Phase 1
N=40
Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT04471207 ↗Enrolled (actual)
40
Serious AEs
7.5%
Results posted
Oct 2023
Primary outcome: Primary: Post Traumatic Stress Disorder Symptom Severity - Clinician Rated — 25.71; 32.00 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Therapist Guided Prolonged Exposure with BioWare Device (Device); Record Only Prolonged Exposure with BioWare Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Traumatic Stress Disorder Symptom Severity - Clinician Rated |
25.71; 32.00 | — |
| PRIMARY Post Traumatic Stress Disorder Symptom Severity - Self Report |
27.11; 50.80 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT04471207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.