What are Prescription Digital Therapeutics (PDT)?

What Is a Prescription Digital Therapeutic?

A prescription digital therapeutic (PDT) is a software-based treatment that may help people manage or treat a medical or mental health disorder.

Most PDTs are accessed through:

• Smartphones
• Tablets
• Computers

Some are designed to teach coping skills, track symptoms, support healthy routines, or reinforce strategies you learn in therapy.

For example, a digital therapeutic for anxiety might help you:

• Practice calming exercises
• Learn Cognitive Behavioral Therapy (CBT) skills
• Track stress patterns
• Build healthier sleep or breathing routines

A digital therapeutic for insomnia might guide you through sleep-focused CBT exercises between appointments.

Some prescription digital therapeutics are meant to be used on their own, while others work best alongside:

• Therapy
• Medication
• Coaching
• Ongoing care from a clinician

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How Are PDTs Different From Mental Health Apps?

Not every mental health app is a prescription digital therapeutic.

Today, thousands of mental health apps are available in app stores. Some focus on meditation, mood tracking, journaling, sleep, or mindfulness. Others are designed by healthcare companies or researchers.

Prescription digital therapeutics are different because they are developed as medical tools and reviewed through FDA pathways for software-based medical devices.

That said, the difference is not always simple or obvious.

Some free or low-cost mental health apps may still offer evidence-based tools or helpful support. At the same time, an app labeled as a prescription digital therapeutic is not automatically the best fit for every person.

Experts interviewed in an ADAA podcast about digital therapeutics emphasized an important point: people should focus less on labels and more on whether a tool is:

• Safe
• Evidence-informed
• Updated regularly
• Respectful of privacy
• Helpful for their specific needs

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Do Digital Therapeutics Require Prescriptions?

Some do, and some do not.

The term “prescription digital therapeutic” usually refers to software tools that are intended to be prescribed or used under the guidance of a clinician.

But the language around digital therapeutics is still evolving.

In practice, many people use digital mental health tools without a formal prescription. A therapist or psychiatrist may recommend an app as part of treatment, even if it is not technically prescribed the way medication is.

Some tools also require:

• Enrollment through a healthcare provider
• Insurance authorization
• A prescription code or clinician access

Others can be downloaded directly by consumers.

If you are unsure whether a digital therapeutic requires a prescription, ask:

• Is this tool meant to be used with a clinician?
• Can I access it on my own?
• Is it covered by insurance?
• What evidence supports it?

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Are Prescription Digital Therapeutics FDA Authorized?

Some prescription digital therapeutics are reviewed or authorized by the FDA as software-based medical devices.

This is different from a general wellness app that anyone can upload to an app store.

FDA authorization usually means the developer submitted research or safety information for review. But it does not necessarily mean:

• The app works for everyone
• The app replaces therapy or medication
• The app is risk-free
• The app is the “best” option available

Experts in the ADAA podcast noted that FDA authorization in this space can still be confusing for both clinicians and patients because digital mental health technology is changing quickly.

It is also important to know that some trusted mental health apps and digital tools may not go through FDA review at all, even if they are backed by research or used by healthcare systems.

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How PDTs May Support Mental Health Care

For many people, mental health treatment happens between appointments.

A therapist might teach a coping skill during a session, but the real challenge is using that skill later:

• During a stressful workday
• After a difficult conversation
• Late at night when anxiety spikes
• During periods of depression or isolation

Digital tools may help bridge those gaps.

Prescription digital therapeutics and mental health apps may support care by helping you:

• Practice therapy skills between visits
• Track mood, sleep, or stress patterns
• Build routines and healthy habits
• Stay engaged with treatment goals
• Receive reminders or guided exercises
• Better understand how daily experiences affect your mental health

Some tools can also help clinicians understand patterns over time.

For example, a person may notice:

• Their anxiety gets worse after poor sleep
• Their mood changes on weekends
• Their stress increases in certain environments

This type of tracking can help make treatment more personalized and more connected to everyday life.

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What Are the Limits of PDTs?

Digital tools can be helpful, but they are not a replacement for comprehensive mental healthcare.

Research suggests that mental health apps often work best when they are used alongside care from a clinician.

Some people may also stop using apps quickly if:

• The app feels overwhelming
• The exercises are hard to maintain
• The content does not feel relevant
• The tool is difficult to use

Privacy is another important concern.

Before using any mental health app or digital therapeutic, check:

• What personal information is collected
• Whether your information is shared
• Whether the app has a privacy policy
• How often the app is updated

Be cautious about apps that:

• Make unrealistic promises
• Claim to “cure” mental health disorders
• Push fear-based messaging
• Request excessive personal data
• Lack transparency about who created them

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What to Ask Before Using a PDT or Mental Health App

If you are thinking about using a prescription digital therapeutic or another mental health app, consider asking:

• Has this tool been studied for my concern?
• Is it meant to be used with a clinician?
• What information does it collect about me?
• How often is the app updated?
• How much does it cost?
• Will insurance cover it?
• How will I know whether it is helping?
• What should I do if my symptoms get worse?

You can also ask a therapist, psychiatrist, primary care doctor, or other licensed mental health professional whether they recommend a specific tool.

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Learn More From ADAA

This page was informed by an upcoming ADAA podcast conversation hosted by Gabe Howard, an award-winning mental health podcast host, speaker, and advocate living with bipolar and anxiety disorders.

In the podcast, experts discuss:

• The difference between wellness apps and digital therapeutics
• Why digital mental health tools can be confusing
• How apps may support care between appointments
• Why privacy, personalization, and clinician involvement matter

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When to Seek Additional Help

Mental health apps and digital tools are not designed for emergencies or crisis situations.

If you are struggling with severe anxiety, depression, thoughts of self-harm, or another mental health crisis, reach out to a licensed mental health professional or emergency support service right away.

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Find Support

Prescription digital therapeutics may become one part of a larger mental health treatment plan, but they work best when paired with trusted support and evidence-based care.

To learn more about treatment options or connect with a licensed mental health professional:

• Learn about anxiety, depression, PTSD, and related disorders
• Check out ADAA’s Find Your Therapist directory

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