Clinical Research in the NIMH Office of the Clinical Director

National Institute Of Mental Health

Investigators

Linked publications, trials & patents

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. This study was transferred to a new PI in 2024 (ZIA MH002927); OCD staff remain as Associate Investigators and assist with logistical efforts for recruitment of participants. The Ask Suicide Screening Questions (ASQ) is a brief 4 item suicide risk screening tool. The ASQ toolkit, available on NIMH’s website (www.nimh.nih.gov/asq) includes the screening tool, the Brief Suicide Safety Assessment guides for further assessment of patients that screen positive, in various medical settings, and youth and adult suicide risk clinical pathways. Additionally, the ASQ has been translated in over 23 languages, which are also available on the toolkit website. ASQ has been validated in several languages globally through collaborations. This past year, the validation studies in Argentina, Portugal, Ethiopia, and Nepal were concluded, and the Argentinian Spanish ASQ study and the Nepali ASQ study were published. The OCD study (NCT04317118) on developing and validating the ASQ for youth with neurodevelopmental disorders finished data collection and analysis is underway. Additionally, the ASQ training team is actively collaborating with the Indian Health Services (IHS) and rolled out the ASQ in all IHS facilities with training in person or virtually over 10 regions of the US. OCD staff consulted with several IHS hospitals and clinics to provide training on suicide risk screening and assessment; an example is the successful in person training in Phoenix in the Spring of 2025. The ASQ team continues to conduct several secondary data analyses using public datasets to answer clinically driven research questions about the management of patients at risk for suicide. Most recently, ASQ screening has been fully implemented in all the outpatient clinics in the NIH Clinical Center. Lastly, the ASQ research team has continued ongoing public health outreach by providing requested technical assistance to hospitals and clinics around the nation on implementation of suicide risk screening programs in various medical settings. Tailored clinical pathways that address resource-limited settings are developed in collaboration with the local site teams to make implementation of universal suicide risk screening feasible. OCD staff have established expertise in the mental health aspects of coping with chronic medical illnesses across the lifespan. Working with the Pediatric Oncology Branch, NCI, OCD researchers developed "Checking In", a brief electronic interactive screening measure of distress designed to identify emotional, physical, social, practical and spiritual concerns of pediatric patients. We reported on the importance of documenting youth self-report, separate from parent report, on the e-screening tool Checking IN which is useful in detecting symptom interference leading to psychosocial distress, particularly related to fatigue, sleep difficulties, and attention based on a real-time assessment of symptom interference and documentation over time (multiple visits). OCD collaborations with NCI also led to an updated version based on patient surveys of VOICING MY CHOiCES, an advance care planning guide for adolescents and young adults with life-limiting diseases. There are a variety of research projects aimed at better understanding the neuropsychiatric manifestations of various complex medical conditions related to patients treated in the Psychiatry Consultation Liaison Service through partnerships with NIH investigators across different institutes, including NCI, NIAID and NINDS. These include investigations of rare primary immune deficiencies, such as chronic granulomatous disease and VEXAS syndrome, with a focus on their psychiatric manifestations, drug-drug interactions and the potential adverse effects of medications. Another study includes evaluation and assessment of patients with focal hand dystonias receiving deep brain stimulation using pre and post procedure psychiatric diagnostic evaluations. Exploration of the psychosocial aspects rare diseases and cancers, including CDH1 deficiency and RUNX1 deficiencies, is conducted to understand how these complex illnesses impact the mental health and well-being of patients. Additionally, the role of psychiatry in bone marrow transplant care, including improving sleep for hospitalized patients undergoing these procedures, understanding rates of mental illness and the role of psychotropic medication use. Finally, through questionnaires and literature reviews, efforts are being to create a clinical care pathway on the management of pediatric patients with autism in medical settings. Better identification of mental health and other supportive resources, such as occupational therapy or behavioral therapists, will assist coping and adaptation for patients with neurodevelopmental disorders and other serious medical disorders and their families while hospitalized for complex medical care such as bone marrow transplants. OCD staff have a strong interest in education and training, with ongoing projects in various areas including updates in pediatric consultation-liaison (C-L) psychiatry and strategies for how to train C-L fellows in liaison psychiatry by creating national standards of practice. PCLS Faculty regularly lecture staff in NIH Clinical Center 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 and the importance of integrated care. 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 Subcortical 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), post-acute sequelae of SARS-CoV-2 infection (PASC), antiphospholipid syndrome, lymphatic anomalies, and Gaucher syndrome. The NCS also plays a vital role in assisting NINDS researchers who are studying Parkinson's disease, epilepsy and other disorders in understanding neurocognitive profiles associated with each disease. Neuropsychiatric studies in HIV-related research: 1) NIH Intramural NeuroHIV Program-2 intramural protocols (NCT01875588) 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.