Stat News
By Mario Aguilar
July 27, 2022
MARIA FABRIZIO FOR STAT
This site version was edited by:
Joaquim Cardoso MSc.
health transformation — research and strategy institute
mental health unit
July 27, 2022
It’s a problem so complex, so fraught with stigma and treatment complications, that innovation has crept forward slowly even as a crisis escalates: suicide prevention.
But for several years, a small New Haven, Conn.-based startup has quietly been building technology to move the needle on suicide rates among the people at highest risk: those with a history of attempts or who have suicidal thoughts and have expressed a strong desire to die.
The company, called Oui Therapeutics, has raised roughly $26 million from high-profile investors like CVS Health Ventures and First Round Capital to develop and launch an app designed to train people how to quell their suicidal impulses.
It pulls from in-person therapy methods that have shown dramatic reductions in suicide attempts — nearly 60% — in a randomized trial of soldiers at high risk.
The company, called Oui Therapeutics, has raised roughly $26 million from high-profile investors like CVS Health Ventures and First Round Capital to develop and launch an app designed to train people how to quell their suicidal impulses.
It pulls from in-person therapy methods that have shown dramatic reductions in suicide attempts — nearly 60% — in a randomized trial of soldiers at high risk.
“You could argue it’s the single biggest gap between the evidence and the outcomes in all of health care,” said Seth Feuerstein, Oui’s co-founder and CEO. “We know there are things you can do, and almost no one gets access to those things.”
If the research bears out and the app secures buy-in from regulators, it could become a powerful tool in curbing suicide, which kills over 45,000 people in the U.S. each year.
If the research bears out and the app secures buy-in from regulators, it could become a powerful tool in curbing suicide, which kills over 45,000 people in the U.S. each year.
Oui is part of a broader constellation of efforts — including a new national suicide prevention hotline number and the development of prevention frameworks like Zero Suicide — in recent years that aim to address rates that have risen stubbornly high.
In April, Oui launched a randomized clinical trial testing the app, called Aviva, alongside other treatments for adults at high risk.
Over the course of 10 weeks, the app guides people through a series of lessons and activities meant to help them better understand what happens when they become acutely suicidal and steps they can take to survive.
Though the standalone app may be years away from Food and Drug Administration clearance, the company has been testing Aviva through pilot programs already with patients like Michelle, who was introduced to the app through a teletherapy medical group affiliated with Oui that she was referred to by her insurer, Aetna.
She attempted suicide last fall after an abrupt falling-out with her daughters.
“That was the only way out I could figure out to stop the pain,” she said. It’s precisely that moment of acute risk that the app’s lessons are designed to address. It guides patients through making and practicing a plan for what to do when they start feeling upset. It also helps them find reasons for hope — in Michelle’s case, the possibility of reconciling with her children and grandchildren — to carry them through difficult times. “If I choose suicide, that will never happen,” she said. “If I choose to stay alive, that could come true.”
It took two months after being discharged from a behavioral health unit before Michelle, who is only being identified by her first name to protect her privacy, was able to start receiving in-person therapy. She clung to the app like a life preserver in the raw, emotional days after arriving home.
She believes the app helped save her life because she knows the statistics: People who have attempted suicide are at extremely high risk for future attempts, especially in the short period of time after leaving the hospital.
It’s the goal of prevention during that dangerous window that has insurance companies like Aetna paying attention to what Oui is trying to do.
Suicide attempts can result in death or highly expensive care.
There’s a dearth of FDA-approved options specifically to treat suicidality, so Feuerstein believes Aviva would be an appealing option to insurers who’ve been otherwise hesitant to cover mental health apps over concerns about their efficacy.
“Even if they don’t want to do the right thing, financially, they’ll be incentivized to do the right thing,” he said.
That is, if Oui can show its worth.
M. David Rudd, one of the four leading suicide researchers that Oui recruited as scientific co-founders, started working on the problem during the Gulf War, where he served as a military psychologist.
At the time, preventing suicide was primarily thought of as treating underlying conditions like depression.
But in conducting research, Rudd realized that there were issues specific to suicide, like the ability to regulate the rapid onset of emotional pain, as well as feelings such as worthlessness or hopelessness.
Over decades, Rudd and collaborators conducted research to adapt cognitive behavioral therapy, or CBT, to suicidality, culminating in a clinical trial at the Army base in Fort Carson, Colo.
Soldiers who had attempted suicide or had ideation with intent were randomized to a group that received usual treatment, including psychotherapy and medication, or to a group that received that care on top of CBT specifically designed to target suicidality.
After two years, 18 of 76 participants in the control group made an attempt, versus 8 of 76 in the experimental group.
It’s a shockingly simple — and short — intervention, just 12 hourlong sessions to teach people to recognize and understand their suicidal thoughts.
They’re taught emotional self-regulation skills, how to reduce feelings of hopelessness, and work with a therapist to create a plan of action that instructs them to reach out for help if they need it.
In the final two sessions, patients are asked to imagine the details of their previous suicidal episodes and emotions and then to practice using their new skills to resolve the crisis.
“What people discover very quickly is that you can respond to really significant emotional upset just a little bit differently, and as a result, your urge or motivation to die is diminished significantly,” said Rudd.
“People can learn some really simple things that ultimately make a big difference.”
Feuerstein, a psychiatrist and lawyer by training, stumbled upon the research when it was published in 2015.
He was working as an executive at Magellan Health at the time, and was stunned by a study that seemed to defy everything he had learned about suicide. “How have I never heard of this?” he recalled thinking.
Feuerstein brought an entirely different perspective about what can make a difference in care.
It wasn’t just the treatment that had the potential for impact, but the technology that could scale it. He was an early proponent of what today is called digital therapeutics, having co-founded a company called Cobalt Therapeutics, which developed computer software initially distributed on DVD-ROM discs to treat insomnia. In 2014, the company was acquired by Magellan for $8 million.
In starting to research suicide, what surprised Feuerstein the most was the stigma that led many people to want to shy away from talking about it.
He recalls a prominent psychiatrist asking him why he would want to accept the liability for patients at very high risk taking their own lives.
“If I was developing a cancer drug, and I said I could cure 50% of the malignancies and have it not happen again, you wouldn’t ask me why I want all the liability for the ones who get the recurrence,” said Feuerstein. “You’d say that’s a huge breakthrough.”
There is risk inherent to working with patients who are suicidal, as there is with cancer and other life-threatening illnesses, and anyone hoping to make an impact will have get comfortable with the idea that some of the patients in their studies and programs will die.
Rudd puts it another way: “The most significant thing that elevates risk for individuals that are struggling with these issues is not getting treatment.”
Though some hospital systems and large mental health care providers have adopted comprehensive suicide prevention programs, these are expensive and difficult to implement, in part because clinicians across the board aren’t well-trained in treating people who are suicidal.
The work is “uniquely stressful,” said Rudd, and the efficacy of treatments like the CBT tested in Colorado are linked to how precisely they’re delivered.
He said that the intervention is so simple that clinicians “veer off of it because they like to do more complicated things” like trying to address a patient’s underlying trauma or anxiety at the same time.
Software, meanwhile, can do the same thing every time without getting burned out.
Software, meanwhile, can do the same thing every time without getting burned out.
“The reality of being able to reach large numbers of individuals with a high fidelity intervention that we were really struggling to reach handfuls of people with is really a wonderful step forward,” said Rudd.
That can be a boon to consistency — but it also brings an enormous amount of pressure on how the treatment is translated digitally.
If therapy is delivered by a provider, that clinician can adapt as needed. But the software, for the most part, is locked.
So to develop the app, Oui Therapeutics, including key members of the Cobalt team, brought on a number of leading researchers, including Rudd and his frequent collaborator Craig Bryan, and Barbara Stanley and Greg Brown, known for their work on safety planning for people at risk of suicide.
Leng Lee, a Oui co-founder and its VP of product, said to turn CBT treatment into an engaging digital journey, the team had to strike the right tone.
“Cutesy isn’t probably going to be appropriate,” he said. “It’s a serious topic, but you don’t want to be doom and gloom. You want to walk a fine line. You want to be respectful, but you also need to be engaging.”
During the first session, users learn how suicide risk rises and falls and and are guided through creating a safety plan. An animated character is shown locking up a large rifle. “With suicide risk, time is your friend,” the narrator explains. “‘My plan’ will help you with things to do to pass the time. As time goes on, the risk will lower.”
Each session also contains scripted videos in which actors describe intense suicidal moments as well as how they used the skills from treatment, which Michelle found especially relatable. “They get it,” she said. “They understand. They’ve been through it.”
She still receives daily reminders from the app. Some days, she’ll dismiss the notification because things are going well.
“But those days that I need a little help, it’s like my angel watching over me saying, I gotta do something different,” she said.
With app development completed, Oui must now overcome the regulatory and business hurdles to success.
The company completed a feasibility study of Aviva in 2021 and recently launched a 391-person randomized control trial that will test the application’s efficacy versus a group that is receiving a sham application, containing educational content.
Though the study is slated to run through 2025, it will conclude sooner if the clinical trial shows significant results.
Despite a recent spate of clearances for digital therapeutics, there are signs that the FDA may still be somewhat skittish about an app to treat suicidality.
Before beginning studies, the company applied for an investigational device exemption, which the FDA requires for companies testing potentially dangerous medical devices.
Feuerstein also noted that the FDA excluded products addressing suicidal patients from an emergency use authorization for mental health apps during the pandemic.
Even if Aviva is cleared, no prescription digital therapeutic product has earned widespread coverage from payers, though the early partnerships Oui and its spinout medical group have struck with Aetna and CVS Ventures would seem to position them on the right track.
Through CVS Ventures, Oui has had access to the very decision-makers who will evaluate the product for coverage later.
Feuerstein said he is confident that given the scope and difficulty of the problem, payers will rally around the app in the way that they haven’t for other products.
Josh Kopelman, founder and partner of Oui investor First Round Capital, said he found the idea appealing precisely because it felt like an opportunity that was being ignored and didn’t fit into established frameworks.
He said that to First Round — known for its early bets on Uber and Square — the economic and social incentives are so clear that the app will be paid for if it delivers results. “Did we need to know how they would charge for it, how payers would cover it? No.”
Feuerstein, like his investors, firmly believes that they’ve found a novel approach to an issue that’s seen little progress in treatment.
But even if it proves effective, it remains an open question whether it would be equally accessible to everyone who needs it, including low-income individuals or those without commercial health insurance, people without access to smartphones, and certain groups already marginalized in medicine.
Aviva, if it is adopted, will be far from the only solution needed to curb the suicide rate. But if it can tackle even a piece of that crisis, Oui would be an anomaly on two fronts:
a rare success among mental health tech companies that continue to struggle, and a landmark advance on a disease for which treatment has been stagnant for years.
Aviva, if it is adopted, will be far from the only solution needed to curb the suicide rate. But if it can tackle even a piece of that crisis, Oui would be an anomaly on two fronts:
a rare success among mental health tech companies that continue to struggle, and a landmark advance on a disease for which treatment has been stagnant for years.
If you or someone you know may be considering suicide, contact the 988 Suicide & Crisis Lifeline: call or text 988 or chat 988lifeline.org. For TTY users: Use your preferred relay service or dial 711 then 988.
About the Author
Health Tech Correspondent
Mario covers how technology is transforming health care.
Originally published at https://www.statnews.com on July 27, 2022.
Names mentioned
Seth Feuerstein, Oui’s co-founder and CEO
M. David Rudd, one of the four leading suicide researchers that Oui recruited as scientific co-founders
Oui Therapeutics, Craig Bryan, and Barbara Stanley and Greg Brown
Josh Kopelman, founder and partner of Oui investor First Round Capital,
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