COGFLEX: Pilot Translational Intervention for Pediatric Bipolar Disorder

COGFLEX：小儿双相情感障碍的试点转化干预

基本信息

批准号：
8441508
负责人：
DANIEL P DICKSTEIN
金额：
$ 19.62万
依托单位：
EMMA PENDLETON BRADLEY HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-03-08 至 2014-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8441508
关键词：
Accounting Adolescent Adult Affect Animals Antipsychotic Agents Applications Grants Area Attention deficit hyperactivity disorder Base of the Brain Behavior Behavioral Biology Biometry Bipolar Disorder Brain Child Clinical Cognitive Cognitive Therapy Cognitive deficits Cognitive remediation Collaborations Computer Assisted Computers Corpus striatum structure Data Development Diagnostic Distal Family Feedback Functional Magnetic Resonance Imaging Functional disorder Goals Health Hospitalization Human Incidence Intervention Interview Learning Lesion Lithium Measures Mediating Mental Depression Mental disorders Morbidity - disease rate Names National Institute of Mental Health Outcome Outcome Measure Participant Performance Pharmaceutical Preparations Phase Prefrontal Cortex Process Psychiatric Hospitals Psychiatric therapeutic procedure Psychotherapy Public Health Randomized Randomized Controlled Trials Research Research Methodology Reversal Learning Rewards Sampling Schizophrenia Staging Stimulus Strategic Planning Symptoms Task Performances Testing Thinking Training Translating Translational Research Translations Unipolar Depression Video Games Work Youth base behavior measurement brain behavior childhood bipolar disorder cognitive training design effective intervention effective therapy efficacy testing flexibility innovation learned behavior neuroimaging nonhuman primate novel relating to nervous system remediation research and development response skills suicide rate therapy development treatment response treatment strategy

项目摘要

DESCRIPTION (provided by applicant): Pediatric bipolar disorder (BD) is a growing health problem, whose incidence has risen 40-fold in the past decade and now accounts for 20% of all children discharged from psychiatric hospitals. Of the current treatments for this burgeoning public health problem, virtually none are based on our understanding of the biology of pediatric BD. A growing body of research has shown that pediatric BD involves behavioral and brain alterations mediating cognitive flexibility-i.e., the ability to adapt one's thinking and behavior n response to changing rewards. This includes my own work showing that BD youths have behavioral and functional MRI neural alterations in reversal learning. THE PRIMARY OBJECTIVE of this R21/R33 Translational Novel Interventions grant application is to accelerate the translation of our data implicating brain/behavior alterations in reversal learning and cognitive flexibility in the pathophysiology of pediatric BD into a novel, mechanism-based, non-medication intervention using computer-assisted cognitive remediation for reversal learning (referred to as COGFLEX). OUR CENTRAL HYPOTHESIS is that COGFLEX will be feasible and acceptable for pediatric BD, given that others have shown similar interventions for related cognitive processes are a feasible, acceptable, and effective treatment component for adults with BD, unipolar depression, ADHD, and schizophrenia, and in children with ADHD. OUR RESEARCH METHOD: R21 PHASE: In collaboration with our cross-disciplinary team of experts in video game development, treatment development, cognitive remediation in children, pediatric BD, and biostatistics, we will refine our COGFLEX intervention, gather normative data for skill-building levels in 50 typically-developing children, and conduct a stage 1a open trial of the behavior, brain, and symptom effects of COGFLEX on 15 BD children. R33 PHASE: We will conduct a stage 1b randomized controlled trial of feasibility and acceptability in 40 pediatric BD participants, half randomized to receive the full COGFLEX intervention with 10 skill-building levels, and half receiving a control task (COGFLEX level 1 only). We will refine our intervention and submit an R01 application specifically designed and powered to test its efficacy for pediatric BD. SIGNIFICANCE: Our approach aligns with the objectives of PAR 11-177 and NIMH's strategies 3.1 Develop Novel Interventions and 1.4 RDoC project because we seek to develop a novel, mechanism-based non- medication intervention for pediatric BD, applying lessons learned from studies of observable behavior and neuroimaging-i.e., reversal learning. Thus, this project has the potential to transform the treatment for the NIMH high-priority area of pediatric BD by allowing critical refinements for a novel mechanism-based intervention.

描述（由申请人提供）：小儿双相情感障碍（BD）是一个日益严重的健康问题，其发病率在过去十年中已经上升了40倍，现在占从精神病医院出院的所有儿童的20％。在当前对这个新兴公共卫生问题的治疗方法中，几乎没有一个基于我们对小儿BD生物学的理解。越来越多的研究表明，小儿BD涉及介导认知灵活性的行为和大脑改变 - 即适应人们的思维和行为n对改变奖励的反应的能力。这包括我自己的工作，表明BD青年在逆转学习中具有行为和功能性MRI神经改变。此R21/R33转化新颖干预授予的应用的主要目的是加速我们数据的翻译，这意味着大脑/行为改变了逆转学习中的大脑/行为改变儿科BD的病理生理学中的认知灵活性，用于使用计算机辅助的认知补充对基于机制的，基于机制的，基于机制的，非用药的干预措施（参考）逆转（引用）cogfflex（参考）。我们的中心假设是，鉴于其他人对相关认知过程显示出相似的干预措施是可行，可接受且有效的治疗成分，对于患有BD，单极抑郁症，ADHD，ADHD和精神分裂症的成年人以及ADHD儿童的可行，可接受且有效的治疗成分。我们的研究方法：R21阶段：与我们在视频游戏开发，治疗，治疗开发，儿童的认知补救措施，儿科BD和生物统计学方面的认知补救和生物统计学方面的专家团队合作，我们将在50个典型开发儿童和1a级开放式脑袋和症状的cogflex干预措施中收集规范性数据，以进行50个典型开发儿童的技能构建水平和症状。 R33阶段：我们将在40个小儿BD参与者中进行1B期间的可行性和可接受性随机对照试验，一半随机接受了10个技能建设水平的完整COGFLEX干预措施，一半接受控制任务（仅COGFLEX级别1）。我们将完善干预措施，并提交专门设计和启动的R01应用程序，以测试其对小儿BD的功效。意义：我们的方法与第11-177款和NIMH策略的目标保持一致。3.1制定新的干预措施和1.4 RDOC项目，因为我们试图开发针对小儿BD的新型，基于机制的非药物干预，应用了从可观察的行为和神经模仿的研究中学到的经验教训。因此，该项目有可能通过允许对基于机制的新干预进行批判性改进来改变小儿BD的NIMH高优先级领域的处理。