"Digital therapeutic" is a term of art. It describes software that has been evaluated by a regulator (in the US, the FDA) for a specific clinical claim, and that — in many cases — can be prescribed by a clinician the way a medication is. The category is younger than the marketing around it suggests, the evidence base is uneven, and the commercial story has been turbulent. For schizophrenia specifically, only a handful of products exist, and what counts as "approved" depends on whose definition you use.
This is a snapshot, not a recommendation. If something here interests you, your starting point is a conversation with your prescriber.
An FDA-cleared device has passed the 510(k) pathway, meaning it is "substantially equivalent" to an existing approved device. FDA-authorised usually refers to De Novo authorisation — a newer pathway for first-of-a-kind low-to-moderate-risk devices. Neither is the same as full premarket approval (PMA), which is rare for software.
The landscape
Most "mental health apps" are not regulated as medical devices. They are wellness products, sold direct to consumer, with no FDA review. A small number of companies have chosen to pursue regulatory clearance, which is expensive and slow but allows specific clinical claims and, in principle, insurance reimbursement.
The mid-2020s saw several high-profile setbacks in the digital therapeutics industry, with one of the largest companies (Pear Therapeutics) declaring bankruptcy in 2023 in part because reimbursement did not arrive at scale. The lesson the field has been absorbing is that an FDA clearance does not automatically translate into payer coverage, prescriber adoption, or patient use.
Schizophrenia-specific products
CT-155 / "Rejoyn for schizophrenia" and similar adjunctive apps
Several companies have pursued or are pursuing FDA clearance for software intended to be used alongside antipsychotic medication, often delivering structured exercises drawn from CBT for psychosis. The evidence base is still being assembled; published trials so far show modest effects on symptom scales and engagement that decays meaningfully over months.
Cognitive remediation software
Cognitive remediation — structured exercises targeting attention, memory, and executive function — has reasonable evidence in schizophrenia. Several products exist (CogPack, BrainHQ from Posit Science with a schizophrenia indication, others), with some FDA-cleared versions for related cognitive indications. The 2007 Cochrane review and follow-on work by Wykes and colleagues established that cognitive remediation produces small-to-moderate gains in cognition and, when paired with vocational rehabilitation, in real-world functioning.
Digital symptom monitoring (FDA-listed/registered)
Products that combine passive sensing and active patient-reported outcomes to track relapse risk — Mindstrong was an early example, and others have followed — sit in a grey zone. Some are registered with the FDA as low-risk Class I or Class II software, but few have specific schizophrenia indications.
What the evidence supports
Across published trials, the patterns are reasonably consistent:
- Effect sizes for digital therapeutics in schizophrenia are small to moderate when measured at the end of a controlled trial.
- Engagement drops meaningfully after the first few weeks. Long-term users are a minority.
- The combination of digital tools plus a real human in the loop (a coach, peer worker, or clinician) consistently outperforms unsupported app use.
- No digital therapeutic in schizophrenia has yet shown effects comparable to even modest doses of antipsychotic medication. They are adjuncts, not replacements.
A 2021 review in JMIR Mental Health by Aref-Adib and colleagues looked at digital interventions for psychosis and concluded that the field is "promising but immature," which remains a fair summary today.
Things that are not digital therapeutics, even though marketing sometimes implies they are
- Most consumer mental health apps (Calm, Headspace, etc.) — wellness products without specific clinical claims for schizophrenia.
- AI chatbots offering "therapy" — at this writing, none have FDA clearance for schizophrenia.
- Reminder apps and journaling tools — useful but not regulated as medical devices.
- Frida (the app this blog belongs to) — Frida is not currently classified as a digital therapeutic. We are a stability tracking and self-management platform, not a regulated medical device.
Reimbursement: the unsolved problem
Even FDA-cleared digital therapeutics struggle to get covered by insurance. The CPT code structure, payer policies, and prior authorisation requirements have not kept pace with the technology. Many products that exist on paper are difficult to actually access through standard insurance. Some are sold direct-to-patient at out-of-pocket cost.
How to evaluate a product
- Look for the FDA clearance letter, not just a vague "FDA-cleared" claim on a website. The letter specifies the indication and the population studied.
- Read the published evidence, not just the press release. Peer-reviewed trials in real journals are very different from preprints or company-funded white papers.
- Ask who pays. If a product is technically available but insurance won't cover it and out-of-pocket cost is high, access is theoretical.
- Check engagement assumptions. A trial that excluded everyone who didn't open the app daily for the first week is not measuring what real-world adoption looks like.
- Talk to your prescriber. A prescriber who has not heard of the product is not necessarily out of touch — most have not, because uptake is low.
No app yet replaces antipsychotic medication for active schizophrenia. If a product implies otherwise, that is a reason for caution, not enthusiasm.
Where the field is heading
The next few years will probably bring more cognitive remediation products, more clearance for digital monitoring tools paired with telepsychiatry, and continued slow expansion of insurance coverage. The big unsolved problems — engagement, reimbursement, real-world effectiveness — will keep shaping which products survive.
The honest path forward, as a patient, is curiosity without credulity. Ask what a product is actually claiming, what evidence supports it, and what role it would play alongside medication and therapy. The good answers will hold up to those questions.
This article is for educational purposes only and is not medical advice, diagnosis, or treatment. Always consult a qualified mental health professional. If you or someone you know is in crisis, call or text 988 in the US, or your local emergency number.