Mental Health Startup Uses Voice ‘Biomarkers’ To Detect Signs Of Depression And Anxiety

Young female character having a panic attack, an imaginary monster shadow silhouette, mental health issues, psychology

The quick brown fox jumps over the lazy dog,” Rima Seiilova-Olson says slowly and emphatically over Zoom.

The simple sentence holds enormous value for mental health care, she explains, smiling as if to acknowledge that it might be less than obvious how a silly phrase could be so meaningful to a computer programmer and leader of an artificial intelligence startup.

The short saying contains every letter of the alphabet and phoneme in the English language, says Seiilova-Olson, an immigrant from Kazakhstan who is cofounder and chief scientist of Kintsugi Mindful Wellness. Kintsugi believes these sounds offer invaluable insight that can help mental health providers better support people with depression and anxiety.

The Bay Area-based company is building AI software that analyzes short clips of speech to detect depression and anxiety. This so-called voice biomarker software is being integrated into clinical call centers, telehealth services and remote monitoring apps to screen and triage patients reaching out for support, helping providers more quickly and easily assess their needs and respond.

“There’s just not a lot of visibility as to who is severely depressed or anxious.”

Kintsugi CEO and co-founder Grace Chang

Seiilova-Olson, 36, first met co-founder and CEO Grace Chang, 40, a Taiwanese immigrant now based in Berkeley, in 2019 at an open AI hackathon in San Francisco. Surprised to cross paths at a male-dominated event, the women began comparing notes about their respective personal challenges trying to access mental health care:

Seiilova-Olson had struggled to secure a therapist during postpartum depression with her first child, and when Chang had needed her own support, she said it had taken months for anyone from Kaiser to call her back.

“Living in the Bay Area, you can push a button and a car can come to you or food can come to you,” Chang says. “But this was really a challenge.” As engineers, they viewed the dilemma differently than clinicians might.

“We saw this as an infrastructure problem, where you have so many people trying to jam through that front door,” Chang explains. “But there’s just not a lot of visibility as to who is severely depressed or anxious, who is low-to-moderate. And if we could provide this information to those frontline practitioners, then we’d maybe have an opportunity to greatly alleviate that bottleneck.”

Kintsugi was born out of that idea in 2019. It sits in a competitive space of health tech startups like Ellipsis Health and Winter Light Labs that are using voice biomarkers to detect mental health or cognitive issues, built on research showing that certain linguistic patterns and characteristics of a person’s voice can be correlated with psychiatric or neurological conditions.

Kintsugi last year raised $8 million in seed funding led by Acrew Capital, and in February, announced it had closed a $20 million Series A round led by Insight Partners, which valued the company at nearly $85 million, according to PitchBook.

In-person mental health facilities typically use questionnaires to gauge the severity of patients’ anxiety or depression, measures known as PHQ-9 and GAD-7 scores. But during telehealth visits or phone consults — where face-to-face interaction is lost, making it harder to pick up on symptoms — Kintsugi’s technology helps to fill that gap.

Nicha Cumberbatch, assistant director of public health at Spora Health, a provider focused on health equity and people of color, uses Kintsugi’s software to assess women in its all-virtual, doula-led maternal health program, Spora Mommas.

The voice analysis tool, which Spora began using for patient consultations a few weeks ago, has helped Cumberbatch identify women who are, or may be at risk of, experiencing anxiety and depression before, during or after their pregnancies. When a patient starts speaking to a Spora clinician or doula on Zoom, Kintsugi’s AI begins listening to and analyzing her voice.

After processing 20 seconds of speech, the AI will then spit out the patient’s PHQ-9 and GAD-7. The employee can then use that mental health score to decide what additional testing may be needed and how best to advise or direct the patient to resources — like a psychiatrist, cognitive behavioral therapist or obstetrician.

Cumberbatch says Kintsugi’s technology is allowing her to “​​keep a more watchful eye” on her patients “and then move forward with proactive recommendations around mitigating their symptoms.” And while it’s not meant to replace clinicians or formal medical evaluations, she adds, it can be used as a screening tool to “allow us to have a more well-rounded, 360-view of the patient when we don’t have them in front of our face.”

“That technology… [allows] us to have a more well-rounded, 360-view of the patient when we don’t have them in front of our face.”

Nicha Cumberbatch, assistant director of public health at Spora Health

Dr. ​​Jaskanwal Deep Singh Sara, a Mayo Clinic cardiologist who has collaborated with Ellipsis and led research on potential uses of voice biomarkers for cardiology, cautions that while the technology is promising for health care, the field has a long way to go to ensure that it’s accurate, safe and beneficial for patients and clinicians alike.

“It’s not ready for primetime by any stretch of the imagination yet,” Dr. Sara says. Studies in psychiatry, neurology, cardiology and other areas have shown an association between voice biomarkers and various conditions or diseases, but they haven’t shown how this relationship can be used to improve clinical outcomes, he says.

Such research is “not the same as saying, ‘How can we instrumentalize it in clinical practice, and how feasible is it? How effective is it in gauging an individual’s medical trajectory?’” he explains. “If it doesn’t provide any benefits in terms of how we manage them, then the question is: why would you do it?”

He says addressing those questions is “one of many next steps that we have to undertake on this” and that larger clinical trials are needed to answer them. “If it makes health care delivery cheaper or more efficient, or if it improves outcomes for patients, then that’s great,” he adds. “But I think we need to demonstrate that first with clinical trials, and that hasn’t been done.”

To address these issues and validate its software, Kintsugi is conducting clinical studies, including with the University of Arkansas for Medical Sciences, and the National Science Foundation has awarded Kintsugi multiple grants to ramp up its research. The company is also pursuing FDA “de novo” clearance and continuing to build its own dataset to improve its machine learning models.

(Data and insights from Kintsugi’s voice journaling app, as well as conversations with call centers or telehealth providers and clinical collaborations with various hospitals, all become part of an enormous dataset that feeds Kintsugi’s AI.) Seiilova-Olson says this self-generated, unfettered proprietary dataset is what sets Kintsugi apart in the AI health care space — where many technologies are reliant on outside data from electronic health records.

That collection of troves of data on individuals’ speech can be concerning — particularly in the mental health and wellness space, which is widely considered a regulatory Wild West. (These products and services are often not subject to the same laws and stringent standards that govern how licensed clinicians provide formal medical care to patients.)

But Kintsugi’s founders say that patient privacy is protected because what matters for its technology is not what people are saying, but how they are saying it. Patients are also asked for their consent to be recorded and care is not affected by their decision to opt in or opt out, according to the founders.

Kintsugi says it has served an estimated 34,000 patients. The company is currently working with a large health system with 90 hospitals and clinics across 22 states, and they are active in a care management call center that services roughly 20 million calls per year. It is also partnering with Pegasystems, which offers customer service tools for health care and other industries, to help payers and providers handle inbound calls.

Chang says other customers include Fortune 10 enterprise payers, pharmaceutical organizations and digital health applications focused on remote patient monitoring, but that she could not yet share their names. Kintsugi’s clinical partners include Children’s Hospital Colorado, Joe DiMaggio Children’s Hospital in Florida, Chelsea and Westminster Hospital in London and SJD Barcelona Children’s Hospital in Spain, Chang said.

Prentice Tom, Kintsugi’s chief medical officer, adds that it’s working with the University of Arkansas to explore how the tool can be used to possibly identify patients with suicidal ideation, or increased or severe suicide risk, as well as with Loma Linda University, to look at how the technology can be used to spot burnout amongst clinicians.

The team is also looking for ways to expand availability and uses for younger and elderly patients, as well as for maternal and postpartum populations. And beyond patients themselves, it’s perhaps nurses who are benefiting most from Kintsugi’s work, according to the founding team: having a triage tool that helps reduce administrative work or the time spent asking generic questions enables nurses to more seamlessly move patients in their journey.

But Tom, a Harvard-trained emergency medicine physician and former faculty member at Stanford University’s Department of Emergency Medicine, says Kintsugi is now doing far more than addressing infrastructure issues alone. It’s democratizing access to mental health care, Tom said, moving away from a physician-centric paradigm that caters more to people with significant enough depression that they require medical evaluation.

“This tool actually creates a view of mental health in terms of mental wellness,” Tom said, “where everyone has the opportunity to understand where they sit on the spectrum and that actually stratifies treatment options well beyond the current infrastructure.”

I’m a Senior Writer at Forbes covering the intersection of technology and society. Before joining Forbes, I spent three years as a tech reporter at Politico, where I covered

Source: Mental Health Startup Uses Voice ‘Biomarkers’ To Detect Signs Of Depression And Anxiety

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Organic Based EV Battery Turns To Ethanol For a Boost In Energy Density

While on the face of it, the lithium-batteries that power electric vehicles play an important role in our ongoing shift to sustainable transport, they aren’t without environmental problems of their own. Batteries that use organic, readily available materials in place of rare metals are seen as a promising part of the solution to this dilemma, and new research led by University of Houston scientists demonstrates how the performance of these eco-friendly devices might be brought up to speed.

As demand for electronic devices and vehicles continues to grow, so does the reliance on lithium-ion batteries that rely on scarce metals. Front and center of this dilemma is cobalt, the mining of which is not only associated with environmental degradation and pollution of water supplies, but plagued by ethical issues such as the exploitation of child labor. The use of these metals also makes recycling the batteries difficult at the end of their lives.

However, we are seeing some exciting advances being made in the development of batteries that do away with these types of materials and use organic ones instead. These have included organic-based batteries that can break down in acid for recycling, a heavier reliance on cheaper and more environmentally friendly nickel, and even one from IBM that uses materials found in seawater.

The new device marries this organic architecture with another promising branch of battery research focusing on the use of solid-state electrolytes. Typical batteries move their electrical charge between two electrodes, a cathode and anode, in a liquid electrolyte solution, but scientists are making great inroads into alternative designs that use a solid electrolyte instead. This type of architecture could also allow batteries to work with a lithium metal anode, which could store as much as 10 times the energy of current devices.

The scientists behind the new battery have solved what they say is a key limitation of organic-based, solid-state lithium batteries. Where cobalt-based cathodes afford these batteries a high energy density, ones made from organic materials suffer from limited energy density, which the team found to be because of microscopic structures within the cathode. “Cobalt-based cathodes are often favored because the microstructure is naturally ideal but forming the ideal microstructure in an organic-based solid-state battery is more challenging,” says study author Jibo Zhang.

Working with a cathode made from an organic material called pyrene-4,5,9,10-tetraone (PTO), the scientists used ethanol as a solvent to alter its microstructure. This treatment resulted in a new arrangement that allowed for better transport of ions within the cathode and boosted its energy density to 302 Wh/kg, which the team says is 83 percent higher than current state-of-the-art solid-state batteries with organic cathodes.

“We are developing low-cost, earth-abundant, cobalt-free organic-based cathode materials for a solid-state battery that will no longer require scarce transition metals found in mines,” says Yao. “This research is a step forward in increasing EV battery energy density using this more sustainable alternative.”

Nick Lavars

 

By: Nick Lavars

 

Source: Organic-based EV battery turns to ethanol for a boost in energy density

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How To Stop Overthinking

Need to know

If you’re an over-thinker, you’ll know exactly how it goes. A problem keeps popping up in your mind – for instance, a health worry or a dilemma at work – and you just can’t stop dwelling on it, as you desperately try to find some meaning or solution. Round and round the thoughts go but, unfortunately, the solutions rarely arrive.

In my daily work as a meta cognitive clinical psychologist, I encounter many people who, in trying to find answers or meaning, or in attempting to make the right decision, spend most of their waking hours scrutinizing their minds for solutions. Ironically, in this process of trying to figure out how to proceed in life, they come to a standstill.

When we spend too much time analyzing our problems and dilemmas, we often end up more at a loss than we were to begin with. On top of that, persistent overthinking can result in a wide range of symptoms such as insomnia, trouble concentrating and loss of energy which, in turn, often leads to further worries regarding one’s symptoms, thereby creating a vicious cycle of overthinking. In some cases, this eventually leads to chronic anxiety or depression.

When overthinking and the associated symptoms spiral and become unbearable, it’s usual for us to look for ways to calm down. Many common strategies sound reasonable or useful, but research shows that they can inadvertently cause more harm than good and typically lead to even more overthinking. You might recognize some of them in your own behavior:

Constantly looking out for threats: there’s nothing wrong with this strategy if you feel in control, but it can quickly backfire. Take health concerns. If, as a way to calm your worries, you start to excessively scan yourself or the people you care about for signs of illness, this threat monitoring will lead only to a heightened sense of danger and more health-related worries.

Another example is constantly keeping an eye out for whether people like you, trying to figure out what they think of you, which inadvertently results in you becoming more distant, non-participatory and worried, and not being able to enjoy their company.

Seeking answers and reassurance: it’s completely natural to seek reassurance from people close to you, and to look for answers as to how to cope better. However, if you come to a point where you depend on these strategies to calm you down and reduce your worries, you’re on a slippery slope.

For instance, some of my clients spend several hours a day Googling, hoping to find reassurance or, at least, an explanation as to why they’re feeling down. Yet this strategy often leads to even more worries, since Googling relatively common symptoms typically yields a wide range of search results, including diagnoses that you hadn’t even thought of.

Excessive planning: of course, there’s nothing wrong with moderate levels of planning. It’s perfectly healthy to keep a calendar or to leave notes for yourself. However, some people plan their lives down to the tiniest detail and this can become problematic. In addition to being rather time-consuming, excessive planning can have other negative effects including exacerbating worries.

For instance, when planning carefully, it’s tempting to try to predict all the things that could possibly interfere with a plan and how to potentially handle such events should they occur, thereby initiating a process of worry. Others plan meticulously because they believe that they won’t be able to cope otherwise, which can lead to excessive worries when planning isn’t possible or unexpected events arise.

Aside from these unhelpful strategies, another key factor that can perpetuate overthinking is your beliefs about thinking (the term ‘meta cognitive’ in ‘meta cognitive therapy’ – the clinical approach I use – actually refers to thinking about thinking). When my clients start meta cognitive therapy, many of them are convinced that they have no control of their thought processes.

They believe that their thoughts just appear and automatically attract attention – and that they can’t control whether these thoughts develop into hour-long ruminations about how bad things are now, or into catastrophic worries about what could go wrong in the future.

I have some good news: you don’t have to live with excessive worry. It’s an enduring myth that overthinking is an innate trait, like eye color or crooked toes, meaning that it can’t be changed and you simply have to live with it.

Adrian Wells, the clinical psychologist at the University of Manchester who founded meta cognitive therapy, discovered that overthinking – that is, worrying and rumination – is a learned strategy that we choose, consciously or unconsciously, as a way to try to deal with our difficult thoughts and feelings. It’s not a fixed trait, but a habit that we fall into, and we can learn to change it if we want.

In my first 10 years practicing as a clinical psychologist, I worked in traditional cognitive behavioral therapy. CBT teaches us that we need to spend time on our thoughts and beliefs in order to challenge them and transform them into more realistic or compassionate versions. When I was introduced to meta cognitive therapy, in which the focus is on simply letting go of your thoughts (Wells jokingly calls it ‘lazy therapy’), it radically changed my understanding of mental illnesses.

In 2020, together with Wells and other colleagues, we published the results of a large randomized trial involving 174 clients with depression. We found that those who participated in meta cognitive therapy benefited more than others allocated to receive CBT (74 per cent met the formal criteria for recovery at post-treatment, versus 52 per cent of those in the CBT group, and this was largely maintained at follow-up).

Together with my own client work and the experiences of other therapists using metacognitive therapy, this finding has convinced me that the cause of mental illnesses isn’t our negative thoughts per se, and therefore the solution is not to spend yet more time on them. On the contrary, the cause of mental illnesses is too much time spent dwelling on our negative thoughts, and so the solution is to spend less time on them.

This realization created a tsunami of thoughts within my own mind. For years, through CBT, I have helped my clients spend more time on their negative thoughts, but what if there were better ways I could have helped them? True, many of my clients felt CBT had helped them (and it certainly is beneficial to many), but I no longer believe it’s the optimal approach. For the past 10 years I have completely changed my methods and I exclusively use meta cognitive therapy to help people think less and, in so doing, cope better with their mental health problems.

Whether you just worry a little more than you’d like to, or you suffer from an anxiety disorder or depression, metacognitive strategies can help you reduce the overthinking that contributes to your symptoms. Metacognitive therapy is about discovering that you can choose whether or not you engage in a thought regardless of its content or the feelings it gives rise to.

In the following section, I’ll take you through some of the steps I use in metacognitive therapy to help my clients reduce their overthinking and learn that overthinking isn’t something that happens to us – it’s within our control.

What to do

Get to know your trigger thoughts and let them be

It is estimated that the human brain produces thousands of separate thoughts, associations and memories every single day. Most of these thoughts are without significance; they come and go without us noticing. Some thoughts, however, attract our attention. In metacognitive therapy, these thoughts are referred to as ‘trigger thoughts’. If you pay them enough attention, these thoughts can trigger an explosion of bodily sensations and feelings, and a myriad of associations.

Some trigger thoughts can activate warmth and joy about an exciting upcoming project, meeting a friend, or a holiday you’re looking forward to. These kinds of trigger thoughts are, of course, unproblematic. Other trigger thoughts, however, might activate a long series of further thoughts that can develop into worries or ruminations.

Worries typically form around hypothetical scenarios and start with ‘What if…’ statements such as: ‘What if I make the wrong decision?’ ‘What if they won’t like me?’ ‘What if I get ill?’ and so on. Typical rumination, on the other hand, starts with thoughts about what, why and how: ‘What is wrong with me?’ ‘Why am I feeling this way?’ ‘How do I get better?’

You can compare these thoughts to trains at a busy railway station. There are departures all the time to a wide array of different destinations. Each train can represent a thought or a sequence of thoughts. For instance, a thought such as ‘What if they won’t like me?’ could arrive at the mental railway platform.

You could ‘catch’ the thought and you’ll likely soon notice several other thoughts join in: ‘I won’t be able to handle it if they dislike me.’ ‘Perhaps, then, I shouldn’t go.’ Or you could dismiss the thought, similar to letting the train pass by, and turn your attention back to whatever you were doing. When you don’t expend energy on a thought, you’ll find it will either stay on the platform for later or simply pass you by.

So, it’s not the trigger thought in and of itself that will overwhelm you and lead to a variety of unpleasant symptoms; nor is it the amount of trigger thoughts you have (everyone has them). The problems arise if you continuously jump on to each train – that is, if you begin to analyze the thought and engage in extensive worry or rumination – then it’s like you’re adding more and more carriages to the train, one after another; the train gets heavier and slower, and will eventually have trouble passing even the slightest hill. The same goes for your trigger thoughts: the more time you spend engaging in these thoughts, the slower and heavier you will feel.

Recognise what you can and can’t control

If you’re used to boarding most trains rather uncritically – that is, continuously engaging in trigger thoughts and starting to worry and ruminate for long periods of time – then, unfortunately, you’re well on your way to developing an unhealthy pattern. If you repeat this pattern over and over again, it might begin to feel as if it happens automatically. You might, understandably, come to believe that it’s outside your control.

It’s true, the trigger thoughts themselves are completely automatic – you don’t have any say as to what trains will arrive at your mental railway station. However, you do have a choice over which trains to board. You can choose whether or not to engage in a trigger thought. You can control whether you ‘answer’ the thought or follow it up with more questions.

In trying to understand this differently, instead of in terms of trains, you might picture your thoughts as someone calling you on the phone. Of course, you don’t decide whether the phone rings, who calls or when it rings. (Unfortunately, in this case it’s not the kind of phone you can just turn off!) But you do choose whether to answer the phone or just let it ring and turn your attention back to whatever you were doing.

The sound of the phone might be loud, annoying and attract your attention, but what happens if you just leave it be? Eventually it stops ringing. While thoughts and phones are, of course, different things, this metaphor carries a key message in metacognitive therapy: While trigger thoughts are beyond your control, you can control whether you engage with them.

Thoughts are, in principle, ephemeral, although you might not see them this way. Try asking yourself how many of the thoughts you had yesterday you can remember today. To be honest, out of the several thousand I had, I’m not sure I can recall even 10 thoughts. Why is that? Most of the thoughts we have come and go almost instantly because we don’t grant them any special attention but leave them and return to whatever we were doing. Even though you might not be aware of it, you’re already capable of choosing not to engage in a conversation with your thoughts, just as you can ignore the phone that keeps calling.

Postpone and reduce your worries and ruminations

Many chronic overthinkers struggle to change their belief that their thoughts can be brought under control, and perhaps you’re still not convinced. One way of challenging your belief further is to explore whether you’re able to postpone worries and ruminations. I recommend that my clients introduce a so-called ‘worry/rumination time’. It has to be a set time of the day, for instance 7.30pm to 8pm, where you allow yourself to worry and ruminate freely.

That way, when trigger thoughts or feelings occur during the day – for instance, you feel the need to evaluate your health or reflect upon what your friends think of you – try postponing these thoughts to your scheduled worry/rumination time (you might tell yourself: ‘I’ll deal with this later’). This set time is also useful for any planning or reassurance-seeking for which you feel the need. One note of caution: you might want to avoid scheduling your worry time within one or two hours of when you plan to go to bed, especially if you’re prone to insomnia or other sleep difficulties.

Introducing a set worry/rumination time serves several functions. First, it’s an experiment that challenges the belief that worries and ruminations are uncontrollable. When dedicating themselves to this experiment, most of my clients find that it is indeed possible to postpone worries or ruminations. While this might seem a hard goal, in fact it’s something you already do on a daily basis without realizing.

For instance, any time you notice an alarming newspaper headline on your way to work and start worrying, but then remember that you’re in a hurry and so turn your attention back to getting to work – that’s you controlling your thoughts. Or maybe you’re sitting in a café with a friend and you overhear a conversation at another table that triggers unpleasant memories, but instead of dwelling on them, you decide to redirect your attention back to the conversation with your friend.

Again, that’s you controlling your thoughts. In the same way, you can learn to consciously ignore your own internal trigger thoughts, thereby experiencing that you really do have a choice in whether you choose to engage in them or not.

A second function of setting worry/rumination time is that it’s a way of discovering that trigger thoughts are ephemeral and ever-changing. For instance, the thoughts that seemed highly relevant and important in the morning will often seem less important when you arrive at your worry/rumination time later in the day. You might even discover that you’re not able to recall some of the thoughts that triggered you.

All feelings, whether positive or negative, are usually ephemeral if we tolerate them and let them be. Of course, not all thoughts disappear forever when you postpone processing them – some thoughts might be about important issues that you really need to address. Regardless, as most of my clients find, it’s much more constructive to deal with these issues within a defined time of the day instead of endlessly problem-solving while you’re trying to go about your daily responsibilities.

Finally, while this might seem obvious, the worry/rumination time is a way of reducing and containing the amount of time you spend worrying and ruminating. As I explained earlier, it’s not the trigger thought in and of itself that causes unpleasant symptoms, nor is it the amount of trigger thoughts. It’s the time spent engaging in these thoughts, ruminating and worrying, that weighs us down. By allocating a set period of time for worry and rumination, you’re more likely to feel in control and prevent yourself becoming overwhelmed.

Avoid avoidance and train your attention

For people struggling under the burden of overthinking, it’s all too easy to develop a fear of one’s own trigger thoughts. After all, if you feel at their mercy, you might be tempted to avoid them occurring in the first place. Unfortunately, not only is this largely futile, it’s also counterproductive – avoidance of triggering situations will hamper your life and, moreover, to the extent that you’re at all successful in avoiding situations that prompt trigger thoughts, you won’t get the chance to practice letting go of these thoughts. After all, you can’t learn to ride a bike without a bike.

Inspired by the above, and if you feel ready, I recommend that you give yourself daily challenges that involve trigger thoughts, and that you practice instructing yourself to leave them alone until a designated worry-time. This will help you become more adept at leaving your trigger thoughts alone and to realize that you’re in control of your worries and ruminations. You won’t succeed every time but, just like learning to ride a bike, you need to get up again every time you fall and keep biking until you get the hang of it.

Some people struggle to develop this skill. In that case, in metacognitive therapy we use attention training to help clients realize that they can shift their attention regardless of inner inputs, such as trigger thoughts, and outer input, such as external stressors. I usually ask my clients to do the following 10-minute exercise. Maybe reading this will inspire you to try it out yourself:

  • Tune in to three or more environmental sounds, such as: traffic; birdsong; chatter from a nearby radio or TV; children playing; building work, or whatever. You need to find somewhere where these ambient sounds are going on. It’s helpful if some of the noises you select are nearer and louder, while others are further away and quieter.
  • Of the three or more sounds you’ve selected, practise tuning in to just one at a time for approximately 10 seconds each (you could use a digital timer to help you) and let the others fade into the background. After the 10 seconds is up, switch your focus to another of your chosen sounds.
  • After two minutes, repeat the exercise, but switching more quickly between the sounds – now focusing on each one for just two to four seconds each.
  • The aim of the exercise is to become familiar with, and adept at, shifting your attention. When you’re feeling more confident you could introduce a recording of a trigger thought into the exercise, and practise switching your attention away from and back to the sound of that thought.

Another exercise you could try that I use in my clinic is the windowpane exercise – this will further illustrate that your attention is under your control, independent of the existence of trigger thoughts in your head. I write one or two trigger thoughts in washable ink on a window (such as: ‘What if I fail my driving test?’ or ‘What if she finds me boring?’), then I ask my client to practise looking through the words to notice the scene beyond – the trees, the sky, the buildings, whatever the view is from the window.

Then I ask them to switch their attention back to the words again, now back to the details of the view. The purpose here is to familiarise clients with the sensation that we can control our attention. If you give it a try, you’ll find that, while the written thoughts remain in view, you can control whether you focus on them or whether you let them fade and enjoy the world outside instead. Please note, if you find this exercise at all difficult, I recommend that you wait and try it with a professional metacognitive clinician (see the ‘Learn More’ section to find out how)…..

By: Pia Callesen

Source: How to stop overthinking | Psyche Guides

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Blood Pressure

Pfizer Has A Head Start, But The Covid-19 Vaccine Market Is Still Up For Grabs

Pfizer and BioNTech pulled ahead in the race to develop a Covid-19 vaccine this week, announcing preliminary data showing 90% effectiveness. Financial markets rallied on the tantalizing prospect that a return to normalcy is getting closer. But the lead may be short-lived as competitors, whose vaccines may be easier to transport or administer, are gearing up to report data in the coming weeks and months. “Pfizer will probably have a first-mover advantage, but won’t last that long,” says Damien Conover, director of healthcare equity research at Morningstar. “It’ll probably only be two or three months at the most.” 

While there are winners and losers in normal drug development, with the first company to enter a particular therapeutic area often gaining a significant advantage, that isn’t the case with Covid-19 vaccines, says Bunny Ellerin, director of the Healthcare and Pharmaceutical Management Program at Columbia Business School. “The pandemic affects everybody. The universe of people that you need to cover is huge,” she says. “There’s no one player that can provide vaccines for the entire world.” 

One of the main reasons why Pfizer’s preliminary data was so striking is that the mechanism the vaccine uses, messenger RNA or mRNA, has never been approved for use in humans before. To have 90% effectiveness, even among a small number of patients in ongoing trials, is very high compared to other common vaccines. For example, the yearly influenza vaccine can reduce the risk of flu from around 40% to 60%, depending on the year. “It’s tremendously powerful for the industry,” says Ellerin. “It shows that this platform can work and therefore will be used in the future.” It also bodes well for biotech company Moderna, which is developing a competing mRNA-based vaccine, and is planning to release interim data soon.

A supply of coarse dry ice pellets.
A supply of coarse dry ice pellets. Leon Neal/Getty Images

The Distribution Dilemma 

The downside of the current formulation of Pfizer’s mRNA vaccine is that it needs to be stored at ultra-low temperatures instead of the usual 2 to 8℃ (36 to 46℉) for many vaccines on the market. As Pfizer collects more stability data, it has determined the vaccine can stay at 2 to 8℃ for up to 5 days, but longer term storage needs to be around -70℃ (-94℉). “There’s never been a vaccine in the United States that required that kind of storage temperature prior to use,” says Dr. Kelly Moore, associate director for immunization education at the Immunization Action Coalition and an external advisor to Pfizer. 

This poses a unique challenge, given that there isn’t much ultra-low capacity freezer space in the United States or globally, says Prashant Yadav, an expert on healthcare supply chains and a professor at INSEAD. “The only places where we have ultra-cold chain equipment are either academic medical centers, so fairly big hospital systems, or a few of the sites that FedEx, UPS or [the big distributors] have created,” he says.

The usual route for routine vaccines is to go from the manufacturer to a big distribution center, run by a company like McKesson, Cardinal or AmeriSource Bergen, which then sends them to another stocking warehouse outside of major metropolitan areas, says Yadav. From there, the vaccines are sent to doctor’s offices, pharmacies, and hospitals as needed, which requires refrigerators in the warehouses and at the point of care. 

There are some freezers available for certain products, like oncology drugs and clinical trial materials, but these usually run from 0 to -20℃ (32 to -4℉), which isn’t cold enough for Pfizer’s vaccine. “The only way to distribute will then be to ship the product, either almost daily, or at least multiple times a week from the manufacturer to the point of vaccination” for ultra-cold chain products, says Yadav.

Other vaccines in development don’t need to be frozen and will only require refrigeration.

That’s Pfizer’s initial plan, to store its Covid-19 vaccines at ultra-cold storage sites in Kalamazoo, Michigan and Pleasant Prairie, Wisconsin, and then send them directly from there to point of use, according to a spokesperson. Pfizer, which is continuing to study storage conditions at warmer temperatures, has also designed special thermal shippers, “which can be used as temporary storage units by refilling with dry ice for up to 15 days of storage.” 

A Moderna spokesperson said the company expects its mRNA vaccine to be stored at -20℃ (-4℉), “which is an easier and more established protocol than deep freezing,” and close in temperature to a home freezer. “We expect to allow refrigerated conditions of 2 to 8℃ (36 to 46℉) for up to about a week,” the company said. 

But other vaccines in development that use different mechanisms, such as the protein subunit vaccine being developed by Novavax, don’t need to be frozen and will only require refrigeration, potentially making them easier to distribute through existing channels. The federal government’s Operation Warp Speed program is providing $1.6 billion to support large-scale manufacturing of 100 million doses of Novavax’s vaccine candidate. The program has also provided up to nearly $2 billion in funding to Moderna for the development and manufacturing of 100 million doses of its vaccine candidate, as well as agreed to purchase up to 100 million doses of Pfizer’s vaccine, once it gets regulatory approval, at a price of $1.95 billion.

In the first phase, the program “anticipates having a limited supply of COVID-19 vaccines to distribute, which should ease initial concern over potential long-term storage of vaccine doses,” according to a U.S. Department of Health and Human Services spokesperson. “The intent is to distribute vaccines to state-identified locations when vaccine administration can quickly follow, meaning that frequently the vaccines will be administered before needing to use storage other than the containers the vaccines are shipped in.” The effort includes the CDC, Department of Defense, private sector companies and state governments. 

Florida Volunteers Take Part In COVID-19 Vaccine Trials
A volunteer gets a vaccine as part of the Operation Warp Speed program. Joe Raedle/Getty Images

One Shot Too Many?

One of the other logistical hurdles is that the majority of vaccine candidates require a two-shot regimen, meaning patients get one shot and then must return for a second shot around 3 weeks later. While common vaccines, like the flu, may have pre-filled syringes or one-shot doses, most of the Covid-19 vaccines are going to be shipped in multi-dose vials. That means once providers open the vial, they must use the contents within 24-hours. “If we were to wait for things to be more convenient, thousands and thousands of people would die in the meantime, and that’s not a price we’re willing to pay,” says Moore, who is advising Pfizer.

During a pandemic, the first step is getting a safe and effective vaccine to market, with advancements like one-shot doses coming further down the line. The exception is Johnson & Johnson, which  is one of the only companies that is evaluating both single-dose and two-dose regimens as part of its Phase 3 trial. The company has received $456 million in federal funding for development and $1 billion for the first 100 million doses. 

Covid-19 vaccines will likely need to be given to large numbers of people in one go, so as not to waste any of the product given the temperature and multi-dosing constraints. “Mass vaccination clinics are not not something that we typically think of for routine immunization, but it’s certainly something that public health and healthcare facilities are very familiar with,” Moore says, harkening as far back as the 1950s when the polio vaccine was given to children in school. The first priority will be to inoculate frontline workers taking care of Covid-19 patients, and then moving to high-risk populations. The general public should set realistic expectations, given that the rollout won’t happen overnight. 

Human behavior will also be a factor when it comes to who decides to get immunized and who opts-out.

And even with all of the planning by companies and governments, there will still be some kinks along the way. On average, there is around 5 to 10% general wastage of vaccines, due to a range of issues, varying from incorrect storage temperature to open multidose vials and not having enough patients within the given period, says Yadav, the supply chain expert. “The production of vaccines is largely a technical feat,” he says. “But once it gets out of Pfizer’s factory gate, it’s not just about the logistics science, it starts to get into social science, because human behavior is at play.”

Human behavior will also be a factor when it comes to who decides to get immunized and who opts-out. The speed at which the companies and government are trying to get Covid-19 vaccines to market means there isn’t the type of long-term data associated with other vaccines. A big unanswered question is “how well does this vaccine work to keep you from getting infected compared to how well does it work to keep you from getting sick?” says Moore. 

One of the biggest issues with Covid-19 is asymptomatic spread, meaning people who don’t show outward signs of a viral infection but are spreading it to others. If the vaccine reduces symptoms but doesn’t stop infection, that means communities would have to continue other protocols, like mask-wearing and social distancing for longer than expected. It’s also not clear for how long immunity might last.

“The public needs to understand why vaccine manufacturers and experts in vaccines think that despite this uncertainty, we feel like it’s a good idea to move forward with vaccinating the public anyway and not waiting,” says Moore. “We will continue to gather information, so that we can address those areas of uncertainty in the months ahead and years ahead, and finally put this pandemic to rest.” Follow me on Twitter or LinkedIn. Send me a secure tip.

Katie Jennings

 Katie Jennings

I am a staff writer at Forbes covering healthcare, with a focus on digital health and new technologies. I was previously a healthcare reporter for POLITICO covering the European Union from Brussels and the New Jersey Statehouse from Trenton. I have also written for the Los Angeles Times and Business Insider. I was a 2019-2020 Knight-Bagehot Fellow in business and economics reporting at Columbia University. Email me at kjennings@forbes.com or find me on Twitter @katiedjennings.

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Associated Press

Pfizer says an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19. This is “the first peek behind the curtain,” says Paul Duprex, director of University of Pittsburgh’s Center for Vaccine Research. (Nov. 9) Subscribe for more Breaking News: http://smarturl.it/AssociatedPress Website: https://apnews.com Twitter: https://twitter.com/AP Facebook: https://facebook.com/APNews Google+: https://plus.google.com/1158922418018… Instagram: https://www.instagram.com/APNews/ ​ You can license this story through AP Archive: http://www.aparchive.com/metadata/you…

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