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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment 3MDR for PTSD?

Research suggests that 3MDR, a therapy involving virtual reality and walking while discussing trauma, may help veterans with treatment-resistant PTSD by reducing symptoms and improving well-being. Participants reported feeling more engaged and empowered, and some experienced positive changes like better self-understanding and closure. ^{1 2 3 4 5}

Is 3MDR therapy safe for humans?

The available research on 3MDR therapy, primarily focused on military veterans with PTSD, does not report any specific safety concerns, suggesting it is generally safe for human use. ^{1 3 4 5 6}

How is 3MDR treatment different from other PTSD treatments?

3MDR is unique because it combines virtual reality with physical movement, like walking on a treadmill, to help people actively engage with and process traumatic memories. This immersive and interactive approach is different from traditional therapies, which often rely on talking or medication alone. ^{1 3 4 5 6}

Research Team

Michael J Roy, MD, MPH

Principal Investigator

Unformed Services University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Moving Toward and Through Trauma: Participant Experiences of Multi-Modal Motion-Assisted Memory Desensitization and Reconsolidation (3MDR). [2023]

2. United States 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. [2021]

3. United States 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. [2023]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Quantitative changes in mental health measures with 3MDR treatment for Canadian military members and veterans. [2022]

6. Canada 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. [2022]