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The Largest and Longest Study of Patients with Schizophrenia Interacting with Digital Therapeutics Results Released

Pear Therapeutics to Bring to Market Digital Therapeutics Based on Clinical Research from Dr. Dror Ben-Zeev et al for Patients with Severe Mental Illness


News provided by

Pear Therapeutics

Aug 25, 2016, 04:00 ET

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BOSTON and SAN FRANCISCO, Aug. 25, 2016 /PRNewswire/ -- Pear Therapeutics (PEAR), the creator of prescription digital therapies called eFormulations™, announced today results from a real-world implementation study examining a research version of THRIVE™, PEAR's digital therapy for treating patients with Serious Mental Illness including schizophrenia, schizoaffective disorder, and bipolar disorder.  The study was led by Dr. Dror Ben-Zeev PhD, Director of the mHealth for Mental Health Program at Dartmouth College and Associate Professor of the Departments of Psychiatry and Biomedical Data Science at The Geisel School of Medicine at Dartmouth College and colleagues. PEAR has partnered with Dr. Ben-Zeev to bring cutting edge treatments through research studies and into the hands of the patients and providers who need them most.  

The study, published as "mHealth for Schizophrenia: Patient Engagement With a Mobile Phone Intervention Following Hospital Discharge1" examined the engagement of patients with schizophrenia-spectrum disorders with the digital therapy intervention for a period of 3-6 months post hospital discharge.  The study evaluated 342 participants between 18-60 years of age, who had been diagnosed with a psychotic disorder and were discharged from a psychiatric hospitalization within 60 days. The study, supported by a grant from the Department of Health and Human Services, Centers for Medicare & Medicaid Services, is to date the largest and longest study examining the interaction of patients with schizophrenia with a digital therapy.

"This study debunks the concern that patients who are not clinically stable are not capable of using mobile interventions." 
     Dror Ben-Zeev, PhD, Director of the mHealth for Mental Health Program at Dartmouth College

The study demonstrated robust usage of and engagement with the research version of THRIVE™.  Seventy-four percent (73.6%) of patients were successfully able to use the digital therapy 3-6 months after discharge, and on average, participants used the digital therapy for 82% of the weeks they had a mobile phone.  The study found that patients engaged with the app every other day, and when engaged, they used on-demand features more than once per day.  Patients who used the app for the entirety of the study averaged 4.3 days of use per week.

In previous studies, the digital therapy has shown efficacy in treating schizophrenia across a 33-patient longitudinal study where patients demonstrated an 8% improvement in the Positive and Negative Syndrome Scale (PANSS), the primary endpoint in clinical trials for schizophrenia treatments.  Study participants, already taking antipsychotics at study start, were offered access to the research version of THRIVE™ and followed over 1 month of use, during which time patients engaged with the digital therapy 86.5% of days they had the device, an average of 5.2 times a day.  The research version of THRIVE™ is being or has been evaluated across 7 clinical studies in 504 patients.

"Patients with schizophrenia are traditionally considered a high risk patient population and the period immediately following hospitalization is of particularly high risk.  This study debunks the concern that patients who are not clinically stable are not capable of using mobile interventions," said Dror Ben-Zeev, PhD, Director of the mHealth for Mental Health Program at Dartmouth College.

"Coupled with prior results demonstrating enhanced outcomes in patients with schizophrenia-spectrum disorders, this study suggests that THRIVE™ could be an efficacious, long-lived therapeutic intervention.  We are particularly excited to have the opportunity to bring THRIVE™ through regulatory approval and payor reimbursement.  We are committed to making this product part of the standard of care for treating Serious Mental Illness," said Corey McCann, President and Chief Executive Officer of PEAR.

About THRIVE™
THRIVE is a digital therapy for treating patients with schizophrenia, schizoaffective disorder, and bipolar disorder.  THRIVE delivers daily prompts to encourage patient engagement, and contains therapeutic modules that offer content designed to help individuals manage their disease.  Modules include content designed to manage positive symptoms of schizophrenia and support medication adherence, with a specific emphasis on voices, social function, medication adherence, sleep behaviors, and mood.  

About Pear Therapeutics
Pear Therapeutics is a privately held eHealth company with offices in Boston and San Francisco.  The Company develops digital therapies to address a broad range of severe conditions including addiction, schizophrenia, pain, post-traumatic stress disorder, anxiety, depression, and insomnia. PEAR's eFormulation™ platform combines pharmaceutical preparations with user-friendly, customizable, and scientifically validated software applications.  PEAR's patented approach provides better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers.  For additional information please visit: www.peartherapeutics.com.

Addendum
The publication referenced was part of a multi-state project funded by the Center for Medicare and Medicaid Innovation (CMMI) and led by PI Dr. John Kane at the Zucker Hillside Hospital. The effort included a team of researchers from multiple institutions, including Dr. Dror Ben-Zeev.  In the project, FOCUS, the research version of PEAR's digital therapy THRIVE™ was deployed as part of a multi-component relapse prevention effort called Improving Care Reducing Costs (ICRC). ICRC was the first comprehensive technology-aided program of its kind for people with schizophrenia who were recently discharged from psychiatric hospitalization. 

Thrive™ is an investigational device. Limited by Federal law to investigational use. Not available for commercial sale in the U.S.

SOURCE Pear Therapeutics

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