Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App

The University of Texas System (UT)

Status

Enrolling

Conditions

Traumatic Brain Injury

PTSD

Trauma and Stressor Related Disorders

Treatments

Behavioral: Stress NAVIGATOR (Mobile Health Application)

Behavioral: SIT NAVIGATOR

Study type

Interventional

Funder types

Other

Identifiers

NCT06494319

HSC-MS-23-0547

Details and patient eligibility

About

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 and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),

Enrollment

20 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.