3MDR Therapy for PTSD
(CARE4PTSD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Uniformed Services University of the Health Sciences
Must not be taking: Benzodiazepines
Disqualifiers: Epilepsy, Psychotic disorder, Bipolar, others
No Placebo Group
Approved in 5 Jurisdictions
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.
12345Is 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.
13456How 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.
13456Eligibility 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
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: 3MDR delivered via Augmented Reality Head Mounted DisplayExperimental Treatment1 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 monitorActive Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Uniformed Services UniversityBethesda, MD
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Who Is Running the Clinical Trial?
Uniformed Services University of the Health SciencesLead Sponsor
Military Traumatic Brain Injury Initiative, USUHSCollaborator
Center for Neuroscience and Regenerative Medicine, USUHSCollaborator
Center for Rehabilitation Sciences Research, USUHSCollaborator
References
Moving Toward and Through Trauma: Participant Experiences of Multi-Modal Motion-Assisted Memory Desensitization and Reconsolidation (3MDR). [2023]Introduction: Military members and Veterans are at risk of developing combat-related, treatment-resistant posttraumatic stress disorder (TR-PTSD) and moral injury (MI). Conventional trauma-focused therapies (TFTs) have shown limited success. Novel interventions including Multi-modal Motion-assisted Memory Desensitization and Reconsolidation therapy (3MDR) may prove successful in treating TR-PTSD. Objective: To qualitatively study the experiences of Canadian military members and Veterans with TR-PTSD who received the 3MDR intervention. Methods: This study explored qualitative data from a larger mixed-method waitlist control trial testing the efficacy of 3MDR in military members and veterans. Qualitative data were recorded and collected from 3MDR sessions, session debriefings and follow-up interviews up to 6 months post-intervention; the data were then thematically analyzed. Results: Three themes emerged from the data: (1) the participants' experiences with 3MDR; (2) perceived outcomes of 3MDR; and (3) keys to successful 3MDR treatment. Participants expressed that 3MDR provided an immersive environment, active engagement and empowerment. The role of the therapist as a coach and "fireteam partner" supports the participants' control over their therapy. The multi-modal nature of 3MDR, combining treadmill-walking toward self-selected trauma imagery with components of multiple conventional TFTs, was key to helping participants engage with and attribute new meaning to the memory of the traumatic experience. Discussion: Preliminary thematic analysis of participant experiences of 3MDR indicate that 3MDR has potential as an effective intervention for combat-related TR-PTSD, with significant functional, well-being and relational improvements reported post-intervention. Conclusion: Military members and Veterans are at risk of developing TR-PTSD, with worse outcomes than in civilians. Further research is needed into 3MDR and its use with other trauma-affected populations.
Perceived treatment processes and effects of interactive motion-assisted exposure therapy for veterans with treatment-resistant posttraumatic stress disorder: a mixed methods study. [2021]Background: A novel intervention, Multi-modular motion-assisted memory desensitization and reconsolidation (3MDR), aims to reduce avoidance and improve engagement for patients with posttraumatic stress disorder (PTSD) who did not sufficiently respond to previous treatments. It has been found to effectively reduce PTSD symptoms for veterans with treatment-resistant PTSD. Symptomatic measures alone might not capture all treatment effects, and addition of qualitative outcomes may provide deeper understanding of treatment processes and treatment-induced changes. Objective: To study the perspectives of veterans with treatment-resistant PTSD on 3MDR treatment processes and effects and explore the relation of their experiences to PTSD symptom improvement. Method: A convergent parallel mixed methods design was applied. For the qualitative part, open-ended question interviews were conducted until data saturation was reached (N = 10). Thematic analysis, rooted in grounded theory, was performed. Quantitative data included pre- to posttreatment responder status based on a structured clinical interview for PTSD. Results: Treatment processes endorsed by the veterans were engaging, regulating distress, feeling supported, facing traumatic memories, allowing emotions, associating, and disengaging from trauma. In terms of effects, veterans reported positive changes following 3MDR, including openness, new learning, self-understanding, closure, and reintegration. High comparability across themes was observed for responders and non-responders, except for the themes closure and reintegration, which were reported more often or more in depth by responders. Conclusions: Veterans indicated 3MDR treatment processes that complied with its aims of breaking through avoidance and increasing engagement, thereby facilitating traumatic memory retrieval and processing. However, this did not necessarily translate into PTSD symptom improvement for all veterans. Walking towards trauma-related pictures was highlighted as unique component of 3MDR and connected to specific treatment processes and effects. Positive changes following 3MDR were experienced outside the domain of PTSD symptom improvement, implicating that 3MDR may beneficially impact veterans beyond symptom changes alone.
Factors associated with the outcomes of a novel virtual reality therapy for military veterans with PTSD: Theory development using a mixed methods analysis. [2023]Multi-modular motion-assisted memory desensitization and reconsolidation therapy (3MDR) is a new psychological intervention for people with post-traumatic stress disorder (PTSD). 3MDR is immersive, delivered in a virtual reality environment, and emphasises engagement, recollection and reprocessing.
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]To explore the potential efficacy of multi-modular motion-assisted memory desensitization and reprocessing (3MDR) in British military veterans with treatment-resistant service-related PTSD.
Quantitative changes in mental health measures with 3MDR treatment for Canadian military members and veterans. [2022]Military members and veterans are at elevated risk of treatment-resistant posttraumatic stress disorder (TR-PTSD) due to higher rates of exposure to potentially traumatic events during the course of duty. Knowledge of TR-PTSD is limited, and specific protocols or evidence-based TR-PTSD therapies are lacking. Multimodal motion-assisted memory desensitization and reconsolidation (3MDR) therapy is an emerging intervention for combat-related TR-PTSD. The purpose of this study was to preliminarily assess the effectiveness of 3MDR in addressing TR-PTSD in Canadian military members and veterans.
The Redesign and Validation of Multimodal Motion-Assisted Memory Desensitization and Reconsolidation Hardware and Software: Mixed Methods, Modified Delphi-Based Validation Study. [2022]In recent years, the delivery of evidence-based therapies targeting posttraumatic stress disorder (PTSD) has been the focus of the Departments of Defense in countries such as Canada, the Netherlands, and the United States. More than 66% of military members continue to experience symptoms of PTSD that significantly impact their daily functioning and quality of life after completing evidence-based treatments. Innovative, engaging, and effective treatments for PTSD are needed. Multimodal motion-assisted memory desensitization and reconsolidation (3MDR) is an exposure-based, virtual reality-supported therapy used to treat military members and veterans with treatment-resistant PTSD. Given the demonstrated efficacy of 3MDR in recently published randomized control trials, there is both an interest in and a need to adapt the intervention to other populations affected by trauma and to improve accessibility to the treatment.