Office of the Clinical Director Clinical Services Research

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NIMH Clinical Research Support: The aim of the Research Volunteer (RV) protocol (17-M-0181) is to recruit and screen adult volunteers in good health for participation in research studies in the NIMH IRP (NCT03304665). The study includes optional brain MRI and MEG that will help build a normative set of scans linked to clinical information collected from healthy RVs. Deidentified data from RVs are broadly shared with other researchers 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 appointment for clinical evaluation for study eligibility. Since the inception of the study in fall 2017, 800 volunteers, most of whom are new to NIH, have consented and undergone initial screening; over 200 have been enrolled and had in-person assessment; more than 100 have had a brain MRI. There is a strong interest by NIMH research groups for referrals of RVs. Recruitment of RVs is ongoing. Data from the study have been submitted to the NIMH Data Archive (NDA) repository. Suicide Risk in the Medical Setting: The Director of NIMH, Dr. Joshua Gordon, established suicide prevention research as an NIMH priority and has a mission to reduce the national suicide rate by 20% by the year 2025. As suicide risk screening is now a national priority for 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. Our suicide risk screen study for pediatric patients in the emergency room resulted in such a validated tool, the ASQ (Ask Suicide Screening Questions). Due to public demand, the ASQ has been translated into 14 languages (Spanish, French, Dutch, Italian, Arabic, Portuguese, Hebrew, Korean, Japanese, Russian, Vietnamese, Somali, Urdu and Chinese). It is currently being implemented in emergency departments, inpatient medical units and outpatient primary care clinics where it has subsequently been validated in the U.S. and abroad. The ASQ toolkit is on the NIMH website http://www.nimh.nih.gov/ASQ for public use. The expanded toolkit includes materials necessary for hospitals to implement their own suicide risk screening programs and has been updated to include the nation's first Youth Suicide Risk Clinical Pathways for Emergency Departments and inpatient medical surgical units. The ASQ Toolkit has been viewed by the public with over 310,000 unique pageviews and has guided medical practitioners in hospital settings across the country and around the world. We have 5 IRB-approved protocols addressing suicide screening in different medical settings (NCT00623493, NCT02140177, NCT02050867, NCT02830334). Four of the five protocols have completed data collection; we are currently writing manuscripts to disseminate results. We are developing a screening tool for individuals with Autism Spectrum Disorder and Intellectual Disabilities. We collaborate with the Indian Health Service (IHS) to integrate universal suicide risk screening in all their medical facilities, and with school and detention facilities to assist in their utilization of the ASQ to screen students and inmates, respectively. Our ASQ training team visited an American Indian reservation in Fall 2019 and as a result suicide risk screening is now universal in Whiteriver Hospital. Plans for continuing the pilot in a second AI/AN reservation hospital were delayed due to COVID-19. At the NIH CC, suicide risk screening in adult and pediatric inpatients was initiated successfully. With nationwide concerns that suicidal behavior is on the rise, our public health outreach has increased; we continue to consult on suicide risk screening program implementations across the country. We consult to the NIMH Global Team and the American Academy of Pediatrics to help launch pilot suicide risk screening programs in Ethiopia and Argentina. Mental Health Aspects of Coping with Chronic Medical Illness: Clinical work on the PCLS and Neuropsychology Assessment Service (NAS) has led us to many collaborative research projects with other NIH Institutes. Work with the Pediatric Oncology Branch, NCI, is currently 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 further testing the instrument with several extramural institutions. OCD researchers also lead and facilitate national efforts to educate patients and families on pediatric catatonia as well as on pediatric somatic symptom disorders and delirium. They are also developing curricula for child psychiatrists on diagnosis and management of mental health concerns in youth with chronic medical illness. Neuropsychiatric Aspects of Immune and Infectious Disorders (including HIV/AIDS), Genetic, and other Disorders: The NAS is involved in a broad range of research protocols studying cognitive and emotional functioning in various medical groups. These research protocols include genetic disorders (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, progressive multifocal leukoencephalopathy, Ebola, anti-NMDA receptor encephalitis), brain tumor (re-irradiation effects), and chronic fatigue syndrome. In addition, the NAS 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 activities in the OCD fall into two categories: 1) NIH Intramural NeuroHIV Program, and 2) Collaborations with multi-site research networks, including an NIH DoD HIV/AIDS associated neurocognitive disorder protocol. The NIMH OCD, NINDS and NIAID have developed 2 intramural protocols (NCT01875588; NCT01692236) investigating HIV-related neurocognitive disorders, which are a clinical challenge and threat to the long-term health of people living with HIV/AIDS. In addition, 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 NIAID, NIDA, NIA, NICHD, NEI, and NIH Office of AIDS Research, NIMH supports the annual NIH Intramural NeuroHIV Research Workshop, 2020, where work on the role of interpersonal and childhood trauma and HIV was presented and published this year. NIMH OCD COVID-19 Research: 1) NIMH is collaborating with NIAID investigators on "A Longitudinal Study of COVID-19 Sequelae and Immunity" (Protocol 20-I-0123) and will assist in characterizing mental health states through on-line self-report mental health questionnaires and screening measures, as well as direct clinical evaluations of several hundred patients and healthy volunteers over the next three 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. The study will describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers. Since the study began in April 2020, 3,000 people have enrolled and completed baseline questionnaires. 3) A COVID-19 adapted suicide risk screening telehealth pathway is available at the ASQ Toolkit website.