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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

Must not have

Use of benzodiazepines on a regular basis within the previous 30 days

History of epilepsy or a seizure disorder, other than febrile seizures that occurred during childhood and have not recurred since

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been using benzodiazepines regularly for the last 30 days.

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I have had epilepsy or seizures, except for childhood febrile seizures that stopped.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician Administered PTSD scale for DSM5 (CAPS-5)

PTSD Checklist for DSM5 (PCL5)

Secondary study objectives

Brief Resilience Scale (BRS)

Insomnia Severity Index (ISI)

Neurobehavioral Symptom Inventory (NSI)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met