3MDR to Treat PTSD With mTBI (3MDR)
(3MDR Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Walter Reed National Military Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 for mTBI, and standard treatments for PTSD frequently achieve only transient, modest impact. Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) is a novel treatment for PTSD combining aspects of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR), within the Computer Assisted Rehabilitation Environment (CAREN). The added benefit of the eye movement (EM) component of EMDR is controversial; the purpose of this pilot study is therefore to: 1) obtain an initial estimate of the efficacy of 3MDR in service members with comorbid PTSD and mTBI, and 2) determine the impact of EM on treatment response. The investigators hypothesize that 3MDR will significantly improve symptom severity, both with and without EM. Population: Participants will be active or retired service members with a history of mTBI who meet criteria for probable PTSD on the PCL5. It is anticipated that participants will be recruited through the Center for Neuroscience and Regenerative Medicine (CNRM) Recruitment Core and the National Intrepid Center of Excellence (NICoE). Design type and procedures: This is a pilot, controlled clinical trial in which all 20 participants with comorbid PTSD and mTBI receive 10 sessions (3 preparatory, 6 3MDR treatment, and 1 conclusion), but will be randomized to either include EM (EM+) or not (EM-). In the preparatory sessions, the therapist will help each participant select 2 songs and 14 pictures to be used in their treatment sessions. The therapist will help the participant rate the pictures from least to most impactful. Each 3MDR treatment session will start by playing the first song, to bring them back to the time of their trauma. This will be done while the participant walks on the CAREN's embedded treadmill through the 3MDR virtual environment (VE) projected onto the system's curved screen. This is followed by a display of one of their pictures, a manifestation of their trauma, which they directly face and walk down a hallway toward, until the picture looms before them. The therapist, standing next to the participant along the treadmill's edge, will query the participant about what the picture means to them, how it makes them feel, etc., while the CAREN operator superimposes key words (said by the participant) over the picture, which the therapist later asks the participant to read aloud. Then, for \~60 seconds, the EM+ group will see a red ball "bounce" across the screen in front of the picture, and a number appears on the ball as it touches the screen's edge. The participant will be asked to recite each number aloud. This element is absent for EM- participants. All participants repeats these procedures for 5-7 pictures in each 3MDR treatment session; the pictures used will be agreed upon by therapist and participant, targeting more impactful pictures, whether repeats or new, in later sessions. The pictures are followed by playing the second song, chosen to bring the participant back to present day. The participant will walk at a comfortable pace throughout the session, with each session lasting typically \~60 minutes. The primary outcome measure will be change in PCL-5 score from pre- to post-intervention, with additional measures at 3 and 6 months.

Research Team

Eligibility Criteria

Inclusion Criteria

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.

Treatment Details

Interventions

Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy (Behavioral Intervention)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: 3MDR With Eye Movement Component (EM+)Experimental Treatment1 Intervention

All participants will complete 10 treatment sessions (3 preparatory, 6 3MDR and 1 concluding), led by a trained therapist, with the only difference between the intervention groups being the presence (EM+) or absence (EM-) of the eye movement component. For those in the EM+ intervention group, the EM component starts after the participant has thoroughly discussed a picture with the therapist; a red ball starts at one edge of the screen, moves rapidly back and forth across it, and upon reaching either edge, a 2-digit number appears superimposed in white on the ball. The number changes every time the ball meets either edge. The participant is asked to track the ball and call out the displayed numbers.

Group II: 3MDR Without Eye Movement Component (EM-)Active Control1 Intervention

All participants will complete 10 treatment sessions (three preparatory sessions, six 3MDR sessions and one concluding session; see Table 1), led by a therapist who has been completed training in the conduct of this form of therapy, with the only difference between the intervention groups being the presence (EM+) or absence (EM-) of the eye movement component.There will be no exposure to the distractor stimulus (red ball) for those in the EM- intervention group.