Recruiting

Computer Monitor vs. Augmented Reality

Sponsor:

Uniformed Services University of the Health Sciences

Code:

NCT05244564

Conditions

Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05244564

Start date

Apr 30, 2023

Status verified date

Jul, 2025

Completion date

Oct 30, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

"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.

Primary outcome measure

  • Clinician Administered PTSD scale for DSM5 (CAPS-5) [ Time Frame: 3 months ]
  • PTSD Checklist for DSM5 (PCL5) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Hannah Attalah, BA

301-412-8187care4ptsd@gmail.com

Michael Roy, MD, MPH

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

Locations

Uniformed Services University

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Paula Bellini, MA

703-463-0289paula.bellini.ctr@usuhs.edu

More Information

Sponsor

Uniformed Services University of the Health Sciences

Last update posted

Jul 15, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences on 2025-07-15.