AI Behavior Health Chatbot App Fast-Tracked by FDA (Psychology Today):
Recently the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to Wysa’s AI-based digital mental health conversational agent that delivers cognitive behavioral therapy (CBT) via a smartphone to adults suffering from depression, anxiety, and chronic musculoskeletal pain…
Wysa’s admittance to the FDA Breakthrough Devices Program signifies a giant leap forward for artificial intelligence in the mental health industry. According to the FDA, the designation was supported by a clinical trial that “found Wysa to be more effective than standard orthopedic care and comparable to in-person psychological counseling” … The study authors affiliated with the Washington University in St Louis School of Medicine in St Louis, Missouri, and the University of Washington in Seattle, Washington, wrote:
- Patients who received a digital mental health intervention as part of orthopedic care reported greater two-month mean improvements in depression, pain interference, and physical function than patients who received usual orthopedic care.
- They also reported a greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared with orthopedic patients who received in-person psychological counseling.
Wysa, a leading artificial intelligence (AI) based digital companion for behavioral health, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its AI-based digital mental health conversational agent for patients 18 years and older with a diagnosis of chronic musculoskeletal pain (defined as pain lasting longer than three months) and depression and anxiety.
The device delivers cognitive behavioral therapy (CBT) via a smartphone-based conversational agent to reduce the symptoms of depression and anxiety, reduce pain interference, and improve physical function.
The designation follows an independent peer reviewed clinical trial, published in JMIR, that found Wysa to be effective for managing chronic pain and associated depression and anxiety, which was found to be more effective than standard orthopedic care, and comparable to in-person psychological counseling.