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Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
NCT06494319 · The University of Texas Health Science Center, Houston
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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),
Eligibility criteria
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
Enrollment target: 20 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-05-28
Estimated completion: 2025-06-30
Last updated: 2024-07-10
Interventions
Behavioral: Stress NAVIGATOR (Mobile Health Application)Behavioral: SIT NAVIGATOR
Primary outcomes
- • Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) (end of study (about 11-14 weeks after baseline))
- • Increasing resilience as assessed by The Connor-Davidson Resilience Scale-10 (CD-RISC-10)4 (end of study (about 11-14 weeks after baseline))
- • Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8-item (CSQ-8) (4 weeks after baseline)
Sponsor
The University of Texas Health Science Center, Houston · other
Contacts & investigators
ContactSarah Jackson, PhD · contact · Sarah.E.Jackson@uth.tmc.edu · (281) 825-9923
InvestigatorSarah Jackson, PhD · principal_investigator, The University of Texas Health Science Center, Houston
All locations (1)
The University of Texas Health Science Center at HoustonRecruiting
Houston, Texas, United States