Office of the Clinical Director Clinical Services Research

National Institute Of Mental Health

Investigators

Linked publications & trials

Abstract

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 to maximize scientific impact. 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. Since 2017, 1177 volunteers have consented and undergone initial screening; over 200 have been enrolled and had in-person assessment; 152 have had a brain MRI and 68 have had MEG recordings. The Neuropsychology Consult Service provides training and oversight in cognitive test administration. Protocol participation was halted due to the COVID-19 pandemic from March 2020 until November 2021 and is now actively enrolling new participants. Suicide Risk in the Medical Setting: The NIMH Director has established suicide prevention research as an NIMH priority. As suicide risk screening is a national priority in medical settings, non-mental health clinicians require valid, psychometrically-sound screening instruments for assessing suicide risk that have been validated empirically with medically ill patients in hospital settings. The ASQ (Ask Suicide Screening Questions) has been validated in several medical settings (emergency departments, inpatient medical units and outpatient primary care clinics) 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 (viewed by the public with over 270,000 unique pageviews) and includes materials necessary for hospitals to implement their own suicide risk screening programs. It includes the nation's first youth suicide risk clinical pathways for emergency departments and inpatient medical surgical units. We have completed 4 of our 5 IRB-approved protocols addressing suicide screening in various medical settings while one study remains active (NCT04317118). In collaboration, we are developing/testing a screening tool for individuals with Autism Spectrum Disorder and Intellectual Disabilities and with school and detention facilities to assist in their utilization of the ASQ to screen students and inmates. We collaborate with the Indian Health Service (IHS) to integrate universal suicide risk screening in all their medical facilities. In Fall 2019, our ASQ training team helped implement universal suicide risk screening at Whiteriver Hospital. Plans for a second AI/AN reservation hospital pilot in were delayed due to COVID-19. In FY2022, through our collaboration with IHS, we received a dataset with over 20,000 ED encounters with AI/AN adult and youth patients, a group who have the highest rates of suicide compared to any other race/ethnicities; this important dataset, under analysis, is 99% AI/AN. We participated in several NIMH Roundtables for youth 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 with plans to develop it in CC outpatient departments. With nationwide concerns that suicidal behavior is on the rise, our public health outreach has increased; we consult frequently on implementation of suicide risk screening programs across the country and the world. Mental Health Aspects of Coping with Chronic Medical Illness: Work with the Pediatric Oncology Branch, NCI, is focused on the development and validation of "Checking In", a brief electronic interactive screening measure of distress designed to identify emotional, physical, social, practical and spiritual concerns of pediatric patients. Feasibility testing at NIH is completed and we are testing the instrument with several extramural institutions. OCD researchers also lead and facilitate national efforts to educate patients and families on pediatric catatonia, pediatric somatic symptom disorders, and delirium. They are developing curricula for child psychiatrists on diagnosis and management of mental health concerns in youth with chronic medical illness and pain. PCLS Faculty regularly speak to CC departments and the ICs about the intersection of mental and medical health to raise awareness and knowledge of the impact on 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 NCS is involved in a broad range of research protocols studying cognitive and emotional functioning in various medical groups (such as Mobius syndrome, methylmalonic academia, McCune-Albright syndrome, Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy (CADASIL), Chediak-Higashi syndrome), infectious and immune diseases (HIV, COVID-19, anti-NMDA receptor encephalitis and other autoimmune brain disorders presenting with psychosis), brain tumor (re-irradiation effects), Gulf War Syndrome, and chronic fatigue syndrome (ME-CFS). 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 on-line self-report mental health questionnaires and screening measures and direct clinical evaluations of one hundred patients and one hundred control participants at baseline and one year. Neurocognition is assessed using NIH Toolbox tasks. 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 works 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 are monitored for anxiety levels during the time they will receive a second dose of the vaccine in a controlled setting (ICU) and for an additional 6 months to track psychological status. 5) In addition, the NCS collaborates on (PI: Avi Nath, NCT04573062) Natural History of Post-Coronavirus Disease 19 Convalescence at NIH.