Clinical Trial of 3MDR to Treat PTSD With mTBI, With and Without Eye Movement (3MDR)

This is a pilot prospective, randomized, interventional controlled clinical trial. Our study at the NICoE site will specifically target active or retired SMs who are OIF/OEF/OND veterans of any age and either gender who meet criteria for PTSD and have a lifetime history of mTBI. Comorbid PTSD and mTBI is highly prevalent in SMs and veterans of the recent wars in Afghanistan and Iraq, and having both diagnoses is associated with significantly greater symptom severity than either PTSD or mTBI alone (Brenner et al., 2010). TBI, the great majority of which is mTBI, is one of the most challenging, significant, and costly problems facing the DoD, and inhibiting readiness, whether in times of war or peace. Currently, no therapy has yet been proven efficacious in reducing persistent symptoms after TBI. Many patients with PTSD, particularly when it is combat-related, still suffer from substantial residual symptoms even after undergoing evidence-based psychotherapy (Watts et al., 2013; Bradley et al., 2001; Bison et al., 2007) and many even maintain their PTSD diagnosis (Steenkamp et al., 2015). The novel elements of 3MDR may prove to be particularly beneficial for those with both PTSD and a history of mTBI. If our approach is proven effective, there will be a sizeable population for whom this treatment could be provided, translating into both individual and DoD-wide benefit. Both TBI and PTSD have become signature wounds of the wars in Iraq and Afghanistan and pose significant health concerns for many military personnel. Currently, no intervention has yet been proven efficacious in reducing long-term symptoms of TBI. Furthermore, individuals with PTSD often have persistent symptoms even after completing validated treatments.

The proposed research has the potential to have a significant positive impact on the care of individuals with both PTSD and mTBI. As previously stated, 3MDR combines emotional exposure, dual-task processing, attenuation of working memory resources, and physical activity. Physical activity may be particularly beneficial in enhancing blood flow to the brain and facilitating production of beneficial factors such as brain-derived neurotrophic factor (BDNF). In addition, participants have the opportunity to demonstrate to themselves that they can actively overcome their avoidance by approaching and walking toward, or deliberately confronting, representations of their own traumatic memories. This approach may be particularly useful or of interest to veterans and SMs, who are accustomed to being physically active, may be less inclined to turn to pharmacotherapy than others with PTSD, and also have had high dropout rates and greater resistance to established, more traditional therapies. This relatively short treatment approach could have tremendous implications for improvement in symptoms as well as quality of life in individuals with PTSD and mTBI. Prior to any other study procedures, written informed consent will be obtained from each participant by the principal investigator (PI) or another study staff member trained by the PI to obtain informed consent. The PI will then complete a medical history and a series of questionnaires, to include a review of inclusion and exclusion criteria, to ensure that each participant is eligible to be enrolled in the study. A random number table will be used to randomly assign participants to either the eye movement (EM+) or no eye movement (EM-) group.

Table 1

Weeks Months 0

1 2 3 4 5 6 7 8 9 10 3 6 Consent X