← Back to Search

Therapist Guided Prolonged Exposure with BioWare Device for Post-Traumatic Stress Disorder

Phase 1
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment (after 10-12 sessions of prolonged exposure). participants had 24 weeks to complete treatment.
Awards & highlights

Study Summary

This study is evaluating whether a technology system can help improve the effectiveness of a therapy for PTSD.

Eligible Conditions
  • Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment (after 10-12 sessions of prolonged exposure). participants had 24 weeks to complete treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (after 10-12 sessions of prolonged exposure). participants had 24 weeks to complete treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
Post Traumatic Stress Disorder Symptom Severity - Self Report

Side effects data

From 2022 Phase 1 trial • 40 Patients • NCT04471207
17%
Headache or Migraine
14%
Cough
10%
Gastrointestinal Discomfort
10%
Fever
10%
Pain in Lower Extremities
7%
Sinusitis
3%
Spinal Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
Intelligent Biometrics - Prolonged Exposure (Record Only).

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intelligent Biometrics - Prolonged Exposure (Therapist Guided).Experimental Treatment1 Intervention
In the therapist-guided group, Study Therapists will virtually accompany patients during IVEs and use actionable biometric and subjective 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.
Group II: Intelligent Biometrics - Prolonged Exposure (Record Only).Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapist Guided Prolonged Exposure with BioWare Device
2020
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

ZeriscopeUNKNOWN
Medical University of South CarolinaLead Sponsor
931 Previous Clinical Trials
7,393,970 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
Sudie E. Back 2020. "Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04471207.
~8 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top