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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 is a Phase 2 study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 20 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03796936
The ClinicalTrials.gov registry entry for NCT03796936 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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