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NCT03796936 · ClinicalTrials.gov registry record · Phase 2
3MDR to Treat PTSD With mTBI (3MDR)
A Phase 2 study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT03796936: Completed Phase 2 study, sponsored by Walter Reed National Military Medical Center.
NCT03796936 is a Phase 2 study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03796936, a Phase 2 study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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
Primary Outcome
The well-validated PCL-5 will assess self-reported PTSD symptom severity; range 0-84, higher score represents greater severity.
Interventions
- BEHAVIORAL Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-01-11 |
| Est. Completion | 2022-06-22 |
| Phase | Phase 2 |
What the finished NCT03796936 record still lists
NCT03796936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy is the first listed.
NCT03796936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03796936 about?
NCT03796936 is a clinical study titled "3MDR to Treat PTSD With mTBI (3MDR)". 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-...
What is the current status of trial NCT03796936?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2019-01-11. Estimated completion is 2022-06-22.
What interventions are being tested in trial NCT03796936?
The interventions under investigation include: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03796936?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03796936's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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