Citation

Back SE, Acierno R, Saraiya TC, Harley B, Wangelin B, Jarnecke AM, McTeague LM, Brown DG, Ana ES, Rothbaum AO, Adams RJ. Contemp. Clin. Trials Commun. 2022; 28: e100940.

Copyright

(Copyright © 2022, Elsevier Publishing)

DOI

10.1016/j.conctc.2022.100940

PMID

35664505

PMCID

PMC9160482

Abstract

Prolonged Exposure (PE) therapy is one of the most efficacious, evidence-based treatments for posttraumatic stress disorder (PTSD). A key component of PE involves in vivo exposures (IVEs) during which patients approach situations or activities in "real life" that are safe but avoided because they elicit a fear response. Despite their critical role in treatment, little research has focused on IVEs. This gap in knowledge is primarily due to the fact that IVEs are typically conducted by patients in between therapy sessions, leaving clinicians reliant upon patient self-report. This approach has numerous shortcomings, which the current study addresses by leveraging technology to develop an innovative device that allows for physiological, biomarker-driven, therapist-guided IVEs. The new system enables clinicians to virtually accompany patients during IVEs and provides real-time physiological (heart rate, skin conductance) and self-report (subjective units of distress) data that clinicians can use to modify the exposure and optimize therapeutic value. This Small Business Innovation Research (SBIR) Phase I project aims to: (1) integrate physiological sensors and live audio/visual streaming into a system for clinicians to guide patients during IVEs; (2) determine feasibility and acceptability of the system; and (3) conduct a pilot randomized clinical trial among veterans with PTSD (N = 40) to evaluate the preliminary efficacy of the system in reducing PTSD symptoms during PE. This paper describes the rationale, design, and methodology of the Phase I project. The findings from this study have the potential to innovate clinical practice, advance the science of exposure therapy, and improve clinical outcomes.

Language: en

Keywords

PTSD; Technology; Veterans; Military; Posttraumatic stress disorder; CAPS-5, Clinician-Administered PTSD Scale for DSM-5; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; FDA, U.S. Food and Drug Administration; IRB, Institutional Review Board; MINI, Mini International Neuropsychiatric Interview; MUSC, Medical University of South Carolina; PCL-5, PTSD Checklist for DSM-5; Physiology; PTSD, posttraumatic stress disorder; RCT, randomized controlled trial; U.S., United States; VA, U.S. Department of Veterans Affairs