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NCT04471207 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
A Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT04471207: Completed Phase 1 study, sponsored by Medical University of South Carolina.
NCT04471207 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04471207, a Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered assessment for posttraumatic stress symptoms. The assessment is administered at baseline, mid treatment and end of treatment. The CAPS-5 is a 30 item assessment that assesses 20 symptoms of PTSD, with scores ranging from 0-80. Lower scores represent fewer and less sever symptoms of PTSD.
Interventions
- DEVICE Therapist Guided Prolonged Exposure with BioWare Device
- DEVICE Record Only Prolonged Exposure with BioWare Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2022-03-08 |
| Phase | Phase 1 |
What the finished NCT04471207 record still lists
NCT04471207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Therapist Guided Prolonged Exposure with BioWare Device is the first listed.
NCT04471207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04471207 about?
NCT04471207 is a clinical study titled "Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial". 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 rate...
What is the current status of trial NCT04471207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-06-08. Estimated completion is 2022-03-08.
What interventions are being tested in trial NCT04471207?
The interventions under investigation include: Therapist Guided Prolonged Exposure with BioWare Device (DEVICE), Record Only Prolonged Exposure with BioWare Device (DEVICE).
Who is sponsoring clinical trial NCT04471207?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04471207's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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