Status:
COMPLETED
3MDR to Treat PTSD With mTBI (3MDR)
Lead Sponsor:
Walter Reed National Military Medical Center
Collaborating Sponsors:
Uniformed Services University of the Health Sciences
Conditions:
Posttraumatic Stress Disorder
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background and Purpose: Posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) are persistent and frequently comorbid complications of recent combat. There is no proven treatment ...
Detailed Description
This is a pilot prospective, randomized, interventional controlled clinical trial. Our study at the NICoE site will specifically target active or retired SMs who are OIF/OEF/OND veterans of any age an...
Eligibility Criteria
Inclusion
- Military service member or veteran
- Diagnosis of probable PTSD, as manifest by a PCL-5 score of 34 or greater
- History of mild traumatic injury (mTBI) at least 3 months prior, documented by the OSU TBI-ID.
Exclusion
- History of moderate, severe, or penetrating TBI
- History of a psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation
- Use of benzodiazepines on a regular basis within the past 30 days.
- Inability to walk continuously, at a normal pace, for up to 60 minutes
- Inability to follow verbal command and/or observe safety precautions
- Women who are pregnant, based on self-reported date of last menses
- Does not demonstrate capacity for informed consent
Key Trial Info
Start Date :
January 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03796936
Start Date
January 11 2019
End Date
June 22 2022
Last Update
July 18 2025
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889