Computer Monitor vs Augmented Reality 3MDR for PTSD PTSD: A Randomized Controlled Trial (CARE4PTSD)

July 14, 2025 updated by: Michael Roy, Uniformed Services University of the Health Sciences

Computer Monitor Versus Augmented Reality: Expanding 3MDR Therapy for PTSD

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Posttraumatic stress disorder (PTSD) frequently occurs after combat and other life-threatening or traumatic events. Currently available treatments for PTSD often have a brief, limited effect, or are not well-tolerated. Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) is a new and unique treatment for PTSD that has been commonly referred to as "walk and talk" therapy, because you walk on a treadmill as you work through your symptoms with a therapist. 3MDR also combines some features of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR), and has usually been conducted in the Computer Assisted Rehabilitation Environment (CAREN), a sophisticated virtual reality "cave". Previous clinical studies by us and others across several nations have proven the effectiveness of the 3MDR approach in treating symptoms of PTSD. However, the CAREN is large, expensive (~$1 million), and only available in a few places around the world. To try to make 3MDR available to more people, this study will compare how much PTSD symptoms change with 3MDR delivered via two different mechanisms: 1) walking on a regular treadmill while wearing goggles (known as augmented reality head-mounted display, or AR HMD, specifically the Microsoft Hololens2) that allow you to see the treadmill and things around you in the real world, while also seeing pictures in a virtual world, with 2) walking on the same treadmill, with presentation of pictures on a 34-inch curved high definition gaming computer monitor positioned at eye level directly in front of the treadmill. There will be a total of 60 participants in the study, all at Uniformed Services University. After completing the informed consent process, all participants will be evaluated to confirm that they meet criteria for PTSD. There will be two introductory sessions where you meet the therapist you will be working with, and they will help you choose music and pictures that will be used in your later sessions. These introductory sessions can be done in person or virtually. In the third session you will try walking on the treadmill with a sample picture, via either the AR HMD or the computer monitor, depending on which approach you are randomized to receive-you have an equal chance of either. Starting with the 4th session, you will be talking through the pictures you have chosen, with your therapist. You will spend about 10 minutes on each picture, and do 5 or 6 pictures each session, and will do this through session 9. After that, you will complete a brief questionnaire about your symptoms. If you still have significant symptoms, you will do another 2 sessions of talking through your pictures, then do another questionnaire, and again will do two more sessions if you still have symptoms. There is then one final wrap-up session, which can be done either in person or virtually, to discuss how you did with the therapy, and whether you might need any more therapy to help you if you have any symptoms left to address. Depending on how quickly your symptoms improve, you may do a total of 10, 12 or 14 therapy sessions in this study. After you have finished the therapy sessions, you will again be assessed to see how much your symptoms have improved, and you will do this again 3 and 6 months later.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD scale for DSM5 (CAPS-5)
Time Frame: 3 months
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)
Time Frame: 3 months
The PTSD Checklist for DSM5 (PCL5), a well-validated 20-item self-report measure of PTSD symptom severity.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire Depression module (PHQ-9)
Time Frame: 3 months
The Patient Health Questionnaire Depression module (PHQ-9) is a well-validated instrument for assessing depression symptom severity.
3 months
Insomnia Severity Index (ISI)
Time Frame: 3 months
The Insomnia Severity Index (ISI) is a validated method with which to evaluate insomnia and sleep difficulties.
3 months
Neurobehavioral Symptom Inventory (NSI)
Time Frame: 3 months
The Neurobehavioral Symptom Inventory (NSI) is a validated instrument for assessing postconcussive symptom severity.
3 months
Brief Resilience Scale (BRS)
Time Frame: 3 months
The Brief Resilience Scale (BRS) is a validated instrument used to assess resilience.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uniformed Services University of the Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Center for Rehabilitation Sciences Research, USUHS
Military Traumatic Brain Injury Initiative, USUHS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Roy, MD, MPH, Unformed Services University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USUHS.2021-076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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