Developing an Online Therapeutic Intervention for Chronic Pain in Veterans
Phase: NA
Conditions: Chronic Pain
Sponsor: VA Office of Research and Development



INFORMATION SHEET
Version Date:  (9/30/2021)
Title of Study: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans 
__________________________________________________________________               
Principal Investigator:  _Erin Reilly, Ph.D.____________ VA Facility: VA Bedford Healthcare System
Sponsor of Study:___Department of Veterans Affairs_____________________________________
Page 1 of 8
We are asking you to choose whether or not to volunteer for a research study.  This consent 
form will give you information about the study to help you decide whether you want to 
participate. Taking part in this study is completely voluntary.  
SUMMARY OF IMPORTANT INFORMATION 
This information gives you an overview of the research. More information about these topics 
may be found in the pages that follow.  
1.
WHAT IS THE STUDY ABOUT AND WHY ARE WE DOING IT?
This study is focused on assessing an online intervention, Veteran ACT for Chronic Pain 
(VACT-CP) with a waitlist control group, to evaluate whether VACT-CP is usable, acceptable, 
and potentially helps Veterans with chronic pain to improve their functioning and pain-related
symptoms. This study is being funded by the Rehabilitation R&D within the Department of 
Veterans Affairs. In addition to online website use,study activities related to completing 
assessments will take place, depending on your preference, either virtually or at the Bedford 
VAMC.
2.
WHAT DOES THE STUDY INVOLVE AND HOW LONG WILL IT LAST?  
If you decide to participate in this study, you will be randomly assigned to an online therapeutic 
intervention or a waitlist control group. This process is like flipping a coin. 
For this study, you will have 1 study visit to determine your eligibility for this study. This visit will 
involve an interview and several questionnaires. You will have the choice to complete this visit 
and these assessments in person, online, or over the phone.This visit will take about 2 hours of 
your time. If you are eligible for this study, you will be invited to participate in the research study, 
in either the group receiving the online VACT-CP program or the waitlist control group.If you are 
part of the VACT-CP program, you will participate in 7 20min online sessions. For both groups, 
there will be a midpoint assessment session where you wil take a series of surveys, which will 
take approximately 1.5 hours. After 7 weeks, both groups will fill out questionnaires and an 
interview that will take appximately 2 hours. One month later, we will ask you to answer several 
questionnaires on again. This follow-up study assessment session will take about 1 hour of your 
time. You will be given $60 for the first study visit.You will be paid $40 for the midpoint surveys. 
You will also be paid $60 at the end of 7 weeks, and a final $40 for the 1-month follow-up visit. 
You will be paid by a voucher that you can take to the agent cashier or by giftcard.
3. WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
We cannot and do not guarantee or promise that you will receive any benefits from this study.
However, participating may benefit Veterans suffering from chronic pain by exploring a new and 
emerging technology, and providing feedback on the potential future directions online 
interventions. Receiving the VACT-CP intervention in this study may also benefit you by helping 

INFORMATION SHEET
Version Date:  (9/30/2021)
Title of Study: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans 
__________________________________________________________________               
Principal Investigator:  _Erin Reilly, Ph.D.____________ VA Facility: VA Bedford Healthcare System
Sponsor of Study:___Department of Veterans Affairs_____________________________________
Page 2 of 8
you learn mood and stress management skills, value-based goal setting for activities, and 
gaining education around chronic pain and different treatment options.
4. WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS 
STUDY?
There is the possibility that answering some questions may be emotionally upsetting. You have 
the choice to not answer any question that makes you feel uncomfortable. You have the choice 
to not answer any question that make you feel uncomfortable. You have the right to speak to the 
study PI at any time by contacting Dr. Erin Reilly at (781) 687-4191.
5.
DO YOU HAVE TO TAKE PART IN THE STUDY?
Participation in this research study is voluntary. If you decide to take part in the study, it should 
be because you want to volunteer. You will not lose any services, benefits or rights you would 
normally have if you choose not to volunteer. You may also discontinue participation at any 
time.
6.
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of the study is Dr. Erin Reilly of the VA Bedford Healthcare System.  If you 
have questions, suggestions, or concerns regarding this study or you want to withdraw from the 
study her contact information is: 781-687-4191.
RESEARCH DETAILS
WHAT IS THE PURPOSE OF THIS STUDY?
You are invited to participate in a research study designed to evaluate a new, online therapeutic 
intervention to improve the functioning of Veterans with chronic pain called VACT-CP. You have 
been invited because you have chronic pain. With this research we hope to learn whether 
VACT-CP is helpful in improving the functioning and pain symptoms of Veterans with chronic 
pain.
HOW LONG WILL I BE IN THE STUDY?
This research study is expected to take approximately 2 years. Your individual participation in 
the project will take 11 weeks.
WHAT WILL HAPPEN AND WHAT CAN I EXPECT IF I TAKE PART IN THIS STUDY?
Intake and Interview Procedures. If you decide to participate in this research study, you will 
have an in-person or phone screening with a member of the research team and you will be 
asked to complete questionnaires. We will ask you about your health concerns, pain levels, and 
technology experiences. You will also be asked questions about possible current and past 
psychological or emotional difficulties and substance use. This is done because such problems 

INFORMATION SHEET
Version Date:  (9/30/2021)
Title of Study: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans 
__________________________________________________________________               
Principal Investigator:  _Erin Reilly, Ph.D.____________ VA Facility: VA Bedford Healthcare System
Sponsor of Study:___Department of Veterans Affairs_____________________________________
Page 3 of 8
are sometimes associated with pain-related difficulties, and because such problems may affect 
your efforts to improve your functioning. These interviews and questionnaires will take about 2
hours of your time. We will also ask for the names, contact information, and a release of
information for people that you know that would help us be able to get in touch with you. If you
do not meet eligibility criteria during this in-person screening, you will be excluded from
participation. If you meet eligibility criteria, you will be asked to participate in the initial research
phase of the study.
Initial Research Phase. You will be randomly assigned (like a flip of a coin) to one of two 
groups (VACT-CP or Waitlist). The reason you will be randomly assigned to a group, rather than 
you choosing a group is so that researchers can determine the possible usefulness of the 
VACT-CP online intervention compared to a group who are not receiving this intervention. We 
expect that 40 people will be randomized in this study.
VACT-CP Group A: (20 participants)
If you are assigned to VACT-CP, you will receive access to the online modules, which you will 
have 7 weeks to complete. Each module will be available to use for a week, and there will be a 
total of 7 modules you will be asked to complete. The initial module is devoted to an explanation
of the treatment rationale, initial psychoeducation on pain-related symptoms, pain interference, 
and focal concepts of ACT, and assessment of individual pain symptoms. Modules 2-4 will focus 
on values clarification, acceptance and willingness, mindfulness, with an emphasis on tolerance 
of pain-related experiences. Modules 5-6 will continue to this focus, and incorporate goal-
creation and committed action exercises. Module 7 will consolidate and provide feedback on 
goal-related achievements, and will focus on planning for the future.  All content will be 
presented interactively, through text-based conversations with Coach Anne that appear as short 
videos on your the screen. You will hear what Coach Anne “says”, and respond to her queries 
using forced-choice text options that will trigger different responses from Coach Anne as the 
conversation progresses, to allow the system to responsively interact in a personalized manner 
with you. During the course of VACT-CP, you will complete the following surveys at four time 
points: approximately 2 hours for baseline assessments, a total of approximately 2.5 hours to 
test the 7-module VACT-CP program and interview over 7 weeks, 1.5 hours for the mid-point 
survey at week 3, approximately 2 hours for the 7 week/post-intervention assessment, and
approximately 1 hour for the 1 month follow-up surveys. The online modules will take about 20
minutes of your time each week (7 modules total), and you will complete online exercises 
related to you pain, mood, values, and setting goals for the next week. A research staff member 
will also briefly check in with you at weeks 3 and 6 (approximately 15 minutes) to see if you are 
experiencing any concerns or issues with the technology that we can assist with.
Waitlist Group B: (20 participants)
If you are assigned to the waitlist, you will wait 11 weeks to gain access to the VACT-CP online 
intervention – although it wil be your choice if you would like to use it at that time. During those 
11 weeks, you will complete the surveys at different time points. The duration of these surveys 
are the following: approximately 1.5 hour for baseline assessments, 1.5 hours for the mid-point 
survey at week 3, approximately 2 hours for the 7 week assessment, and approximately 1 hour 
for the 1 month follow-up surveys (week 11). In addition, you will be provided with a list of 

INFORMATION SHEET
Version Date:  (9/30/2021)
Title of Study: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans 
__________________________________________________________________               
Principal Investigator:  _Erin Reilly, Ph.D.____________ VA Facility: VA Bedford Healthcare System
Sponsor of Study:___Department of Veterans Affairs_____________________________________
Page 4 of 8
common pain treatment options and pain management resources at the VA Bedford Healthcare 
System that you may choose to engage in during this time. At the end of 11 weeks, you will be 
provided with your own username and password so that you can use the online VACT-CP 
system if you would like to. There is no requirement that you use the online VACT-CP system 
after your 11-week survey assessment. It is your choice to use VACT-CP if you are still 
interested in using the online program to learn about managing your pain. You wil not be 
required to take additional surveys if you choose to use the VACT-CP online website; however, 
a research staff member will also briefly check in with you at weeks 3 and 6 (approximately 15 
minutes) to see if you are experiencing any concerns or issues with the technology that we can 
assist with.
WHAT ARE THE POSSIBLE RISKS OR DISCOMFORTS OF TAKING PART IN THIS 
STUDY?
The intake, mid-point, and follow-up interviews and questionnaires will take time to complete. 
We estimate it will take approximately 6 hours total over the 11 weeks to complete interviews
and study questionnaires.
You may be uncomfortable answering questions about substance use, emotional and pain-
related problems. If you are uncomfortable with any part of the surveys or interview, you may 
skip the question or take a break. You will have the opportunity to take breaks to minimize 
fatigue and discomfort. Please let the research staff know if you become too uncomfortable. You 
can also contact the researchers if your symptoms bother you after you go home. If needed, we 
will contact the psychologist on this study to evaluate you by phone or in person to see if you 
need any more treatment.
Also, some questionnaires include questions about whether you have had thoughts of harming
yourself or others. If the research staff is concerned about your safety during the study, a study
clinician may evaluate you and refer you for further evaluation and/or treatment. If a clinician
determines that you are a danger to yourself or others, you may be held in a hospital against 
your will. These actions are to insure your safety and the safety of others.
At any point during the study, we will discharge you if we are concerned that staying in the study
may cause you physical or psychological harm. If the research team discharges you from the
study, we will contact your regular clinician to coordinate and provide you with the most
Department of Veterans Affairs  appropriate care to address these issues. If you do not have a 
regular clinician, we will discuss possible sources of medical care and encourage you to seek 
treatment.
Confidentiality of Information:
Participation in this research may involve a loss of privacy. Your research records will be kept
as confidential as possible. Only a code number will identify your research records. The code
number will not be based on any information that could be used to identify you (for example, 

INFORMATION SHEET
Version Date:  (9/30/2021)
Title of Study: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans 
__________________________________________________________________               
Principal Investigator:  _Erin Reilly, Ph.D.____________ VA Facility: VA Bedford Healthcare System
Sponsor of Study:___Department of Veterans Affairs_____________________________________
Page 5 of 8
social security number, initials, birth date, etc.) The master list linking names to code numbers
will be kept separately from the research data.
All research information collected will be kept in locked files or on VA secure server spaces. 
Your identity will not be revealed in any reports or publications resulting from this study. Only 
authorized persons will have access to the information gathered in this study. Federal Agencies 
such as the Office for Human Research Protection (OHRP), Government Accountability Office 
(GAO) and Food and Drug Administration (FDA) may have access to the records. The 
Department of Veterans Affairs (VA) requires some information to be recorded in the VA 
electronic medical record for all Veteran and non-Veteran research subjects. Therefore, if you 
participate in this study, a medical record will be created if you do not already have one. A note 
on your enrollemnt in this study will be added to your medical record so your care providers are 
aware that your are participating. In addition to the research team, and the VA staff who provide 
clinical services, other researchers may be granted approval to access this information in the 
future. Federal laws and regulations that protect privacy of medical records will apply to your VA 
record.
Other risks:
There is a risk that you may not be able to improve your chronic pain. However, we will monitor 
you very closely and will take numerous safety precautions to ensure your safety and well-
being.
Unanticipated risks:
If you have any unusual or uncomfortable feelings during the study, contact the PI or research 
staff. You can reach a study staff by calling a member of the research team during normal 
business hours. You can also come in to the Mental Health Clinic (Hours: Monday-Friday, 8:00 
am-4:00 pm; Building 78, 2nd Floor; 781-687-4333). You may also come in to the Bedford 
VAMC Urgent Care Center during their main hours (Monday-Friday, 8:00 am-4:00 pm; Building 
78, 1st Floor; 781-687-2654) or after hours. You may also call the doctor on call after hours 
(781-275-7500). If you become suicidal, hospitalization is possible.
Since we are concerned about your health and safety, there are some situations when we will
contact your primary care physician or other clinical professional that is providing care for you,
such as to inform him/her that:
• You need to be taken to Urgent Care for medical reasons
• You report suicidal thoughts or homicidal thoughts
• You are hospitalized
• You experience serious side effects that are a concern to you and/or the study team
• You experience an adverse event or reaction that occurs in the course of the study where the 
PCP has not already been informed
• You may be potentially harmed by continued participation in the study.

INFORMATION SHEET
Version Date:  (9/30/2021)
Title of Study: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans 
__________________________________________________________________               
Principal Investigator:  _Erin Reilly, Ph.D.____________ VA Facility: VA Bedford Healthcare System
Sponsor of Study:___Department of Veterans Affairs_____________________________________
Page 6 of 8
WHAT ARE THE POSSIBLE BENEFITS OF THIS STUDY?
Your participation may or may not be of benefit to you. The benefits to you include an online 
care pain intervention, and careful monitoring during treatment. However, we cannot and do not 
guarantee or promise that you will receive any benefits from this study. If you participation does 
not benefit you, it will be of benefit to others, as it will contribute to the effort to learn more about 
the treatment of Veterans with chronic pain.
WHAT OTHER CHOICES DO I HAVE IF I DO NOT WANT TO JOIN THIS STUDY?
You are free to decline entrance into or withdraw your participation in this study at any time. If
you decline to participate or withdraw from the study, and you desire treatment elsewhere, you
will be provided with information about alternative mental health treatment in the VA and in the
community. Mental health treatments at the VA include medications and counseling. Similar
treatments are available through treatments in the community. A decision not to participate in
this study or to withdraw from this study will not affect your ability to participate in other VA
treatment, including mental health treatment.
HOW WILL MY PRIVATE INFORMATION BE PROTECTED?
Participation in this research may involve a loss of privacy. However, numerous safeguards will 
keep electronic and hard copy data secure. Your research records will be kept as confidential as 
possible.  All research information will be kept in locked files at all times.  Your identity will not be 
revealed in any reports or publications resulting from this study. Only a code number will identify 
your research records.  The code number will not be based on any information that could be used 
to identify you (for example, social security number, initials, birth date, etc.) 
Only authorized persons will have access to the information gathered in this study.   Federal 
Agencies such as the Office for Human Research Protection (OHRP) and the Government 
Accountability Office (GAO) may have access to the records.  
Identifiers might be removed from the identifiable private information collected.  After the 
removal, the information could be used for future research studies without additional consent 
from you.
We have obtained a Certificate of Confidentiality from the Federal Government.  This helps 
protect your privacy by allowing us to refuse to release your name or other information outside 
of the research study, even by a court order.  The Certificate of Confidentiality will not be used 
to prevent disclosures to local authorities of certain communicable diseases, physical or sexual 
abuse, child or elder abuse or neglect, or harm or risk of imminant harm to self or others.  The 
Certificate does not protect you if  you, someone in your family, or someone you know 
voluntarily releases information about you. 
We will include information about your study participation in your medical record. A medical 
record will be created if you do not already have one.  In addition to the research team, other 

INFORMATION SHEET
Version Date:  (9/30/2021)  
Title of Study: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans 
__________________________________________________________________               
Principal Investigator:  _Erin Reilly, Ph.D.____________ VA Facility: VA Bedford Healthcare System  
Sponsor of Study:___Department of Veterans Affairs_____________________________________
Page 7 of 8
researchers may be granted approval to access this information in the future.  Federal laws and 
regulation that protect privacy of medical records will apply to your VA record.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by 
U.S. Law.  This website will not include information that can identify you.  At most, the website 
will include a summary of the results.  You can search this website at any time.
WHAT ARE THE COSTS TO ME IF I TAKE PART IN THIS STUDY?
You, or your insurance, will not be charged for any treatments or procedures that are part of this 
study.  If you usually pay co-payments for VA care and medications, you will still pay these co-
payments for VA care and medications that are not part of this study.  
DO I HAVE TO TAKE PART IN THE STUDY?
Participation in this research study is voluntary. You may refuse to participate and your refusal 
to participate will involve no penalty or loss of benefits to which you are entitled. You may also 
discontinue participation at any time without penalty or loss of benefits to which you are 
entitled.
You may withdraw from this study at any time without penalty or loss of VA or other benefits to 
which you are entitled. 
For data already collected prior to the participant’s withdrawal, we will continue to review the 
data already collected for the study but cannot collect further information, except from public
records.  
RIGHT OF INVESTIGATOR TO TERMINATE MY PARTICIPATION (Include if applicable)
Investigators may end your participation in this study if they feel it is in your best interest, and/or 
if you are not complying by program rules. The reason for your discontinuation will be explained 
to you. If you stop participating in the study for one of these reasons, you will have the option of 
obtaining mental health treatment in the Mental Health Clinic, through your other health care 
providers, or will be referred to local mental health treatment providers. If you withdraw at any 
point during the study, we will still use the data that has already been collected. However, you 
may choose to withdraw your study data if you indicate this to research staff. If you decide to 
withdraw, you may also continue to fill out questionnaires at each assessment point until the 
end of the study, and you will be compensated for your time and travel for your participation. If 
you decide to withdraw and decide not to fill out questionnaires, you will not be compensated 
and will be discontinued from the study.
WILL I BE TOLD NEW INFORMATION ABOUT THIS STUDY?
The study team will inform you of any important information about your participation that may 
affect you or your willingness to be in this study.

INFORMATION SHEET
Version Date:  (9/30/2021)
Title of Study: Developing an Online Therapeutic Intervention for Chronic Pain in Veterans 
__________________________________________________________________               
Principal Investigator:  _Erin Reilly, Ph.D.____________ VA Facility: VA Bedford Healthcare System
Sponsor of Study:___Department of Veterans Affairs_____________________________________
Page 8 of 8
WHAT WILL HAPPEN IF I AM INJURED BECAUSE OF MY BEING IN THE STUDY?
If you should have a medical concern or get hurt or sick as a result of taking part in this study, 
call Dr. Erin Reilly at 781-687-4191 during the day or have the doctor on call (781-687-
2000) paged after hours.
VA Medical Facilities shall provide, or arrange for, necessary medical treatment to a research 
subject injured as a result of participation in a research project. This does not apply to treatment 
for injuries due to non-compliance by the subject with the study procedures. No money has 
been set aside for compensation in case of injury as a result of participating in this study 
however I have been told that I would still have the right to file any legal action.
WHO DO I CONTACT ABOUT THIS STUDY IF I HAVE QUESTIONS?
If you have any questions about the research, you may contact  Dr. Erin Reilly at 781-687-4191.
If you have any questions, concerns, or complaints about your rights as a study participant, or 
you want to make sure this is a valid VA study, you may contact the Institutional Review Board 
Coordinator, Denise Carr at 781-687-2839, and the information will be given to the Institutional 
Review Board (IRB). This is the Board that is responsible for overseeing the safety of human 
participants in this study.  
AGREEMENT TO PARTICIPATE IN THE RESEARCH STUDY
Dr. Reilly or study staff have explained the research study to you.  You have been told of the 
risks or discomforts and possible benefits of the study. You have been told of other choices of 
treatment available to you.  You have been given the chance to ask questions and obtain 
answers.