NCT06494319 · The University of Texas Health Science Center, Houston
Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
What this study is 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),
View original scientific description
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),
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2024 · Source of record for eligibility and locations