Millions of Americans struggle with mental health disorders, but research and treatment in this field often stumble over the same roadblock: the lack of precise, objective tools to measure outcomes.<\/p>\n
On Wednesday, the Digital Medicine Society (DiMe)<\/a> \u2014 a nonprofit that connects experts to advance the safe and effective use of digital tools in healthcare \u2014 unveiled a new initiative to address this sweeping problem.<\/p>\n The organization, in partnership with FDA, is launching the project within its Digital Measurement Collaborative community (DATAcc). More than 20 organizations \u2014 including telehealth providers, digital health startups, biotech companies and research collectives \u2014 will work together to establish a standardized set of digital measures for the evaluation of common mental health disorders. These measures will include specific features of sleep, speech and physical activity that are scientifically proven to reflect a person\u2019s mental health status.<\/p>\n Some of the participating organizations include the American Psychological Association<\/a>, BetterHelp<\/a>, Mass General Brigham<\/a>, Otsuka<\/a>, Talkspace<\/a> and the UCLA Depression Grand Challenge<\/a>.<\/p>\n The ultimate goals of the new project are to improve patient care, enable better reimbursements for providers and accelerate the development of new tools.<\/p>\n Moving beyond checklists<\/p>\n There has been a proliferation of digital treatments for mental health over the past decade \u2014 but the tools to measure whether these actually work are outdated, often relying on blunt, subjective questionnaires like the PHQ-9<\/a> for depression or the GAD-7<\/a> for anxiety, explained DiMe CEO Jennifer Goldsack.<\/p>\n Questionnaires don\u2019t capture day-to-day patient changes, making it difficult to guide clinical decisions or prove effectiveness for reimbursement, she noted.<\/p>\n \u201cAny clinician that would say we don\u2019t yet have the necessary tools in the toolbox to really know how a patient is doing \u2014 to really know whether a drug that they\u2019ve prescribed or a treatment pathway is working. But there\u2019s an enormous opportunity to use the high-resolution streams of data that we are capturing from sensor technologies to deeply understand the impact of a mental health condition on a patient with and without therapy,\u201d Goldsack remarked.<\/p>\n This type of sensor-based data \u2014 such as changes in sleep patterns, physical activity levels, stress responses or speech cadence \u2014 can give real-time insights into a patient\u2019s mental health, she said.\u00a0<\/p>\n For example, an anxious patient might consistently sleep fewer hours, or a depressed patient\u2019s speech patterns might slow and flatten. These concrete, quantitative measures can be tracked over time \u2014 and that helps reveal whether or not treatment can deliver measurable improvement.<\/p>\n There are several companies participating in DiMe\u2019s new project that sell devices that collect this type of data \u2014 including Emteq Labs<\/a>, which sells wearable sensors to measure things like facial muscle movement and heart rate; Linus Health<\/a>, which offers cognitive assessments that incorporate speech and eye tracking; Ksana Health<\/a>, which collects data on patients\u2019 activity, sleep and phone usage; and Feel Therapeutics<\/a>, which provides technology to monitor the mental state of participants in clinical trials for behavioral drugs.<\/p>\n Creating shared measures<\/p>\n Sharon Kaplow, vice president of clinical operations at Feel Therapeutics, said her company is thrilled to join DiMe\u2019s initiative.<\/p>\n She noted that current mental health measurement methods are episodic and subjective.\u00a0<\/p>\n \u201cThey often rely on patient self-reports, which can be biased and require considerable time and effort from both patients and clinicians. As a result, these methods fail to monitor patients remotely or detect subtle, early changes in a patient\u2019s condition, which are critical for timely intervention,\u201d Kaplow stated.<\/p>\n In seeking to establish a standardized set of digital measures that allow for passive and continuous monitoring of mental health patients in a more objective manner, DiMe is taking a big swing to solve an issue that the mental health space has been struggling with for a while, she declared.<\/p>\n Feel Therapeutics, which formed 10 years ago, has been dedicated to helping solve this same problem for its entire existence. The company uses wearable and mobile sensors to monitor physiological data such as electrodermal activity, heart rate variability, skin temperature and physical activity, along with behavioral data from users\u2019 mobile phones, to track changes in their emotional states, mood, sleep, psychomotor activity and social activity, she explained.<\/p>\n Another mental health executive involved in DiMe\u2019s project \u2014 Erin Boyd, chief growth officer at Talkspace \u2014 noted that while her company and many others in the space pride themselves on providing \u201coutcomes-based care,\u201d there has never been industry standards for measuring the outcomes of mental health care.<\/p>\n \u201cIt\u2019s not like the range your blood pressure should be in or the range your cholesterol should be in,\u201d she remarked, noting that each company tends to operate on its own set of standards.<\/p>\n For years, Talkspace and other mental health providers have been publishing peer-reviewed research on how they are measuring the outcomes of their care, Boyd pointed out. By uniting these independent efforts under one collective, she believes the industry will quickly be able to come up with a common language for digital standards.<\/p>\n Boyd noted that DiMe\u2019s initiative features a diverse group of organizations, calling it \u201ca good mix that you don\u2019t see come together very often.\u201d<\/p>\n Turning consensus into action<\/p>\n DiMe plans to release its core set of digital measures for mental health conditions by the end of the first quarter of 2026, Goldsack said.\u00a0<\/p>\n \u201cWe want to understand if the treatment pathway that they\u2019re on is actually working. One, so if it is, we can reimburse for it. And two, if it\u2019s not, we can course correct and get them onto another therapeutic pathway. That\u2019s the gap that this project is going to address,\u201d Goldsack declared.<\/p>\n The creation of a common \u201cmeasurement ontology\u201d will ensure that all industry stakeholders\u2019 methods are consistent and trusted \u2014 as well as suited for various uses, whether they be for clinical, regulatory or reimbursement reasons, she stated.<\/p>\n She pointed out that while today\u2019s sensor technologies can measure almost anything, the industry is still figuring out which measures are the most clinically relevant and valuable.\u00a0<\/p>\n Too often, digital health tools focus on what they measure rather than how well they measure it or how easily the data fits into care and research workflows, Goldsack said..<\/p>\n DiMe\u2019s initiative brings together experts from across the industry to agree \u2014 upfront and in a precompetitive setting \u2014 on a set of digital measures for mental health that works for all players in the space. Goldsack noted that the measures will likely have to do with things like sleep, physical activity, speech and body language.<\/p>\n The team will go beyond plain-language definitions \u2014 instead creating detailed technical standards and data requirements so product developers, clinicians, researchers and payers can all use the measures \u201coff the shelf\u201d with confidence, she explained.<\/p>\n This approach seeks to remove the R&D burden from individual companies, as well as create market clarity around the metrics that truly matter for clinical care, reimbursement and regulatory approval, Goldsack added.<\/p>\n Another mental health executive involved in DiMe\u2019s project \u2014 Russell DuBois, vice president of clinical quality, operations and innovation at BetterHelp \u2014 said he hopes the set of digital measures allow most people to easily understand their mental health in a way that feels accurate and honest to them.\u00a0<\/p>\n \u201cNot a lot of people know what a PHQ-9 or GAD-7 is or what their results mean, but introducing wearables data, like how an effective virtual therapy session might lead to increased physical activity or improve heart rate variability, helps people more easily connect how what they do affects how they feel,\u201d he declared.<\/p>\n He said he also hopes that the measures unlock the ability for mental health to be measured and managed at a much larger scale than it is today.\u00a0<\/p>\n In his view, using behavioral data from wearables as a proxy for our traditional patient-reported outcome measures will allow providers to better understand how their populations are really doing \u2014 as well as improve their ability to get people the appropriate level of care.<\/p>\n Ultimately, the project\u2019s participants believe a set of new digital standards should replace traditional patient-reported outcome measures like the PHQ-9 and the GAD-7.<\/p>\n In addition to developing a core set of digital measures, DiMe\u2019s collaborative will also produce a three-part series of implementation playbooks. These will explain how to use the measures for clinical trials, digital phenotyping and post-market use.<\/p>\n Why now?<\/p>\n Now is the perfect time for DiMe to launch this initiative, Goldsack believes. She pointed out the Peterson Health Technology Institute recently issued a report<\/a> that identified the urgent need for better measures to track the clinical and economic value of digital mental health solutions.<\/p>\n Additionally, CMS\u2019 proposed rule for the 2026 Medicare Physician Fee Schedule supports<\/a> broader use of digital measures to track outcomes in specialty and value-based care, and the White House\u2019s new \u201cMake Health Tech Great Again\u201d agenda also calls for<\/a> better national infrastructure around digital measurement in healthcare.<\/p>\n DiMe\u2019s project also aligns with FDA and White House priorities to expand remote monitoring, shift to preventive care and focus on evidence-backed tools, Goldsack added.\u00a0<\/p>\n She said she is pleased to have the FDA as a partner organization for the initiative, as the regulatory agency is ensuring the project\u2019s work meets requirements for clearance and use in trials.<\/p>\n By establishing a shared language for mental health outcomes measurement, DiMe and its partners hope to bring clarity to a space long plagued by subjectivity. If successful, their work could redefine how mental health is understood, treated and paid for.<\/p>\n Photo: Richard Drury, Getty Images<\/p>\n","protected":false},"excerpt":{"rendered":"Millions of Americans struggle with mental health disorders, but research and treatment in this field often stumble over…\n","protected":false},"author":2,"featured_media":83809,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[60],"tags":[97,259,260],"class_list":{"0":"post-83808","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-mental-health","8":"tag-health","9":"tag-mental-health","10":"tag-mentalhealth"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/83808","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=83808"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/83808\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/83809"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=83808"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=83808"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=83808"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}