NCT04471207

Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

Intelligent Biometrics to Optimize Prolonged Exposure for PTSD

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Posttraumatic stress disorder (PTSD) is a debilitating mental health condition that increases suicide risk and affects up to 20% of military veterans and 8% of the general population. Prolonged Exposure (PE) is a highly effective behavioral (talk therapy) intervention for PTSD. However, dropout rates are high (25-30%) and an estimated one-third of patients who complete PE still report symptoms of PTSD at the end of treatment. This study directly addresses these limitations by using a clinical trial to evaluate the ability of an innovative technology system to improve PE therapy for veterans with PTSD.

Detailed description

Posttraumatic stress disorder (PTSD) is a chronic and debilitating psychiatric condition. Prolonged Exposure (PE) therapy is a highly effective, evidence-based treatment for PTSD; however, dropout rates are high and approximately one-third of patients who complete treatment remain symptomatic. The proposed study will employ a randomized clinical trial (N=40 treatment-seeking veterans with current PTSD) to evaluate the acceptability, feasibility and preliminary efficacy of a technological enhancement (IB-PE), and investigate predictors of outcome by accomplishing the following milestones: (1a) Evaluate ability of IB-PE (therapist guided vs. record only) in reducing PTSD severity from baseline to end of treatment; and (2b) Use a variety of in vivo exposures (IVEs) to identify biometric and behavioral indicators (high heart rate, skin conductance) with high predictive value of treatment response. We will use a technology system of discrete wearables (camera, microphone) to allow therapists to accompany participants during IVEs. The system will pair with a cellular application and record information such as heart rate and skin conductance. This system will also allow the participant to communicate with the study therapist during the guided in vivo exercises.

Conditions

• PTSD

Interventions

Type	Name	Description
DEVICE	Therapist Guided Prolonged Exposure with BioWare Device	Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist guided group, Study Therapists will use actionable data during in vivo exposures (IVEs) (galvanic skin response \[GSR\], heart rate \[HR\], and subjective units of distress \[SUDS\]) to modify the assignments in real-time. All participants receive at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
DEVICE	Record Only Prolonged Exposure with BioWare Device	In the record-only group, passive data collection will be utilized to collect and store biometric and behavioral data for future offline analyses to investigate predictors of outcome. All participants receive at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.

Timeline

• Start date: 2020-06-08
• Primary completion: 2022-02-03
• Completion: 2022-03-08
• First posted: 2020-07-15
• Last updated: 2023-10-31
• Results posted: 2023-10-31

Locations

1 site across 1 country: United States