Clinical Research in the NIMH Office of the Clinical Director

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NIMH Clinical Research Support: The aim of the Research Volunteer (RV) protocol (NCT03304665) is to recruit and screen adult healthy volunteers for participation in NIMH IRP research studies. The study includes optional brain MRI and MEG studies to help build a normative set of scans. Deidentified data from RVs, submitted to the NIMH Data Archive (NDA) and OpenNeuro repositories, are broadly shared. Study highlights include use of an online website for initial consent and self-report survey measures, followed by an in-person clinical evaluation appointment for study eligibility. To date, 2019 volunteered and have undergone initial screening, 399 have completed in-person assessments, 245 completed a brain MRI, and 122 have had MEG recordings. Suicide Risk in the Medical Setting: The ASQ (Ask Suicide Screening Questions), a 4 item item screening tool, has been validated in youth and adults and has been translated into over 18 languages. It is being validated in other countries such as Pakistan, Ethiopia, Argentina and Nepal. The ASQ toolkit is on the NIMH website http://www.nimh.nih.gov/ASQ for public use (with over 168,100 unique pageviews in 2023). It includes materials necessary for hospitals to implement their own suicide risk screening programs as well as the nation's first youth suicide risk clinical pathways for emergency departments and inpatient medical surgical units. This past year we also worked with extramural collaborators to publish an outpatient primary care suicide risk clinical pathway for adults. One study remains active (NCT04317118) developing and testing a suicide risk screening tool for individuals with Autism Spectrum Disorder and Intellectual Disabilities. NIMH OCD researchers also work with schools and detention facilities to assist in their utilization of the ASQ to screen students and inmates. In Fall 2019, our ASQ training team helped implement universal suicide risk screening at Whiteriver Hospital. Data is now available on over 300,000 encounters in a population that is 99% AI/AN and that data has been presented nationally at the Pediatric Academic Societies conference in April 2023. In July 2023, our research group visited the second pilot site in Elko, Nevada, an IHS outpatient medical center. We trained staff who will be implementing suicide risk screening in the fall of 2023. IHS has plans, with assistance from our team, to implement suicide risk screening in all IHS medical settings across the country. We also participated in several NIMH Roundtables for youth and child suicide prevention, targeting pediatricians, school counselors, and others who work with youth. At the NIH CC, suicide risk screening in adult and pediatric inpatients has been implemented and we are actively working to implement in CC outpatient departments. With nationwide concerns that suicidal behavior is on the rise, our public health outreach has increased from teaching non-mental health clinicians how to use evidence-informed clinical pathways to consulting on implementation of suicide risk screening programs across the country and the world. Mental Health Aspects of Coping with Chronic Medical Illness: Working with the Pediatric Oncology Branch, NCI, we developed "Checking In", a brief electronic interactive screening measure of distress designed to identify emotional, physical, social, practical and spiritual concerns of pediatric patients. OCD researchers also lead and facilitate national efforts to educate patients and families on pediatric catatonia, pediatric somatic symptom disorders, and delirium. PCLS Faculty regularly speak to CC departments and the other Institutes to raise awareness and share knowledge about the intersection of mental and medical health in research subjects enrolled in clinical trials in the intramural program. Neuropsychiatric Aspects of Immune and Infectious Disorders (including HIV/AIDS), Genetic, and other Disorders: The Neuropsychology Consult Service (NCS) is involved in a broad range of research protocols studying cognitive and emotional functioning in various medical groups (such as Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy (CADASIL), neonatal onset inflammatory disorder (NOMID), infectious and immune diseases (HIV, COVID-19, anti-NMDA receptor encephalitis and other autoimmune brain disorders presenting with psychosis (in collaboration with PI: Nath, NCT02435810)), brain tumor (re-irradiation effects), Gulf War Syndrome, chronic fatigue syndrome (ME-CFS) and Gaucher syndrome. The NCS also plays a vital role in assisting NINDS researchers who are studying Parkinson's disease, epilepsy and other disorders. Neuropsychiatric studies in HIV-related research: 1) NIH Intramural NeuroHIV Program-2 intramural protocols (NCT01875588; NCT01692236) investigating HIV-related neurocognitive disorders with NINDS and NIAID, and 2) Collaborations with multi-site research networks, including an NIH DoD HIV/AIDS associated neurocognitive disorder protocol. The OCD supports the assessment of mental health needs of HIV/AIDS patients with substance abuse disorders including opiate use disorders in an interdisciplinary approach to HIV and mental health in DC and MD community sites with the CC and NIAID. With NIAID, NIDA, NIA, NICHD, NEI, and NIH Office of AIDS Research, NIMH supports the annual NIH Intramural NeuroHIV Research Workshop. COVID-19 Research: 1) NIMH OCD is collaborating with NIAID investigators on "A Longitudinal Study of COVID-19 Sequelae and Immunity" (NCT004411147) to characterize mental health status through every six month on-line self-report mental health questionnaires and screening measures and direct clinical evaluations of one hundred patients and one hundred control participants at enrollment and yearly intervals using NIH Toolbox tasks. Mental health questionnaires and screening measures are tracked every 6 months for up to 3 years. 2) The Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers protocol leverages existing NIMH studies to accomplish time-sensitive research on the mental health impact of environmental stressors imposed by the COVID-19 pandemic. Since the study began in April 2020, over 3,000 people have enrolled and completed baseline questionnaires; the study is now data analysis. 3) A COVID-19 adapted suicide risk screening telehealth pathway is available at the ASQ Toolkit website. 4) COVID Vaccine Allergy Reactions-The NIMH study team worked in collaboration with NIAID to assess the mental health of study subjects at baseline and throughout the study including the post-vaccine period to understand psychological responses to having experienced an allergic reaction to the vaccine. Participants were monitored for anxiety levels during the time they received a second dose of the vaccine in a controlled setting (ICU) and for an additional 6 months to track psychological status. This study has been completed and data analysis is underway. 5) In addition, the NCS collaborates on (PI: Avi Nath, NCT04573062) Natural History of Post-Coronavirus Disease 19 Convalescence at NIH to study post-acute sequelae of SARS-CoV-2 infection (PASC).