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Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

Primary Purpose

PTSD

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Therapist Guided Prolonged Exposure with BioWare Device

Record Only Prolonged Exposure with BioWare Device

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Military, Veterans

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Participants must meet DSM-5 diagnostic criteria for current (i.e., past 6 months) PTSD (assessed via the Clinician Administered PTSD Scale for DSM-5). Subjects may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD.
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation.

Exclusion Criteria:

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 VA, MUSC and in the local community. Individuals with mild 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.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intelligent Biometrics - Prolonged Exposure (Therapist Guided).

Intelligent Biometrics - Prolonged Exposure (Record Only).

Arm Description

In the therapist-guided group, Study Therapists will virtually accompany patients during IVEs and use actionable biometric and subjective data during IVEs (e.g., HR, GSR, SUDS) to modify the assignments in real-time.

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.

Outcomes

Primary Outcome Measures

Change in Post Traumatic Stress Disorder symptom severity - clinician rated

Clinician Administered PTSD Scale (CAPS-5) for clinician-rated PTSD symptoms

Change in Post Traumatic Stress Disorder symptom severity - self report

Posttraumatic Checklist for DSM-5 (PCL-5) for self-reported symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT04471207

First Posted

April 14, 2020

Last Updated

July 22, 2022

Sponsor

Medical University of South Carolina

Collaborators

Zeriscope

1. Study Identification

Unique Protocol Identification Number

NCT04471207

Brief Title

Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

Official Title

Intelligent Biometrics to Optimize Prolonged Exposure for PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

June 8, 2020 (Actual)

Primary Completion Date

February 3, 2022 (Actual)

Study Completion Date

March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

Collaborators

Zeriscope

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Posttraumatic stress disorder (PTSD) is a chronic and debilitating psychiatric condition. Prolonged Exposure (PE) therapy is a highly effective, evidence-based treatment for PTSD; however, dropout rates are high and approximately one-third of patients who 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, feasibility and preliminary efficacy of a technological enhancement (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 technology system of discrete wearables (camera, microphone) to allow therapists to accompany participants during IVEs. The system will pair with a cellular application and record information such as heart rate and skin conductance. This system will also allow the participant to communicate with the study therapist during the guided in vivo exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD

Keywords

PTSD, Military, Veterans

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intelligent Biometrics - Prolonged Exposure (Therapist Guided).

Arm Type

Experimental

Arm Description

Arm Title

Intelligent Biometrics - Prolonged Exposure (Record Only).

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Therapist Guided Prolonged Exposure with BioWare Device

Intervention Description

Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist guided group, Study Therapists will use actionable data during IVEs (e.g., HR, GSR, SUDS) to modify the assignments in real-time.

Intervention Type

Device

Intervention Name(s)

Record Only Prolonged Exposure with BioWare Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Post Traumatic Stress Disorder symptom severity - clinician rated

Description

Clinician Administered PTSD Scale (CAPS-5) for clinician-rated PTSD symptoms

Time Frame

10-12 weeks

Title

Change in Post Traumatic Stress Disorder symptom severity - self report

Description

Posttraumatic Checklist for DSM-5 (PCL-5) for self-reported symptoms

Time Frame

10-12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Participants must meet DSM-5 diagnostic criteria for current (i.e., past 6 months) PTSD (assessed via the Clinician Administered PTSD Scale for DSM-5). Subjects may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. Exclusion Criteria: 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 VA, MUSC and in the local community. Individuals with mild 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.

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

36347106

Citation

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.

Results Reference

derived

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Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

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