NCT04471207

Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

Completed Phase 1 Results posted Last updated 31 October 2023

What this trial tests

Phase 1 trial testing Therapist Guided Prolonged Exposure with BioWare Device in PTSD in 40 participants. Completed in 8 March 2022.

Timeline

8 June 2020

Primary endpoint
3 February 2022

8 March 2022

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	8 June 2020
Primary completion	3 February 2022
Estimated completion	8 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Therapist Guided Prolonged Exposure with BioWare Device
• Record Only Prolonged Exposure with BioWare Device

Conditions studied

• PTSD — all drugs for PTSD →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 75, any sex, with PTSD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post Traumatic Stress Disorder Symptom Severity - Clinician Rated Primary · End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.

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.

Group	Value	95% CI
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).	25.71	± 14.65
Intelligent Biometrics - Prolonged Exposure (Record Only).	32.00	± 11.64

Post Traumatic Stress Disorder Symptom Severity - Self Report Primary · End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.

Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) is a twenty item assessment for self-reported symptoms of posttraumatic stress symptoms. Assessment was administered at baseline, and weekly through the end of treatment. Each of the twenty items has a score of 0-4. Lower scores represent fewer posttraumatic stress symptoms. Scores range from 0 to 80.

Group	Value	95% CI
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).	27.11	± 18.56
Intelligent Biometrics - Prolonged Exposure (Record Only).	50.80	± 17.34

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline through follow up, approximately 4 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intelligent Biometrics - Prolonged Exposure (Therapist Guided).

Serious: 1/29 (3%)

Deaths: 0/29

Intelligent Biometrics - Prolonged Exposure (Record Only).

Serious: 2/11 (18%)

Deaths: 0/11

Serious adverse events (3 terms)

Reaction	System	Intelligent Biometrics - P…	Intelligent Biometrics - P…
Intestinal Lymphangiectasia	Blood and lymphatic system disorders	—	—
Spinal Injury	Musculoskeletal and connective tissue disorders	—	—
Transient Ischemic	Nervous system disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Intelligent Biometrics - P…	Intelligent Biometrics - P…
Headache or Migraine	Nervous system disorders	—	—
Cough	Infections and infestations	—	—
Gastrointestinal Discomfort	Gastrointestinal disorders	—	—
Fever	Infections and infestations	—	—
Pain in Lower Extremities	Musculoskeletal and connective tissue disorders	—	—
Sinusitis	Infections and infestations	—	—

Most-reported serious reactions: Intestinal Lymphangiectasia, Spinal Injury, Transient Ischemic.

Data from ClinicalTrials.gov NCT04471207 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Technology-enhanced in vivo exposures in Prolonged Exposure for PTSD: A pilot randomized controlled trial.
   Saraiya TC, Jarnecke AM, Rothbaum AO, Wangelin B, et al · · 2022 · cited 5× · PMID 36347106 · DOI 10.1016/j.jpsychires.2022.10.056
2. The Impact of COVID-19 on Psychotherapy Participation Among Individuals With Posttraumatic Stress Disorder Enrolled in Treatment Research.
   McLean CP, Back SE, Capone C, Morland L, et al · · 2022 · cited 5× · PMID 34291832 · DOI 10.1002/jts.22718
3. We're in This Together: A Case Study of the Concurrent Delivery of Prolonged Exposure Therapy to Intimate Partners With PTSD.
   Saraiya TC, Ana EJS, Jarnecke AM, Feigl H, et al · · 2024 · PMID 39720667 · DOI 10.1016/j.cbpra.2023.03.002