Stress Disorders, Post-TraumaticCARE4PTSDNCT05244564
Computer Monitor vs Augmented Reality 3MDR for PTSD PTSD: A Randomized Controlled Trial
A study testing Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) in people with Stress Disorders, Post-Traumatic, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2023to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Uniformed Services University
Bethesda, Maryland, 20814
Paula Bellini, MA, 703-463-0289, paula.bellini.ctr@usuhs.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
Patient Health Questionnaire Depression module (PHQ-9)
The Patient Health Questionnaire Depression module (PHQ-9) is a well-validated instrument for assessing depression symptom severity.
Measured: 3 months
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a validated method with which to evaluate insomnia and sleep difficulties.
Measured: 3 months
Neurobehavioral Symptom Inventory (NSI)
The Neurobehavioral Symptom Inventory (NSI) is a validated instrument for assessing postconcussive symptom severity.
Measured: 3 months
Brief Resilience Scale (BRS)
The Brief Resilience Scale (BRS) is a validated instrument used to assess resilience.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start30 Apr 2023
- Primary completion31 May 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All receive the 3MDR intervention, but are randomized to delivery via AR HMD vs via curved high definition gaming computer monitor
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- Military Traumatic Brain Injury Initiative, USUHS, Center for Rehabilitation Sciences Research, USUHS
- Responsible party
- Principal investigator, Michael Roy, Uniformed Services University of the Health Sciences
- Investigators
- Michael Roy, MD, MPH, Principal investigator, Unformed Services University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244564
- Sponsor's protocol ID
- USUHS.2021-076
- Acronym
- CARE4PTSD
- Status last verified
- Jul 2025
- First submitted
- 11 Aug 2021
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Monitor Versus Augmented Reality: Expanding 3MDR Therapy for PTSD
- ClinicalTrials.gov ID
- NCT05244564
- Acronym / sponsor ID
- CARE4PTSD / USUHS.2021-076
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- Military Traumatic Brain Injury Initiative, USUHS, Center for Rehabilitation Sciences Research, USUHS
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All receive the 3MDR intervention, but are randomized to delivery via AR HMD vs via curved high definition gaming computer monitor
| Arm | Type | Receives |
|---|---|---|
| 3MDR delivered via Augmented Reality Head Mounted Display | Experimental | Other: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR)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. |
| 3MDR delivered via 34-inch curved screen high definition gaming computer monitor | Active comparator | Other: Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | 3MDR delivered via 34-inch curved screen high definition gaming computer monitor, 3MDR delivered via Augmented Reality Head Mounted Display |
Primary outcome
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.
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.
4 secondary outcomes
Patient Health Questionnaire Depression module (PHQ-9)
Time frame: 3 months
Insomnia Severity Index (ISI)
Time frame: 3 months
Neurobehavioral Symptom Inventory (NSI)
Time frame: 3 months
Brief Resilience Scale (BRS)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Roy, MD, MPH principal investigator
Unformed Services University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) in people with Stress Disorders, Post-Traumatic, run by Uniformed Services University of the Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Attalah, BA (301-412-8187, care4ptsd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD scale for DSM5 (CAPS-5) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.