Development of a Psychosocial Treatment for Psychotic Depression

描述（由申请人提供）：这个指导患者导向的研究职业发展奖（K23）申请是为了支持Gaudiano博士作为一名独立的研究科学家，在严重情绪障碍的综合心理社会和药物治疗方面具有专业知识。最初的目标将是开发和评估治疗精神病性抑郁症的辅助干预措施。这一研究领域意义重大，因为目前还没有针对这一高危人群开发和测试的行之有效的心理社会治疗方法。拟议中的项目建立在高迪亚诺博士之前开发精神谱系障碍患者治疗方法的经验基础上，但在关键领域提供了额外的必要培训。Gaudiano博士的培训目标是：1)通过设计一种新的心理社会干预来理解精神病性抑郁症的现象学和治疗；2)获得与药物治疗使用相关的临床和研究问题的经验，作为后续R01提交的一部分，为更大规模的研究提供信息；3)发展联合治疗试验的设计、执行和统计分析方面的专业知识；4)在与严重精神疾病患者人群的临床和研究工作中增加伦理和多元文化问题的知识；5)拓展基金写作和稿件准备技能。这些目标将通过以下途径实现：1)布朗医学院/巴特勒医院的可用资源；2)博士提供的高质量指导。伊万·米勒和劳伦斯·普莱斯，以及其他顾问导师；3)完成正式的课程、研讨会和有指导的临床经验；4)研究方案的实施。作为K23奖的一部分，Gaudiano博士将完成一项为期5年的研究计划，重点是开发和评估一种新的心理社会干预精神病性抑郁症，称为基于接受的抑郁症和精神病治疗（ADAPT）。该研究项目的目的是：1)通过开展一项初步公开试验（n = 12），为ADAPT制定一份综合治疗手册；2)开展一项随机对照先导研究，比较首次住院的精神病性抑郁症患者的常规医院护理和半结构化门诊药物治疗加或不加ADAPT (n = 60)；3)制定治疗师培训计划；4)制定治疗师依从性和能力评定量表；5)调整和指定一种半结构化的药物治疗方案，用于随后的大规模临床试验。

DESCRIPTION (provided by applicant): This Mentored Patient-Oriented Research Career Development Award (K23) application is to request support for Dr. Gaudiano's development as an independent research scientist with expertise in combined psychosocial and pharmacological treatments for severe mood disorders. The initial goal will be to develop and evaluate an adjunctive intervention for treating psychotic depression. This research area is significant because currently there are no well-validated psychosocial treatments developed and tested for this high-risk population. The proposed project builds on Dr. Gaudiano's prior experience developing treatments for individuals with psychotic-spectrum disorders, but provides additional needed training in crucial areas. Dr. Gaudiano's training goals are to: 1) understand the phenomenology and treatment of psychotic depression by designing a novel psychosocial intervention; 2) gain experience in the clinical and research issues related to the use of pharmacotherapy to inform a larger-scale study as part of a subsequent R01 submission; 3) develop expertise in the design, execution, and statistical analysis of combined treatment trials; 4) increase knowledge of ethical and multicultural issues in clinical and research work with severely mentally ill patient populations; and 5) expand grant writing and manuscript preparation skills. These goals will be achieved through: 1) resources available at Brown Medical School/Butler Hospital; 2) high quality mentorship provided by Drs. Ivan Miller and Lawrence Price, and other consultant mentors; 3) completion of formal coursework, seminars, and supervised clinical experiences; and 4) implementation of the proposed research program. As part of this K23 award, Dr. Gaudiano will complete a 5-year research plan focused on developing and evaluating a novel psychosocial intervention for psychotic depression, called Acceptance-Based Depression and Psychosis Treatment (ADAPT). The aims of the research project are to: 1) develop a comprehensive treatment manual for ADAPT by conducting an initial open trial (n = 12); 2) conduct a randomized controlled pilot study comparing routine hospital care and semi-structured outpatient pharmacotherapy with or without the addition of ADAPT for patients initially hospitalized with psychotic depression (n = 60); 3) develop a therapist training program; 4) develop therapist adherence and competence rating scales; and 5) adapt and specify a semi-structured pharmacotherapy protocol for use in a subsequent larger-scale clinical trial.