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