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Principal Investigator: Maryland Pao
Organization: NATIONAL INSTITUTE OF MENTAL HEALTH
Fiscal Year: 2024
Award: $1,130,023
Funding agency: National Institute of Mental Health
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 Carlos Zarate in 2024 (ZIA MH002927-15).
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 along with youth and adult clinical pathways and Brief Suicide Safety Assessment guides for various medical settings. Additionally, the ASQ has been translated in over 23 languages, which are also available on the toolkit website, and has been validated in several languages. This past year, the validation studies in Argentina, Portugal, Ethiopia, and Nepal were concluded, and the Argentinian Spanish ASQ study was published. OCD study (NCT04317118) on developing and validating the ASQ for youth with neurodevelopmental disorders remains active and recruitment will conclude later this year. Additionally, the ASQ training team is actively collaborating with the Indian Health Services (IHS) to roll out the ASQ in all IHS facilities. OCD staff have consulted with several IHS hospitals and clinics to provide training on suicide risk screening and assessment with a successful pilot in Elko, Nevada in July 2023. 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 implemented as pilots at two NIH CC outpatient clinics with plans to implement suicide risk screening in all outpatient clinics at the CC. Lastly, the ASQ research team has increased ongoing public health outreach to assist hospitals and clinics around the nation to implement suicide risk screening programs in the past year. 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. Our research has also tried to identify the disparities in suicide rates in different diverse populations related to age, race, gender, and settings.
Mental Health Aspects of Coping with Chronic Medical Illness: 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. Youth self-report on the e-screening tool Checking IN 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 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), post-acute sequelae of SARS-CoV-2 infection (PASC) 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" (NCT04411147) 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 findings have been published. 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).
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