Computer Monitor vs Augmented Reality 3MDR for PTSD PTSD: A Randomized Controlled Trial

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Uniformed Services University of the Health Sciences
Study ID
NCT05244564
Status
Recruiting
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Conditions

  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) — OTHER
    "Walk and talk" therapy, walking on a treadmill while talking with a therapist about self-chosen pictures representative of one's trauma; 3MDR also includes some features of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR) therapy.

Study Details

This is a prospective randomized controlled trial comparing two ways of delivering 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. There will be 10-14 therapy sessions that are 60-90 minutes long, about once a week, and symptoms will be assessed before and after the therapy as well as 3 and 6 months after completing therapy. 3MDR asks you to choose pictures and music that are integrated into a virtual reality environment. You will be walking on a treadmill throughout each therapy session, while the therapist stands next to the treadmill and asks you questions about the pictures you chose.

Key Dates

Start date
Apr 30, 2023
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 3MDR delivered via Augmented Reality Head Mounted Display
    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.
  • Active Comparator: 3MDR delivered via 34-inch curved screen high definition gaming computer monitor
    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.

Primary Outcome Measure

Clinician Administered PTSD scale for DSM5 (CAPS-5) [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Uniformed Services UniversityBethesdaMaryland20814
Paula Bellini, MA
[email protected]
703-463-0289

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Uniformed Services University· Bethesda, MD

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