An open-label virtual clinical trial to evaluate an FDA-authorized prescription digital therapeutic (PDT) (Somryst; Pear Therapeutics, Inc., Boston, MA) for treating chronic insomnia has enrolled the first participant. The PDT can be used on a mobile device such as a smartphone or tablet.
The PDT is intended to provide a neurobehavioral intervention, cognitive behavioral therapy for insomnia (CBTi) that has been proven effective for reducing insomnia.
The DREAM study (NCT04325464) will enroll approximately 350 participants ages 22 to 75 with chronic insomnia as defined by an Insomnia Severity Index (ISI) score of 8 or above, and insomnia symptoms for at least 3 months.
The aim of the study is to examine the real-world impact of the therapy on chronic insomnia, depression, and anxiety symptoms. The study will also collect self-reported data for quality of life, work attendance, and productivity during the study and the 1-year follow-up.
The decentralized, site-less approach allows the study to progress, even as COVID-19 constrains the ability to safely conduct clinical studies and real-world research that involves in-clinic visits. Eligible participants across the US can enroll and participate without visiting a physical clinical site.
“Insomnia, anxiety, and depression are on the rise due to the COVID-19 pandemic,” said Yuri Maricich, MD, chief medical officer, Pear Therapeutics. “Cognitive behavioral therapy for insomnia (CBTi) is considered first-line treatment for chronic insomnia, but the majority of people do not have access to nor receive the recommended treatment. By delivering CBTi digitally, we can learn from people with chronic insomnia, address their critical needs, and remove the barriers for accessing guideline recommended treatment.”
Omar Bushara, BA; Rimas V. Lukas, MD; and Jessica W. Templer, MD
Adam M. Staffaroni, PhD; Elena Tsoy, PhD; Jack Taylor, BS; Adam L. Boxer, MD, PhD; and Katherine L. Possin, PhD
Nupur Ghoshal, MD, PhD