Category Archives: Posttraumatic Stress Disorder

Long-term Risks of Mental Health Outcomes Post-Covid-19

The short-term consequences from COVID-19 have been described after the initial “acute” infection passes. These have included not only a variety of physical symptoms, but also psychiatric symptoms have been reported. A team of VA researches has been shining a light on various dangerous and enduring consequences that can arise following the initial COVID bout. These COVID complications include mental health disorders.

A study published this week in the British Medical Journal (BMJ) by researchers with the VA St. Louis Health Care System focused on mental health disorders following COVID-19 infection.  They found that, even in people not needing hospitalization while infected with COVID-19, serious health issues related to mental health could persist, or pop up, in the weeks and months following the acute stage. They describe that the reasons for the increased mental health risks after COVID are not completely clear. Biologic changes may occur in the body that affect the brain, and nonbiologic changes such as social isolation and trauma may also be at play.

The researchers analyzed medical records in a database within VA, which operates the largest integrated health care system in the United States. The analysis included nearly 154,000 patients who had tested positive for COVID-19 in a defined time frame from March 2020 into January 2021. (The time frame predated the delta and omicron variants, as well as wide availability of vaccines.) A comparison was made of these patients’ health information with data from more than 11 million people who had not had COVID-19 infection—about half of them from the same time frame and the other half from a pre-pandemic timespan.

The research group compared the mental health risks for those who had COVID-19 and survived the first 30 days of infection with the same health outcomes among those who were not infected. Over a study period of about a year, the researchers identified elevated risks for issues such as anxiety, depression, stress disorders, opioid use, substance use disorders, and sleep conditions. 

“We’ve all suffered some sort of distress from this pandemic—maybe a measure of anxiety or difficulty sleeping,” says lead investigator Al-Aly. “But these challenges are magnified, especially in those who were admitted to the hospital during the acute part of their COVID battle but also in many who experienced only mild or moderate symptoms.”

Compared to those who did not have COVID, those in the COVID group had a 60 percent higher risk of having any mental health disorder or mental health-related prescriptions.

Findings by the type of mental health issue were:

  • Anxiety: 35 percent higher risk in the COVID-19 group
  • Depression: 39 percent higher risk
  • Sleep disorder: 41 percent higher risk
  • Opioid use: 76 percent higher risk
  • Opioid use disorder: 34 percent higher risk
  • Non-opioid substance use disorders: 20 percent higher risk.
Hospitalized COVID-19 patients fared the worst. (BMJ 2022)

Given the large number of people with COVID-19, these findings could translate into a huge impact in the United States and around the world, the authors point out. A strength of our research was the large number of patients and the ability to leverage the breadth and depth of the VA’s electronic health records system,” highlights Al-Aly. As a pioneer in the use of electronic health records, VA “can offer answers to questions about areas including the pandemic that would be hard for others to address.”

The researchers were a multidisciplinary research team for making the rigorous analysis possible brought together public health experts from across disciplines, successfully marrying the medical and research perspectives. An Editorial in the BMJ by lead researcher points out that mental health disorders represent one part of the multifaceted nature of long covid which can affect nearly every organ system (including the brain, heart, and kidneys). Our results should be used to promote awareness of this risk among people with covid-19 and to guide efforts for the early identification and treatment of affected individuals.

Research Article: Xie Y, Xu E, Al-Aly Z. Risks of mental health outcomes in people with covid-19: cohort study. BMJ 2022; 376 (Published 16 February 2022)

Non-Invasive Vagus Nerve Stimulation for Treatment of Posttraumatic Stress Disorder

A Vagus Nerve Stimulation(nVNS) device called gammaCore™, this week has received a Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the treatment of posttraumatic stress disorder (PTSD) after showing a reduction of symptoms of PTSD by 31% when compared to sham treatment.

The Breakthrough Device Designation was supported, in part, by research from an Emory-Georgia Tech team led by J. Douglas Bremner, M.D., in the Departments of Psychiatry and Radiology at the Emory University School of Medicine, and Omer T. Inan, Ph.D., from the School of Electrical and Computer Engineering and the Coulter Department of Biomedical Engineering at the Georgia Institute of Technology in Atlanta, Georgia. Their research, built upon a strong mechanistic rationale and animal studies, shows nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory, and reduces symptoms of PTSD by 31% when compared to a sham stimulation.

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to critical medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

Why PTSD?

PTSD is a highly prevalent and disabling disorder with limited approved treatment options. According to the U.S. Department of Veterans Affairs National Center for PTSD, approximately 15 million adults in the U.S. experience PTSD each year. In the Military and Veterans Administration alone, PTSD is reported to affect between 10-20% of veterans who served in each Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF), the Gulf War (Desert Storm), and the Vietnam War. More than half of all patients with PTSD report severely impaired quality of life in areas including mood, social and family relationships, leisure activities, sense of well-being and life satisfaction.

According to one of the investigators, Dr. Douglas Bremner commented, “Current treatments for PTSD involving medication and psychotherapy have limitations due to limited efficacy, possible side effects, and the unwillingness of many PTSD patients to engage in therapies that involve reliving traumatic memories. gammaCore represents a new class of treatment separate from medication or psychotherapy that is safe, relatively free of side effects, and does not involve costly and invasive procedures for implantation, like previous VNS devices approved by the FDA for treatment of refractory depression.”

Gammacore device has been previously approved by the FDA for: (Source: https://www.gammacore.com/)

Migraine – Clinically proven to treat and prevent migraines in users ages 12 and up. Help reduce migraines days without additional drugs.

Cluster Headache – The only clinically proven device to treat and prevent cluster headache attacks, while providing fast, reliable relief for those suffering with cluster headache.

Hemicrania Continua (HC) & Paroxysmal Hemicrania (PH) – 1st and ONLY device for HC and PH treatment, proven to reduce pain severity or headache frequency.

COVID-19 – Emergency Use Authorization to treat users with known or suspected COVID-19 and experiencing reduced airflow.

Sources:

FDA
Fact sheet for healthcare workers

Instructions for use of gammaCore

gammaCore™ Press release