A:  Mindfulness-based interventions are evidence-based approaches for improving pain and other conditions associated with pain such as depression, and one of about a dozen nonpharmacological treatments that the VA has identified for pain.  Mindfulness is generally defined as the ability to pay attention to the present moment, in a non-judgmental way. Mindfulness-based interventions teach mindfulness skills, which have been shown to improve chronic pain through multiple pathways. Currently, the most common and widely studied mindfulness-based intervention is called Mindfulness-Based Stress Reduction (MBSR).

A:  While MBSR is often a beneficial approach to pain management, with many studies on it, it has some features that make it difficult to implement at a wide scale since it is very resource-intensive. It requires a trained mindfulness instructor, a lot of time and space at the facility, as well as being a very intensive course for participants. Participants are expected to attend eight two-and-a-half-hour sessions, in addition to one all-day retreat, and do daily 45-minute practice sessions. From the perspective of veterans, they are looking at traveling to the VA, which may be far from their homes, and finding parking, which is often far from the building. So, a two-and-a-half-hour class could be many more hours out of their day. What results is that a lot of people drop out or end up not adhering to the intervention. Given the obstacles presented by MBSR, we wanted to create a mindfulness-based intervention that retains the key components of MBSR but is more veteran-centric and easier to implement on a wide scale.

A:  Mindfulness based interventions teach mindfulness skills—for example, learning to pay attention to your thoughts, feelings and bodily sensations, with curiosity, instead of with frustration, anger or judgment. Mindfulness-based therapies are important in pain management because pain is a mind-body experience that can worsen and intensify when one is clenching in anger or frustration. In our mindfulness course, we use key components of MBSR to teach skills for paying attention to our thoughts, feelings, and sensations and demonstrating how they, and our reactions to them, are linked to our experience of pain. Understanding that relationship, and how these skills help with pain management is critical. A trained mindfulness instructor explains the key components of mindfulness, so a person understands the difference between, say, pain experienced after running a race, and anger over pain preventing him or her from doing activities. Then we explain how building empathy, curiosity, and kindness within oneself can help develop a perspective to better cope with pain, and this often initiates conversation and make a person feel better.

The other component of these interventions is mindful movement, like chi gong, yoga, other small movements. Again, these practices emphasize the mind-body connection. We also incorporate mindful mini practices to help cope with small stressors or pains that can crop up during the day. Altogether, these therapies offer a tool kit to put people with pain a little more in charge of some of their pain. We’ve found that participants in our pilot study really liked learning new coping strategies, and knowing how to calm anxiety, depression, anger, frustration, and all of those emotions that contribute to and exacerbate pain.

A: The LAMP (Learning to Apply Mindfulness to Pain) Trial is testing two different mindfulness-based interventions for improving veteran’s experience of pain and comorbid conditions such as PTSD (post-traumatic stress disorder), anxiety, and depression. These two conditions, or pathways, will then be compared to the usual MBSR care pathway.

The idea is to use behavioral change principles behind MBSR, but make it easier for people to stick to the interventions. Luckily, there have been a number of studies showing that shorter mindfulness courses and different delivery platforms for mindfulness-based interventions were also effective at reducing one’s experience of pain. In the “Mobile+Group LAMP” condition, we have a trained mindfulness instructor delivering the mindfulness intervention via prerecorded video modules to eliminate the need for a certified MBSR instructor and participants onsite. We also have group sessions with a facilitator who is not required to be a mindfulness expert, but might be a health coach or someone with facilitation skills who can deliver and facilitate the group discussion, which is a big part of MBSR. This approach also incorporates many of the behavioral change principles that improve engagement and adherence; we have added a mobile app to help with that, so if participants miss a session, they can do the entire session on their app. We also give all the participants a workbook to do exercises, just like an MBSR program would require. They also can use their app, do their mindful practices, and are not required to do 45 minutes of practice a day. The other condition is called “Mobile LAMP,” which has the entire program, with the same coursework, app, videos, workbooks and practices, but no group component.

A:  In the UG3 phase, we got a lot of valuable input from our stakeholder advisory group, which included women leaders and veterans who are very active in the women’s veteran community, including Erin Krebs, MD, MPH, who at one point ran the Women’s Health Clinic at the VA. We also have our veterans’ engagement panel and that’s a racially, ethnically, and gender diverse panel of veterans who have experience in VA care. From their input, we really were able to fine tune the interventions. We met with veterans, showed them components, and got their feedback on what needed to be clearer in our approaches and materials. The Pain Management Collaboratory Work Groups were also instrumental in helping us with trial design, harmonizing measures and key constructs. We did alter our methods, designs and measures based on that feedback.

We included the no-group option after drawing lessons from other VA researchers’ findings that a large percentage of female veterans, who are more likely than women outside to VA to have experienced military sexual trauma and sexual harassment, felt uncomfortable closing their eyes in a group that included men. We have also found that veterans in some other MBSR programs didn’t necessarily understand how mindfulness was helping with their pain, and so we’re really providing a lot of guidance on how everything that participants are doing in the program can help them with their pain.

We were also able to do a pilot study, where we ran veterans through the three conditions, and we made one significant change based on that. What we found is that participants in the Mobile LAMP condition were less engaged than participants in the Mobile + ¬Group LAMP condition and participants in usual care; they were less likely to return their surveys, and more likely to be frustrated with the app than the participants in the other two groups. So, we developed a three-call protocol, where participants in the Mobile LAMP condition get a pre-intervention call with a facilitator who makes sure that the app is working, answers technical questions, and explains the program and highlights that the program is more than the app; it also has video courses, daily practices, and reflection exercises in the workbook that are important to complete. The Mobile-Only group will also get a check-in call in the middle of the program, and then they will get a call at the very end to make sure that they have a plan for continuing the practices that worked for them.

A:  The COVID-19 pandemic is affecting our participants and sites differently, depending on what area they are located in nationally. We have a four-site trial, with participants in Minneapolis (Minn.), Los Angeles (Calif.), Durham (N.C.), and Indianapolis (Ind.); and each location has a different level of virus spread and mandates to control the spread. We made the difficult decision to do our group sessions remotely since, at the time, our VA facility in Minneapolis, and other facilities, were closed to nonessential care, and so we would not have been able to hold those group sessions in the facilities anyway. Our co-investigator, Roni Evans, PhD and another investigator, Alex Haley JD, MBA, were able to successfully transition their NIH study, which was similar, from an in-person meeting to a remote platform via Zoom. They found that participants in their study were still engaged, participating, and, for the most part, were really satisfied. Additionally, there are some benefits to the online format: it is safer and eliminates traveling for rural veterans and parking difficulties. It also removes the additional work and anxiety of going through the COVID screening process. We have approval for this change, but we are delaying the start of our trial in order to add some other components that are necessary to make the online experience a really good one.

Additionally, all of the 11 projects in the Pain Management Collaboratory saw the need to assess the impact of the COVID-19 pandemic on our participants. We are measuring other factors, in addition to pain, including pain, anxiety, depression and stress that also now could be affected by how individual participants are impacted by the novel coronavirus. So, collectively, we came up with a short battery of items that every site in the trial is going to be using to assess the impact of COVID. For example, we’re looking at how COVID-19 affects a person’s financial life or social life, as well as access to established pain treatments. We are asking about whether or not they are able to do the activities that help manage their pain, and their social interactions, or isolation, as the case may be, which is a very important consideration with pain. I think it’s incredible that we were able to get that measure pulled together, and we’ll be able to see where our participants are in terms of their COVID impact.

A:  I love being part of the Pain Management Collaboratory because I get to work closely with pain experts in the field regularly in real time. Many of us have such a close collaborative relationship that has spanned 15 or more years, and so we’ve built a lot of trust. That trust enables us share freely and problem solve together.

For instance, when the COVID crisis happened, we had to scramble to figure out the implications for all of our trials. We were able to work together quickly in real time to come up with measures that everybody would add to their battery of baseline measures, and potentially throughout, to gauge the impact of COVID. There’d be no way to do this if we weren’t already collaborating and harmonizing our measures. Now, we can compare across files and account for the different trials in different parts of the country, where the impact of COVID is different. If we didn’t have all the same measures, we wouldn’t be able to harmonize it to compare.

In general, we’ve really been able to make sure that we’re greater than the sum of our parts. The idea of harmonizing is really interesting because often principal investigators are sort of like in their silos—they’re the leaders and they do their own thing—and what happens for the field is that everybody is using different measures and it’s not comparable. Because the Pain Management Collaboratory has a Coordinating Center, and they did a lot to build rapport, we’ve been able to work together to develop measures that we are all going to use. So that’s been huge.

The major health organizations like the Centers for Disease Control and Prevention, the American College of Physicians, the Department of Defense, the VA are already recommending multimodal approaches to pain treatment that incorporate evidence-based, nonpharmacological approaches to shift us away from the old opioid-centered model that contributed to our opioid crisis, but we still need to address the chronic pain crisis and know what modalities, combination of therapies, and “dosages” are appropriate for various pain conditions. Usually, there’s a huge delay between when the research is published and when it gets implemented and sometimes it never does, but I feel really confident that we’ll be well-poised for our research to be implemented into practice, especially in the VA because we have, as operational partners, the VHA Pain Management office, that’s very committed to nonpharmacological treatments, and the Office of Patient Centered Care and Cultural Transformation that runs the Whole Health program.