Addressing Challenges in Schizophrenia Research

应对精神分裂症研究的挑战

• 批准号: 7104210
• 负责人: THOMAS SCOTT STROUP
• 金额: $ 17.15万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-11 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7104210
• 关键词: antipsychotic agents; awareness; clinical research; decision making; human data; human subject; longitudinal human study; patient oriented research; schizophrenia; therapy compliance

DESCRIPTION (provided by applicant): This K23 Mentored Patient-Oriented Research Career Development Award will enable the candidate to develop the skills and experience necessary to become an independent investigator and scholar in interventions research for schizophrenia. The candidate is making a transition from health services to interventions research in order to address directly problems he has confronted as a clinician. The primary focus of work will be medication adherence. The overarching hypothesis is that medication non-adherence is a multifactorial barrier to good outcomes that is surmountable with specific interventions, or combinations of interventions, that address the underlying causes. An additional focus is on the decision-making capacity of persons with schizophrenia, which has important implications for medication adherence and for human subjects protections. The career objectives are to: 1) Improve understanding of the theory, concepts, and methodology related to design and analysis methods for clinical trials, 2) Gain additional exposure to issues and theoretical underpinnings of human subjects protections in vulnerable populations, with an emphasis on decision-making capacity, 3) Establish credibility as an investigator in the area of medication adherence and decision-making capacity, 4) Design and pilot test a novel clinical effectiveness trial addressing medication adherence and outcomes in a group of schizophrenic patients at high risk of non-adherence. Supervised research with experienced mentors is the main component of the career development plan. Coursework, tutorials, and workshops will be the mechanism to further develop methodologic skills and to develop expertise in treatment adherence and decision-making capacity. Two research projects will be pursued. Project 1 will use data collected in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial to conduct a novel longitudinal evaluation of medication adherence, awareness of illness, and decision-making capacity. Project 2 will establish the feasibility of a longitudinal effectiveness trial examining an intervention to improve medication adherence and outcomes in schizophrenia. This pilot study will build upon what is learned in Project 1 and will guide the design and provide preliminary data for a subsequent R01 application. At the end of the career development period, the applicant will have the skills and experience needed to lead studies of interventions designed to improve treatment adherence. The applicant's career will focus on designing and testing interventions to improve outcomes of persons who are severely affected by schizophrenia.

描述（由申请人提供）：该 K23 指导的以患者为导向的研究职业发展奖将使候选人能够发展成为精神分裂症干预研究的独立研究者和学者所需的技能和经验。该候选人正在从卫生服务转向干预研究，以直接解决他作为临床医生所面临的问题。工作的主要重点是药物依从性。总体假设是，药物不依从性是获得良好结果的多因素障碍，可以通过解决根本原因的特定干预措施或干预措施组合来克服。另外一个重点是精神分裂症患者的决策能力，这对于药物依从性和人类受试者的保护具有重要影响。职业目标是：1) 提高对与临床试验设计和分析方法相关的理论、概念和方法的理解，2) 进一步了解弱势群体中受试者保护的问题和理论基础，重点是决策能力，3) 建立作为药物依从性和决策能力领域研究者的可信度，4) 设计和试点测试一项针对药物治疗的新型临床有效性试验 一组具有不依从性高风险的精神分裂症患者的依从性和结果。由经验丰富的导师指导的研究是职业发展计划的主要组成部分。课程、辅导和研讨会将成为进一步发展方法技能并发展治疗依从性和决策能力方面的专业知识的机制。将开展两个研究项目。项目 1 将使用临床抗精神病药物干预效果试验 (CATIE) 精神分裂症试验中收集的数据，对药物依从性、疾病意识和决策能力进行新颖的纵向评估。项目 2 将建立纵向有效性试验的可行性，以检查改善精神分裂症药物依从性和结果的干预措施。该试点研究将以项目 1 中学到的知识为基础，指导设计并为后续 R01 应用提供初步数据。在职业发展期结束时，申请人将拥有领导旨在提高治疗依从性的干预措施研究所需的技能和经验。申请人的职业生涯将专注于设计和测试干预措施，以改善受精神分裂症严重影响的人的治疗结果。