Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

NCT04471207 | Completed Phase 1 Results DMC

• 1 other identifier: 00094890
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD

Keywords

PTSD; Military; Veterans

Outcome Measures

Primary Outcomes (2)

• Post Traumatic Stress Disorder Symptom Severity - Clinician Rated

  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.

  End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.

• Post Traumatic Stress Disorder Symptom Severity - Self Report

  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.

  End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.

Study Arms (2)

Intelligent Biometrics - Prolonged Exposure (Therapist Guided).

EXPERIMENTAL

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.

Device: Therapist Guided Prolonged Exposure with BioWare Device

Intelligent Biometrics - Prolonged Exposure (Record Only).

ACTIVE COMPARATOR

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.

Device: Record Only Prolonged Exposure with BioWare Device

Interventions

Therapist Guided Prolonged Exposure with BioWare Device 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.

Intelligent Biometrics - Prolonged Exposure (Therapist Guided).

Record Only Prolonged Exposure with BioWare Device 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.

Intelligent Biometrics - Prolonged Exposure (Record Only).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female; any race or ethnicity; aged 18-75 years.
• U.S. Military veteran, any branch or era.
• Participants must be able to comprehend English.

You may not qualify if:

• Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation.
• Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders. Those participants will be referred clinically to ensure they have appropriate level of clinical care.
• Participants meeting DSM-5 criteria for a current (past 6 months) moderate to severe substance use disorder. Those participants will be referred to addiction treatment centers at the Veterans Affairs, Medical University of South Carolina and in the local community. Individuals with mild substance use disorder (SUD) will be included.
• Participants considered an immediate suicidal or homicidal risk or who are likely to require hospitalization during the course of the study for suicidality. Those participants will be referred clinically for care.
• Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks.
• Participants enrolled in ongoing evidence-based behavioral therapy for PTSD who are not willing to discontinue these therapies for the duration of the trial. Attendance at therapeutic activities other than study sessions will be closely monitored using the Treatment Services Review.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Zeriscope: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

Related Publications (1)

• Saraiya TC, Jarnecke AM, Rothbaum AO, Wangelin B, McTeague LM, Acierno R, Brown DG, Bristol E, Feigl H, Reese M, Cobb AR, Harley B, Adams RJ, Back SE. Technology-enhanced in vivo exposures in Prolonged Exposure for PTSD: A pilot randomized controlled trial. J Psychiatr Res. 2022 Dec;156:467-475. doi: 10.1016/j.jpsychires.2022.10.056. Epub 2022 Nov 1.

  PMID: 36347106 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

The sample size was small, particularly for the Non-Guided group due to the focus on gaining experience with the clinician-guided IVEs in the Guided group. Thus, power to detect some effects was low, and the findings should be considered preliminary. Guided group also received more attention than Non-Guided group through the delivery of clinician-guided IVEs. This study did not compare between self-guided IVEs with the device and self-guided IVEs without the device.

Results Point of Contact

• Title: Stacey Sellers
• Organization: Medical University of South Carolina

sellersst@musc.edu

843-792-5807

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: July 15, 2020
• Study Start: June 8, 2020
• Primary Completion: February 3, 2022
• Study Completion: March 8, 2022
• Last Updated: October 31, 2023
• Results First Posted: October 31, 2023

Record last verified: 2023-10

Locations

US (1)