NCT06494319 Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
| NCT ID | NCT06494319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-05-28 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-05-28 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Sarah Jackson, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06494319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06494319 currently recruiting?
Yes, NCT06494319 is actively recruiting participants. Contact the research team at Sarah.E.Jackson@uth.tmc.edu for enrollment information.
Where is the NCT06494319 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06494319 clinical trial?
NCT06494319 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Sarah Jackson, PhD at The University of Texas Health Science Center, Houston. The trial plans to enroll 20 participants.
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