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

NCT05244564 | Recruiting

• 1 other identifier: USUHS.2021-076
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD scale for DSM5 (CAPS-5)

  The primary outcome measure will be the Clinician Administered PTSD scale for DSM5 (CAPS-5), the gold standard measure for PTSD diagnosis, to assess PTSD symptom severity.

  3 months

• PTSD Checklist for DSM5 (PCL5)

  The PTSD Checklist for DSM5 (PCL5), a well-validated 20-item self-report measure of PTSD symptom severity.

  3 months

Secondary Outcomes (4)

• Patient Health Questionnaire Depression module (PHQ-9)

  3 months

• Insomnia Severity Index (ISI)

  3 months

• Neurobehavioral Symptom Inventory (NSI)

  3 months

• Brief Resilience Scale (BRS)

  3 months

Study Arms (2)

3MDR delivered via Augmented Reality Head Mounted Display

EXPERIMENTAL

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.

Other: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR)

3MDR delivered via 34-inch curved screen high definition gaming computer monitor

ACTIVE COMPARATOR

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.

Other: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR)

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.

3MDR delivered via 34-inch curved screen high definition gaming computer monitor; 3MDR delivered via Augmented Reality Head Mounted Display

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Service member, veteran, retiree, or DEERS-eligible dependent, male or female, at least 18 years or older
• 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

You may not qualify if:

• History of epilepsy or a seizure disorder, other than febrile seizures that occurred during childhood and have not recurred since
• History of a psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation
• Use of benzodiazepines on a regular basis within the previous 30 days

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Military Traumatic Brain Injury Initiative, USUHS: collaborator
• Center for Rehabilitation Sciences Research, USUHS: collaborator

Study Sites (1)

Uniformed Services University

Bethesda, Maryland, 20814, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Michael Roy, MD, MPH

  Unformed Services University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Attalah, BA

CONTACT

301-412-8187; care4ptsd@gmail.com

Michael Roy, MD, MPH

CONTACT

301-295-9601; michael.roy@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: All receive the 3MDR intervention, but are randomized to delivery via AR HMD vs via curved high definition gaming computer monitor

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: February 17, 2022
• Study Start: April 30, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)