Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intelligent Biometrics to Optimize Prolonged Exposure for PTSD

Conditions
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PTSD

Intervention / Treatment
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* Device: Therapist Guided Prolonged Exposure with BioWare Device
* Device: Record Only Prolonged Exposure with BioWare Device


Participation Criteria
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Eligibility Criteria
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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 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for current (i.e., past 6 months) posttraumatic stress disorder (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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intelligent Biometrics - Prolonged Exposure (Therapist Guided).<br>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<br>* 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.<br>|
| Active Comparator: Intelligent Biometrics - Prolonged Exposure (Record Only).<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Veterans, Military