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Behavioural Intervention

3MDR Therapy for PTSD (CARE4PTSD Trial)

N/A
Waitlist Available
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
Select...
I have been diagnosed with PTSD.
Select...
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 in the Computer Assisted Rehabilitation Environment (CAREN)Active 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?

Uniformed Services University of the Health SciencesLead Sponsor
116 Previous Clinical Trials
91,356 Total Patients Enrolled
Center for Neuroscience and Regenerative Medicine, USUHSUNKNOWN
Center for Rehabilitation Sciences Research, USUHSUNKNOWN

Media Library

3MDR (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05244564 — N/A
Post-Traumatic Stress Disorder Research Study Groups: 3MDR delivered in the Computer Assisted Rehabilitation Environment (CAREN), 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the intended aims of this experiment?

"This medical trial will measure its primary outcome, PTSD Checklist for DSM5 (PCL5), over a period of three months. Assessing secondary outcomes include Patient Health Questionnaire Depression module (PHQ-9) to evaluate depression symptom severity, the Insomnia Severity Index (ISI) to gauge sleep difficulties and Brief Resilience Scale (BRS) which is utilized as an instrument used to assess resilience."

Answered by AI

How many participants are being recruited for this trial?

"True. Clinicaltrials.gov shows that this medical investigation, which commenced on September 20th 2021, is currently seeking participants. 60 patients are still required to be enrolled at one particular facility."

Answered by AI

Are there any available vacancies for individuals to partake in this trial?

"Affirmative. According to the information provided on clinicaltrials.gov, this medical research is presently recruiting participants and was originally posted on September 20th 2021. The target enrolment number for this single site trial is 60 patients."

Answered by AI

Who else is applying?

What state do they live in?
Quebec
Ohio
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Uniformed Services University
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I cannot find anything that is effective for this condition.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
CAREN vs Augmented Reality 3MDR for PTSD PTSD: A Randomized Controlled Trial
Michael Roy 2021. "CAREN vs Augmented Reality 3MDR for PTSD PTSD: A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05244564.
~17 spots leftby Apr 2025
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