NAMI to FNIH: Grand Rounds on Mental Health Innovation w/ Dr. Christine Crawford & Steve Hoffmann

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Mark Mullen: [00:00:00] Welcome back to Psychiatry Boot Camp. Today we are joined by Dr. Christine Crawford, who is the chief medical officer at the National Alliance on Mental Illness, NAMI. Most of us are probably familiar with that organization. And we're also joined by Steve Hoffmann, who is the senior vice president and chief preclinical officer at the Foundation for the National Institutes of Health.

that's the FNIH. We're gonna start with Dr. Crawford, who in addition to serving as the CMO at NAMI, is the author of NAMI's second book, titled You Are Not Alone: For Parents and Caregivers: The NAMI Guide to Navigating Your Child's Mental Health. Dr. Crawford's also an assistant professor of psychiatry at Boston University School of Medicine.

Dr. Crawford, we're excited to have you join us on Psychiatry Boot Camp. Before we jump into the conversation, is there anything else you'd like to add to this introduction? 

Christine M. Crawford, MD, MPH: No, that's perfect. 

Mark Mullen: Let's dive right in. So for anybody who is [00:01:00] unfamiliar with NAMI and its mission, Dr. Crawford, could you explain to our audience what NAMI is and what your role looks like as chief medical officer?

Christine M. Crawford, MD, MPH: Absolutely. I'm so happy to be here and have an opportunity to talk about mental health in general because as a child and adolescent psychiatrist, there's not that many of us out there in the country, so I really love any opportunity to talk about mental health. So NAMI, the National Alliance on Mental Illness, is the country's largest grassroots organization that's dedicated to improve-- improving the lives of individuals living with mental health conditions, but also we're a group that's really big on advocacy work and really thinking about what do people who are living with mental health conditions need in order to thrive and lead productive lives.

And that includes having support through their caregivers and making sure that their caregivers have the knowledge and information that they need in order to best support these individuals. So we're all across the [00:02:00] country. There's six hundred and fifty of us all throughout the country, so there's one in your backyard.

We offer support groups. We offer educational workshops that are delivered by peers. We have educational workshops that are delivered by caregivers to other caregivers. So it's a beautiful community to be a part of, especially when you don't know where to start. When you are beginning your mental health journey, this is a community that can really help guide the way for you and really be a nice place for support.

Mark Mullen: When I think of advocacy organizations in the mental health space, to be honest with you, it's pretty much-- at s- at least in terms of people who are championing the patient voice, it's pretty much NAMI way up here and then everybody else down below. I've had the opportunity to go to some NAMI trainings as a part of my training and community engagement, and I'm always amazed by how committed the volunteers are.

I think it's a, an organization that has positively impacted so many lives, and because it's positively [00:03:00] impacted so many lives, the energy behind the volunteers, the peer support specialists, the educators is really infectious, so it's just amazing work that you're doing there. 

Christine M. Crawford, MD, MPH: Yeah, and the reality is so many people, their lives are touched by mental illness, and they oftentimes feel alone in that journey.

And so NAMI really makes people not feel alone in that journey, having that sense of connection, not feeling lonely, not feeling confused and isolated. and that energy that you talked about, it just helps fuel people's mental health recovery, actually. You know, that socialization piece is really important.

So I think that a lot more clinicians need to be aware of NAMI and how big of an organization that it is and how amazing of a resource that it could be for your patients, 'cause it can actually help improve their mental health outcomes. 

Mark Mullen: Yeah, so often, actually, especially with young patients with a strong support system, someone from the [00:04:00] family, like a parent, will, you know, when the, what did I miss?

Are there any other questions? And the question from the support system is like, what can we do? Where can we learn about this? And I think NAMI is the perfect first stop for people like that to sort of orient them to what the healthcare system looks like for people with mental health problems, the options that are available to them, and then to plug them in with other people who are going through similar things.

So I just can't thank you enough for that. So I wanna talk a little bit about your book, You Are Not Alone: For Parents and Caregivers, The NAMI Guide to Navigating Your Child's Mental Health. And I understand that it draws on both your personal and your professional roles in terms of being a psychiatrist and also a parent What initially drew you to writing this book?

What, was your thought that said, "Okay, I need to put this down on paper and publish it"? 

Christine M. Crawford, MD, MPH: So every time I would meet with patients, I would meet with parents, there was just so much confusion about what mental health looks like in kids, what parents, what other caregivers should do to support their kids' mental health.

Teachers were [00:05:00] also kind of lost on how they could support their students in the classroom who were struggling. And people just didn't know where to start when it came to engaging with the mental health system. And I was really taken aback by all of these conversations, and I thought to myself, "My goodness, wouldn't it be great if there was a guide, to give parents, to give the adults that are in the lives of these kids so that they know how to better support these individuals, but also that they have the confidence and they feel a sense of empowerment to care for, the kids that are in their lives?"

And as a parent, I actually wrote this book when my kids were one and two. now they're five and six, and I'm a single mom of these two girls. And while I was writing it, I was thinking to myself, you know, if one of my kids were to be diagnosed with a mental health condition and I did not have this clinical background, what would I [00:06:00] want and need in order to take care of my kids?

And I actually was inspired by the book What to Expect While Expecting, because- 

Mark Mullen: Yeah, Emily Oster, right? No, is that Emily Oster? 

Christine M. Crawford, MD, MPH: No, it's like the super old book that has like a bajillion different versions, and it walks you through like month zero to month nine of pregnancy. And now mind you, Mark, I went to medical school.

I did an OBGYN rotation. I bought that book 'cause I didn't know what to do. and so it was just so comforting to have some sort of roadmap or guide, some sort of understanding about the process. So that was the same sort of approach that I used, while writing this book. So in addition to my clinical experience and expertise and professional experience, or personal experience as well, I interviewed 80 people across the country parents, caregivers, teachers, coaches, kids themselves, young adults, because I'm not the only expert [00:07:00] in the room when it comes to mental health.

People who are living this each and every day are the true experts. So they share their stories. They share the knowledge that they've learned on their journeys, and I put that all into this book. It really covers what mental health looks like in kids as young as three up to 18, how to navigate the mental health system.

How to know if you are the one with the problem or your kid actually has the problem, and understanding the cast of characters in the mental health space as well. so it's a really comprehensive book, but it's an easy book to read because I'm-- my-- I wrote the book in the same way that I talk to my patients in the clinic.

And all of the money, all of the proceeds from this book goes straight back into NAMI, so that we have more supports, more educational workshops available. So it goes back into the organization, which is great. 

Mark Mullen: I appreciate your candor in terms of how you got the idea for the book. [00:08:00] We did not read What to Expect When You're Expecting.

We read Expecting Better by Emily Oster and swore by it and Moms on Call. And so we would be in a situation, and it would be like, "I have no idea what to do here." So having a little guide that you can pull out and reference in those moments, especially those big inflection points in your life, I can't overstate the importance of that.

So in deciding what to include in the book, you relied on your professional expertise. You had a lot of conversations with parents and caregivers. One thing that you talk about is sort of how to start this-- like how-- the, the question is, how do I know whether or not I need mental health treatment? How do I know if I have a problem?

And as a, brief aside, to me, one of the things that makes NAMI so important as an advocacy organization is that historically, NAMI has had a focus on individuals with severe and persistent mental illness. And often, when you do have severe and persistent mental illness, as a-- as part and parcel of being that ill, you don't understand that you have a problem.

And so that really complicates the treatment picture in terms of how someone [00:09:00] interfaces with the mental health system. So I think that focusing on that question of how and when to begin psychiatric treatment and how to have that conversation is important. If we're focusing specifically on children and adolescents, which is your specialty, what would be some of these distress signals that should signal to parents or caregivers, "I might need to think about seeking professional assistance"?

Christine M. Crawford, MD, MPH: This is a question that always comes up because kids are kids when they're at home, especially teenagers. They could be irritable, they could be difficult, oppositional. And so oftentimes there are parents who kinda dismiss some of the changes that they notice in their kids' behavior and just chalk it up to typical teenage behavior or thinking, "Okay, well, maybe this is just something, that my kid will grow out of," right?

And so I talk about this concept called the distress radius, which I literally made up while I was sitting in a coffee shop, because I [00:10:00] was looking at this cup of coffee, and I was like, "Oh, do I actually wanna get a bigger, size?" And so I was kind of thinking about, like, a radius, like the size. And as I was thinking more about it, I was visualizing kind of the impact of a kid's behavior in multiple domains of their life, okay?

So in the middle of that circle is the home. it's the interaction with the family, with the parents. And so as a parent, if you're noticing that your kid is irritable, their appetite has changed, their sleeping habits have changed, maybe they're more isolated, you wanna be curious if this is also behavior that's being observed outside of the home.

So then you're looking at school. Okay, are there changes in their grades? Are they not going to soccer practice as often? Are they talking back to the teachers, right? And then you can expand that out even further. Are we seeing this behavior in their [00:11:00] interactions with church leaders or their interactions with coaches?

And so if you see that this behavior that you're concerned about goes beyond the walls of your home and into other areas of that kid's life, that is a true signal that kid needs some additional support, right? And I think just having that visual, just thinking about how big is the impact of this kid's behavior on this kid's life, right?

And so some of the things that a lot of people don't realize is that when it comes to diagnosing a mental health condition, it's really about how someone is functioning. I really focus on functioning, right? And what that means is, there a change in how this kid is able to get out of bed, brush their teeth, put on their clothes, eat their breakfast?

Is there a change in their ability to fall asleep and to stay asleep? So thinking about their physical functioning, and then also thinking about [00:12:00] socially. Kids are designed to be really invested in their friendships with their peers, right? So if you're noticing that your kid is not hanging out with their friends as often, there's a change in their willingness to, go and meet up with people that they typically would meet up with, that's a change in their social functioning.

And then with kids, academic. I mean, that's pretty much like the big, signal for a lot of parents, if you're noticing that the, the grades are changing or they're skipping school. So thinking about how a kid is functioning physically, socially, and academically are really big, signs that all parents should be looking out for, if they happen to have any concerns about their kids' mental health.

Mark Mullen: And then switching into the clinician role, we talked about how NAMI is probably an underutilized resource. When you say that, what do you mean specifically in terms of, if I'm a clinician, what do I need to know about that NAMI offers in [00:13:00] order to share it with parents and caregivers? 

Christine M. Crawford, MD, MPH: Yeah, I appreciate this question because I actually got connected with NAMI when I was a psychiatry resident at Massachusetts General Hospital.

And I always had an interest in community psychiatry, which is basically psychiatry taking care of- individuals with a whole host of different mental health conditions, but really focusing on vulnerable patients. And we were learning great things, you know, in terms of medication management, psychotherapeutic techniques, and what have you.

But I was always curious about what happens with a patient when they leave my office. What happens with a patient when they're discharged from the hospital? And so, there was this whole aspect of a patient's life that was missing from any discussion about our training and what it was that we needed in order to be the most effective clinicians.

And so, patients spend the majority of their time in their communities, right? [00:14:00] And at home with their friends and family, and that's where we really want them to spend their time. And so, a lot of my attendings and supervisors and folks that I worked with, they didn't-- They heard about NAMI, but they didn't really look at it as a clinical resource that they could offer to their patients.

And what I noticed in my training, and even what I notice right now in my clinical practice, that when I share a resource about a support group, especially for folks who are new in terms of their mental health journey, being able to connect with people in their community about, "Okay, well, if you need to see this type of provider, or if you need to get this or that in your community.

There's people that you could talk to who can really help guide you on how to best support your mental health while you're at home. And then also the caregivers. We know [00:15:00] that patients have best outcomes when they are connected to family and friends who are taking care of them, right? So we need to figure out how to give them the tools and resources that they need to better take care of their loved one by recognizing when their mental health symptoms might be changing, to notice when their level of functioning is changing, and to give them all that language to use so that they can have conversations with their loved one about their, mental health.

So I think that social aspect, the education piece for not only the, the individuals who are living with the mental health condition, but also their family members, I think can only just make people be more attuned to their mental health symptoms as well as other people, and then seek out help earlier on, right?

'Cause people will call them out, and they recognize themselves, "Oh, I think that I'm starting to slip a little bit. I spoke to Susie about this a couple of months ago about how this could [00:16:00] potentially happen during the support group. Let me pick up the phone and call Dr. Crawford." That's really the idea. 

Mark Mullen: It makes me think of other-- like when, I think about the populations that I treat and that I treated during training, some of the populations are particularly spoiled in terms of the resources that are available to them.

I shouldn't use the word spoiled because they're sort of hard-earned resources. But I think about, like, our veterans, for example. They have a lot of wraparound services. I'll often talk to colleagues who choose to work for the VA because if you're a psychiatrist at the VA, you can actually make things happen, right?

There are wraparound services that are available that are covered by the insurance company that You can actually get the patient the care they need. Whereas sometimes when you leave a system like that, you can feel like you're trying to weave things together with paperclips and rubber bands to get the patient the support they need.

The other community that I think of is Alcoholics Anonymous and Al-Anon. So having that support not just for the patient, but also for the families and caregivers. So I, like that NAMI with its, did you [00:17:00] say three hundred and fifty chapters, is really- 

Christine M. Crawford, MD, MPH: Six hundred and fifty chapters. That's nuts. Yeah.

Mark Mullen: That's wild. Yeah. Mm-hmm. So anywhere you are, if you have a patient and you think they could use a support group, if you have a patient's family member, right? Even if that-- even if your patient is not being treated very successfully at that time, by which I mean they don't think they have a problem, they're not coming back to your office, they're not taking their medication, but they do have a support system.

And so how can you leverage that support system to try to make your treatment relationship better? NAMI would be a really good way to do that. 

Christine M. Crawford, MD, MPH: Absolutely. And the information that we have about the mental health conditions and treatments that are on our website, it's really important that people are aware that information exists.

There's a lot of misinformation out there right now when it comes to mental health. And so to know that when you go to a NAMI workshop or go to our website, that the information, the clinical information that we have available is evidence-based. We're not making any of this [00:18:00] stuff up, right? It's actually based on science.

So to be able to translate, you know, the latest things that are happening in the field of psychiatry for this community is really important because we want people to take good care of themselves, but they need to know what's happening in the research field and to know what sort of innovations are happening in the field of mental health so that they can learn about them and actually seek them out on their own.

Mark Mullen: I wanna ask you two more clinical questions, and then I wanna dive into some of that research that's happening in the mental health field with your work with FNIH as well. Two final questions. One is, in these cases where a patient or a family member is skeptical of the psychiatric system, do you have any concrete tips or tricks for working with that patient population to try to bridge that gap and get the patient the help they need?

Christine M. Crawford, MD, MPH: I like to remind everyone that mental health conditions and mental health symptoms are primary care related issues. [00:19:00] People oftentimes, like, bypass the whole primary care thing. They go onto Google and they're typing in best therapist in the area, and then they go straight to that and they're on a wait list for several months, right?

While they continue to experience symptoms. So I tell people, "Talk to your primary care provider about what it is that you're experiencing." And especially for caregivers, talk to your pediatrician. Talk to the pediatric clinician about what is happening with your kid, because at least you're starting a conversation.

Sometimes that- primary care provider can start treatment with, medications, but also they can refer you to a therapist who might actually take your insurance because they're kind of in the same network as everyone else in their community when it comes to therapists and other clinicians. So your PCP is in the know, you know, so they could connect you to a therapist.

But a lot of health centers right [00:20:00] now have behavioral health clinicians that are embedded in the primary care setting. So you could bring up a, a concern about depression or anxiety with your PCP. They could actually step out of the office and pull in a social worker to talk to you right on the spot about your mental health condition.

A lot of people don't realize that. So people wait and wait on these wait lists and in child psychiatry, there's only about ten thousand of us, so people are waiting for a long time. They don't have to wait, just engage with primary care. And if your loved one thinks, "I'm fine, I don't have any issues," still bring it up with the PCP if you're able to, 'cause they could give you some tips on how to navigate and how to support that individual.

And the last thing that I'll say about it too is that You can educate yourself about mental health symptoms and understand when the mental health symptoms kind of tip over to the area [00:21:00] of a safety concern, right? And so even though your loved one's like, "I'm fine, they could be fine up until a certain limit.

So when we're talking about someone who's not able to function, they're talking about thoughts of suicide, they're having psychotic symptoms that's interfering with their daily life, for you, that's a red flag that you need to intervene despite what that individual says. And know about the resource such as 988 to call if you find yourself in a situation with your loved one, you don't know what to do, but things seem to be quite severe.

Give them a call, and they can provide you with guidance. 

Mark Mullen: You've touched my clerkship director heart with your comment about how mental health conditions can be triaged in the primary care setting. Everyone who graduates medical school has at least a month, probably more at most medical schools, of psychiatric training.

And we try to focus on differentiating sick versus not sick and navigating these difficult conversations. And I think there might be a fear from some patients who would prefer to try psychotherapy first. "Well, I can't talk to my doctor about this because all they [00:22:00] can offer is a medication." And maybe your doctor will offer a medication, but really you're just starting a conversation.

And if that's-- if what the doctor offers is not something that you're interested in, you can continue that conversation. But the physician has training in understanding what type of problem you're dealing with and what types of supports might be available to you. And I think as the patient, you know, no one's-- no one comes to their physician with the chief complaint of, "I believe I have a primary psychotic disorder," right?

The complaint is, "I'm suffering, I'm scared, I'm paranoid, I'm anxious." And in talking about it with the physician, you can get a better understanding of those symptoms. But trying to solve those problems your own or saying, "Well, I'm on a wait list for therapy, I'll deal with it in six to 12 months," I think you can miss some really important safety concerns if you take that approach.

Christine M. Crawford, MD, MPH: Absolutely. And another point, too, that's important to make is that I have patients in my clinic that have mental health symptoms, and they're not on a medication. So you can still be engaged [00:23:00] in treatment and still be questioning whether or not you wanna start a medication. That could be true if you're seeing a psychiatrist.

Oftentimes people think if they see a psychiatrist, "Oh, I don't wanna be on a medication. I shouldn't even bother go to the appointment." Still go because there's so many other things that you could take away from that interaction about how to best support yourself and your life, given everything that you're going through outside of medication.

So we have other tools that we can offer people besides meds. 

Mark Mullen: You mentioned that you make a point to have your book be evidence-based, not just anecdotal evidence, and that NAMI really prioritizes evidence-based medicine and making sure that patients have access to high quality information. If you could pick one or two evidence-based techniques that you talk about in your book or that you use with your patients that you think every clinician, let's say even every primary care clinician must know, what's at the top of your mind?

Christine M. Crawford, MD, MPH: Well, I have to tell you my favorite Intervention. My [00:24:00] favorite type of psychotherapy as I'm thinking about it is dialectical behavioral therapy, DBT. I think that DBT skills should be taught in elementary school, middle school, high school, everywhere. And what DBT is, it teaches people how to regulate their emotions, how to deal with frustration, how to communicate more effectively with people, and how to be mindful of yourself, how it is you're presenting in the world, and being mindful of when you're feeling distress and understanding when you need to use some tools or strategies to kind of calm yourself down.

I mean, those sort of things could be applicable to anybody, even though there's been a lot of research in, this particular therapeutic approach being used to individuals who have borderline personality disorder. I just think that these are skills that could be used by anyone, like how to do deep breathing, how to take a step back and do box breathing or count to [00:25:00] five.

These are things that we all could actually use in our daily lives. So I have to say, DBT, that's my favorite. 

Mark Mullen: You know, the first time in my life that I used DBT skills was actually my wedding day. I woke up on my wedding day and I-- Now, the psychiatrists listening are gonna have a field day with this, so feel free, guys.

You know, I'm sure... Feel free to l- you know, draw whatever conclusions you want. It was a very happy day in my life, but I am an Enneagram three, if that means anything to anybody. I'm q- I'm a little bit image conscious, probably not a shocker for a podcast host. And I think the issue was that I had so many people from different areas of my life that were gonna be staring at me all day, and I just couldn't quite deal with that.

and who do I be, right? 'Cause maybe I have a different personality with all these different re- And my, my ego was just sort of shattering on the most important day of my life to date. And I thought, "What am I gonna do?" And I whipped out my DBT skills and oh my God, it w- after, you know, an hour of working on some skills, I was almost as cool of a [00:26:00] cucumber as my wife was that day, which is saying something because she really was very relaxed that day.

So yes, I, fully agree. You don't need to be having, a crisis. Sometimes it can be the happiest day of your life, and you just need to be able to calm down a little bit. So I, think DBT is a great answer to that question. 

Christine M. Crawford, MD, MPH: Yeah, and I'm happy that you were able to use those skills effectively because you actually can call your partner your wife.

it actually worked out- Right. ... such that you did get married- Yeah. ... so you do have a wife, so congrats. 

Mark Mullen: Thank you. Thank you, and thank you to Marsha Linehan and Dialectical Behavioral Therapy. Okay, we're gonna take a quick break. When we come back, we're gonna talk about some exciting work happening at the Foundation for the National Institutes of Health, where Dr.

Crawford and Steve Hoffmann are working on developing a deeper biological understanding of some of the factors that drive major depressin- major depression and depressive symptoms. So sit tight, we'll be right back.

What is the most difficult part about being a mental health professional? Is it the time [00:27:00] spent with patients? I think for most of us, it's probably not. I think for most of us, the most difficult job is dealing with all of the administrative issues that we need to deal with just to make our profession work.

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It's called Medlines. Medlines is a quick weekly wrap-up of everything in the healthcare field, from breakthrough discoveries and research to politics and medical pop culture. The best way to think of Medlines, it's kind of like NPR's Up First, which I listen to every morning, but it's for all things healthcare.

And honestly, I think a podcast for busy healthcare professionals to stay informed without taking a big chunk of time out of our day is long overdue. Medlines is made strictly by healthcare workers for healthcare workers. Of course, credibility is key for this kind of a thing, which is why it's led by an amazing team, including the great Dr.

Glaucomflecken, Will Flanary, and Lady Glaucomflecken, as well as Dr. Matthew Braddock, who was a producer of Psychiatry Boot Camp. And I'm really excited to hear his writing for Medlines. The [00:29:00] rest of the Human Content Podcast team, who is responsible for Psychiatry Boot Camp, is also responsible for Medlines, so you can bet that it's gonna be an amazing podcast and hopefully a staple of your feed.

Plus, New England Journal of Medicine is on board as the inaugural Medlines sponsor. New episodes of Medlines are out now wherever you get your podcasts, with new episodes out every Friday.

Welcome back. Let's now move on to another area where Dr. Crawford finds herself involved, and that is the Foundation for the National Institutes of Health. Turning now to Steve Hoffmann. Steve, what is the FNIH, and what is the relationship between the FNIH and the taxpayer funded National Institutes of Health, NIH?

Steve Hoffmann, MS: Thanks, Mark, and I really appreciate the opportunity to speak with you today and be part of this opportunity with, Dr. Crawford. Folks may know the FNIH is the official nonprofit partner of the NIH, and really we are a global [00:30:00] leader in collaborative biomedical research. We're, that neutral convener where we build and lead trusted public-private partnerships that bring together NIH scientists, life science companies, advocacy organization regulators, you know, the academic and philanthropic communities to really accelerate medical breakthroughs from diagnostics to treatments to large, complex disease understanding that really no one organization could achieve.

We've been around for thirty years. We were actually congressionally mandated as in that partner role to be able to support and augment NIH's efforts. We are uniquely positioned that we're the only organization that can actually take private sector funds and even transfer that, those dollars to augment the traditional pathways and grant efforts of the NIH.

So we really can do some of our own partnering and contracting and development of some of these partnerships, but also really a force [00:31:00] multiplier for NIH in doing this. And to the tune over the last thirty years of around one point six billion dollars we've been able to raise to really move forward some of these health outcomes, treatment responses and other efforts.

Mark Mullen: And the FNIH is not focusing solely on diseases of the central nervous system. You guys are all over the map, is that right? 

Steve Hoffmann, MS: Yeah, I mean, really a broad remit. you know, a lot of the areas in metabolic health, from neuroscience to cancer to immunology. It's not a come one, come all, but certainly there's strategy and design of the types of partnerships that can make the biggest impact.

A lot of focus in the biomarker world, understanding characterizing disease, a lot in new target development for treatment responses. But the FNIH even, you know, goes as far as supports scientists and fellowships and prizes that are involved in development. Again, a lot of times with NIH even to help in financing and supporting buildings on the NIH campus.

But so a pretty broad remit, but definitely a lot of [00:32:00] focus on biomedical health advancements. 

Mark Mullen: Yeah. And when we think about really the greatest technologies that we've developed over the last 100 years, a lot of them are public-private partnerships or technologies that started out in the public sector and then were sort of perfected in the private sector.

So it makes sense to me that in the life sciences, we need an organization like the N- FNIH to help bridge that gap. So if that's the FNIH, Steve, what do you do at the FNIH? 

Steve Hoffmann, MS: Yeah. So as my role as, as, as a senior vice president and our chief preclinical officer is I oversee a lot of the design and development of programs that are on the front side of research.

So we talked about pre-competitive biomarker development. I oversee one of our large programs called the Biomarker Consortium, which is about developing tools, for adoption into clinical trials, tools that ha- generate evidence for regulators to make approval decisions, you know, both medical devices, but as well as biomarkers or endpoints that are used in clinical trials.

I also [00:33:00] oversee one of our major partnerships called the Accelerating Medicines Partnership, which is really a large kind of exploratory way to design new targets, validate new targets, identify new pathways, cell types that might be involved. Several of those, even in the neuro space around schizophrenia, Alzheimer's disease, Parkinson's disease, but several others around areas of heart failure, around inflammation, some of the autoimmune conditions, really trying to understand those diseases and really drive what new cellular pathways might become targets for novel drugs.

Mark Mullen: So let's dive in now to one of these projects that is, I think, just getting started up. This is the MAPD project standing for Multimodal Assessment and Phenotyping in Depression. First of all, killer acronym, I got to say, as an academic, you know, they don't make it much better than that. MAPD, mapping depression.

That's bravo, academic standing ovation. I wish I could give you an award and a medal just for the acronym alone. Let's start with what-- Before we get into study [00:34:00] design and what MAPD we're hoping it's going to show, let's talk about the need for study design. So this is either for Steve or Dr. Crawford.

What problem is MAPD trying to solve? 

Steve Hoffmann, MS: So I'm, fine to start with that. So no doubt it's really designed to address one of the core root causes of poor outcomes in depression research, and that's really the lack of objective and validated tools to help identify which treatments will work best for a given patient.

So precision type of true precision medicine. What we need there is the integration of what we call multimodal biomarkers, right? Multimodal because the complexity of the brain. Think about brain circuits, thinking about neuroimaging, thinking about clinical assessments and the patient-reported responses and symptomology, very much that Christine talked about early on, are important factors.

So it's not all biology, but there is a lot of environmental, social influences that are involved. And so there is not gonna be one single biological test like you might [00:35:00] see in a cancer or, say, for diabetes, you have the insulin ability to follow and track that. But really, the complexity of the brain, the complexity of what depression or other neuropsychiatric conditions are, you're gonna need this multimodal or a compendium of different types of assessments, both biology, both social, both clinical, both patient-related, and that type of compendium is gonna be needed to truly understand the disease and then identify what your depression is and be able to treat and have the right treatment, the right intervention for the right patient.

Mark Mullen: Anything to add, Dr. Crawford? 

Christine M. Crawford, MD, MPH: Yeah. I mean, the reality is that there are millions of Americans who are living with depression. And as a clinician Talking to patients, it could be sometimes hard to engage in this sort of trial-and-error approach when it comes to treatment. You try one antidepressant, it doesn't work.

You try another one, it doesn't work. [00:36:00] But for a different patient, that first antidepressant can work. And so that trial-and-error sort of approach is really frustrating for a lot of patients as well as for a lot of clinicians. So the fact that there is this research that's trying to identify these biomarkers so that for the patient who's sitting in front of us, we could be able to better answer the question of what treatment is going to work for this person in front of me, rather than the question of, okay, what should we use to treat depression?

But it's more individualized, and I think that precision is so needed in this condition that's affecting so many people who are really struggling to find a medication option that truly works for them. 

Mark Mullen: I think regular listeners of this show will know that I am a bit disappointed by the progress that biological psychiatry has made in the last fifty to sixty years in terms of advances that really [00:37:00] improve quality of life for our patients.

And I think a common criticism of trying to find biomarkers in brain diseases is brain diseases are not simply biological, and something like depression is really probably a compendium of different types of present-- different diseases we could even call them, right? Like we think about the biopsychosocial spiritual model, and a s-- relatively small portion of that is biological.

But I really appreciate that, Steve, upfront, you're acknowledging that complexity, and you're saying we don't think that there's gonna be one gene that's gonna cause this or even a set of genes that is gonna cause this. But you wanna better characterize the experiences that people are having and then maybe identify some biomarkers that might be associated with specific neuropsychiatric disturbances that are associated with depression rather than calling major depressive disorder one monolithic entity.

Is that a fair summary? 

Steve Hoffmann, MS: A-absolutely, and I really appreciate that, that augmentation of what we were talking about. And the other thing that's very true in this scenario [00:38:00] too is that most patients that experience depression go through different cycles, go through some general anx-anxiety, issue that's going on, then have maybe a depressive status.

Often, as we were deferring, there's a substance abuse type of effort that then comes into this. They have bipolar episodes and, even schizophrenic episodes. So the real-world reality of what depression is not a singular disease, but it's a syndrome of-- and you're changing through that. And you may need different drug interventions, different cognitive therapies and behavioral therapies throughout that.

And we-- but what we don't have is very well-validated tools to assess that and assess that in that compendium and variety that we talked about. And that's the focus really of where MapD wants to be, and show that r- validated evidence, data-driven ability for us to be able to understand that, align with regulators, align with clinicians, align with then caregivers and, you know, [00:39:00] clinical care researchers, as well 

Mark Mullen: Let's talk about study design.

How is MAPD gonna be designed? 

Steve Hoffmann, MS: Yeah, so a lot of the, what we'll call the framework development has been done over the last year, and a half. Really assembled a who's who across different sectors. Can name them again, but we really went out to academic leadership, pharma leadership, clinicians, nonprofit organizations, and advocacy organizations that are keenly involved in mental health.

And we had set webinars that were in symposia that were focused on prioritizing what were the shovel-ready, what were the best of the different types of assessments, clinical assessments, digital wearables. Are there other novel technologies coming forward like speech and facial recognition, understanding, you know, sleep variation, and as Christine was talking about earlier, becoming an important subgroup that might-- we may need to identify.

We know that omics and a lot of different technologies on protein and [00:40:00] blood and testing and the normal biological variations, that technology has advanced very much as well. Single-cell technologies, the ability to look spatially in organ and do those assessments, brain imaging using EEG, using fMRI, you know, all that in compendium is part of the MAPD program.

And so we had specific webinars in each of those domains and really tried to prioritize what might be the measures that we would need, not nice to have, but need to have to really make this assessment. So the design is a longitudinal study where we're gonna look baseline, we're gonna look at early response in the first couple weeks, maybe within four to eight weeks, and then also at a year as, a design for a longitudinal observational study.

We wanna do this in a phasic way. It's difficult to go out and recruit in any clin- type of observational trial to really identify and get the trust. We talked a little bit about the stigma. We talked about the retention and really, you know, do these patient-- does [00:41:00] this patient population really, fit well with the rigor of clinical trials?

It's a challenge. It's a challenge and a gap that we really have to deal with. But we really wanna do this for, in a pilot phase, for about three hundred patients over the next three years. We wanna make sure that we can have multiple sites that are able to do this compendium of testing, that we can really show the success of this and really do the different testing over the period of time.

But then the goal was to expand that to thousands of patients, really then power the study where you might be able to look at different types of treatment. You can look at different populations. Sure, we wanna anchor this in major depressive syndrome, but you need to bring in folks that are bipolar.

You need to bring in those that have PTSD Those that have general anxiety disorder, because you need to understand that heterogeneity of the patient population within the study as you go forward. 

Mark Mullen: Which right now those patients are essentially s- excluded from studies of depression, right? Often. Often. I mean, that's, [00:42:00] one of the big issues with the- Yep

psychiatric literature is that we're not looking at patients that have multiple different diagnoses. 

Steve Hoffmann, MS: Correct. 

Mark Mullen: So it's a prospective study and you're going to be enrolling patients who have, what, a diagnosis of major depressive disorder, and then you're gonna run this battery of tests, which is like a sleep study EEG, probably a bunch of lab work.

Steve Hoffmann, MS: Correct. 

Mark Mullen: What else you got on there? 

Steve Hoffmann, MS: So you're-- again, there is gonna be subsets where we would look at some of the traditional brain imaging for fMRI that we would do. You're gonna do multi-omic testing, epigenetic testing on blood, some of the standard types of single cell technologies that are now possible.

You're gonna have cognitive assessments that are gonna be part of it, sleep monitoring. You're gonna have speech and video analysis, as I talked about, for facial type recognition. Yeah, you will do some CSF, right, and look at the cerebrospinal fluid to be able to do that on some of the subtypes. But what will probably be much more important are gonna be some [00:43:00] of the novel digital wearable type of assessments, the clinical assessments and interviewing of the patients that are gonna be part of these patient-reported outcomes.

Traditional scales that have been done and used over the years and years, though that's what we have as the current gold standards, they have matured, they have evolved. We now know that there are other assessments that we can do. We need that real world information to be brought in and correlated to these biological efforts.

And from that, the goal of the study really is to subtype and make sure that we can get larger buckets. Folks that might have maybe an immunological or a, inflammatory type of response. Are there those that have sleep and wake disruptions? Are there those that have serotonin and neurotransmitter type of issues?

They are within the population of those that are depressed. Talked about differences in suicidal ideations and, threat and the different loss of interest and others. Those subtypes [00:44:00] probably need to be treated differently, and we really need to be able to bucket populations and patients into the appropriate subgroup to match their treatment to what that subtype may be.

Mark Mullen: So you're gonna enroll three hundred patients initially. You're gonna run this battery of tests. You're gonna look for maybe patterns that run together in terms of inflammatory markers, genes, sleep, speech, et cetera. Are they gonna be randomized in any way? Are they gonna be-- is it gonna be treatment as usual?

They'll just be treated in the clinical environment, and you'll just follow observationally, or what's-- how's that gonna work? 

Steve Hoffmann, MS: Yeah, so the design is to be treatment agnostic. This is about first validating these tools. So there, there is no doubt that there-- people are gonna come in under their standard of care.

We might be able to track as they might change, come off meds, change meds. That's not the original remit of this. But you do-- we do see a time period as we expand and go larger as with success of this program, that we will be able to [00:45:00] then be powered to start asking questions of the treatment response of the particular treatment strategies from there.

But really, if the tools are not well-validated, if the tools are not data-driven and showing that they have that clinical meaningfulness, that they show functionality, as Christine talked about, in rec- you know, recovery or change, well, then that tool is really just a test, right? It's not giving us the information we need to make clinical decisions, to make drug development decisions, and that's where our initial focus is.

So if those tools are not well-validated, then the data that's gonna be produced from them are not gonna be what we need to move forward. 

Mark Mullen: And then are you comparing these three hundred people with major depressive disorder to controls? 

Steve Hoffmann, MS: Yeah. So there will be obviously control populations, those that have not had episodes in, within the group.

The other thing that will be important, and you don't really talk about all the weeds, I guess, of the program, is that we, in parallel, do wanna develop what we'll call a knowledge and data [00:46:00] repository portal that can house this data, that will be able to use AI technologies and other analytical techniques to be able to interrogate this data.

Think of the variety of the types of results we're gonna get, the types of data that's gonna come in from this. You know, you're not gonna be able to just apply standard analytics or standard statistics to this type of a, a database. If we can build that portal, it will also enable us to bring in other datasets to do cross-validation.

It will enable us to have a repository that can be a foundation for additional research, other ancillary studies, and obviously federated collaborative type of data sharing and data engagement. 

Mark Mullen: If we sit down five years from now and discuss this study-- I'll be honest, this is kind of a ridiculous question for a researcher, and you probably shouldn't answer it, but I'm gonna beg you to What are you hoping that we'll be discussing in five years?

Steve Hoffmann, MS: Yeah, I mean, I think the easy question is, this isn't gonna solve every unanswered question about psychiatry, you know, [00:47:00] overnight for doing this. But it can certainly move us beyond the trial and error type of approach toward a more precise data informed type of care. If we can identify in this three to five-year window truly data-driven subsets or phenotypes as, as we call out, then you can start to have the right treatment treat those particular patients, right?

The suffrage will be, less. The ability to, you know, I don't know, have-- not have misses, right? We know darn well that if you have two people that have major depression, and this one has a suicidal ideation that is way higher on that, well, that trial and error period is just unacceptable, right? You just don't wanna have that.

If we can move to the point that we have the tools now to move the science, and we have the tools to describe what depression really is and to be able to select treatments based on those subsets, based on those phenotypes, I think would, see that as a success and be able to [00:48:00] move forward. 

Mark Mullen: Dr.

Crawford, what do you think would be a success in this study? 

Christine M. Crawford, MD, MPH: For me, where I'm in clinic with my patients, with confidence, I could prescribe a medication for them. With confidence, I can make a recommendation for what sort of treatment they should pursue. Now, I wanna be clear, I already have confidence in my clinical ability, but I guess the better word to use is certainty, because we are oftentimes uncertain as to how someone might respond given their specific type of depression.

And also there is limited information for me to know about the type of depression that they have because my clinical judgment is just based off of what a patient tells me. But now, if I can actually look at certain biomarkers, I could have a better understanding of that person's, the complexity of that person's depression.

So having more [00:49:00] certainty about the nature of their condition as well as treatment, that really would make my job a lot easier. 

Mark Mullen: I'm hopeful, too. I think there's a lot that we don't know in psychiatry, and I think that an initiative like this is going to start to help us make progress on that. And I do appreciate, too, that when we talk about things like major depressive disorder, we're focusing on a subset of our, you know, our basically our nine SIGMECAP symptoms.

But there are other things like quality of sleep, et cetera, that we might be able to target to help these patients live more meaningful lives, and that our current DSM diagnosis plus FDA-approved medication and recommended psychotherapy technique might be missing some important signals. and sometimes maybe, I guess the real hope would be that this study would identify some biological signals that have relatively low-hanging fruit in terms of modifying them.

Like, if you can get someone sleeping better because you've identified a certain problem with that sleep, I could see where that would make a real difference in the life of the patient. [00:50:00] 

Christine M. Crawford, MD, MPH: Absolutely. Absolutely. 

Mark Mullen: Steve, do you have any final thoughts for our audience? 

Steve Hoffmann, MS: The one thing I did wanna bring up, and, you two are certainly well-versed in this area as well as many other in neurosciences, we see this as a potential that we saw many years ago for the ADNI program, the Alzheimer's, Disease Neuroimaging Initiative.

That went from understanding really what was going on in Alzheimer's patients or early folks that, that were developing Alzheimer's, looked at those longitudinally, and then that went in. We started looking at CSF samples and biomarkers, and then we now got to the point that we have blood tests, and we have drugs that are available in the Alzheimer's field.

And I, think you could really point to ADNI as a foundational type of change in the way we approached how we were looking at this in a longitudinal type of way, a compendium of data, and many, ancillary efforts, and it became the foundation [00:51:00] of, really research in AD. I see MAPD as having that same potential.

If we can be successful in really developing these tools, creating this large, unprecedented, largest data set that really can identify what depression really is and what it looks like, both biologically, socially, environmentally, and relate these related orders, I think it too could become that really transformational type of program.

So we look for-- this is what public-private partnership can do, and you gotta partner with the right folks and the expertise at the table across the different sectors. NAMI as well is really important to come together. This is just one of the challenges of our time, and this is an area where we just-- we must have progress here.

We need to have progress, and we gotta go all forward to make a program like this and related studies happen. 

Mark Mullen: Dr. Crawford, what about you? Any final thoughts from you? 

Christine M. Crawford, MD, MPH: What I appreciate about this [00:52:00] project is that the researchers understand that you can't design a project without holding the patient in mind, and not only thinking about that per- That patient and holding them in mind, but thinking about them as a person, right?

It's easy to get caught up in all of the science, and that's why I appreciate that this program is incorporating the voices of those who are living with depression and informing the work that they're doing. We oftentimes say at NAMI, "Nothing about us without us," right? And so this is a great model for how research should be done.

We need people who are living with these conditions that are being researched and thinking about treatments. They need a seat at the table to help better inform some of the research design. And Mark, as you heard about all of the assessments that the participants have to do, get cerebral [00:53:00] spinal fluid, fMRI, cog.

That's a lot of stuff, right? And so to have some of the approach for engaging this community in talking about all of the assessments that are needed, the language to use, it's really helpful to, to get the number of participants that they need, but also to inform the researchers the type of language that should be used when talking about this project.

Mark Mullen: Well, I'm really glad you guys are doing this. Thank you for gathering all of this data. Hopefully, the data's in-- I think it will be probably by the end of my career, we'll know a lot more about this. So maybe we'll meet again in five years, and we'll talk about what you guys have found. And to me, this sounds like a study that's gonna go on for a very, long time because you're gonna find a lot of rabbit holes that you're gonna wind up chasing over the course of many years.

So, I'm excited that you guys are assembling this data. Thanks for your hard work kind of on the bench science side of things to help us have more clinical tools that we can use to improve the lives of our patients. And thanks for coming on Psychiatry Boot Camp. 

Christine M. Crawford, MD, MPH: Thanks for having [00:54:00] me. 

Steve Hoffmann, MS: Thanks, Mark

Mark Mullen: Thanks so much for listening to this episode of Psychiatry Boot Camp. If you're enjoying the show, I'd love to know what you think. The best thing you can do for us is leave a rating and review on Apple Podcasts or a rating on Spotify. You can also reach out to me, mark@psychiatrybootcamp.com, with any questions or concerns.

You can find us on TikTok or Instagram @psychbootcamp, and you can connect with the rest of the fun Human Content Podcast family on Instagram or TikTok @humancontentpods. Full video episodes are also now available on YouTube at Psychiatry Boot Camp. Thanks again for listening. I'm your host, Mark Mullen.

Our executive producers are Aron Korney, Rob Goldman, Shahnti Brooke, and me, Mark Mullen. Season Five is produced by Amina Janjua, and this episode outline was by Usma Rizvi. Our editor and engineer is Jason Portizo. Theme music was generously donated by one of my favorite bands, Cave Radio. You [00:55:00] can find Cave Radio on Spotify, and other music was by Omer Ben-Zvi.

To learn about our program disclaimer and ethics policy, our submission verification and licensing terms, and our HIPAA release terms, go to psychiatrybootcamp.com, or you can also reach out to the team with any questions or concerns. Psychiatry Boot Camp is a Human Content production.

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