3MDR Therapy for PTSD

(CARE4PTSD Trial)

Overseen By Michael Roy, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Uniformed Services University of the Health Sciences

Must not be taking: Benzodiazepines

Disqualifiers: Epilepsy, Psychotic disorder, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 6-10 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a therapy called 3MDR (Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation) to assist people with PTSD. It employs virtual reality to help patients confront and process traumatic memories while walking on a treadmill. The study aims to compare two delivery methods: one using a gaming monitor and another with a head-mounted display. Suitable candidates for this trial include those eligible for Department of Defense healthcare, diagnosed with PTSD, and able to walk on a treadmill for up to 90 minutes. As an unphased trial, this study provides a unique opportunity to investigate innovative therapy methods for PTSD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used benzodiazepines regularly in the past 30 days.

What prior data suggests that 3MDR therapy is safe for PTSD treatment?

Research has shown that 3MDR therapy, which stands for Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation, may help treat PTSD. This therapy combines virtual reality and talk therapy to assist individuals in processing traumatic memories.

When delivered on a curved screen, studies have found that 3MDR is generally well-tolerated. Participants report feeling comfortable during sessions, which involve walking on a treadmill and interacting with personalized sights and sounds. There are no significant reports of serious side effects, making it a safe option for many.

Using augmented reality, 3MDR is also well-tolerated. In one case study with a combat veteran, the therapy led to noticeable improvements without any major side effects. This suggests that augmented reality does not compromise safety.

Both methods of delivering 3MDR have a good safety record, with minor discomfort being the most common issue. This might include temporary dizziness or mild emotional distress, typical when dealing with traumatic memories. Overall, 3MDR is considered a safe therapy option for those with PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3MDR therapy for PTSD because it offers a novel approach by using immersive technology to tackle traumatic memories. Unlike traditional PTSD treatments like cognitive behavioral therapy or medications, 3MDR utilizes either a 34-inch curved screen or an augmented reality headset to deliver therapy sessions. This method engages patients in a more interactive and potentially more impactful way, which may enhance emotional processing and integration of traumatic experiences. By incorporating advanced technology, 3MDR could provide a more engaging and effective treatment pathway for individuals struggling with PTSD.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) effectively treats PTSD. This therapy combines elements of virtual reality exposure therapy and Eye Movement Desensitization and Reprocessing, both known to alleviate PTSD symptoms. Studies have found that 3MDR reduces PTSD symptoms in military personnel, including those with PTSD from sexual trauma. In this trial, participants will receive 3MDR therapy through either a curved screen or an augmented reality headset. Both methods aim to provide an immersive experience that supports therapy by helping process traumatic memories in a safe environment. ^{1 2 3 4 5}

Who Is on the Research Team?

Michael J Roy, MD, MPH

Principal Investigator

Unformed Services University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with PTSD, confirmed by CAPS-5, who can walk on a treadmill. Participants must be connected to the Department of Defense healthcare system as service members, veterans, retirees or dependents. Those regularly using benzodiazepines recently, with bipolar disorder, psychotic disorders or active suicidal thoughts—or a history of epilepsy—are excluded.

Inclusion Criteria

I am a service member, veteran, retiree, or DEERS-eligible dependent and am 18 or older.

I have been diagnosed with PTSD.

I can walk by myself or with minimal help and can use a treadmill for up to 90 minutes.

Exclusion Criteria

I have been using benzodiazepines regularly for the last 30 days.

I have had epilepsy or seizures, except for childhood febrile seizures that stopped.

History of a psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Sessions

Participants meet the therapist and choose music and pictures for therapy

2 weeks

2 visits (in-person or virtual)

Treatment

Participants undergo 3MDR therapy sessions using either AR HMD or computer monitor

6-10 weeks

6-10 visits (in-person)

Concluding Session

Final wrap-up session to discuss therapy outcomes and future needs

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for symptom improvement at 3 and 6 months post-treatment

6 months

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• 3MDR

Trial Overview The study compares two methods of delivering 3MDR therapy for PTSD in up to 14 sessions involving walking on a treadmill while interacting with personalized pictures and music in virtual reality. The effectiveness will be assessed before and after treatment and at follow-up intervals.

How Is the Trial Designed?

Group I: 3MDR delivered via Augmented Reality Head Mounted Display Experimental Treatment 1 Intervention

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.

Group II: 3MDR delivered via 34-inch curved screen high definition gaming computer monitor Active Control 1 Intervention

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 is already approved in United States, United Kingdom, Canada for the following indications:

Approved in United States as 3MDR for:

• Posttraumatic stress disorder (PTSD)

Approved in United Kingdom as 3MDR for:

• Posttraumatic stress disorder (PTSD)

Approved in Canada as 3MDR for:

• Posttraumatic stress disorder (PTSD)

Who Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials

130

Recruited

91,100+

Military Traumatic Brain Injury Initiative, USUHS

Collaborator

Trials

1

Recruited

60+

Center for Neuroscience and Regenerative Medicine, USUHS

Collaborator

Trials

1

Recruited

60+

Center for Rehabilitation Sciences Research, USUHS

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

In a study involving 42 British military veterans with treatment-resistant PTSD, the multi-modular motion-assisted memory desensitization and reprocessing (3MDR) showed a significant reduction in PTSD symptoms after 12 weeks, with a mean score difference of -9.38 compared to a delayed treatment group.

The effect size of 3MDR was estimated at 0.65, indicating a moderate to strong effect, and improvements in PTSD symptoms were maintained at a 26-week follow-up, suggesting its potential as a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of multi-modular motion-assisted memory desensitization and reconsolidation (3MDR) for male military veterans with treatment-resistant post-traumatic stress disorder. Bisson, JI., van Deursen, R., Hannigan, B., et al.[2021]

The Multi-modal Motion-assisted Memory Desensitization and Reconsolidation therapy (3MDR) shows promise as an effective intervention for treatment-resistant posttraumatic stress disorder (TR-PTSD) in military members and Veterans, as participants reported significant improvements in functional well-being and relationships after the therapy.

Participants appreciated the immersive and engaging nature of 3MDR, which combines physical activity with trauma processing, highlighting the importance of therapist support in empowering individuals during their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving Toward and Through Trauma: Participant Experiences of Multi-Modal Motion-Assisted Memory Desensitization and Reconsolidation (3MDR). Hamilton, T., Burback, L., Smith-MacDonald, L., et al.[2023]

The 3MDR intervention effectively engages veterans with treatment-resistant PTSD by facilitating the processing of traumatic memories, leading to positive changes such as increased self-understanding and emotional regulation, even if not all participants experienced symptom improvement.

Veterans reported unique aspects of 3MDR, such as walking towards trauma-related images, which contributed to their treatment experience, suggesting that the intervention may provide benefits beyond just reducing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived treatment processes and effects of interactive motion-assisted exposure therapy for veterans with treatment-resistant posttraumatic stress disorder: a mixed methods study. van Gelderen, MJ., Nijdam, MJ., Dubbink, GE., et al.[2021]

The study focused on enhancing the multimodal motion-assisted memory desensitization and reconsolidation (3MDR) therapy, which uses virtual reality to treat military members and veterans with treatment-resistant PTSD, by adapting it for public safety personnel (PSP) and other trauma-affected populations.

Through expert consultations and software validation with 35 PSP participants, the research confirmed that the newly developed 3MDR software is applicable and feasible for trauma-affected PSP, highlighting the need for tailored environments and individual immersion in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Redesign and Validation of Multimodal Motion-Assisted Memory Desensitization and Reconsolidation Hardware and Software: Mixed Methods, Modified Delphi-Based Validation Study. Jones, C., Smith-MacDonald, L., Brown, MRG., et al.[2022]

The study of 10 UK military veterans undergoing multi-modular motion-assisted memory desensitization and reconsolidation therapy (3MDR) revealed three distinct outcome typologies: dramatic improvement, moderate improvement, and minimal improvement, highlighting the varying effectiveness of this virtual reality-based therapy for PTSD.

Factors influencing the effectiveness of 3MDR included individual characteristics (like walking capacity and commitment), aspects of the therapy itself (such as image selection and therapeutic alliance), and the therapy environment, suggesting that personalized approaches may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the outcomes of a novel virtual reality therapy for military veterans with PTSD: Theory development using a mixed methods analysis. Hannigan, B., van Deursen, R., Barawi, K., et al.[2023]

A preliminary study involving 11 military members and veterans with treatment-resistant PTSD (TR-PTSD) showed that six sessions of multimodal motion-assisted memory desensitization and reconsolidation (3MDR) therapy led to significant improvements in PTSD symptoms and related mental health measures.

The results suggest that 3MDR therapy may be an effective treatment option for military-related TR-PTSD, especially for individuals who have not responded to traditional therapies, highlighting its potential as a valuable intervention in a field with limited options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative changes in mental health measures with 3MDR treatment for Canadian military members and veterans. Jones, C., Smith-MacDonald, L., Brown, MRG., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05244564

Computer Monitor vs Augmented Reality 3MDR for PTSD ... This is a prospective randomized controlled trial comparing two ways of delivering Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12410239/

Brief Manual for Multi-Modal Motion-Assisted Memory ... The therapy involves 3 phases—preparation, immersive platform exposure, and post-session reconsolidation—integrating movement, dual-attention ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12410234/

Augmented Reality 3MDR Therapy for the Treatment of ... Multi-Modal Memory Desensitization and Reconsolidation, when delivered via the augmented reality headset, proved to be a viable and effective ...

4. clinicaltrial.be clinicaltrial.be/en/details/32601?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Computer Monitor vs Augmented Reality 3MDR for PTSD ... Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) is a new and unique treatment for PTSD that has been ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1548387/full

Case Report: Multi-modal motion-assisted memory ... The 3MDR-TG treatment protocol integrates multiple interventions known to be effective in treating PGD, PTSD and depressive disorder: (1) ...