Technology-enhanced in vivo exposures in Prolonged Exposure for PTSD: A pilot randomized controlled trial

Abstract

In vivo exposures (IVEs) are a key component of exposure-based treatments, during which patients approach fear-provoking, yet safe, situations in "real life." This pilot study assessed the use of a wearable technology (Bio Ware) during IVEs to enhance Prolonged Exposure (PE) therapy for PTSD. Bio Ware provides a clinician dashboard with real-time physiological and subjective data for clinicians to use for virtually guided IVEs. Participants (N = 40) were randomized to a Guided group that received standard PE and virtual, clinician-guided IVEs with the Bio Ware device, or a Non-Guided group that received standard PE and used the Bio Ware device on their own for IVEs. Multilevel linear models with bootstrapping were completed on the intent-to-treat (ITT; N = 39) and per-protocol samples (PP; n = 23), defined as completing at least eight sessions of PE and using the Bio Ware system during ≥ 1 IVEs. In the PP sample, there were significant effects of treatment condition (b = -14.55, SE = 1.47, 95% CI [-17.58, -11.78], p < .001) and time (b = -1.98, SE = 0.25, 95% CI [-2.47, -1.48], p < .001). While both groups showed reductions in PTSD symptoms, the Guided group evidenced significantly greater reductions than the Non-Guided group. These findings demonstrate the feasibility and safety of leveraging Bio Ware for virtual, clinician-guided IVEs during PE therapy for PTSD and suggest that virtual, clinician-guided exposures may enhance treatment outcomes. CLINICAL TRIAL REGISTRATION: NCT04471207.

Keywords: Clinical trial; Posttraumatic stress disorder; Prolonged exposure; Technology; Wearables.