Status:
RECRUITING
Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
PTSD
Trauma and Stressor Related Disorders
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application ...
Eligibility Criteria
Inclusion
- US Military Veterans / Service Members
- diagnosis of PTSD as measured by a Posttraumatic Symptom Checklist for DSM-5 (PCL-5) score of \>33
- history of combat trauma and/or military service in an imminent danger pay area
- be fluent in English.
- be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- have access to a SmartPhone or tablet to utilize the mobile health app and/OR access the virtual classroom.
- agree to undergo psychometric testing and participate in ongoing assessments throughout the study duration.
- be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study.
Exclusion
- Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.
- Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease/dementia as assessed by the Investigator.
- Active severe substance abuse as assessed by the investigator in accordance with DSM-5 Substance Abuse Disorder criteria, an AUDIT score \> 15, or partial Brief Addiction Monitor (BAM) indicating the presence of illicit substance use other than cannabis (\< 3 times weekly).
- They are currently undergoing another form of treatment other than supportive therapy (\> 2 times per month).
- Engaged in active trauma-focused therapy including Cognitive Processing Therapy (CPT)Prolonged Exposure (PE), or Eye Movement Desensitization and Reprocessing (EMDR).
- Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06494319
Start Date
May 28 2024
End Date
June 30 2025
Last Update
July 10 2024
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030