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

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ClinicalTrials.gov Identifier: NCT03796936
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Michael Roy, Walter Reed National Military Medical Center

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 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.


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Traumatic Brain Injury Behavioral: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 eye movement, EM (EM+), or not (EM-).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of 3MDR to Treat PTSD With mTBI, With and Without Eye Movement (3MDR)
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: 3MDR With Eye Movement Component (EM+)
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.
Behavioral: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy
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)

Active Comparator: 3MDR Without Eye Movement Component (EM-)
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.
Behavioral: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy
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)




Primary Outcome Measures :
  1. Change in PTSD Checklist for DSM5 (PCL-5) score [ Time Frame: Post-intervention session 10, as well as 3 and 6 months later, compared to baseline ]
    The well-validated PCL-5 will assess self-reported PTSD symptom severity; range 0-84, higher score represents greater severity.


Secondary Outcome Measures :
  1. Change in Neurobehavioral Symptom Inventory (NSI) score [ Time Frame: Post-intervention session, and 3 and 6 months later, compared to baseline ]
    measure of postconcussive symptom severity; range 0-88, higher score represents greater severity

  2. Change in Patient Health Questionnaire depression module (PHQ-9) score [ Time Frame: Post-intervention session 10, as well as pre-intervention session 7, and 3 and 6 months later, compared to baseline ]
    measure of depression symptom severity; range 0-27, higher score represents greater severity

  3. Change in Insomnia Severity Index (ISI) score [ Time Frame: Post-intervention session 10, as well as pre-intervention session 7, 3 and 6 months later, compared to baseline ]
    measure of insomnia and sleep concerns; range 0-28, higher score represents greater severity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   we seek to enroll 50% male, 50% female participants
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Military service member or veteran
  2. Diagnosis of probable PTSD, as manifest by a PCL-5 score of 34 or greater
  3. History of mild traumatic injury (mTBI) at least 3 months prior, documented by the OSU TBI-ID.

Exclusion Criteria:

  1. History of moderate, severe, or penetrating TBI
  2. History of a psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation
  3. Use of benzodiazepines on a regular basis within the past 30 days.
  4. Inability to walk continuously, at a normal pace, for up to 60 minutes
  5. Inability to follow verbal command and/or observe safety precautions
  6. Women who are pregnant, based on self-reported date of last menses
  7. Does not demonstrate capacity for informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796936


Locations
United States, Maryland
Walter Reed National Military Medical Center Not yet recruiting
Bethesda, Maryland, United States, 20889
Contact: Michael J Roy, MD, MPH    301-295-9601    michael.roy@usuhs.edu   
Contact: Paula Bellini, MA    301-295-5840    paula.bellini.ctr@usuhs.edu   
Sponsors and Collaborators
Walter Reed National Military Medical Center
Uniformed Services University of the Health Sciences

Responsible Party: Michael Roy, Professor of Medicine & Director, Division of Military Internal Medicine, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT03796936     History of Changes
Other Study ID Numbers: WRNMMC-2018-0201
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available via the Federal Interagency TBI Registry (FITBIR) after the study has been completed and all links to personal identifying information have been destroyed.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be made available after the completion of the study and destruction of links to personal identifying information, and then will be available indefinitely.
URL: https://fitbir.nih.gov/

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Roy, Walter Reed National Military Medical Center:
posttraumatic stress disorder
traumatic brain injury
virtual reality
eye movement desensitization and reprocessing

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders