Headspace targets 2020 FDA nod for prescription meditation app

Headspace is listed as a collaborator on several studies on ClinicalTrials.gov. (davidmulder61/CC BY-SA 2.0)

Headspace is aiming to get FDA clearance for a prescription meditation app by 2020. The mindfulness startup has created a digital health subsidiary to test the app in randomized controlled trials and take it through the regulatory process.

California-based Headspace is a big player in the consumer-focused, app-enabled guided meditation and mindfulness market. Now, the startup is stepping up its interest in the clinical validation of apps.

Headspace is set to reveal which indication it will target first in the coming months and get a clinical trial up and running around the same time. The existing body of research into meditation gives the startup a wide range of possible conditions to target, although the questionable quality of many tests of the efficacy of meditation means some claimed benefits may fail to stand up to rigorous trials.


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For its part, Headspace started gathering evidence of efficacy in relatively simple trials that looked at psychological measures. But, with an FDA filing in its sights, the startup has stepped up its game.

“All of our current studies include much more robust measures, where we’re actually measuring blood samples of cortisol [and] using connected devices. We’ve moved into much more rigorous, multi-site, high-caliber research,” Headspace CSO Megan Jones-Bell told CBS News.

Headspace is listed as a collaborator on several studies on ClinicalTrials.gov, the most recent of which have looked at the effect of mindfulness meditation on chronic pelvic pain and work stress. The chronic pelvic pain study is a feasibility program designed to set the stage for a “full-scale trial.”

Other sponsors are assessing Headspace’s app, without the official collaboration of the company, and alternative meditation technologies in indications as diverse as diabetes, anxiety and cancer-related psychosocial distress. The diabetes study is assessing the effect of three months of Headspace app use on HbA1C levels.

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