource for Veterans, 
the VPMRC, we will employ an iterative process of formative evaluation through two distinct Phases in 
order to optimally revise and modify the VPMRC. All analyses will be conducted in the service of further 
refining and optimizing the usability and effectiveness of the program. Ultimately, these data and the 
subsequent modifications to the VPMRC will produce a resource that can be submitted to examination of 
efficacy through a randomized controlled trial.  
Phase I:  Development of the VPMRC 
Using the Think Aloud protocol, qualitative data will be collected regarding participants’ verbal, audio-
recorded feedback of their experiences with navigating the VPMRC homepage, self-assessment, 
resources, and reviewing the treatment modules. Consistent with a phenomenologic approach (i.e., 
capturing the essence of the participant’s experience), the qualitative feedback collected from each of the 
two study visits for each participant will be transcribed, coded, and systematically analyzed for emerging 
themes. These analyses will be shared with members of the EP and will be used to inform modification of 

Ver. 7/25/2016 13 
 
the VPMRC with respect to the layout of the website, ease of navigation, relevance of the materials 
presented, appeal of the program, understanding of key concepts, appropriateness of the graphics and 
multimedia interface, ease of use, problems encountered, amount of material presented, as well as 
general likes, dislikes, overall functionality of the program, and recommendations for change. 
Quantitative data collected from the Post-intervention Measure will provide information regarding the 
usability, ease of navigation, and functionality of the program and specific modules. Descriptive statistics 
(e.g., means, standard deviations, frequencies) will be calculated for these data. 
All quantitative and qualitative data collected, with input from members of the EP, will be used to 
guide modification of the VPMRC to reduce identified issues with navigation of the site, graphics and 
audio effects, relevance of materials for the population, ease of use with respect to the self-assessment, 
homepage functions, and other related issues. These changes will be made prior to initiating the pilot 
feasibility trial described in Phase II.  
Phase II: Pilot Feasibility Trial of VPMRC 
We will analyze the primary and secondary hypotheses according to the Intent-to-Treat principle. If 
missing data are minimal (e.g., <5%), we will conduct a complete case analysis; otherwise, imputation 
methods will be used to fill in the missing values. Several imputation approaches will be considered after 
inspection of the missing data rates and before any analyses of treatment effects are conducted. These 
approaches would include imputing the worst and best value (i.e., bounds on the treatment effects) and 
using multiple imputation assuming missing at random. These approaches would be supplemented by 
sensitivity analyses assuming nonignorable missingness. Only pre-specified baseline variables that may 
affect the outcome will be considered as adjustment variables in a sensitivity analysis. These variables 
include age, race/ethnicity, gender, educational attainment, and depressive symptom severity. 
The primary endpoint is the mean difference in baseline to post-baseline follow-up scores on the 
primary measure of pain interference (i.e., WHYMPI-Interference Scale) at 10 weeks post-baseline. T-
tests will be utilized to evaluate the effect of treatment on the primary outcome, and an ordinary least 
squares regression model will be used to control for potential confounders. The treatment will be 
represented by an indicator variable. The model fit will be assessed using graphical techniques and 
regression diagnostics. In a sensitivity analysis, we will examine the effect of treatment adjusted for the 
pre-specified set of baseline covariates. Analyses of covariance (ANCOVAs) will be employed to control 
for differences among participants in baseline scores and to determine whether participant characteristics 
are associated with changes in scores on outcome variables across time.   
Because the primary and secondary hypotheses test differences in outcome measure scores across 
time, we will use paired t-tests, or their non-parametric analogs (e.g., Mann-Whitney test) to compare 
mean (or median) scores on the outcomes across time. Given the multiplicity of tests for secondary 
outcomes (i.e., six outcomes) and the power of the study, in addition to maximizing sample size, we will 
use the Bonferroni procedure p-value, which we conservatively estimate to be p =0.008, based on an 
overall significance of p=0.05/6, to account for the number of comparisons. Our six secondary outcomes 
will be examined with the purpose of informing future modifications to the VPMRC and additional 
hypothesis generation. We have not grouped within subsets in order to ensure a more conservative 
approach. Tertiary hypotheses will examine data related to usability (use of and functionality) and 
satisfaction (satisfaction, credibility) with the VPMRC and will be collected only at 10 weeks post-baseline. 
Descriptive statistics will be employed to examine these data in order to describe participants’ 
experiences with the VPMRC. 
As in Phase I, quantitative data from the Post-intervention Measure with added data from the weekly 
phone calls for Phase II regarding usability of and satisfaction with the VPMRC will be used to modify the 
program. In addition, we will use specific primary and secondary outcomes data to inform modification of 
the VPMRC. For instance, if the data suggest a significant reduction in pain interference, but more 
modest changes in fatigue or depression, specific modules, such as Pacing (the pleasant activity 
scheduling coping skill) or Adaptive Stress Response (the using positive coping statements coping skill) 
will be targeted for further content and presentation enhancement to increase benefit to patients on these 
important related outcomes. We will also use data from tertiary outcomes to further modify presentation of 
the various treatment modules.  For example, if certain modules are clearly preferred, as indicated by 
participant report of modules completed and satisfaction with the modules, other, less-preferred modules 
may be further enhanced (e.g., changes to audio-visual aspects, presentation of content within modules) 
to increase use, interest, and satisfaction. 

Ver. 7/25/2016 14 
 
 
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