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STARR News & Updates

February 2024

As Medicaid coverage is unwinding after the Public Health Emergency (PHE) (declared since COVID), there will be new treatment gaps. These gaps could be filled by community nonprofit (charitable) services, peer-run services, and by RESEARCH.


Referring patients to research clinics for consideration of trial participation could be the answer for many people struggling to find care.


Because Medicaid is the largest payer of mental health and substance use care in the nation, many people with mental health or substance use conditions will lose coverage during this unwinding.


Between 8 million to 24 million people will lose Medicaid coverage during the unwinding of Medicaid. Each state's approach to unwinding varies and certain groups are at greater risk of losing their coverage.


According to a January 2024 study published on the JAMA network, "Disenrollment was higher among younger adults, American Indian and Alaska Native and Black or African American patients, those with a lower FPL percentage, those with higher utilization, and those with conditions including HIV/AIDS, mental health conditions, and substance use conditions."


What can you do to fill the gap?


The community mental health centers around you are struggling to find options and resources for their patients, They may be hesitant to refer patients to research sites for many reasons, but there are things that you can do to overcome their hesitation.


First, understand that this is a long game -- it takes time to win trust. The sooner you start, the sooner you will start seeing the benefits.


Check out the STARR website for more information, tips, and resources.


References:

  • https://www.kff.org/medicaid/issue-brief/10-things-to-know-about-the-unwinding-of-the-medicaid-continuous-enrollment-provision/
  • https://jamanetwork.com/journals/jama-health-forum/fullarticle/2813507
  • https://hogg.utexas.edu/the-behavioral-health-effects-of-the-medicaid-unwinding-in-texas

Advocacy Spotlight: Rural Minds - Winner of the STARR Advocate of the Year Award


Rural mental health national nonprofit Rural Minds was selected as the 2023 STARR Coalition Advocacy Organization of the Year. This recognition is given to the advocacy organization that has demonstrated exceptional dedication to advocating on behalf of those living with mental illnesses, their efforts to fight the stigma of mental illness, and their support of the STARR Coalition’s collective efforts to support mental health clinical research.

 

(Continue Right Column: Rural Minds)

The first gene-editing treatment receives FDA approval.


New treatments based on CRISPR have been in the works for years. In the final weeks of 2023, one from Vertex, Casgevy, became the first to earn regulatory approval in both the UK and the US for its ability to cure sickle-cell disease, a life-threatening condition.


Just six weeks later, the FDA widened the approval of Vertex's CRISPR treatment to treat beta thalassemia (TDT), an inherited blood disorder in which the body doesn't make as much beta globin as it should.


The relevance of CRISPR-based treatments like Vertex's Casgevy for mental illnesses lies in the potential of CRISPR technology in treating genetic components of various disorders, including some mental illnesses.


Genetic Basis of Some Mental Illnesses: Certain mental illnesses have a genetic component. For example, disorders like schizophrenia, bipolar disorder, and major depressive disorder have been linked to specific genetic variations. The success of CRISPR in treating diseases with a clear genetic cause, like sickle-cell disease and TDT, opens the door to the possibility of using similar techniques to target and modify genes associated with mental illnesses.


Expanding Understanding of Mental Illnesses: The research and development of CRISPR-based treatments also contribute to a deeper understanding of the genetic underpinnings of mental illnesses. This enhanced understanding can lead to better diagnostic tools and more effective therapeutic strategies beyond gene editing.


The regulatory approval of CRISPR treatments for diseases like sickle-cell disease and TDT indicates a growing acceptance and understanding of gene-editing technologies. This sets a precedent for future approvals and may accelerate the development and testing of CRISPR-based treatments for mental illnesses.


In October 2023, NIH gave Yale a $40 million grant to research CRISPR-based treatments for brain diseases.


It's coming.


References:

  • https://www.biopharmadive.com/news/fda-casgevy-approval-beta-thalassemia-vertex-crispr/704663/
  • https://www.forbes.com/sites/roberthart/2023/12/08/fda-approves-first-crispr-treatment-that-might-cure-sickle-cell/?sh=53b614463045












(Continued from left: Rural Minds)

 

“We thank the STARR Coalition for this award and recognition of the collaborative work that we are doing through Rural Minds to help people in rural communities overcome unique barriers to mental health,” said Rural Minds Executive Director Chuck Strand.


There is a mental health crisis in rural America with suicide rates that are 64% to 68% higher among people living in rural areas compared to people living in large urban areas, according to the latest research from the CDC. To confront rural mental health challenges and the stigma surrounding mental illness, Rural Minds provides free information and services and launched the Rural Mental Health Resilience Program.


Recognizing self-reliance and a do-it-yourself mindset common among many people living in rural communities, the program empowers rural Americans to become part of the solution to improving mental health. In support of Rural Minds’ focus on industry collaboration, the STARR Coalition will be one of the valued program distribution partners to help launch the new Rural Mental Health Resilience Program.

 

“We are honored and grateful to have received the STARR Award on behalf of the 46 million rural Americans we serve,” said Rural Minds Founder and Chairman Jeff Winton. “We look forward to our ongoing collaboration with other nonprofits, corporations, and individuals across the country as we collectively confront this growing health issue facing rural America.”


For More information on Rural Minds, visit their website at www.ruralminds.org

News from the Certified Sites

Neuro-Behavioral Clinical Research hosted The Homeless Charity and Village for the Homeless Memorial Project with The Homeless Charity and Village. Dozens of homemade and decorated blankets were donated to honor those who have died without a home on National Homeless Persons Day. After the ceremony, the blankets were given to those in need.

Segal Trials has a new art installation at their Miami Lakes Inpatient clinic in collaboration with 9MusesArtCenter! 9Muses Art Center is a drop-in center in Fort Lauderdale, FL. They are a program of Mental Health America of Southeast Florida providing free peer-driven behavioral health support to adults with mental health and substance abuse disorders. The center has a fully functioning studio for fine arts classes and ceramic art. All proceeds of the artwork go to the artist.

Segal Trials' Scott Fisher, Lead Psychedelics Facilitator, set up at the Holistic Health Expo at the Pride Center at Equality Park. The Holistic Health Expo was a free community event offering information on holistic wellness options, including psychedelic therapy and new research into psychedelics.

CenExel's Georgia sites including ACMR, iResearch ATL and iResearch Savannah have been busy ringing in the new year by checking in with their Community Partners to determine how they can best help the partners reach their goals this year through the aid of their studies. Enthusiasm and gratitude have filled these conversations, particularly from groups working with marginalized and underserved communities, including the unhoused and those in mental health and longterm SUD recovery (pictured). It is a joy to connect our communities to the missing piece for whole-person health.

Pillar Clinical Research's Chicago office offered CPR lessons to their staff and patients. Mike Johnson, a member of the Chicago team and EMT-trained in CPR by the American Heart Association, owns and operates Mike’s CPR Sessions. In addition to some of the staff, seven of the Pillar research patients were trained in CPR!


We love that Pillar offered this to their patients!

Evolution Research Group (ERG) honored Black History Month by offering a wonderful presentation by Erika Grusinki on Henriette Lacks. The ERG staff gathered to learn more about Ms. Lacks, who died of cervical cancer in 1951 in a racially segregated ward, where doctors cut out a sample of her cancer cells without her permission. The cells became a bedrock of modern medicine. The presentation recognized the significant contributions of Henrietta Lacks, what HeLa Cells are and how HeLa Cells have advanced research, along with the ethical concerns regarding HeLa cells.

February is

Black History Month


Every February, the U.S. honors the essential contributions of African Americans who have helped shape the nation. Black History Month celebrates the rich cultural heritage, triumphs and adversities that are an indelible part of our country's history.


This year's theme is African Americans and the Arts. African American art is infused with African, Caribbean, and the Black American lived experiences. In the fields of visual and performing arts, literature, fashion, folklore, language, film, music, architecture, culinary and other forms of cultural expression, the African American influence has been paramount. African American artists have used art to preserve history and community memory as well as for empowerment. Artistic and cultural movements such as the New Negro, Black Arts, Black Renaissance, hip-hop, and Afrofuturism, have been led by people of African descent and set the standard for popular trends around the world. In 2024, we celebrate the varied history and life of African American arts and artisans.


This month, take some time to learn about and share Black history and the arts.

Gut Microbiome Differs For People With Treatment Resistance in Schizophrenia - Research out of Australia suggests that indicate that individuals with treatment-resistant schizophrenia have significantly different microbiome composition compared to control individuals without psychiatric diagnoses and individuals with treatment-responsive schizophrenia


New study finds that traumatic stress is associated with a smaller cerebellum - Adults with posttraumatic stress disorder (PTSD) have smaller cerebellums, according to new research from a Duke-led brain imaging study. The cerebellum, a part of the brain well-known for helping to coordinate movement and balance, can influence emotion and memory, which are impacted by PTSD. What isn't known yet is whether a smaller cerebellum predisposes a person to PTSD or PTSD shrinks the brain region.


Volume of gray brain matter significantly lower in people with early onset psychosis - Gray matter's primary purpose is to process information in the brain and plays a significant role in day-to-day functions like memory, emotions and movement. New research from King's College Institute of Psychiatry, Psychology & Neuroscience has found an association between a reduction in gray matter in the brain and early onset psychosis (EOP). Analysis of the data revealed that those individuals who developed EOP at a later age had lower volumes of gray matter in a number of small brain regions compared to those with an earlier age of onset.


Researchers find early symptoms of psychosis spectrum disorder in youth occurring at higher rate than expected - A new study co-led by Associate Professor Kristin Cleverley of the University of Toronto Lawrence Bloomberg Faculty of Nursing has found evidence that Psychosis Spectrum Symptoms (PSS) are often present in youth accessing mental health services. The study is one of three projects being led as part of the Toronto Adolescent and Youth (TAY) Cohort Study, which is set to follow 1,500 youth over the course of five years. The goal of the cohort study is to better understand the populations of youth seeking mental health treatment, how their mental health symptoms and functioning change over time, and whether early predictors of psychosis spectrum disorder can be determined.


Psychoactive drug ibogaine found to effectively treat traumatic brain injury in special operations military vets - Stanford University researchers have found that the plant-based psychoactive drug ibogaine, when combined with magnesium to protect the heart, safely and effectively reduces PTSD, anxiety and depression and improves functioning in veterans with TBI. Their new study, published in Nature Medicine, includes detailed data on 30 veterans of U.S. special forces. Controlled clinical trials to assess safety and efficacy are needed to validate these initial open-label findings. (ClinicalTrials.gov registration: NCT04313712)


If psychedelics heal, how do they do it? Even as clinical trials show promise and researchers pursue FDA approval, the mechanisms of action remain elusive. Uncovering them could lead to more effective treatments. Classic psychedelics share a key feature: They have an impact on serotonin receptors in the brain. Serotonin does activate its own receptors and common antidepressants increase the amount of serotonin available to stimulate receptors. Yet, somehow, psychedelics acting on this same system can cause dramatic effects, such as hallucinations or waves of empathy. And, it seems in some cases, healing, which can persist long after the immediate effects of the drugs have worn off.


Q&A: Why regulators may toss cold water on buzz over psychedelics - The nation's first program to sell psychedelic drugs to the public opened in Oregon in June. Several states are funding clinical trials and considering new laws and regulations that would loosen decades-long restrictions on the drugs' manufacture and distribution. Those plans may face federal regulations that classify psychedelics as schedule 1 controlled substances, with no therapeutic value. Some assume federal agencies will not interfere with state-regulated psychedelic programs. That might not be a safe assumption. Oregon and Colorado are choosing to regulate psychedelics very differently than cannabis, which is where problems could arise.


Bipolar disorder linked to early death more than smoking - Data from two large, independent data sets indicate that having bipolar disorder is far more of a risk for premature death than smoking.


Antipsychotic injections upon hospital discharge were associated with a 75% reduction in 30-day rehospitalizations when compared with oral antipsychotics, according to a Rutgers University Health study. The findings support the use of long-acting injections over daily pills for both medical and financial reasons. Standards of care for schizophrenia treatment already call for long-acting injections over daily oral medication but still list pills as an acceptable treatment option. Patients still choose pills over injections for reasons ranging from insurance coverage to fear of needles. For this study—which compared 30-day readmission rates for all patients discharged from a single academic hospital with schizophrenia or schizoaffective disorder from August 2019 to June 2022—240 patients opted for oral medication when they left the hospital, while 103 chose long-acting injections. After 30 days, the readmission rate was 8.3% among patients who received oral medication and 1.9% among patients who received long-acting injections, which can last anywhere from two weeks to six months.


Digital health interventions reduce postpartum anxiety and depression - A recent meta-analysis reveals that digital health interventions significantly alleviate symptoms of postpartum anxiety and depression, underscoring their potential as accessible treatments for new mothers. The study was published in the American Journal of Obstetrics & Gynecology, which evaluated data from Ovid MEDLINE, Embase, Scopus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov.

Sage Therapeutics and Biogen announced that ZURZUVAE™ (zuranolone) is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States. ZURZUVAE was approved by the U.S. Food and Drug Administration (FDA) as the first and only oral, 14-day treatment course for PPD.


Time Magazine recognized Zurzuvae as one of the Best Inventions of 2023 as, for the first time, there’s a pill that specifically treats postpartum depression (PPD). With the FDA's approval of zuranolone, or Zurzuvae, made by Sage Therapeutics and Biogen, women can start to improve their PPD symptoms in as little as three days.

Momentum Grows to Remove Race From

Clinical Algorithms


In the 1820s, physician Thomas Hamilton used his slaves to try to determine how deep black skin went, believing it was thicker than white skin and therefore black skin provided higher pain tolerance.


Thomas Jefferson, claimed that Black people had less kidney output, more heat tolerance, and poorer lung function than White individuals.


In the years that followed, physicians and scientists embraced these unproven theories. Over time, the medical literature echoed some of those ideas, which have been used in ways that cause harm.


A 2016 survey of 222 white medical students and residents published in The Proceedings of the National Academy of Sciences showed that half of them endorsed at least one myth about physiological differences between black people and white people, including that black people’s nerve endings are less sensitive than white people’s.


Medical societies have since been working to remove race from several algorithms and many hospitals have implemented the changes on their own. As early as 2017, individual health systems began shifting away from the use of race in kidney function estimates based on evidence they contributed to delayed referral to nephrologists and kidney transplants among Black patients.


In honor of Black History Month, we celebrate the contributions of African Americans and recognize the rich cultural heritage, triumphs and adversities that are an indelible part of our country's history.


Sources:

  • https://jamanetwork.com/journals/jama/fullarticle/2814170
  • https://issuu.com/jpeterson2022/docs/11279_cmss_report_v4?fr=xKAE9_zU1NQ
  • https://www.nytimes.com/interactive/2019/08/14/magazine/racial-differences-doctors.html
  • https://doi.org/10.1001/jama.2020.13378
  • https://docsouth.unc.edu/southlit/jefferson/jefferson.html


ISCTM 20th Annual Scientific Meeting and Founders Celebration will be held February 21-23 in Washington DC. For more information and to register visit the the ISCTM site here.


ASENT's 2024 Annual Meeting will be held from March 12-14, 2024 at the Hyatt Regency Bethesda, in Bethesda, MD. ASENT 2024 brings together senior leaders from healthcare payers, providers, employers, investors, fast-growing startups, big pharma, policymakers, and innovation centers to improve the process of bringing neurotherapeutics to market. Abstract Submission Deadline is January 22, 2024. For more information, click here.

Anxiety & Depression Association of America’s 2024 Annual Conference: Sex and Gender ~ Navigating the Biological and Social Constructs in Depression and Anxiety Disorders will be held April 11-14, 2024 in Boston, MA.

ACRP 2024 will be held May 3 - May 6 in Anaheim, CA. The Association of Clinical Research Professionals (ACRP) is where clinical researchers go for inspiration, education, and connection.

American Society of Clinical Psychopharmacology (ASCP) 2024 Annual Meeting will be held May 28-31 in Miami Beach, FL. Registration is open, as is the Call for Submissions - Explore them all here.

NAMICon 2024 will engage, challenge and include you in dynamic discussions and inspiring moments. It will introduce you to new ideas and tools you can take with you. It’ll connect you with people who will go from strangers to community—all in the name of mental health awareness, education and advocacy. Join us June 4–6 in Denver for an unforgettable experience. Save the Date!

MHACon 2024 will be held September 19-21 in Washington D.C. and online. At this year's conference, explore ways to DISRUPT systemic barriers, REFORM harmful practices that prevent progress, and TRANSFORM the current landscape, ensuring everyone has equitable opportunity for optimal mental health and well-being.

For the last 35 years, the National Federation of Families has brought together families, parents, community leaders, providers, partners, and legislators at our Annual Conference. We work to leverage our lived experience and learned solutions for the support and advancement of families whose children – of any age – experience mental health and/or substance use challenges.


For more information on the 2024 NFF Annual Conference and submission guidelines, click HERE.

February 19-24 is BrainHealth Week!


Join us for the annual five-day event that offers daily science-based tools to inspire brain-healthy habits that can be incorporated into our daily lives.

 

Get ready for the next BrainHealth Week Daily Text Challenge by texting BRAIN to 888-844-8991.

What changes would make your job better?
Better communication and feedback (with colleagues or supervisors)
Professional Training (job-specific training)
Personal Self Improvement Training (time management, goal setting, etc.)
Prioritizing Staff/Personal Health
Other (please email action@thestarr.org)

Practical Tips for High Performance Without Compromising Workplace Wellbeing


1.Lead By Example. leadership has to show that they prioritize wellbeing and will take time to rest to avoid burnout themselves. There’s no point spending your time and energy promoting wellbeing messages if the leadership isn't.


2.Talk to your staff about what support they need to do their job well. Start with the basics. Do your employees have everything they need to do their job well? Have you asked them? If not, set up brief 15-minute meetings and check in with each staff member.


3. See if there are any benefits you can provide that save your employees money. Evaluate your current wellbeing benefits and programs like gym discounts. Consider augmenting offerings to help relieve monetary pressures, even if minimal. Small subsidies for meals or public transportation go a long way psychologically.


4. Offer flexibility. Bear in mind that burnout can come from inflexibility. Flexibility is vital, especially at the moment, giving the example that companies could give employees the flexibility to commute in cheaper travel windows, or so they can work around care responsibilities.

The mission of the STARR Coalition is to create meaningful change by increasing COMMUNICATION, PARTNERSHIPS, and GOODWILL among stakeholders in the areas of mental health clinical research, advocacy, and treatment with emphasis on community and advocacy engagement, stigma reduction, and ensuring that research is widely recognized as a trusted care option.

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