3/4 Collaboration to Advance Negative Symptom Assessment in Schizophrenia

3/4 合作推进精神分裂症阴性症状评估

基本信息

批准号：
8021033
负责人：
WILLIAM P. HORAN
金额：
$ 27.75万
依托单位：
BRENTWOOD BIOMEDICAL RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-03-01 至 2013-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8021033
关键词：
Academia Address Adverse effects Agreement Antipsychotic Agents Anxiety Applications Grants Area Behavior California Caregiver Burden Caregivers Characteristics Charge Clinical Clinical Trials Cognition Collaborations Communities Conduct Clinical Trials Consensus Consensus Development Conferences Data Data Analyses Data Collection Development Disease Distress Drug Industry Emotional Ensure Evaluation Factor Analysis Gender Generations Government Agencies Gur Health Impairment Industry Interviewer Lead Los Angeles Manuals Maryland Measurement Measures Methods Modeling Moods Motivation National Institute of Mental Health Neurocognitive Occupational Outcome Outpatients Participant Patient Self-Report Patients Pennsylvania Pharmaceutical Preparations Pharmacotherapy Phase Play Positioning Attribute Principal Investigator Procedures Process Property Psychology Psychometrics Recommendation Recruitment Activity Research Research Infrastructure Research Personnel Research Priority Role Sampling Schizoaffective Disorders Schizophrenia Severities Sex Characteristics Site Social Functioning Source Structure Symptoms Techniques Testing Therapy Clinical Trials Training United States Food and Drug Administration Universities Validity and Reliability Woman Work base design disability emotional experience functional outcomes improved instrument meetings member men method development next generation novel programs quality assurance response social sound success symposium theories therapy development

项目摘要

DESCRIPTION (provided by applicant): Negative symptoms are distinct clinical features of schizophrenia that are major determinants of the poor community functioning and poor long-term outcome that characterize the disorder. However, they are only minimally responsive to available treatments and are a substantial burden for care-givers. To address this critical unmet treatment need, the NIMH recently sponsored a consensus development conference to identify research priorities to stimulate the development of novel treatments for negative symptoms. The number one recommendation for advancing research and moving towards new treatment development in this area was to develop a "next generation" assessment instrument that solves the conceptual and methodological problems of existing measures. For the instrument to achieve widespread acceptance, the conference participants concluded that it is essential to follow a transparent, rigorous scale development process using large, diverse, and representative samples. As members of the NIMH-MATRICS Negative Symptoms Workgroup, the Principal Investigators have collaborated with experts from academia, the pharmaceutical industry, and government agencies to develop a new instrument, the Negative Symptom Rating Scale (NSRS). The proposed four-site Collaboration to Advance Negative Symptom Assessment in Schizophrenia (CANSAS), including the Universities of Maryland, Pennsylvania, California-Los Angeles, and California-Berkeley, is designed to carry out the recommendations of this NIMH initiative over a three-year period. These four sites represent areas of ongoing research in schizophrenia and negative symptoms, with the necessary infrastructure and unique expertise to carry out the proposed studies. Study 1 will evaluate the psychometric properties of the beta version of the NSRS in 300 schizophrenia outpatients. Results will guide data-driven refinements of the instrument based on state-of-the-art data analytic techniques, including Item Response Theory analyses and item level factor analyses that will allow us to ascertain how well the NSRS items assesses the underlying negative symptom construct and its putative sub-components, the dimensional structure of the measure, and gender invariance. Study 2 will evaluate the psychometric properties, test-retest reliability, and factor structure via confirmatory factor analysis of the revised NSRS in160 patients with schizophrenia. Convergent/discriminant validity with respect to a range of other clinical and neurocognitive features of schizophrenia, as well as measures of social and emotional functioning will also be evaluated. The multi-site structure of the CANSAS will permit an efficient evaluation of the NSRS in large ethnically and clinically diverse samples, enabling us to rapidly disseminate a final version of the scale to researchers conducting clinical trials and other types of negative symptom research. PUBLIC HEALTH RELEVANCE: Negative symptoms are major determinants of poor functional outcome in schizophrenia and available treatments are largely ineffective for these symptoms. The proposed Collaboration to Advance Negative Symptom Assessment in Schizophrenia (CANSAS) will carry out the main recommendation of the recent NIMH Consensus Development Conference to create and validate a new assessment instrument, the Negative Symptom Rating Scale, for use in clinical trials and other types of research. This state-of-the art instrument will play a central role in the NIMH initiative to stimulate the development of new treatments aimed at reducing the disability associated with negative symptoms.

描述（由申请人提供）：阴性症状是精神分裂症的独特临床特征，是该疾病特征的社区功能不良和长期结果不良的主要决定因素。然而，它们对现有治疗的反应很小，并且对护理人员来说是一个沉重的负担。为了解决这一未满足的关键治疗需求，NIMH 最近主办了一次共识发展会议，以确定研究重点，以刺激针对阴性症状的新型治疗方法的开发。在这一领域推进研究和开发新疗法的首要建议是开发一种“下一代”评估工具，解决现有措施的概念和方法问题。为了使该仪器获得广泛接受，与会者得出的结论是，必须遵循透明、严格的规模开发流程，使用大量、多样化且具有代表性的样本。作为 NIMH-MATRICS 阴性症状工作组的成员，主要研究人员与学术界、制药行业和政府机构的专家合作开发了一种新工具：阴性症状评定量表 (NSRS)。拟议的四所合作机构推进精神分裂症阴性症状评估 (CANSAS)，包括马里兰大学、宾夕法尼亚大学、加利福尼亚大学洛杉矶分校和加利福尼亚大学伯克利分校，旨在通过三个阶段落实 NIMH 倡议的建议。年期间。这四个站点代表了精神分裂症和阴性症状正在进行的研究领域，拥有开展拟议研究所需的基础设施和独特的专业知识。研究 1 将评估 300 名精神分裂症门诊患者的 NSRS 测试版的心理测量特性。结果将指导基于最先进的数据分析技术的数据驱动的仪器改进，包括项目反应理论分析和项目级因素分析，这将使我们能够确定 NSRS 项目评估潜在阴性症状结构的效果及其假定的子组件、度量的维度结构以及性别不变性。研究 2 将通过对 160 名精神分裂症患者修订后的 NSRS 进行验证性因子分析，评估心理测量特性、重测可靠性和因子结构。还将评估精神分裂症一系列其他临床和神经认知特征的收敛/判别效度，以及社交和情感功能的测量。 CANSAS 的多站点结构将允许在大量种族和临床多样化样本中对 NSRS 进行有效评估，使我们能够向进行临床试验和其他类型阴性症状研究的研究人员快速传播该量表的最终版本。公共卫生相关性：阴性症状是精神分裂症功能不良的主要决定因素，现有的治疗方法对这些症状基本上无效。拟议的推进精神分裂症阴性症状评估合作（CANSAS）将执行最近举行的 NIMH 共识发展会议的主要建议，以创建和验证一种新的评估工具，即阴性症状评定量表，用于临床试验和其他类型的评估。研究。这种最先进的仪器将在 NIMH 倡议中发挥核心作用，以刺激新疗法的开发，旨在减少与阴性症状相关的残疾。