BridgeMD
New treatment option for PTSD
Official title Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
ClinicalTrials.gov ID: NCT06494319
What this study is testing
- What it's testing
- 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),
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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...
You likely can't join if
- 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...
- Active severe substance abuse as assessed by the investigator in accordance with DSM-5 Substance Abuse Disorder criteria, an AUDIT score \> 15, or...
- 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...
- Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.