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Behavioural Intervention

3MDR Therapy for PTSD (CARE4PTSD Trial)

N/A
Recruiting
Led By Michael Roy, MD, MPH
Research Sponsored by Uniformed Services University of the Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of PTSD, as confirmed by the CAPS-5
Able to ambulate with contact guard assistance or less, and walk unassisted on a treadmill, at a normal pace, for up to 90 minutes continuously
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

CARE4PTSD Trial Summary

This trial is testing a new way to deliver Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) therapy for posttraumatic stress disorder (PTSD). The study seeks 60 volunteers who have PTSD and are eligible for care in the Department of Defense healthcare system. 3MDR therapy uses virtual reality and walking on a treadmill while the therapist asks questions about pictures you chose.

Who is the study for?
This trial is for adults over 18 with PTSD, confirmed by CAPS-5, who can walk on a treadmill. Participants must be connected to the Department of Defense healthcare system as service members, veterans, retirees or dependents. Those regularly using benzodiazepines recently, with bipolar disorder, psychotic disorders or active suicidal thoughts—or a history of epilepsy—are excluded.Check my eligibility
What is being tested?
The study compares two methods of delivering 3MDR therapy for PTSD in up to 14 sessions involving walking on a treadmill while interacting with personalized pictures and music in virtual reality. The effectiveness will be assessed before and after treatment and at follow-up intervals.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include physical fatigue from treadmill use and emotional discomfort due to confronting traumatic memories during therapy.

CARE4PTSD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PTSD.
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I can walk by myself or with minimal help and can use a treadmill for up to 90 minutes.

CARE4PTSD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Administered PTSD scale for DSM5 (CAPS-5)
PTSD Checklist for DSM5 (PCL5)
Secondary outcome measures
Brief Resilience Scale (BRS)
Insomnia Severity Index (ISI)
Neurobehavioral Symptom Inventory (NSI)
+1 more

CARE4PTSD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 3MDR delivered via Augmented Reality Head Mounted DisplayExperimental Treatment1 Intervention
All participants will complete 10-14 treatment sessions (three preparatory sessions, 6 to 10 3MDR therapy sessions, and one concluding session), led by a therapist who has completed training and/or is experienced in the conduct of this form of therapy.
Group II: 3MDR delivered via 34-inch curved screen high definition gaming computer monitorActive Control1 Intervention
All participants will complete 10-14 treatment sessions (three preparatory sessions, 6 to 10 3MDR therapy sessions, and one concluding session), led by a therapist who has completed training and/or is experienced in the conduct of this form of therapy.

Find a Location

Who is running the clinical trial?

Military Traumatic Brain Injury Initiative, USUHSUNKNOWN
Uniformed Services University of the Health SciencesLead Sponsor
121 Previous Clinical Trials
90,884 Total Patients Enrolled
Center for Neuroscience and Regenerative Medicine, USUHSUNKNOWN

Media Library

3MDR (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05244564 — N/A
Post-Traumatic Stress Disorder Research Study Groups: 3MDR delivered via 34-inch curved screen high definition gaming computer monitor, 3MDR delivered via Augmented Reality Head Mounted Display
Post-Traumatic Stress Disorder Clinical Trial 2023: 3MDR Highlights & Side Effects. Trial Name: NCT05244564 — N/A
3MDR (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05244564 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05244564 — N/A
~35 spots leftby Jan 2026
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