Determining the Right Acupuncture for Good Recovery Over Neuropsychiatric Trauma

PTSD Clinical Trial

Official title: Determining the Right Acupuncture for Good Recovery Over Neuropsychiatric Trauma (DRAGON)

Status Recruiting

Clinical Trial Summary

This study seeks to verify that a specific acupuncture treatment is effective at reducing symptoms of neuropsychiatric trauma found in those diagnosed with Post-Traumatic Stress Disorder (PTSD).

Clinical Trial Description

Traumatic stress experienced by service members negatively affects their ability to psychologically and emotionally cope with operational and family stressors. Physically, chronic pain complaints are higher in those with neuropsychiatric trauma. These can lead to a decrease in quality and duration of life. The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classifies Post-Traumatic Stress Disorder as an anxiety disorder (DSM). To achieve this diagnosis a person must be exposed to a traumatic event and then experience long lasting intrusive symptoms such as nightmares, irritability, flashbacks and trauma related thoughts or feelings that impair their ability to function in their day-to-day activities. These symptoms can be very distressing to individuals, often leading to other mental health disorders such as depression and generalized anxiety. They also frequently have widespread negative effects on their families, friends, co-workers and ultimately the mission of the United States Military. A leading theory regarding the underlying cause of PTSD states that the sympathetic nervous system (fight or flight) is upregulated every time the emotional centers of the brain are reminded of the traumatic event. This upregulation causes symptoms listed above along with physiologic symptoms such as elevations in heart rate, breathing and blood pressure. This can occur even in the absence of the conscious mind recognizing what is triggering this sympathetic response1. The overall effect for a patient is the overwhelming feeling that a terrifying traumatic event experienced many years ago is happening again in the present. Treatments aimed at downregulation of the sympathetic nervous system are common; however, treatments that can "break" the connection between prior trauma, the emotional centers of the brain and the sympathetic nervous system have the potential to treat the true underlying cause of PTSD. Treatment of psychological, emotional, and physical symptoms of Post-Traumatic Stress Disorder (PTSD) can include medication, psychotherapy, or some combination of the two. Evidence supports the idea that receiving traditional treatment for PTSD symptoms such as psychotherapy is something that many veterans are disinclined to do due to a perceived stigma of admitting that they have a mental illness (Mittal); although when adhered to, psychotherapy can cause significant improvement in PTSD symptoms such as sleep disturbance, depression, and suicidality 2. Alternatives to these traditional therapies are needed. Compared to traditional CBT, acupuncture offers a treatment effect for PTSD similar to CBT (Hollifield)6. A systematic review and meta-analysis examining prospective controlled clinical trials found no statistical difference between acupuncture and CBT (Kim)7. Compared to traditional SSRIs, acupuncture may be a treatment option for those experiencing SSRI side effects of sexual dysfunction, weight gain, and sleep disturbance (Kim)7. One part of Acupuncturists Without Borders (AWB) reports that veterans given acupuncture for PTSD reported better sleep with fewer nightmares, a clearer mental state, and less stress (Sneizck)8. Auricular (ear) acupuncture treatments in the veteran and servicemember population diagnosed with PTSD found that those treated had improved sleep, increased relaxation, decreased pain, and improvements in depression symptoms (Huang; Engel; King)9,10,11. Veterans also reacted favorably to the concept of the brief course of auricular acupuncture treatments, especially those who had avoided PTSD treatment due to associated stigma or lack of faith in traditional methods (King)11. There is an urgent need for additional, empirically validated, non-opioid alternative strategies attached to less stigma for symptoms associated with PTSD. Programs across the United States military are showing the effect of integrative medicine approaches, and this study will serve as another building block in the emerging whole person approach to military medicine12. One path to successful PTSD treatments may involve the vagal nerve. The vagal nerve is responsible for connecting the brain's central functions with peripheral organ function all throughout the body and counteracts the sympathetic response ( creating a rest and digest response)13. It regulates the body's stress response; dysregulation of the vagus-controlled hypothalamic-pituitary-adrenal axis is connected to PTSD14. Accordingly, external stimulus to the vagal nerve could forcefully alleviate dysregulation15. Historically, vagal nerve stimulation was achieved through surgical device implantation. Noninvasive vagal nerve stimulation methods are being newly developed and can positively affect a variety of physiologic processes (Bremner)13. We suggest that our acupuncture protocol is another novel method that can stimulate parts of the vagal nerve. MicroRNA biomarkers for posttraumatic stress disorder: MicroRNAs (miRNAs, miRs) are small RNA molecules (~ 22 nucleotides long) and are often, but need not be, post-transcriptional regulators that bind to complementary sequences on target messenger RNA transcripts (mRNA), usually resulting in translational repression and gene silencing. MiRNA may serve as good biomarkers because they are highly stable in serum due to their ability to withstand repeated freeze thaw, enzymatic degradation, and extreme pH conditions. ;

Related Conditions & MeSH terms

• Acupuncture
• Post Traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT05516862
• Study type: Interventional
• Source: Mike O'Callaghan Military Hospital
• Contact: Amanda Crawford, MS
• Phone: 7026533600
• Email: amanda.j.crawford.ctr@health.mil
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Completion date: October 1, 2025