Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- PTSD
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
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...
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 randomized clinical trial (N=40 treatment-seeking veterans with current PTSD) to evaluate the acceptability and preliminary efficacy of 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 system of discrete wearables (camera, microphone) to allow the therapist to accompany a participant on an IVE (e.g: walk through a crowded building). The system will pair with a cellular application, and will record information such as heart rate and skin conductance. This system will also allow the participant to communicate with the study therapist during this guided exercise.
Tracking Information
- NCT #
- NCT04471207
- Collaborators
- Zeriscope
- Investigators
- Not Provided