Clinical Research in the NIMH Office of the Clinical Director

NIMH 临床主任办公室的临床研究

基本信息

批准号：
10929831
负责人：
Maryland Pao
金额：
$ 110.94万
依托单位：
NATIONAL INSTITUTE OF MENTAL HEALTH
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10929831
关键词：
Accident and Emergency department Address Adult Alaska Native Allergic Reaction American Indians Anxiety Appointment Area Argentina Arterial Disorder Autoimmune Awareness Behavioral Black race Brain Diseases Brain Neoplasms COVID-19 COVID-19 pandemic COVID-19 pandemic effects COVID-19 survivors COVID-19 vaccine Catatonia Cerebrum Child Childhood Chronic Chronic Fatigue Syndrome Clinical Clinical Pathways Clinical Research Clinical Trials Cognitive Collaborations Communicable Diseases Communities Consent Consult Consultations Convalescence Country Data Data Analyses Delirium Disease Distress Dose Educational process of instructing Educational workshop Electronics Eligibility Determination Emotional Encephalitis Enrollment Environmental Impact Epilepsy Ethiopia Evaluation Extramural Activities Faculty Family Genetic HIV HIV/AIDS Health Health Status Hospitals Hypersensitivity Immune System Diseases Immunity Inflammatory Inpatients Intellectual functioning disability International Intramural Research Program Knowledge Language Lead Longevity Longitudinal Studies Measures Medical Medical center Mental Health Mental disorders Mission Monitor N-Methyl-D-Aspartate Receptors NIH Office of AIDS Research National Institute of Allergy and Infectious Disease National Institute of Child Health and Human Development National Institute of Drug Abuse National Institute of Mental Health National Institute of Neurological Disorders and Stroke Natural History Neonatal Nepal Neuropsychology Nevada Operative Surgical Procedures Outpatients Pakistan Parkinson Disease Participant Pathway interactions Patient Self-Report Patients Pediatric Oncology Persian Gulf Syndrome Persons Phenotype Play Population Population Heterogeneity Post-Acute Sequelae of SARS-CoV-2 Infection Prevention Research Primary Care Professional counselor Protocols documentation Psyche structure Psychiatrist Psychiatry Psychologist Psychoses Public Health Publishing Questionnaires Rare Diseases Reaction Research Research Personnel Research Subjects Research Support Resources Role Scanning Schools Screening procedure Services Site Sleep Social Workers Societies Spirituality Standardization Students Study Subject Subcortical Infarctions Subcortical Leukoencephalopathy Substance abuse problem Suicide Suicide prevention Surveys Symptoms Syndrome Testing Time Training Translating United States National Institutes of Health Vaccines Visit Work Youth autosome behavioral phenotyping brain magnetic resonance imaging clinical care clinical center clinical training cognitive function coping coronavirus disease data archive data de-identification data submission design emotional functioning environmental stressor experience falls healthy volunteer high risk individuals with autism spectrum disorder interdisciplinary approach irradiation multidisciplinary native youth neuroAIDS neurocognitive disorder neurodevelopment neuropsychiatry opioid use disorder outpatient facility outreach pediatric patients pediatrician physical conditioning programs psychiatric comorbidity psychologic public repository recruit repository research clinical testing research study response screening screening program social suicidal behavior suicidal risk suicide rate symposium telehealth tool volunteer web site

项目摘要

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).

NIMH 临床研究支持：研究志愿者 (RV) 协议 (NCT03304665) 的目的是招募和筛选参与 NIMH IRP 研究的成年健康志愿者。该研究包括可选的脑部 MRI 和 MEG 研究，以帮助建立一套规范的扫描。提交给 NIMH 数据档案 (NDA) 和 OpenNeuro 存储库的 RV 去识别化数据得到广泛共享。研究亮点包括使用在线网站进行初步同意和自我报告调查措施，然后对研究资格进行面对面的临床评估预约。迄今为止，2019 名志愿者自愿接受了初步筛查，399 名志愿者完成了现场评估，245 名志愿者完成了脑部 MRI，122 名志愿者进行了脑磁图记录。医疗环境中的自杀风险：ASQ（提出自杀筛查问题）是一种 4 项筛查工具，已在青少年和成人中得到验证，并已被翻译成超过 18 种语言。它正在巴基斯坦、埃塞俄比亚、阿根廷和尼泊尔等其他国家得到验证。 ASQ 工具包位于 NIMH 网站 http://www.nimh.nih.gov/ASQ 上，供公众使用（2023 年有超过 168,100 次独立页面浏览量）。它包括医院实施自己的自杀风险筛查计划所需的材料，以及全国首个针对急诊科和住院医疗外科单位的青少年自杀风险临床路径。去年，我们还与校外合作者合作，发布了成人门诊初级保健自杀风险临床路径。一项研究仍在进行中 (NCT04317118)，为自闭症谱系障碍和智力障碍患者开发和测试自杀风险筛查工具。 NIMH 强迫症研究人员还与学校和拘留设施合作，协助他们利用 ASQ 来筛查学生和囚犯。 2019 年秋季，我们的 ASQ 培训团队帮助怀特河医院实施了全民自杀风险筛查。目前，我们已经获得了 99% AI/AN 人群中超过 300,000 次就诊的数据，并且该数据已在 2023 年 4 月举行的儿科学术协会会议上在全国范围内公布。2023 年 7 月，我们的研究小组参观了位于埃尔科的第二个试点地点，内华达州，IHS 门诊医疗中心。我们培训了将于 2023 年秋季实施自杀风险筛查的工作人员。IHS 计划在我们团队的协助下，在全国所有 IHS 医疗机构中实施自杀风险筛查。我们还参加了几次针对青少年和儿童自杀预防的 NIMH 圆桌会议，对象包括儿科医生、学校辅导员和其他青少年工作人员。在 NIH CC，已经对成人和儿童住院患者实施了自杀风险筛查，并且我们正在积极努力在 CC 门诊部门实施。随着全国范围内对自杀行为不断增加的担忧，我们的公共卫生外展范围不断扩大，从教授非心理健康临床医生如何使用循证临床途径，到在全国和世界范围内实施自杀风险筛查项目提供咨询。应对慢性疾病的心理健康方面：我们与 NCI 儿科肿瘤科合作开发了“检查”，这是一种简短的电子交互式痛苦筛查措施，旨在识别儿科患者的情感、身体、社交、实际和精神问题。强迫症研究人员还领导和促进全国范围内对患者和家庭进行儿科紧张症、儿科躯体症状障碍和谵妄教育的努力。 PCLS 教员定期与 CC 部门和其他研究所进行交流，以提高对参加校内项目临床试验的研究对象的心理健康和医学健康交叉点的认识并分享知识。免疫和传染病（包括 HIV/艾滋病）、遗传和其他疾病的神经精神方面：神经心理学咨询服务 (NCS) 参与了各种研究方案，研究各个医学团体（例如脑常染色体）的认知和情绪功能伴有皮质下梗死和白质脑病的主动脉病 (CADASIL)、新生儿发病炎症性疾病 (NOMID)、感染性和免疫疾病（HIV、COVID-19、抗 NMDA 受体脑炎和其他表现为精神病的自身免疫性脑部疾病（与 PI 合作：Nath，NCT02435810））、脑肿瘤（再辐射效应）、海湾战争综合症、慢性疲劳综合症(ME-CFS) 和戈谢综合症，NCS 在协助 NINDS 研究人员研究帕金森病、癫痫和其他疾病。 HIV 相关研究中的神经精神病学研究：1) NIH 壁内 NeuroHIV 计划 2 壁内协议（NCT01875588；NCT01692236）与 NINDS 和 NIAID 一起研究 HIV 相关神经认知障碍，2) 与多站点研究网络（包括 NIH DoD HIV）合作/艾滋病相关的神经认知障碍方案。 OCD 支持在 DC 和 MD 社区站点与 CC 和 NIAID 合作，以跨学科方法评估患有药物滥用障碍（包括阿片类药物使用障碍）的 HIV/艾滋病患者的心理健康需求。 NIMH 与 NIAID、NIDA、NIA、NICHD、NEI 和 NIH 艾滋病研究办公室合作，支持年度 NIH 校内神经艾滋病毒研究研讨会。 COVID-19 研究：1) NIMH OCD 正在与 NIAID 研究人员合作开展“COVID-19 后遗症和免疫的纵向研究”(NCT004411147)，通过每六个月一次的在线自我报告心理健康问卷和筛查来描述心理健康状况使用 NIH 工具箱任务在入组时和每年的时间间隔对一百名患者和一百名对照参与者进行测量和直接临床评估。每 6 个月跟踪一次心理健康调查问卷和筛查措施，持续时间长达 3 年。 2) COVID-19 大流行对 NIMH 研究参与者和志愿者的心理健康影响协议利用现有的 NIMH 研究来完成对 COVID-19 大流行造成的环境压力因素对心理健康影响的时间敏感的研究。自 2020 年 4 月开始研究以来，已有 3,000 多人报名并完成了基线调查问卷；现在的研究正在进行数据分析。 3) ASQ 工具包网站上提供了适用于 COVID-19 的自杀风险筛查远程医疗途径。 4) COVID 疫苗过敏反应——NIMH 研究团队与 NIAID 合作，评估研究对象在基线和整个研究期间（包括疫苗接种后时期）的心理健康状况，以了解对疫苗过敏反应的心理反应。在受控环境 (ICU) 中接受第二剂疫苗期间，对参与者的焦虑水平进行监测，并在另外 6 个月内跟踪心理状态。这项研究已经完成，数据分析正在进行中。 5) 此外，NCS 还与 NIH 的冠状病毒后疾病 19 康复自然史 (PI: Avi Nath, NCT04573062) 合作，研究 SARS-CoV-2 感染 (PASC) 的急性后遗症。

项目成果

期刊论文数量（122）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

The feasibility and value of parent input when evaluating the mental health of young adults with and without cancer.

DOI：
10.1002/pon.5348
发表时间：
2020-04
期刊：
Psycho-oncology
影响因子：
3.6
作者：
Chung JY;Clayton EL;Hu H;Pao M;Wiener LS
通讯作者：
Wiener LS

The Emotional and Personal Experiences of the COVID-19 Illness During the Early Pandemic: A Qualitative Study.

DOI：
10.1016/j.jaclp.2022.11.003
发表时间：
2023-03
期刊：
JOURNAL OF THE ACADEMY OF CONSULTATION-LIAISON PSYCHIATRY
影响因子：
2.3
作者：
Raza, Haniya;Guinee, Emily P.;Okeke, Onyi;Shaw, Jacob S.;Gibbons, Alison;Mooneyham, GenaLynne C.;Sneller, Michael;Chung, Joyce Y.
通讯作者：
Chung, Joyce Y.

A Clinical Pathway to Standardize Care of Children With Delirium in Pediatric Inpatient Settings.