Is digital technology on the brink of becoming a viable treatment option for schizophrenia? While many experts are optimistic \u2014 especially about its potential to address negative symptoms \u2014 opinions vary on how quickly these tools could move research into clinical practice. Questions about feasibility, scalability, cost, and access remain major barriers.<\/p>\n
Until last year, no new schizophrenia medication had been approved<\/a> by the FDA for decades. But after disappointing results<\/a> of xanomeline\/trospium chloride (Cobenfy, Bristol Myers Squibb), many clinicians are calling for additional treatment options and are becoming more open to exploring digital and technical solutions.<\/p>\n From mobile apps to virtual therapy platforms, a growing number of digital interventions show promise in managing schizophrenia \u2014 particularly its often intractable negative symptoms.<\/p>\n Clinicians and researchers see digital tools as uniquely positioned to engage patients with schizophrenia, offering low-burden support between appointments. Yet major hurdles remain: Most technologies aren\u2019t yet available outside trials, few are covered by insurance, and evidence is often limited to small studies.<\/p>\n \u201cPeople are frustrated. Treatment is still so limited that I think there\u2019s real excitement about digital options,\u201d said John Torous, MD, psychiatrist and director of Digital Psychiatry at Beth Israel Deaconess Medical Center in Boston.<\/p>\n So far, only one digital therapeutic<\/a> (DTx) designed solely for schizophrenia has received Breakthrough Device Designation from the FDA, and none has received full marketing authorization in the US.<\/p>\n While many other DTx are under investigation, they remain confined to the research stage or are designed to treat related conditions. Others are marketed as \u201cwellness\u201d apps rather than \u201cmedical\u201d apps in order to avoid FDA-clearance requirements.\u00a0<\/p>\n Although the field isn\u2019t quite there yet, Torous believes \u201cwe\u2019re closer than people realize\u201d to practice-changing schizophrenia-focused DTx, especially with the advancement of artificial intelligence (AI) and with at least one large trial<\/a> currently underway.<\/p>\n \u201cIt\u2019s tantalizingly close yet still far away,\u201d Torous said.<\/p>\n App Gap<\/strong><\/p>\n The World Health Organization estimates that approximately 24 million people worldwide have schizophrenia \u2014 about 1 in every 300 individuals.<\/p>\n The condition commonly includes \u201cpositive\u201d symptoms, which involve abnormal experiences such as hallucinations, delusions, and disorganized speech or behavior, and\/or \u201cnegative\u201d symptoms characterized by a loss of normal functioning, including blunted affect, social withdrawal, decreased motivation, loss of pleasure, and cognitive deficits.<\/p>\n Current treatment mainly consists of antipsychotic medications combined with psychosocial therapy. Emerging approaches include avatar therapy<\/a> for hallucinations, virtual reality<\/a> (VR)-based cognitive-behavioral therapy (CBT), and a range of digital apps.<\/p>\n The Pew Research Center reported in November<\/a> that 91% of all Americans own a smartphone, including 79% of adults over the age of 65 years.<\/p>\n \u201cWe have very good data that people with schizophrenia are comfortable using apps,\u201d said Torous, who is also an assistant professor of psychiatry at Harvard Medical School, Boston.<\/p>\n \u201cBut there\u2019s a gap where the apps built in the research world haven\u2019t become accessible tools that you and I can download and give to someone. The FDA hasn\u2019t fully cleared any yet, and of the ones that are direct-to-consumer, none of them are superb,\u201d he said.<\/p>\n While digital tools hold a lot of promise, improvements are needed to make them accessible and scalable, Torous said. \u201cWe have really good theoretical evidence at this point that these can work. So it\u2019s time to put them to a real test in the real world,\u201d he added.<\/p>\n Higher Engagement With Schizophrenia Apps<\/strong><\/p>\n In the US, CT-155 (Boehringer Ingelheim and Click Therapeutics) received Breakthrough Device Designation<\/a> from the FDA last year. The mobile app-based software is designed to address negative symptoms of schizophrenia when used alongside standard pharmaceutical treatment.<\/p>\n In addition, the National Institute for Health and Care Excellence (NICE) released an \u201cearly value assessment<\/a>\u201d last year recommending three healthcare technologies as potential adjunctive treatments for schizophrenia in adults and youth within the UK\u2019s National Health Service \u201cwhile more evidence is generated.\u201d<\/p>\n These included avatar therapy for managing auditory hallucinations; SlowMo, a digital therapeutic that delivers eight app-based therapy sessions aimed at slowing distressing thoughts or paranoia; and CareLoop, a smartphone app designed to monitor psychosis symptoms and help prevent relapse.<\/p>\n \u201cDigital health technologies offer another option for people with psychosis who may otherwise not have psychological interventions,\u201d the NICE report authors wrote.<\/p>\n In an earlier report<\/a>, NICE also recommended gameChange VR for agoraphobia avoidance. This automated CBT product guides users through simulated social situations.<\/p>\n Scores of other digital approaches are being investigated, and most show effectiveness, especially for negative symptoms. At this year\u2019s American Psychiatric Association (APA) annual meeting, nearly every research poster session featured presentations on apps targeting conditions such as insomnia, substance use, anxiety, and schizophrenia.<\/p>\n Interestingly, patient engagement is higher for schizophrenia-focused apps than for those targeting other mental health disorders, Torous noted.<\/p>\n \u201cI think that\u2019s because schizophrenia apps are built really well. There\u2019s a lot of concern regarding harms for these patients, so there\u2019s a real effort not to cut corners. It could be that because more eyes are [monitoring] these apps, there\u2019s more attention to detail,\u201d he said.<\/p>\n A Catch-22<\/strong><\/p>\n So why haven\u2019t more of these research-backed treatments been approved for clinical use? Torous explained that to date most studies have been relatively small, and the research is stuck in a catch-22: Sponsors are hesitant to fund large trials without clear evidence of feasibility \u2014 yet that level of evidence can\u2019t be generated without larger studies.<\/p>\n In addition, key questions remain around how to deliver timely, cost-effective training and how to scale digital therapies for broad implementation. Another major concern: Will insurance ever cover these treatments?<\/p>\n Torous noted that the large phase 3 CONVOKE trial<\/a> could possibly answer a lot of these questions. It has pharmaceutical backing and, if proven effective, could roll out quickly, he said.<\/p>\n Launched in May 2023, CONVOKE is a 16-week randomized controlled trial evaluating the safety and efficacy of CT-155 or a second digital therapeutic smartphone app when used alongside standard antipsychotic treatment for negative symptoms of schizophrenia. The study aims to enroll 432 participants across 54 US sites.<\/p>\n The development company already received<\/a> FDA marketing authorization in April for one of its other DTx smartphone apps (CT-132) for the prevention of episodic migraine. However, the product is not yet available to prescribe or purchase.<\/p>\n While not specifically designed for schizophrenia, several currently accessible apps target-related conditions, particularly depression. Widely available AI-powered chatbots are also showing promise in supporting mental health care.<\/p>\n ChatBots an \u2018Emotional Sanctuary\u2019?<\/strong><\/p>\n In a small 2024 study<\/a> by Torous and Steven Siddals, who was with King\u2019s College London, London, England, at the time of publication, participants reported high engagement and positive effects from using commercial mental health-related generative AI chatbots such as ChatGPT, while emphasizing the need for safety \u201cguardrails.\u201d<\/p>\n \u201cWhat surprised us the most was the depth of emotional support people described. Participants told us it felt like a kind of \u2018emotional sanctuary\u2019 \u2014 a safe space where they could be vulnerable without fear of judgment,\u201d Siddals said in a release.<\/p>\n \u201cIt really was phenomenal how deeply understood people felt talking to [the chatbot], even knowing it wasn\u2019t human,\u201d he told Medscape Medical News.\u00a0It was also used by some participants as a \u201cpractice session\u201d in order to work out feelings before going to in-person appointments.<\/p>\n Siddals emphasized the value of future research to better understand what contributed to the intervention\u2019s success. He noted that AI therapy offers a unique opportunity for in-depth analysis, since \u2014 with patient consent \u2014 researchers can access complete transcripts of interactions.<\/p>\n Building on these promising early findings, results from a larger 200-participant randomized controlled trial published in April<\/a> demonstrated that a generative AI-powered therapy chatbot known as Therabot was linked to significant reductions in major depressive disorder, generalized anxiety disorder, and eating disorders \u2014 though schizophrenia was not among the conditions assessed in the study.<\/p>\n \u201cThe effect sizes weren\u2019t just significant; they were huge and clinically meaningful \u2014 and mirrored what you\u2019d see in a gold standard dose of evidence-based treatment delivered by humans over a longer period of time,\u201d senior study author Nicholas Jacobson, PhD, Dartmouth College\u2019s Geisel School of Medicine, Hanover, New Hampshire, told Medscape Medical News at that time.<\/p>\n However, in a small pilot study<\/a> presented at this year\u2019s APA meeting, a human therapist outperformed an AI model (ChatGPT-3.5) for feedback, collaboration, and guided discovery in the delivery of CBT. Still, the AI did perform well in providing a structured therapeutic approach, the investigators reported.<\/p>\n Blurred Lines<\/strong><\/p>\n There is also a proliferation of so-called \u201cwellness\u201d apps. In an editorial published online<\/a> in Schizophrenia Research\u00a0last year, Torous and colleagues wrote that many digital mental health products \u201cskate the line between medical and wellness classification, a distinction often perceived as a blurred line from the wider public.\u201d This means patients are using wellness apps they believe meet their needs \u2014 if they are able to find them.<\/p>\n At the time the editorial was published, only 10 direct-to-consumer apps specifically designed for schizophrenia were publicly available, with several since abandoned by their developers.<\/p>\n Torous pointed out that while it typically takes about 10 years to bring a new medication to market, digital apps require significant updates within that same timeframe due to the rapid pace of technological change.<\/p>\n