Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
Purpose
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),
Conditions
- PTSD
- Trauma and Stressor Related Disorders
- Traumatic Brain Injury
Eligibility
- Eligible Ages
- Between 18 Years and 79 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- The first 10 participants will do the treatment via the canvas classroom virtually and participate in user experience interviews to improve the quality of the treatment and improve the user experience.Next, the second group of 10 participants will do the treatment with the canvas classroom aided by a mobile health application.These participants will also participate in user experience interviews to improve the quality of the treatment and improve the user experience.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SIT NAVIGATOR plus Stress NAVIGATOR group |
|
|
|
Active Comparator SIT NAVIGATOR only group |
|
Recruiting Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center, Houston