Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

  • End date
    May 31, 2022
  • participants needed
  • sponsor
    Medical University of South Carolina
Updated on 12 September 2021
psychotropic drugs
panic disorder
social phobia
obsessive-compulsive disorder
mood disorder


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.


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.

Condition PTSD, Post-Traumatic Stress Disorders, Post-Traumatic Stress Disorder
Treatment Therapist Guided Prolonged Exposure with BioWare Device, Record Only Prolonged Exposure with BioWare Device
Clinical Study IdentifierNCT04471207
SponsorMedical University of South Carolina
Last Modified on12 September 2021


Yes No Not Sure

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
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