Prescription digital therapeutics (PDTs) are rapidly changing the landscape of mental healthcare, offering new avenues for treatment and increased access for patients. These FDA-authorized apps provide evidence-based interventions for a range of conditions, from depression to substance use disorder, and are designed to complement traditional therapies. However, experts emphasize the need for careful consideration of data privacy, clinician education, and insurance coverage to ensure their successful integration into clinical practice.
FDA-Approved Digital Therapeutics for Mental Health
Several PDTs have already received FDA clearance for various mental health conditions:
- DaylightRx: Cleared in September 2024 for generalized anxiety disorder (GAD) in adults, this app-based therapeutic delivers cognitive behavioral therapy (CBT) through interactive lessons.
- Rejoyn™: Approved in April 2024 as an adjunct to clinician-managed care for major depressive disorder (MDD) in adults, Rejoyn combines Emotional Faces Memory Task (EFMT) exercises with CBT-based lessons.
- MamaLift Plus™: Approved in April 2024, MamaLift Plus is the first prescription digital therapeutic for mild to moderate postpartum depression (PPD) among patients aged 22 years and older. It uses elements of CBT, dialectical behavior therapy (DBT), behavioral activation therapy (BAT), and interpersonal therapy (IPT).
- CT-155: Click Therapeutics received FDA breakthrough device designation for CT-155, an investigational PDT for schizophrenia, in January 2024. It addresses negative symptoms using psychosocial intervention techniques.
- NightWare: Authorized in November 2020 for sleep disturbance in adults with nightmare disorder or post-traumatic stress disorder (PTSD), NightWare uses a smartwatch to detect and interrupt nightmares with gentle vibrations.
- EndeavorRx: Approved in June 2020, this video-game-based intervention aims to improve attention in children aged 8 to 17 years with ADHD.
- reSET and reSET-O: Cleared in 2017 and 2018, respectively, for substance use disorder and opioid use disorder, these apps were acquired by PursueCare in August 2024 after the original developer, Pear Therapeutics, filed for bankruptcy.
Addressing Unmet Needs and Extending Care
PDTs hold promise for addressing the significant unmet needs in mental healthcare, particularly in light of provider shortages. Dr. Arwen Podesta, a psychiatrist with subspecializations in addiction medicine, forensic psychiatry and integrative medicine, notes that PDTs can "extend our treatment, because they really can be effective at helping patients in between our appointments or maybe even when they don’t have access to a prescriber."
These therapeutics can also empower patients by giving them a sense of control over their condition and participation in their own care. According to Dr. Podesta, "Being able to have some self-management and feel like they have some autonomy in their disease outcome and their symptom improvement is really something that elevates patients."
Concerns and Considerations
Despite their potential, the integration of PDTs into mental healthcare is not without its challenges. One major concern is the protection of patient information. Dr. John Torous, director of the digital psychiatry division at Beth Israel Deaconess Medical Center, emphasizes that patients "are putting their data in the hands of these companies, and some have a good track record of privacy while others don’t."
While PDTs are required to adhere to HIPAA rules, the Federal Trade Commission has recently settled with digital mental health companies for privacy violations, highlighting the need for robust safeguards. Access to technology and insurance coverage also pose barriers to widespread adoption. "Coverage from healthcare insurers is imperative for wider use and the success of these treatments," says Dr. Saundra Jain, adjunct clinical affiliate for the School of Nursing at the University of Texas at Austin.
Some clinicians also express skepticism about the evidence supporting PDTs. Dr. Torous notes that the evidence required for FDA authorization of medical devices is often less rigorous than that for medication approval. He also points out that many non-prescription apps may have stronger evidence than FDA-cleared ones.
The Future of Digital Therapeutics in Mental Health
Despite these concerns, many experts believe that PDTs will play an increasingly important role in mental healthcare. Dr. Jain states, "Digital therapeutics are enhancing mental health care by providing accessible new treatment options that complement, rather than compete with, traditional therapies."
By addressing unmet needs, extending care, and empowering patients, PDTs have the potential to transform the way mental health conditions are treated. However, it is crucial to address concerns about data privacy, clinician education, and insurance coverage to ensure their successful and equitable integration into clinical practice.
