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Intelligent Biometrics to Optimize Prolonged Exposure Treatment for PTSD (IB-PE)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43MH122045-01
Agency Tracking Number: R43MH122045
Amount: $952,031.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 104
Solicitation Number: PA18-579
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-13
Award End Date (Contract End Date): 2021-08-31
Small Business Information
234 SEVEN FARMS DR, STE 212
Charleston, SC 29492-8109
United States
DUNS: 079763709
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 WILLIAM HARLEY
 (843) 300-8820
 bill.harley@zeriscope.com
Business Contact
 WILLIAM BROWN
Phone: (843) 300-8820
Email: will.brown@zeriscope.com
Research Institution
N/A
Abstract

PROJECT SUMMARY/ABSTRACT
Posttraumatic Stress Disorder (PTSD) is a debilitating disease affecting millions of American military veterans
and civilians. Prolonged Exposure (PE) therapy is evidence-based and effective but limited by high dropout rates
and incomplete resolution of symptoms in approximately one-third of patients. A crucial component of PE, as
well as interventions for anxiety disorders, is “In Vivo Exposure” (IVE) during which patients approach safe but
avoided stimuli in the “real world.” Typically, patients are given in vivo assignments to complete in-between
therapy sessions, which leaves providers reliant upon patient self-report and may increase risk for patient
disengagement and dropout. At present, there are no digital technology systems that target IVE. The proposed
study directly addresses this critical gap by using intelligent biometrics (IB) to personalize and optimize IVE. The
new system (IB-PE) includes a multidimensional data acquisition and storage system to capture real-time
biomarkers of engagement (e.g., heart rate, skin conductance) and self-report (e.g., subjective units of distress
or SUDS) during IVEs, enabling therapists to virtually accompany patients during IVEs (without leaving the office)
and modify the exercises based on objective biometrics of activation to ensure maximal efficiency and
therapeutic benefit, thereby eliminating traditional shortcomings of standard PE. Furthermore, the system will
record IVEs for offline analysis. Key innovations are that—for the first time—clinicians will be able to
participate in the IVE experience from the office, use real-time biometrics to optimize IVEs and minimize
patient under- or over-engagement, and have the benefit of reviewing IVEs offline to guide treatment
planning. This Phase 1 project will: (1) Integrate physiological biomarker sensors with SUDS and audio/visual
streaming into a system for office-based therapists to use during IVE; (2) Determine feasibility and acceptability
of the new system by measuring ease of use, comfort and utility in a real-world environment; and (3) Conduct a
12-session randomized clinical trial in 40 veterans with PTSD to evaluate preliminary efficacy of IB-PE in
reducing PTSD severity from baseline to session 12. In addition, recorded IVE sessions will be analyzed to
identify biological and behavioral indicators with high predictive value of treatment response. At the conclusion
of this project, a comfortable and unobtrusive system will be ready for larger definitive trials of IB-PE. It is
expected that the IB-PE system will, through technology-enabled human support and guidance, result in clinically
significant reduction of PTSD symptoms achieved with fewer sessions, thereby lowering costs and improving
access. This application is directly responsive to the FOA (PA-18-579) encouraging STTR grant applications to
support research and development of priority research topics - complex technologies that require funding levels
and durations beyond those reflected in the standard STTR guidelines. The findings from this study have the
potential to innovate and transform clinical practice, and significantly improve exposure therapy for PTSD.PROJECT NARRATIVE
Posttraumatic stress disorder (PTSD) is a chronic and debilitating psychiatric condition. Prolonged Exposure
(PE) therapy is an effective, evidence-based treatment for PTSD; however, approximately one-quarter of
patients drop out prematurely and one-third who do complete treatment remain symptomatic. The proposed
study will employ a novel mobile technology system to optimize patient engagement, retention and clinical
outcomes.

* Information listed above is at the time of submission. *

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