Panic Disorder Novel Treatment: Freespira, with Dr. Robert Cuyler

Robert: so I published a paper in November and the data set about 1, 500 patients, about 95 percent of the people who use the system, we had pre treatment and post treatment symptom data.

So we’re able to see not only are you using it regularly, is your physiology getting regulated, but we’re also able to see at the individual patient level, but also at the massive level whether symptoms are getting better.

Bruce: welcome to the future of psychiatry podcast, where we explore novel technology and new innovations in mental health.

I’m your host, Dr. Bassi, an addiction physician and biomedical engineer. Today I’m with Dr. Rob Cuyler. He’s the chief clinical officer at Freespira. He works on the clinical training and supervision of Freespira’s Licensed Clinical Assessors and Coaches. Freespira is the only FDA cleared, medication free, digital therapeutic treatment for PTSD and panic disorder.

It works by changing some core breathing patterns and stabilizing the respiratory rate with pacing tones and gives you some feedback on your output of your CO2 levels. It’s designed to be used 17 minutes twice a day for four weeks to change some core breathing patterns to address PTSD and panic disorder.

Dr. Bob, welcome

Robert: thank you. Glad to be with you today.

Bruce: Tell us a little bit about Freespira. What does it do?

Robert: Oh, Freespira is a very interesting if you think about it is respiratory biofeedback. It’s a system which is hardware software data analytics that gives people breath to breath feedback of their respiratory style, the respiratory rate, but also their exhaled CO2 levels. And I’m sure as we dig into this, I’ll explain to you a little more about why that’s an important part of respiration that we’re measuring.

But the system teaches people who have specific conditions, namely those with recurrent panic disorder or PTSD, who most of the time have Dysfunctional patterns of breathing all the time, but they have dysfunctional breathing during symptom surges. And so we teach people how to normalize their breathing for ordinary life, but also teach people how to regulate their physiology when they are stressed.

Exposed to triggering situations or feel like that panic sensation is coming on.

Bruce: Interesting. Yeah. A lot of mindful meditation I know revolves around being able to refocus on breathing and finding a regular cadence of breathing. So could you tell us a little bit more about the origin of Freespira?

Robert: sure. Really quite an interesting story. The founder of the company was actually a participant in a clinical trial that was conducted at Stanford University in the mid 2000s, and she had experienced basically, life crippling recurrent panic attacks, and in her participation in this clinical trial, by the end of the clinical trial, her panic attacks were basically done, they were basically resolved, and she said, this needs to come to the world, so she started with, she had a software background, worked with some engineering consultants, kitchen tables, and really kind of put together a prototype for what Freespira is now, which is a respiratory biofeedback device that measures those respiratory parameters that I just told you about.

That was really the origin of the story. And it was her passion about her profound recovery from what had really been kind of a crippling recurrent panic attacks, that really led her to found the company and get this whole process started.

Bruce: Interesting. So there’s something about the link there between the breathing and the treatment of the issue itself. Why do you think there’s such a close connection there between your breathing patterns and panic disorder or breathing patterns and PTSD?

Robert: great question. So if we go back a little further, about 30 years ago, there was a brilliant biological psychiatrist named Donald Klein. Who first started conceptualizing and studying dysfunctional breathing in panic conditions. And he conceptualized what he called a faulty suffocation alarm. That people who have a vulnerability to panic are extremely sensitive to sensations of shortness of breath.

And in response, they engage in compensatory breathing that kind of solves the discomfort for the moment, but creates what’s really kind of an unstable breathing pattern that ends up setting the stage for the next panic attack. So what we call hyperventilation, I think just about everybody recognizes somebody who’s having a panic attack is hyperventilating.

Well, about 70 percent of people with Panic disorder over breathe all the time. I sometimes say they’re breathing enough to sustain a brisk walk or a light jog when they’re sitting comfortably in their chair. Feels absolutely normal to them because according to Klein, they’re sort of resetting their breathing thermostat, but in a way that backfires.

There are other subtle kinds of breathing irregularities like holding your breath, yawning, sighing, that are all these kind of subclinical, subtle aspects of respiratory dysfunction that are really pretty specific to conditions that are in the panic family. We’ll talk a little bit, about how the heck PTSD fits there as well, but it was really that conceptualization about dysfunctional breathing, it’s relation to the balance of carbon dioxide and oxygen in the system that really led to this group out of Stanford and Southern Methodist University to start doing research. Really kind of asking an elegant question, if dysfunctional breathing is in the mix, what would happen if you taught people how to normalize their breathing?

And in that clinical trial that our founder participated in, that was the first piece of literature that I read and it was jaw dropping for me. So I’m a psychologist with 40 year background. I have yet to get a patient with severe panic well in 28 days. And in this particular study, 70 percent of the subjects were markedly well within 28 days and their improvement persisted a year post treatment.

So, teaching people how to breathe in a different way with that benefit lasting a full year, you know, when you consider With meds, the likelihood, if you stop taking a benzodiazepine or an antidepressant, you’re going to get symptomatic again, you know, to have stable outcomes out to a full year post treatment was really eye opening to me, that was a real big ingredient in my getting involved in this company.

Bruce: Interesting. So when it comes to learning how to breathe, it’s interesting because obviously in our medulla that carries quite a bit of involuntary control over our breathing.

And then we can understand or make artificial pauses to our breathing if we need to. But then our medulla kicks in. And so what you’re saying is that you can train your breathing, but is that going to be the training of your breathing at a baseline? Or is this, you think that, Oh, maybe my breathing is dysregulated because I’m panicking now. And now I can start to re regulate it. Back over again.

Robert: Yeah. So, actually we give two kinds of feedback. So one, to be clear, we are not intended to use this device to interrupt a panic attack in process is really to retrain the brain and retrain normal breathing. So the individual is breathing through a simple nasal cannula. So we’re measuring their exhaled breath.

And we’re measuring their respiratory rate and their exhaled CO2 level. And their job is to pace their breathing to a rising and falling audio tone. In other words, we are teaching paced breathing. Over the month, we go from, fast to slow, from 13 respirations per minute, finally down to six respirations per minute.

And while the person is pacing their breathing in that way, they’re also looking at a graph. of their exhaled CO2 level, and their job is to adjust their respiratory volume to move and hold their CO2 level in the normal zone, i. e. in balance with their oxygen level. And none of us are intuitively aware of our CO2 level, so that’s where the feedback comes in.

And like I said, most people. who have these conditions tend to overbreathe at rest. They breathe more than is really necessary, and it’s really kind of like their thermostat has been reset. We actually have evidence in our clinical trials that this normalization, the slowing of respiratory rate and the normal range CO2 levels is measurable as improved out to a full year post treatment.

So it’s evidence that we’ve, that people are actually retraining their ordinary respiratory style in a way that persists.

Bruce: And what is it about CO2 levels that is related to your breathing? Can you give somebody who’s not familiar kind of a bird’s eye view of why that physiology is important in the breathing pattern versus wearing some sort of chest strap that is measuring just simply breathing patterns alone?

Robert: Right. Well, the body aims for a balance between carbon dioxide and oxygen. And in people with these conditions, that balance is out of whack and We think we don’t have, we have a lot of sort of wraparound evidence without anything that, you know, nails it conclusively. But good reason to believe that this kind of dysfunctional breathing sort of interrupts with the balance or the homeostasis of anxiety symptoms.

And that people who breathe in this dysregulated way are sort of easily tripped into full bore panic. The other thing I’ll add about CO2, which is really quite fascinating. Is if you give people with a history of panic attacks a single gulp of CO2 enriched air, you provoke panic attacks on the spot in those folks, in many of their close relatives, and interestingly, in PTSD, the same pattern of reactivity to a single gulp of CO2, and not only triggering

kind of symptoms in PTSD, but for some people it triggers dissociative symptoms, and recurrence of traumatic flashbacks. Isn’t that fascinating how a single gulp of stale air can provoke a traumatic memory? So that’s one point of connection between panic and PTSD. Good reason to believe that this dysfunctional balance between carbon dioxide and oxygen seems to be an ingredient in triggering of symptoms.

And if you learn how to stabilize, but if you’re also learning a self management skill, which is what we hear from patients over and over again, feeling like my heart’s starting to race, or I think I had a skipped heartbeat, or oh my God, the sixth person got in the elevator with me, that new breathing style becomes readily available to them.

My very first patient said, Doc, it’s kind of weird. But I can hear those rising and falling tones in my head. And if I’m feeling stressed, I can pace myself and I don’t get triggered into a panic attack anymore.

Bruce: interesting. So I remember a lot of people probably can recall somebody would suggest breathing into a paper bag. Wouldn’t that increase the amount of CO2 that is rebreathed into one system and worsen?

Robert: It’s it’s that’s been debunked as a remedy. Well, one thing to remember about panic attacks is they tend to last five, 10, 15 minutes, and then they go away. And you have something that makes some sense and I’m doing something, but the panic attack is going to go away on its own. So the paper bag remedy has been debunked as a, you know, as a quick fix for your panic attacks.

Bruce: Well, just physiologically, it wouldn’t make a whole lot of sense either.

Robert: We’re exactly on the same page.

Bruce: So how do I know if I am somebody who has panic disorder and more prone to dysregulated breathing or would, is it safe to say the vast majority of people are prone to that issue and would benefit from Freespira and it’s worth giving it a try.

Robert: Well, you know , when you look at epidemiology, somewhere between 10 and 15 percent of the population has either recurrent panic attacks or PTSD. So it’s a pretty substantial condition. The other thing is that panic attacks are not subtle. yOu know, it’s this sudden surge of bodily distress.

It’s really interesting when you look at the other diagnoses in the DSM, the symptoms of panic attacks and panic disorder are 70 percent physiological. So there are fast racing heartbeat. Chest tightness, shortness of breath, chest pain, tremulousness, dizziness. Where they’re mistaken is that people feel like they’re having a cardiac event.

So they may go to the emergency room and then the emergency room says, you know, ma’am or sir, your heart is absolutely fine, you had a panic attack. And they are so dramatic. And come on so rapidly that they’re hard to mistake for anything else once you’ve been clarified that you don’t have heart disease.

And interestingly, in PTSD about 75 percent of people have some degree of panic symptom in the symptom mix. And panic attacks and PTSD tend to be triggered by traumatic reminders, as opposed to kind of coming out of the blue, which is sometimes more the case for people with panic attack without that kind of traumatic history.

So it’s not subtle. I have had one near panic attack in my life, and I distinctly remember it, and I’m really glad I haven’t had more. Like I said, it is not subtle. It’s very unpleasant, intensely, terrifying to the point that people feel like they’re dying, they’re out of control, they’re losing it.

Consequently, many people Go to cardiologist. They go to neurologist. They go to the emergency room. Physicians tell me they have never had a shift in their life without somebody coming with a panic attack and without heart disease. so it’s a brief, sheer terror during that episode.

Bruce: So you mentioned that Freespira is not designed to be used during a panic attack, but to help train breathing at baseline. But when somebody is having a panic attack, would they not tap into some of what they’ve learned from Freespira?

Robert: Oh, absolutely. That is the intent and

 

that self management skills. So without treatment, what happens? I’ll just give you a quick example. Somebody who may experiences. Oh, my God, I felt like I had a skipped heartbeat and my chest feels tight and if they get anxious about those first symptoms, then they get more anxious.

Their breathing gets, gets more dysregulated and then it escalates into a full bore panic attack. What we hear over and over from our patients is I felt something coming on and I breathed my way through it. That’s a paraphrase of what I’ve read thousands of times. I review progress notes from our coaches every night.

So I’m looking at 30, 40 case reports a night hearing by way of our coaches, what our patients are telling us about what they’re doing. And so that that’s something that we hear over and over again. I have a skill now that I didn’t use to where I’m aware when symptoms are coming on and I have a tangible skill that I can use that seems to nip in the bud.

The symptoms that used to escalate out of control.

Bruce: Gotcha. That’s helpful to know. So what can a patient expect when it comes to using Freespira at home? Walk us through some parts of the patient experience.

Robert: Yeah. Well, first is a backdrop in order to get it because we’re an FDA cleared intervention. We have to have a referral from a licensed health care professional. The FDA gave us the latitude because it’s a very safe intervention that non physicians can authorize or prescribe it. And so once that person is authorized, we go through, well, actually before we go through a couple of things, we determine that the individual is not pregnant or intending to get pregnant.

Actually, mom’s respiratory physiology changes significantly in the third trimester. We’ve not been tested for safety during pregnancy. We’re not a good fit for somebody who has late stage lung disease like advanced COPD. but if you’ve been cleared and you don’t have any medical contraindications, a system gets sent to your home and you’re assigned a health coach and you get that nice box from FedEx.

You open up the system and then a health coach. We’ll spend about 45 minutes with you educating you about why and how to use the system. So it’s an actual piece of hardware. There’s a tablet computer, a small respiratory sensor. The user breathes through a simple nasal cannula that’s measuring. Their exhalation, and the software actually, once they’ve been trained, walks them through every step of this 17 minute protocol that they’re going to do.

I can kind of describe simply, we take a brief baseline of your of your breathing for 2 minutes. For 10 minutes, you breathe in sync with a rising and falling audio tone. Final five minutes, the audio tones go away, which is really intended to develop the self modulated breathing style without being dependent on the machine to do so, because the system comes back at the end of 28 days.

I kind of liken it to the training wheels coming off the bicycle. You know, you could sell the training wheels, but after you learn how to ride the bike, you don’t need it. And it’s really kind of the same with normalized breathing. So that health coach teaches some basic principles of diaphragmatic breathing a rationale about why normalizing their breathing might be helpful.

And then that coach watches them during a first session. Sometimes when I work with a patient, I can see them and their shoulders are heaving and they’re breathing with their upper chest and their diaphragm. And as I want you to do something, I want you to put a hand on your chest and make that, that part of your breathing quiet.

Put your hand on your belly and feel your belly. Your belly just rise and barely rise and fall as you breathe in and out. That’s the kind of breathing style. So our coaches are modeling essentially a normalized breathing style. So we’ve got the coach. We’ve got the system, but we also have data analytics.

So the tablet computer is connected by by Bluetooth to the sensor, and then at the end of every session, the data goes up to the cloud. So both the user and our health coach has access to the data so that they can go back and looked at their past experience. And that patient may say. I’m getting my pace breathing down, but I need some help.

My CO2 level is still way out of whack coach. How can I get past that? Or if the coach sees that the person has not done sessions for a day and a half, they check in and say, Is there a problem? How can I help you? So that coach is educating and promoting good adherence and that coach is available for about 15 minutes a week for the four weeks of the treatment.

So the coach is supporting that use, answering questions. gently encouraging that people kind of resume parts of their daily life that they’ve given up. I think this is worth mentioning. Both panic and PTSD avoidance becomes a real part of the symptom complex. So you have people with panic attacks who won’t drive on the freeway because they had an 18 wheeler in their view.

I’m here. I’m from Houston, Texas. If you can imagine getting around Houston, Texas without ever. Getting on the freeway. We

have some people who won’t drive over a bridge. I’ve worked with multiple people who have had panic attacks in flight, who either won’t fly… Or they have two Xanax and a martini before they get on a plane, which is not a very functional way of dealing with that.

And so the people have compressed their lives, giving up things in order to avoid a panic triggering episode. I have to repeat a brief story. We’re also working with veterans with PTSD and one of our coaches wrapped up a session right before supervision and said, veteran, I just finished with. said he took his five year old daughter to the movies for the first time in her life.

And we all got it. So this guy, combat veteran who could not walk in a dark room full of strangers. And for him, that was the marker that he was improved, that he felt safe doing that. So what we hear is that people begin to test and give up these parts of their lives that they’ve avoided. out of a fear that they’ll have a next symptom surge.

Bruce: Wow, that’s an incredible story. So what kind of data, you mentioned that some of the user data gets uploaded and they can see that data on a portal, what other data is analyzed and, what kind of additional feedback is given to the participant in the coach.

Robert: So the, the coach is reviewing that, that session by session data. So they may be able to either say you’re on the right track. you know, sometimes people in the very beginning have some fairly mild side effects, like a sense of air hunger or shortness of breath, and they get coached that, you know, this often happens, but it eases, the coaches are seeing adherence, they may be seeing somebody who’s CO2 level is way out of whack, so they may coach the individual.

Let’s not pay attention to that for the moment. Let’s just get you breathing with, you know, The pace tones. And so let’s get that under your belt before we take on adjusting respiratory volume. So that data that we collect is usable at the individual patient level. We also have symptom questionnaires that are available, that are on the tablet the patient is prompted on a weekly basis.

So both the individual, as well as the coach and the referring clinician are able to see. in an automated way, how the symptoms are progressing over time. So I published a paper in November and the data set about 1, 500 patients, about 95 percent of the people who use the system, we had pre treatment and post treatment symptom data.

So we’re able to see not only are you using it regularly, is your physiology getting regulated, but we’re also able to see at the individual patient level, but also at the massive level. whether symptoms are getting better.

Bruce: So, when a patient comes to somebody at Freespira, has the typical person already tried a number of interventions before and would you recommend that or would you recommend say somebody hasn’t ever seen a mental health clinician before to first start off with using Freespira? Or do you think it, it doesn’t really matter? It’s more dependent on the patient’s interest.

Robert: Great question. The vast majority of people that we see have had prior treatment, sometimes multiple treatments. We often hear people say, you know, I did talk therapy and it didn’t really help. The therapist was really nice. Other parts of my life got better, but my panic attacks or my PTSD did not really change.

It’s very common. that we see people who want a non medication approach. as I’m sure you know, benzodiazepines are routinely used for panic and those can be problematic medications with risk of abuse over time. Antidepressants work pretty darn good, but they’re slow to work and they have significant side effects and symptoms tend to come back if you, if you discontinue the medication.

So, you know, personally, it’s rare for me to get a referral for somebody who is Never been treated before. I most often get referrals from psychiatrist colleagues who said this is somebody who is symptomatic again and does not want to come within a mile of an antidepressant. They really didn’t like it before.

You know, is this an option? So we are mostly treating actually in our clinical trials. What’s interesting. is the average enrollment in two of the clinical trials for panic disorder had a 10 year history of diagnosed panic disorder before they entered the trial. We had a trial that was done at the Palo Alto VA.

Average duration of PTSD was 19 years. So we, in the clinical trials, were enrolling people with chronic conditions and multiple other treatment interventions. I really like to think about this as an option, as a tool that’s in the toolkit for both individual and clinician. And for some people, I think it would be a great fit for somebody who has not had other treatments, who is relatively uncomplicated.

And every expectation is that we would be as beneficial as somebody who had a chronic condition. But we’re still a relatively new intervention, so it’s kind of unusual for us to see. Somebody who has not had other treatments. The other thing that’s in the mix. So I’m a psychologist and a talk therapist.

And the best research therapies for both panic and PTSD involve gradual exposure to stimulus that provoke symptoms. So prolonged exposure therapy or systematic desensitization, they work great for people who can tolerate it. If you look at the literature, for example, in PTSD, in veterans, over half of veterans who enroll in a clinical trial with prolonged exposure will drop out.

And so the, the conclusion is that the treatment is very beneficial for people who can tolerate it. But there are a lot of people who do not want to go there for a treatment that requires them to revisit their traumatic memories or provocative situations like The 18 wheeler on the freeway, and so with Freespira, there’s no our coaches don’t take a history.

We only hear what people tell us, and there is no need for them to revisit their personal lives or their trauma. Sometimes they tell us but what we find is, I think it’s a combination of learning a self management skill that does not require revisiting painful memories that we think is a real important ingredient in the very good adherence rates that we see both in research and in actual clinical use.

Bruce: That’s so interesting. I totally agree with that. That’s a neat advantage of it. So I know that Freespira is FDA approved for panic disorder and PTSD. And we often in psychiatry use treatments that aren’t necessarily formally approved by the FDA for particular disorder. Would Freespira help an individual who has generalized anxiety disorder?

And if so, did the company think it might be helpful to get additional approval for that or not necessarily?

Robert: Sure. Well, one thing because we are FDA cleared as a company, we can only. Discuss treatments that have the FDA clearance and so we cannot go off label. Sometimes we have clinicians that do there’s a percentage of people who have generalized anxiety who also have panic symptoms. There are a lot of people with social anxiety who have panic symptoms and so actually part of our FDA clearance is if we can identify that this person is having panic attacks, no matter what the other diagnosis is, we are on label there, but we do have, for example, we’ve got a clinical trial that’s underway at University of Texas that’s open to a much broader range so that Social anxiety, generalized anxiety and such are eligible for enrollment in the trial.

So, the possibility, is that as that trial comes to completion, we may be able to approach the FDA for additional clearances, because we’ve got data. So, you need safety data, you need efficacy data. We have also been involved in some other research. Early stage looking at sleep apnea in veterans, sleep apnea is very common in veterans and actually compliant use of CPAP is very poor in veterans, much worse than civilians even though that’s poor also.

So we’ve got some work underway looking at whether, using this intervention that teaches people how to normalize their breathing may make them more tolerant of wearing a CPAP at night to address their sleep CPAP. So every week, I think of 3 other research projects that I wish we had done. I think there’s tremendous opportunity in the future looking at comorbid conditions.

There are a lot of medical conditions that have a linkage with panic attacks. There’s been some research that’s done with asthma. with positive outcomes for actually the Stanford based protocol that did not use our instrumentation. There are high rates of panic attacks in IBS, in migraine. sO there are other conditions that I think would be early stage.

COPD is another where rates of panic attack are about five to eight times the general population. But we’re a very research and data driven company. So… We’ve got to get the bandwidth time and funds to be able to pursue these additional things. So a long winded answer to your question. We don’t quite know.

And as a company, we need data to be able to then support it. But we’ve got a grant application underway right now for additional research on PTSD. We’ve got a trial going. Right now that’s open to GAd. And social anxiety and other anxiety disorders. Interestingly, the literature has us has led us to believe that that OCD travels in different circuitry in the brain, and we don’t have any reason to believe that something that addresses carbon dioxide balance would have an impact on OCD. So they’re not eligible for this particular trial going on.

Bruce: Gotcha. That’s interesting. How does it work for PTSD? I know the phenotype for PTSD, even two people who have the same diagnosis can be very different. It’s quite a heterogeneous group. Are there certain symptoms for PTSD that it works particularly well for?

Robert: You know, it’s a great question and we’re still learning. So one thing that is fascinating in the literature, there’s a really well done epidemiological study that describes a strong bi directional relationship between panic and PTSD. So the likelihood, if you have panic risk, and you’re exposed to trauma that you’re going to develop PTSD.

There’s a high risk if you have PTSD that you’re going to develop panic symptoms. So there’s a, that interesting bi directional, we think they’re overlapping conditions. When we undertook the trial at the Palo Alto VA, I have to tell you, I was somewhere between skeptical and cautiously optimistic because they are quite distinct conditions.

And we had very, very positive Outcomes there. What was interesting is that the participants in the PTSD trial had very dysregulated breathing at baseline. Actually their clinical improvement was noticeably better than people who did not have seriously dysregulated breathing, but both populations had really substantial recoveries.

So 80 percent of the people in that trial who were not selected because of their breathing characteristics had clinically meaningful symptom reductions, 50 percent no longer qualified for a diagnosis of PTSD, six months post treatment. So there’s a lot left there to learn. I originally thought that the kind of hyper vigilance, hyper awareness, you know, scanning the world for danger would be the symptom category that was most likely to, you know, to see reductions.

But actually, we saw strong reductions across the board in PTSD symptoms. Interestingly, there were also decreases in suicidal ideation. There were decreases in depression. We’ve got another data analytic project queued up where we’re going to kind of look at symptom category, but I’ve been surprised, you know, this is really at the, the individual patient level hearing about people who’s.

Dissociative symptoms have gone away or people whose traumatic nightmares have really diminished, or if they have a nightmare, they put themselves back to sleep more readily. That’s fascinating to think about, and we don’t understand it, but I think there are a lot of effective treatments that we don’t really know fully why they work.

I read something a while back. It was only in the last 10 or 15 years ago that we understand why Tylenol gets rid of your headache. You don’t have headache because you have a Tylenol deficit, right? So there are a lot of things in medicine and in psychiatry that work without us fully understanding why, and my own opinion is there’s a combination of normalizing physiology, but also building self management skills that are really important because one aspect of PTSD and panic is a sense of being out of control, that you can either out of the blue or like I said when that You know, car backfires in the parking lot that all of a sudden you were back in your trauma.

And what’s what’s fascinating is people articulating that they have a sense that they have a usable tool allows them to kind of nip the symptom surge in the bud. That would be the way that I would kind of describe, you know, having worked with patients and read the descriptions of thousands of notes now where people are talking about.

You know, if and how this treatment is working.

Bruce: Interesting. You mentioned a pregnancy as one contraindication. Are there other contraindications to using this?

Robert: Yeah, the only other real official medical contraindication, would be late stage lung disease like COPD where carbon dioxide retention is the problem. So instead of hyperventilating and have very low CO2 levels, you’d have people who have abnormally high CO2 levels. We’re also not a good fit for people who are, you know, in serious psychiatric acuity, who are at, you know, at current risk of suicide.

And also you need some availability to stability of housing access to Internet or cell signal and willingness to take on something that you practice twice a day. So, as part of our screening, we asked the question, you know, do you think you can commit yourselves to doing this twice a day for the next month?

If you’re changing jobs. If you know, if you have no access to internet signal or cell signal, or if life is just too unhinged and topsy turvy, you may say it may be wetter to better to wait and take this on a little bit later.

Bruce: Gotcha. Gotcha. That makes sense.

Robert: We’ve certainly treated some people with reasonable success with basically stable bipolar. You know, they’re not currently symptomatic. We don’t have any research for people with other psychos like psychosis, like schizophrenia. So on some of those, we kind of take. Case by case, and we have some clinicians that prescribe off label and, you know, it’s part of medicine that’s certainly frequent and acceptable.

And we also learn sometimes we, we learn what kind of characteristics we may coach somebody say, you know, it might be better to work with your doctor and get your medications regulated and have some more stability. And then let’s revisit and take that on when life is a little bit of, on a smoother glide.

Bruce: That’s smart. And on this topic of patient safety, are there other precautions that are taken for the patients? I know you mentioned the 1st session is monitored with the coach during the session. What are the types of measures are taken?

Robert: Well, I think that’s in the weekly coaching. If we hear from a patient that, for example, they’re developing suicidal ideation, or if they have, you know, the degree of depression that’s keeping them from using this regularly, we always have a clinician of record. And so we would ask that person to talk to their doctor.

 

Those are the kind of people where it’s really kind of safer to do this in tandem with them actively seeing a psychiatrist or a psychologist. But if there’s a, if there’s a level of concern, our coaches in consultation with me will contact that referring clinician or primary care doctor and just basically do a, do a check in to make sure that we’re proceeding safely.

Bruce: Interesting. And let’s talk about the timeframe for the treatment as well. I know that Freespira is supposed to be used for 4 weeks. Are there any patients who use it beyond 4 weeks? Or is it?. I mean, I think one of the main advantages of Freespira is that the effects are very durable and long lasting up to a year afterwards, you even mentioned.

So do people use it beyond that if they’d like to continue with it?

Robert: So on a case by case basis, we may go beyond 28 days for some people that maybe had some travel in the middle. Are they’re saying I’m getting it, but I’m not quite there. And so our coaches will then work with them for an additional week or two. The other thing that we do, you know, when I use that metaphor of the training wheels off the bicycle, we also have an app of the pacing tones.

So most people have really kind of learned how to normalize their respiratory volume. That’s what we need. Somewhat complicated sensor to do, but for our alumni, we send them an app that they have on their phone. They say they can dial in. I want to breathe for three minutes at six respirations per minute with the pacing tones that they’re used to hearing.

So this is their, their, their alumni gift that they can take with them that reinforces that kind of breathing style. What’s also interesting, you know, because of our FDA protocol, we recommend the 28 day course. We certainly know that some people are significantly improved long before the end of four weeks.

Interestingly, we have a pretty fair number of people who 7 to 10 days in are already saying, I am noticeably better already. What we don’t know We always advocate for doing the full month. We would hate to encourage somebody to stop early and then perhaps they don’t have it down because we don’t know whether durability of the treatment is going to hold up.

If you’ve only done it for. 17 days instead of 28 days. So we recommend the full 28 days. What we have found is that when people get to about 60 percent of the recommended 56 sessions, their clinical benefit is pretty well in place. So we have kind of a dose response curve that says by the time you’ve kind of gotten to the point three weeks in, you’re, you’re starting to see the symptomatic improvement kind of level out at that.

Bruce: Interesting. So you mentioned it sounds highly effective. It sounds like there’s many studies to support this there. 10 years. Some people even notice benefit within a few weeks. Are there any Potential is there room for improvement? Is the team working on any additional features with free spirit? Or what is the what lies ahead in the future?

Robert: Yeah. I think there are a couple of things that lie ahead. One is looking at whether we have applicability to other conditions. And so we talked about that a little bit. I think the extension to social anxiety, generalized anxiety, phobias, those are kind of things that are really sort of rich. And then the other is in the direction.

Medical comorbidities and a lot of times panic symptoms are really under recognized. I did a lot of work with chronic headache and a lot of times you look at two different people with migraine. 1 person who panics at the migraine offset and then goes to the emergency room and then the other closes the drapes, you know, so there’s a lot of reactivity to distress that drives medical overutilization.

So it’d be very interesting to see if we were able to sort of create that same sorts of self control and symptom reduction for people who have medical conditions that have connections to panic symptoms. I think the other real opportunity that we have in the future. Is in our interface and, you know, probably a gamified interface.

Right now you’re seeing two graphs and you’re trying to get your lines conform with the graph. And I think when we can say in terms of what we’re doing already is working pretty darn well, you know, study after study, we’re seeing that 70 percent plus people who do this are significantly better in a month.

But in in terms of improvement and engagement, I think a gamified interface is something that I would really like us to go. We are in the process of presenting data to the FDA. That’s kind of in the works for adolescence. Right now. We’re FDA cleared for ages 18 and above during the pandemic interventions like ours that were safe behavioral health interventions.

We had a waiver by the by the by the FDA process. to be able to offer to adolescents. What we’ve seen so far is that our clinical outcomes and our adherence is about as good in adolescents as it is in adults. But I think something that was more gamified would be that much more engaging, not only for the people 17 and younger, but those of us who were older, who still have brains kind of like Wired, like kids.

Bruce: for the individuals who don’t seem to benefit from Freespira. Do you have any hypotheses as to why that was the case? Do you feel like it was something about the coaching or the interface or their physiology that didn’t lend well to the setup?

Robert: Is that when a major depression is in the severe category, where it’s hard to have the energy to do much of anything, to get out of bed in the morning, that’s, that’s not a great fit. So you need, you need that kind of self direction, motivation, and energy to be able to do it regularly.

The other category in people… There’s a concept called anxiety sensitivity, which is you’re afraid of being afraid and terribly afraid of symptoms. And so for some people, transitory air hunger. That they feel they feel like, oh, my God, I can’t get a breath. You know, I’m suffocating. We have some people who stop early, because of that sensation of air hunger.

And I think in terms of future developments, I could see us trying to profile better. Who has that early air hunger and easing them into the intervention much more gradually so that they are not scared in their first session. You’re kind of the metaphor that I sometimes use is, you know, if you want to participate in that fun run, the first time you jog around the block, you’re going to feel short of breath, right?

Feeling short of breath is a signal that you’ve exercised. But if you react to that shortness of breath by saying, I’m going to sit on the couch and I’m never going to run again. You’re not going to achieve your goal. So we try to educate that that sensation of air hunger or shortness of breath is going to go away.

And please give this a little ways for some people. They are so scared of that sensation that they discontinue early.

Bruce: That makes sense. Yeah. What is your mission and how has that evolved over time as Freespira has grown to meet the needs of the public.

Robert: Yeah, I think, you know, from our founder who said this really worked in the world needs to have it. So our mission is really to offer you know, technology based mental health interventions to the world. A strategy has changed. When we began, we thought that this might be something that would be adopted by office practitioners, and that turned out to be complicated.

One is you have to learn a new system. You’d have to bundle that into what you’re already doing with the patient. We spend about a month training each of our coaches, and there’s no way, Doc, that I could say the Hey, how about you spend a month training on this before we send you a system to use with your patients? And besides, there’s not any additional payment that you’re going to get for,

you know, for using it. So we have really kind of shifted then to using our own employed coaches who do this all day, every day. Terrifically trained, great motivators, all sorts of tips and tweaks that they can recommend to patients.

And also our model has really been to pursue insurance coverage, as opposed to people using this direct to consumer out of pocket. So right now we are available in the VA on a, clinicians referral, we are covered by multiple health plans, but we’re still a novel intervention. And so we are really kind of going insurer by insurer, payer by payer, presenting our evidence base, looking, you know, we help them do data analytics.

Many times they are surprised how frequent and how costly panic and PTSD are in their populations. And so there is, you know, there’s not only the human quality of life improvement, but there’s also economic return. We’ve got some several different projects that have shown significant reductions in medical spending for people who’ve been treated with the intervention.

So it’s still, you know, an everyday focus for us to educate. And advocate for better insurance coverage. We’re very involved with the Digital Therapeutic Alliance. There’s a bill before Congress right now, you know, when Medicare was created in 1965 technology like this was off in the future. And so there’s not a clear benefit category.

So we are. asking Congress to direct Medicare to create a benefit category that would fit for digital therapeutics. So those are really the kind of growth and advocacy efforts that we’re involved in.

Bruce: Interesting. What challenges lie ahead for you or the company or as a clinician?

Robert: I think better recognition coding and insurance coverage is the main thing. Once we have it in place, because of our data analytics, we have quarterly meetings with all of our healthcare insurers where we can say, Your clinical outcomes are as good as every other user. 70 percent of your users are markedly better.

The dropout rates are low. So we have a data driven approach. So I know you’re a psychiatrist and a prescriber. It would be like if you were able to go. to an insurance company and to say, we can tell you that your patient filled the prescription, swallowed the pill, their physiology changed and their blood pressure went down.

So we have all of those data analytics. And so we have an absolute transparency with our payer customers where we can say, we’re going to share with you how this is used, the clinical benefit of your users. And you take a look at it, and if it’s not sufficient, we’ve not lost coverage anywhere that we’ve gained it, but, I think that’s also part of our network here, other companies in the digital therapeutic realm, those kind of data analytics are really characteristic of companies that are doing this, where we are measuring adherence and clinical benefits, so we’re able to go beyond an initial clinical trial and say, people in the real world using this intervention Have the same kind of metrics, the same kind of benefits as was seen in a formal academic clinical trial.

Bruce: do you have any recommendations for an individual who’s interested in innovating in mental health?

Robert: Please pursue it with your eyes open. There are wonderful ideas that take a long time to get to market. that have hurdles that you have never anticipated. Regulators are conservative. They are slow. We really took the position that we were not going to be a wellness device. We were not going to be direct to consumer that we needed an evidence base.

We needed publications. We needed active research. We needed the FDA to review. And even with all of that. It’s taken a long time for us to really have the kind of momentum that we’re experiencing now, so I would say, please pursue your ideas with your eyes open with funding streams to have to have evidence behind your intervention every time I see it listed, you know, whether they’re 10, 20, 30.000 health apps that are available in app stores, many of which say, well, good for your stress relief with absolutely no evidence. We’re in a different category. We’re treating specific conditions. I think the other thing. our own perspective is that interventions that can really demonstrate benefit in specific conditions. You know, some of our colleagues are working on post stroke rehabilitation, some are working on autism, some are working on fibromyalgia, and all using the same kind of approach of research and evidence base.

I personally think That some of these conditions specific, complicated, costly, life impairing conditions are really where digital therapeutics are going to get their, get their firm footing.

Bruce: Interesting. Yeah, I agree with you on that. Are there any new novel treatments within psychiatry other than free spirit that excite you that you feel like are very innovative and worth mentioning on the future of psychiatry podcast?

Robert: Sure, it’s really fascinating to follow research that’s going on with psychedelics. You know, they have just come, you know, into the public and scientific eye and it’s fascinating. And there’s some really good work emerging there. I have a concern that because of the nature of psychedelics, the experience is going to have to be intensively coached.

And we have a real shortage of mental health professionals. I was talking to a psychiatrist who’s part of a trial of psilocybin for PTSD. And there are two trained clinicians. In the room with each individual for an eight hour stint, and so I have a concern that psychedelics are going to be kind of boutique II that they’re going to be very expensive clinics that are going to give kind of concierge treatments.

I think the opportunity is in the pharmaceutical research that is going to find the essence of psychedelics that are not as trippy that people can. Take them without the mind altering aspects. So that’s one category. I think they’re fascinating things that are happening in virtual reality. And I think that’s going to be another arena, for example, like an exposure therapies to be able to have a graduated exposure with the person kind of in control of the stimuli that they see by virtual reality, I think there are also going to be some interesting things where the Freespira will be or not. I don’t know of digital therapeutics used in conjunction with pharmaceuticals, where there may be an augmentation approach. It would be very interesting.

You know, there’s people that I talked about that are too, disturbed by their air hunger and discontinue Freespira, you know, were there a medication that would ease some of that physiologic reactivity that could be used on a very single or several doses of medication to ease that person into the self, you know, the, the skill building aspects of Freespira, those are some of the things and, and we see more of pharma developing digital therapeutic arms. And so I know in that industry, there’s a lot of work going on about finding synergy between these digital therapeutic approaches and pharmacologic approaches.

Bruce: Interesting.

Well, this is a really awesome conversation, Dr. Cuyler you’re really insightful and I appreciate the time that you’ve taken today to teach us a little bit about panic disorder, PTSD, and how Freespira can help with breathing re regulation.

Do you have any closing comments about how individuals may be able to use Freespira?

Robert: Yeah, I think one takeaway from seeing thousands of patients as a representative of the company. Don’t give up. There’s a lot of demoralization that goes on when people develop chronic conditions and have an openness to try something new that has an evidence base to it. I’d really encourage people to, to not just live with their horribly constricted life zone that they’ve, you know, kind of shrunk into, because we have seen so many people who were telling us that they live a fuller life than they did beforehand.

Bruce: That’s incredible. Well, thank you so much. I appreciate it.

Robert: Thank you for the opportunity.

Bruce: I’d appreciate it if you please like and share the podcast with your colleagues. It would be especially helpful for us. And if you’d like, please leave us a rating on your favorite podcatcher. If you’re a clinician, I developed a course on how to start a private practice. And for patients, I’ve also developed a course on ACT and CBT based lessons for treating and helping anxiety.

And you can find those all on our website as well. Thank you so much. And I’ll see you in the next episode.