Status:
COMPLETED
Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Zeriscope
Conditions:
PTSD
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 Exposu...
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 rat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04471207
Start Date
June 8 2020
End Date
March 8 2022
Last Update
October 31 2023
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29401