Digital therapeutics are on the rise and here to stay. Many digital therapeutics are designed for the treatment of mental health conditions, primarily anxiety and depression disorders, and incorporate evidence-based practices such as cognitive-behavioral therapy (CBT). Over the past decade, there have been roughly 500 clinical trials examining digital therapeutics, with about 180 involving actual interventions.
Following results of a pilot study following about 5,000 participants who used the Happify Health app, the company has announced plans to pursue a prescription digital therapeutic (PDT) indicated for the treatment of migraine headaches.
Migraines are a neurological condition that can have debilitating effects. It’s estimated that up to 12% of Americans (almost a sixth) suffer from some kind of migraine, with women being three times as likely to suffer from them than men. Migraines can’t be cured, only managed, which is why pharmaceuticals have emerged as the primary treatment. These include “abortive” and preventative medications, which are designed to treat a migraine when it happens or prevent one from happening, respectively. However, these medications can have side effects. Happify Health is taking a different approach. The Happify app is a series of games and activities (grounded in CBT) designed to help reduce stress and improve users mood.
The study followed people who used the app regularly while completing happiness and migraine assessments. According to the whitepaper published on the pilot study, the goal was to focus on the underlying psychological symptoms that could be causing frequent migraine headaches. Findings suggested that not only was the Happify Health app able to help reduce stress of users, but this reduction in stress was linked to a significant decrease in frequency of migraines. About 17% of participants reported a reduction in migraine frequency. Additionally, about 12% reported that migraine pain was improved.
Happify notes that their goal is to prepare a PDT product to start randomized controlled trials in 2022.