Efficacy of a Cognitive Remediation Treatment Program for Bipolar Disorder

双相情感障碍认知矫正治疗方案的疗效

• 批准号: 8110347
• 负责人: KATHRYN Eve LEWANDOWSKI
• 金额: $ 14.99万
• 依托单位: MCLEAN HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-01 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8110347
• 关键词: Address; Adult; Age; Area; Award; Behavioral; Bipolar Disorder; Brain; Characteristics; Clinical; Clinical Trials; Cognition; Cognitive; Cognitive deficits; Cognitive remediation; Collaborations; Communities; Computers; Control Groups; Development; Diagnosis; Disease; Dose; Elements; Environment; Evaluation; Exhibits; Functional disorder; Funding; Future; Goals; Health; Hospitals; Hour; Image; Impaired cognition; Intervention; Intervention Studies; Investigation; K-Series Research Career Programs; Measures; Mediating; Mediator of activation protein; Mental Health; Mental disorders; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methods; National Institute of Mental Health; Neurobehavioral Manifestations; Neurocognition; Neurocognitive; Neurocognitive Deficit; Neurosciences; Onset of illness; Outcome; Outcome Study; Outpatients; Participant; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Phenotype; Populations at Risk; Positioning Attribute; Protocols documentation; Psychologist; Psychopathology; Psychotic Disorders; Public Health; Randomized; Recommendation; Recording of previous events; Recruitment Activity; Research; Research Personnel; Research Project Grants; Research Support; Review Literature; Sampling; Schizoaffective Disorders; Schizophrenia; Scientist; Secondary to; Secure; Site; Symptoms; Techniques; Time; Training; Training Programs; Treatment outcome; Work; base; career; cognitive change; cognitive enhancement; cognitive function; cognitive neuroscience; design; executive function; experience; fitness; functional improvement; functional outcomes; improved; insight; instructor; interest; knowledge base; medical schools; neuroimaging; novel; patient oriented research; processing speed; programs; psychosocial; skills; treatment program; visual memory

DESCRIPTION (provided by applicant): This is an application for a K23-Mentored Patient-Oriented Research Career Development Award entitled "Efficacy of a Cognitive Remediation Treatment Program for Bipolar Disorder". The candidate is an instructor and assistant research psychologist at McLean Hospital/Harvard Medical School with a background in neurocognitive and behavioral deficits in patients with psychosis and at risk populations. Clinically, the candidate has focused on treatment of adults with severe and persistent mental illness, including patients with schizophrenia (SZ), schizoaffective disorder (SZA), and bipolar disorder (BD). The candidate's work in cognitive phenotypes of psychotic illness and her clinical interests have converged on an interest in the implementation of novel treatment approaches to address cognitive dysfunction in psychosis. She now aims to apply her research and clinical experience to psychosocial clinical trials work specifically targeting neurocognitive dysfunction in patients with BD with psychosis and, ultimately, other psychotic illnesses. Cognitive dysfunction is increasingly recognized as a major feature of BD, present by illness onset, persistent into euthymia, and associated with functional outcome. Deficits are qualitatively similar to those seen in SZ, and may be quantitatively similar in some patient groups (50-55), e.g. in patients with a history of psychosis. Despite strong associations between cognitive impairment and functional outcomes in BD, treatment for these symptoms at present is inadequate. Pharmacotherapies do little to address cognitive symptoms, and may even worsen them. Psychosocial cognitive remediation (CR) treatments have been developed to target these symptoms and their functional correlates, and have shown early promise in patients with SZ in improving both neurocognition and community functioning. However, despite the overlap of neurocognitive deficits between patients with SZ and BD, no studies to date have extended neuroscience- based CR to patients with BD. The present proposal aims to assess the efficacy of CR treatment in patients with BD with a history of psychosis using a 70-hour CR paradigm compared to a dose- matched computer-based control. It is hypothesized that patients in the CR group will exhibit improvements in cognitive and community functioning compared to controls, which will persist during a 6-month durability phase. Additionally, putative mechanisms of functional change will be examined, including mediator effects of cognitive and clinical change on community functioning. 130 patients with BD with a history of psychosis recruited from the Psychotic Disorders Programs at McLean Hospital will be randomized into either the CR or computer control group. CR will be administered using the PositScience Brain Fitness and InSight programs, neuroscience-based training programs that have shown early promise in patients with SZ and are used actively by the Mentor (Dr. Keshavan) and an Advisor (Dr. Vinogradov) on this project. Participants will be assessed on measures of clinical, cognitive, and community functioning at baseline, following the 70-hour treatment or control phase, and again 6 months later. This project is in keeping with the NIH's stated strategic priorities for improving mental health outcomes in patients and strengthening the impact of NIMH-supported research on public health, with specific recommendations for broad implementation of effective psychosocial interventions. The candidate's research examining neurocognition across diagnoses and over time, and her pilot work examining CR in patients with psychosis indicate that a) patients with BD exhibit significant and persistent neurocognitive deficits, b) CR is well-tolerated in patients with BD with psychosis, c) the candidate has access to patients who are appropriate for the proposed study, and d) the candidate can develop and implement longitudinal and treatment-outcome studies of neurocognition in patients with psychotic illness. As an instructor and assistant research psychologist at McLean Hospital/Harvard Medical School, the candidate is well positioned to continue to develop her work toward a career as an independent investigator. She has gained extensive experience with patient oriented research, and now seeks additional training in clinical trials work, CR techniques, quantitative methods, and cognitive neuroscience techniques (including neuroimaging) in order to develop expertise in CR clinical trials and a knowledge base in cognitive neuroscience. Training in these areas is necessary for the development of her academic identity as a clinical scientist conducting independent investigations of CR in BD and other major psychotic illnesses. Additionally, in future work the candidate aims to develop collaborations with experts in cognitive neuroscience and imaging toward identifying mechanisms of cognitive change after CR treatment. The candidate has assembled a team of mentors and advisors for this project who are experts in CR (including the use of the CR programs selected for the present proposal), clinical trails, outcomes in bipolar disorder, quantitative methods in longitudinal research, and cognitive neuroscience and neuroimaging, and with whom she has demonstrated effective and productive collaborations. Additionally, a number of courses have been selected in key training areas, and are available to her through Harvard and its affiliates. Together with the rich training environment of McLean Hospital - Harvard's largest psychiatric training site - the above mentorship and didactics will allow the candidate to develop the skills and expertise necessary to transition to an independent research career, and, by the end of the award period, to develop next phase research projects and secure federal funding in order to undertake them.

描述(由申请人提供)：这是一份K23指导的以患者为导向的研究职业发展奖的申请书，题为“双相情感障碍认知矫正治疗计划的有效性”。候选人是麦克莱恩医院/哈佛医学院的讲师和助理研究心理学家，具有精神病患者和高危人群的神经认知和行为缺陷背景。在临床上，候选人专注于治疗患有严重和持续性精神疾病的成年人，包括精神分裂症(SZ)、分裂情感障碍(SZA)和双相情感障碍(BD)患者。这位候选人在精神病认知表型方面的工作和她的临床兴趣都集中在实施新的治疗方法来解决精神病认知功能障碍上。她现在的目标是将她的研究和临床经验应用于心理社会临床试验工作，专门针对患有精神障碍的BD患者的神经认知功能障碍，最终还有其他精神疾病。认知功能障碍日益被认为是BD的一个主要特征，表现为疾病起病，持续到欣快期，并与功能结局相关。缺陷在质量上类似于在深圳看到的，并且在某些患者组(50-55)中可能在数量上相似，例如在有精神病病史的患者中。尽管认知障碍与BD的功能结局之间存在很强的相关性，但目前对这些症状的治疗还不够充分。药物疗法对解决认知症状几乎无济于事，甚至可能会加剧这些症状。心理社会认知补救(CR)治疗是针对这些症状及其功能相关性而开发的，并已在SZ患者的早期改善神经认知和社区功能方面显示出希望。然而，尽管SZ和BD患者之间存在神经认知缺陷的重叠，但到目前为止还没有研究将基于神经科学的CR扩展到BD患者。本提案旨在评估有精神病史的BD患者采用70小时CR治疗的疗效，并与剂量匹配的计算机对照进行比较。据推测，与对照组相比，CR组患者的认知和社区功能将有所改善，这种改善将持续6个月的耐受期。此外，还将研究功能变化的可能机制，包括认知和临床变化对社区功能的中介作用。130名有精神病史的BD患者从McLean医院的精神病障碍项目中招募，将被随机分为CR组或计算机控制组。CR将通过PositScience Brain Fitness and Insight计划实施，这是一项以神经科学为基础的训练计划，已在SZ患者中显示出早期的希望，并由导师(Keshavan博士)和顾问(Vinogradov博士)在该项目中积极使用。在70小时的治疗或对照阶段之后，参与者将在基线时接受临床、认知和社区功能测量，并在6个月后再次进行评估。该项目符合美国国立卫生研究院提出的改善患者心理健康结果和加强NIMH支持的研究对公共健康的影响的战略优先事项，并就广泛实施有效的心理社会干预措施提出了具体建议。候选人对不同诊断和时间的神经认知的研究，以及她对精神病患者CR的试点工作表明，a)BD患者表现出显著的和持续的神经认知缺陷，b)BD精神病患者对CR耐受性良好，c)候选人可以接触到适合建议研究的患者，以及d)候选人可以开发和实施对精神病患者神经认知的纵向和治疗结果研究。作为麦克莱恩医院/哈佛医学院的讲师和助理研究心理学家，候选人处于有利地位，可以继续发展她的工作，成为一名独立调查人员。她在以患者为中心的研究方面获得了丰富的经验，现在正在寻求在临床试验工作、CR技术、定量方法和认知神经科学技术(包括神经成像)方面的额外培训，以发展CR临床试验的专业知识和认知神经科学的知识库。这些领域的培训对于发展她的学术身份是必要的，她是一名临床科学家，负责对BD和其他主要精神疾病的CR进行独立调查。此外，在未来的工作中，候选人的目标是与认知神经科学和成像专家开展合作，以确定CR治疗后认知变化的机制。这位候选人已经为这个项目组建了一个导师和顾问团队，他们是CR(包括为本提案选择的CR项目的使用)、临床试验、双相情感障碍的结果、纵向研究中的定量方法以及认知神经科学和神经成像方面的专家，她与这些人进行了有效和富有成效的合作。此外，在关键培训领域选择了一些课程，并通过哈佛及其附属机构向她提供这些课程。再加上麦克莱恩医院--哈佛最大的精神病学培训基地--丰富的培训环境，上述指导和教学将使候选人能够发展过渡到独立研究职业所需的技能和专业知识，并在获奖期结束时开发下一阶段的研究项目，并获得联邦资金，以便实施这些项目。