PTSD and Clinical Research

A people-centered look at a little-known consideration

As June winds to a close and with it, PTSD Awareness Month, now seems an opportune time to leave as a parting “awareness month” thought the presence of PTSD in the clinical research landscape outside of mental health-specific studies, like are conducted at HBRF.

Say “PTSD” to any public group in America and the image evoked is usually one of a military combat veteran, especially among generations that grew up immersed in the decades-long conflicts in Iraq and Afghanistan. PTSD Awareness month exists to encourage thought and dialogue around Post-Traumatic Stress Disorder (PTSD) and it’s visible and hidden impacts on American society, communities, and families, which often means illuminating circumstances other than combat that can lead to a diagnosis of PTSD (if you or a loved one are a military veteran struggling with PTSD, the U.S. Department of Veterans Affairs runs an information-heavy campaign throughout the month of June. Check it out by clicking here.). At HBRF, consideration of PTSD often takes two forms — one, in the shape of people before us, right now; the other, in considerations of clinical trial and protocol site design and administration.

To the former, HBRF studies degenerative diseases and injury conditions with no known effective cure. To date HBRF has yet to sponsor or execute research devoted to mental health, but regularly observes improvements in mental health across dozens of disease states and includes non-PTSD-specific mental health markers as part of quality-of-life measures in every protocol designed. But how realistic is it to expect someone who suffers a life-changing traumatic injury that brings them to HBRF, such as spinal cord or brain injury, not to also struggle with depression, anxiety, and a plethora of other symptoms that could reasonably be diagnosed by a licensed professional as PTSD? People living with degenerative diseases and traumatic injury are also contending with a new mental and emotional reality, which may be difficult ones at times or persistently, to a degree that may lead to a diagnosis of PTSD. This is where the “people before us” part comes in. HBRF administers high volumes of mesenchymal stem cells over a long period of time, which means we get to know our research participants. We often have a front-row seat to their emotional journey as they hope, pray, and work at rehabilitation plans and everything that adjusting to their post-injury body entails. Our first point is a simple one, in the spirit of awareness:

People who have suffered traumatic injury may also struggle with anxiety, depression, and other symptoms than can lead to a diagnosis of PTSD.

A compelling body of research suggests that not only can those who suffer a traumatic injury develop PTSD, they are more likely to. There is increasing evidence that incurring a traumatic brain injury (TBI), for example, especially mild or repeated TBI, increases risk of onset of PTSD.[1] As much as 20%, or more, of those with spinal cord injuries meet or will meet diagnostic criteria for PTSD related to their injury.[2] Concerning degenerative conditions, PTSD has been reported to measurably increase risk of dementia in veterans and civilians, and numerous case reports describe delayed onset PTSD in individuals developing dementia and conditions such as Alzheimer’s Disease, suggesting a complex relationship between these two conditions.[3] Given such findings, researchers increasingly voice the need for more work to establish possible links between PTSD and other degenerative neurological conditions, such as Parkinson’s Disease.[4]

The statistics can be disheartening, which leads to our second primary point, considerations of clinical trial site design and administration — HBRF is intentionally beautiful.

Many (too many) clinical trial locations are spartan in décor, minimally clean, and located in questionable parts of major cities where the rent is low. There, contact with clinicians is terse, short, and hurried. How likely is someone feeling emotionally vulnerable, whether they have a diagnosis of “PTSD” or not, to feel comfortable in such a locale? Many will outright avoid clinical trial participation, and those who find the inner strength will certainly not enjoy their experience. HBRF is a direct response to the patient-driven desire for something different. If you are going to be with us month after month during the course of a protocol, we want your time to be valued and have value. At HBRF wide windows create airy, light-filled spaces in which no one feels constrained or constricted, through which can be enjoyed views of a lake and abundant wildlife, and in which clinical staff is directed to devote their full attention to every research participant. Whether individuals arrive internally happy or struggling, we succeed when time at HBRF helps participants experience relaxed hope. Our third point, then, is:

Among the best ways we can honor the mental and emotional well-being of the research participants we serve, is through demonstrated caring such as providing a beautiful space and caring, engaged clinical staff.

It is our hope that other clinical research sites embrace the HBRF model. Research attests healing from PTSD is possible, including through cell therapy — recent work establishing quantitative links between inflammation and PTSD[5] is quite encouraging for the future of cell therapy in PTSD treatment, given the quantitative and qualitatively demonstrated immunomodulatory properties of the mesenchymal stem cells studied at HBRF.[6] In whatever form science progresses, this is the most important point of discussion during PTSD Awareness Month:

If you are hurting, if you are suffering — you are not alone. There is hope.

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In need of support? Call the National Mental Health Hotline at (866)903–3787 to speak to a professional and learn about available resources.

Military veterans can reach the U.S. Department of Veterans Affairs crisis line by dialing 988 (press 1) or texting 838255. You do NOT have to be enrolled in the VA to utilize this resource.

[1] Bryant R. “Post-traumatic stress disorder vs traumatic brain injury.: Dialogues Clin Neurosci. 2011;13(3):251–62. doi: 10.31887/DCNS.2011.13.2/rbryant. PMID: 22034252; PMCID: PMC3182010.

[2] Otis C, Marchand A, Courtois F. “Risk factors for posttraumatic stress disorder in persons with spinal cord injury.” Top Spinal Cord Inj Rehabil. 2012 Summer;18(3):253–63. doi: 10.1310/sci1803–253. PMID: 23459174; PMCID: PMC3584775.

[3] Desmarais P, Weidman D, Wassef A, Bruneau MA, Friedland J, Bajsarowicz P, Thibodeau MP, Herrmann N, Nguyen QD. “The Interplay Between Post-traumatic Stress Disorder and Dementia: A Systematic Review.” Am J Geriatr Psychiatry. 2020 Jan;28(1):48–60. doi: 10.1016/j.jagp.2019.08.006. Epub 2019 Aug 9. PMID: 31488352.

[4] Jones MB, Gates R, Gibson L, Broadway D, Bhatti G, Tea J, Guerra A, Li R, Varman B, Elammari M, Jorge RE, Marsh L. “Post-Traumatic Stress Disorder and Risk of Degenerative Synucleinopathies: Systematic Review and Meta-Analysis.” Am J Geriatr Psychiatry. 2023 May 3:S1064–7481(23)00291–9. doi: 10.1016/j.jagp.2023.04.016. Epub ahead of print. PMID: 37236879.

[5] Katrinli, S., Oliveira, N.C.S., Felger, J.C. et al. « The role of the immune system in posttraumatic stress disorder.” Transl Psychiatry 12, 313 (2022). https://doi.org/10.1038/s41398-022-02094-7.

[6] Vij R, Tripathy M, Kim H, Park H, Cheng T, Lotfi D, Chang D. Frequency-dependent effect of intravenous administration of human adipose-derived mesenchymal stem cell therapy for severe Systemic Lupus Erythematosus: A case report. J Transl Autoimmun. 2022 Sep 23;5:100166. doi: 10.1016/j.jtauto.2022.100166. PMID: 36187443; PMCID: PMC9523069.