What is this about? / “Explanation of Study”
You are being asked to participate in a research study conducted by Dr. Diana Burgess at the Minneapolis VA Healthcare System (Mpls VAHCS). This is a study to see if a mindfulness program will help reduce pain and improve quality of life among Veterans with chronic pain. In this program, you will learn “mindfulness practices” – techniques aimed at helping people become aware of their body and work with their thoughts and emotions, to better manage their pain. These techniques have been shown to improve people’s chronic pain and overall well-being. You are being asked to participate because your name was selected from a list of patients at the VA with a chronic pain diagnosis. Your participation in this research study is voluntary. You may choose not to participate at all, and you can leave the study at any time without penalty or loss of benefits to which you were otherwise entitled.
Why is this study being done?
We are conducting this study to find out whether our mindfulness program will improve pain and well-being among Veterans with chronic pain.
How did you get my name?
We’re reaching out to people who are in the VA system who have received a pain diagnosis at least twice during the last couple of years.
What is mindfulness? / There are physical reasons for my pain – how can “thinking happy thoughts” help me?
Mindfulness focuses on learning how to become more aware of your body, thoughts, and feelings. This skill can be helpful for managing pain and stress. You can think of it this way: most of us are automatically reactive to pain by default (we look for anything to distract us or numb it) and mindfulness trains us to be proactive (we find new ways to self-manage the pain so it’s less of a problem even if medication or distraction don’t help the pain go away). Part of what we hope you’d learn if you were in the program is more about the relationship between your body and mind, which has also been shown to help with pain self-management.
While there are physical reasons for pain, there is also often a lot of emotion and thoughts that come with these physical sensations of pain. Mindfulness has been shown to be really helpful in lessening the impact of negative thoughts and emotions, which helps the physical pain to become less of a problem in daily life.
Studies show mindfulness can be helpful for:
• Pain
• Stress
• Mood
• Sleep
• Overall well-being
What will happen if I participate in this study?
If you agree to participate, you will:
- Be asked to complete a short survey to see if you are eligible for the study. For example, you will need to have access to a smart phone.
- The study staff will also review your medical record to see if there is any reason it is not in your best interest to participate in the study.
- Complete 4 surveys during a 12-month period:
- A survey at the beginning of the study completed online.
- 3 surveys completed about 10 weeks, 6 months, and 12 months after the first survey, completed online, on paper via mail, or over the phone.
- Each survey takes about 20 to 30 minutes. You may skip any question(s) you feel uncomfortable answering or discontinue the study at any time.
- Have a 1/3 chance you will be selected to participate in the online “Group Mindfulness” program using online video conferencing, consisting of 9 weekly group sessions that are about 1½ hours long. You will also be asked to do daily “practice” of up to 20 minutes using a mobile app on your phone. The group sessions will randomly be observed by additional study staff, to make sure we are doing a good job. You will be asked to download a mobile application (app) onto your phone and accept the permissions requirements.
- Have a 1/3 chance you will be selected to participate in the “Mobile Mindfulness” program, consisting of 8 sessions, of about 45-60 minutes each. You will access the online program using the mobile app on your phone. A facilitator will give you a call at the beginning, middle, and end of the program to check in and help guide you. You will also be asked to do daily “practice” of up to 20 minutes using the app. There are 8 sessions on the app, but they are not delivered to the app in real time, so you can do them at your convenience. You will be asked to download a mobile application (app) onto your phone and accept the permissions requirements.
- Have a 1/3 chance you will be selected to participate in the “Normal Activity group” in which you will not participate in a mindfulness program. After the study is over you will be given the mobile mindfulness program to do on your own if you choose.
How long will I have access to the app?
Until end of study, which will be May 2024. We hope we find that the mindfulness program is helpful, and then we’d figure out how to make the app available through the VA.
Can I use the app on a tablet device?
We can’t help much with troubleshooting if there are issues with the app on your tablet, but some people are finding it works fine and they like using it on a bigger screen than their phone, so it’s worth a try downloading it. (The app developer says they don’t support the app on tablets, so if something isn’t working, they would say they couldn’t help. However, some members of the LAMP team have tested it on their own tablets, and it worked fine.)
How do I get to the screener?
You’ll need to go online to complete the screener. Do you have the email we sent to you? Listed in that email is the website (https://z.umn.edu/LAMP) and your personal PIN that you’ll need in order to get into the survey. You can also contact the LAMP Study staff via a phone (1 (877) 467-5079) or email ([email protected]), to obtain your PIN number. LAMP project emails can come from the [email protected] address, or the [email protected], but should have “LAMP” in the sender’s name. You can check your junk and spam folders to see if it could have gone in there.
This seems like it could be a big-time commitment. I’m not sure if I’m available. When does this start? What if I can’t commit now but will be freer later?
Since this is a research study, we have the 3 sections – normal activity, mobile mindfulness, and group mindfulness – and the computer will randomly assign you to only one of these sections. There will be specific dates and times the group mindfulness sessions are held, but for each phase, we decide these timeslots based on what will work for the most people, so we don’t know ahead of time what the timeslots will be. The session dates will begin about 6-8 weeks out from the time you complete the screener survey. There are no specific dates or times to commit to for the normal activity group or the mobile mindfulness group. But, since it’s random and we don’t know which group you’ll be assigned to, you need to be ready to commit the most time possible. If you know you wouldn’t be able to commit to weekly 1 ½ hour Zoom sessions starting about 6-8 weeks after the screener survey, please just let us know you’re interested in a future phase, but not available right now. We’ll possibly reach out to you again later and see if that time is better for you to participate. If you think you might be able to commit to 1 ½ hour Zoom sessions starting 6-8 weeks from now, we would love for you to go online and complete the screener survey. If you’re eligible, you will be asked to complete the baseline survey for the study. Study staff will review your medical chart after that. If you are eligible for the study at this point then study staff will call you to go over next steps for the study, and the dates for your study participation. At that time, we’ll be able to tell you the timeslots we’re offering (we don’t know these ahead of time because we schedule them based on when most people can make them). If on this call, the dates that we list off as your anticipated study participation do not work for your schedule, then we can mark you down as interested but not available at the moment. We can possibly reach out to you later to see if it works better for you. The schedule and time commitment for this study can be confusing. If you have further questions, please give us a call or send an email (877-467-5079 or [email protected]).
What if I only want to be in the [normal activity/mobile mindfulness/group mindfulness group]?
Once we determine if you’re eligible, you will be randomly assigned to a group. The computer does this, and the study staff have no control over who gets into which group.
How many participants are anticipated to participate in the study?
Our goal is to enroll up to 950 Veterans to be in this study.
How long will my participation last in the research study?
This research study is expected to take approximately 4 years. Your individual participation in the project will take 20-30 minutes for each of the 4 surveys (occurring at the start and at about 10 weeks, 6 months, and 12 months after the start). If you are selected to participate in the “Group Mindfulness” program, you will be participating in 9 video conference sessions, about 1½ hours long, as well up to 20 minutes of daily practice over 8 weeks. If you are selected to participate in the “Mobile Mindfulness” program, you will be participating in 3 phone calls and 8 sessions, 45-60 minutes long, as well as about up to 20 minutes of daily practice over 8 weeks. If you are selected to participate in the “Normal Activity” group, you will only be asked to complete the surveys. Regardless of which group you’re in, your total participation will last about 14 months.
Who is sponsoring the LAMP project?
This project is funded by the Department of Defense.
Is it possible for my participation to be ended for any reason?
We may have to end your participation in this study for the following reasons:
- You display abusive behavior toward other participants and/or the study staff.
- The study staff believe it is not in your best interest to stay in the study.
- You become ineligible to participate.
- You do not follow instructions from the researchers.
- The study is suspended or canceled.
- You choose to withdraw consent.
Are there any risks or discomforts?
There is the possibility that you may be uncomfortable answering some of the questions.
You may withdraw from the study at any time by calling the Study Coordinator at 877-467-5079.
As with any study, there is a risk of loss of privacy. We will make every effort to protect your privacy, and we will not contact your providers at your facility regarding your participation. We will only break confidentiality if you express an intent to harm yourself or others, at which point we would disclose only the information necessary to protect you or others. We will communicate with you directly whenever possible.
Risks associated with this type of mindfulness program are considered minimal and rare.
- Some people may experience minor discomfort while performing mindfulness practices in certain positions (e.g., sitting, walking, gentle movements).
- Some people experience difficult feelings (e.g., sadness, anxiousness) or other mental symptoms while engaging in a mindfulness or meditation practice or when participating in group activities.
Can I get medical treatment and compensation for injury?
Every reasonable safety measure will be used to protect your well-being. If you are injured as a result of taking part in this study, the VA will provide necessary medical treatment at no cost to you unless the injury was due to you not following the study procedures.
You do not give up any of your legal rights and you do not release the VA from any liability by agreeing to participate in this study.
Are there any benefits?
There are many benefits of mindfulness practice. Mindfulness practice has been shown to improve chronic pain and conditions that often co-occur with pain, like depression and insomnia. Mindfulness practice has also been shown to reduce stress and improve people’s general health. Your participation may benefit others in the future by guiding the development of strategies to improve healthcare within the VA, particularly for Veterans with chronic pain.
Who will see my information?
We are committed to respecting your privacy and to keeping your personal information confidential. When choosing to take part in this study, you are giving us permission to use your information, including health information in your medical records that can identify you. If all identifiers are removed from your private information that are collected during this research, that information could be used for future research studies or distributed to another investigator for future research studies without your additional agreement.
The information collected for this study will be kept confidential. There are times when we might have to show your records to other people. For example, someone from the Office of Human Research Protections, the Government Accountability Office, the Office of the Inspector General, the VA Office of Research Oversight, the VA Central IRB, our local Research and Development Committee, and other study monitors may look at or copy portions of records that identify you. The Department of Defense (DoD) may access your records as part of its human subject’s protection oversight activities.
If we discover that you are experiencing worsening depression or suicidal thoughts, we will share this with your VA primary physician and, if you have one, with your mental health provider immediately. If you express an imminent intent to harm yourself or others, we will break confidentiality, disclosing only the information necessary to protect you or others.
Will I receive any payment if I participate in this study? When will I get my check?
As a thank you for your time, you will receive $25 for each of the four surveys you complete for a total of $100. Once we receive your completed survey, you will receive a $25 check in about 4 business weeks.
Who can I talk to about the study?
In the event of a research related injury, please immediately contact Dr. Diana Burgess at 612-467-1591. If you have any questions, comments or concerns about the research, please contact the study staff at 877-467-5079 or [email protected].
If you have questions about your rights as a study participant, or you want to make sure this is a valid VA study, you may contact the VA Central Institutional Review Board (IRB) toll free at 1-877-254-3130.
I’m Catholic/Jewish/Muslim/etc. Are you going to teach me a new religion and tell me to do something that goes against my religion?
While mindfulness, including meditation, is part of some spiritual traditions, the mindfulness tools used in this program are not affiliated with any religion and are taught from a secular, science-based perspective. We want you to be comfortable with the program, so please talk to your religious leader about it if you are concerned.
Why am I not eligible?
For the purposes of our study, we’re looking for people with smartphones, who are available and able to participate in any of the groups, and who have a certain type of pain. We realize these requirements limit who will be able to participate.
I’m not eligible to participate because X, but do you have other information about mindfulness/pain management you could share?
Yes, we can additional VA information here: https://lamp.umn.edu/MoreInfo
You can also discuss with your primary care provider options for how to incorporate integrative health and other non-drug chronic pain management tools into your personal healthcare routine.
Will this affect my service connection or disability?
No! We are not connected to pension and compensation. Any information that you share with study staff will remain confidential and only be shared with people on the LAMP study research team.
Can my [husband/wife/friend] be part of this study too?
Because of the study design, we’re unfortunately not able to take volunteers. It’s possible they’d be sent an email too, and then they’re welcome to participate, but it’s a bit arbitrary who gets an email and who doesn’t.
Can I participate if I’m blind?
If you have a computer or phone that can read the questions to you, you can answer the eligibility questions and see if you’re eligible to continue with the baseline. Your phone would also need to read information on the app to you, if you end up in that study group. We haven’t done a lot of testing with the survey or app to know which readers work or don’t work, so it’s up to you if you’d like to try it out. We also don’t know much about the options Zoom has for people who are blind. You would need to be able to use Zoom and be present at the group sessions if you end up in that study group.
Can I get the results for the study?
Yes. We’re looking forward to sharing general results (never specific information about individual participants). It will take several years before they’re ready to share.
I’ve moved, can I still participate?
If you’re eligible based on the screener questions and other eligibility criteria, you can still participate. We are contacting people who have had at least 2 pain diagnoses in the last couple years and show up in the VA system.
What email address do LAMP project emails come from?
LAMP project emails can come from the [email protected] address or [email protected], but should have “LAMP” in the sender’s name. You can check your junk and spam folders to see if it could have gone in there. Sometimes we do run into email servers that filter our emails out without you knowing it – like university accounts. LAMP staff members can try sending emails to another email account. Please call the LAMP study number, 1 (877) 467-5079, or email us at [email protected], to let us know what email address you would like us to send LAMP study emails to.