Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

针对精神分裂症阴性症状的移动辅助认知行为疗法

• 批准号: 9332469
• 负责人: ERIC L GRANHOLM
• 金额: $ 65.37万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2018-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9332469
• 关键词: Attitude; Behavioral; Biological Markers; Cellular Phone; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Communities; Devices; Disease; Dose; Goals; Group Therapy; Hour; Intervention; Investigational Therapies; Lead; Measures; Mediating; Mediation; Modeling; Modification; Motivation; Mydriasis; Neurocognitive Deficit; Patients; Performance; Persons; Phase; Problem Solving; Psychological Theory; Psychophysiology; Psychotherapy; Public Health; Pupil; Quality of life; Reporting; Research; Schizophrenia; Severities; Socialization; Symptoms; Testing; Therapeutic Intervention; base; brief intervention; cognitive task; demographics; economic impact; functional disability; functional outcomes; improved; improved functioning; multi-component intervention; novel; predicting response; psychosocial; public health relevance; reduce symptoms; response; secondary outcome; skills training; social skills; symptom treatment; therapy adherence; therapy development

 DESCRIPTION (provided by applicant): Schizophrenia is one of the most devastating diseases known to humankind and is one of the top 10 causes globally of profound functional disability. Negative symptoms of schizophrenia account for much of the poor functional outcome in schizophrenia and are an unmet treatment need in a large proportion of patients. We propose to use an experimental therapeutics approach to test a novel psychosocial intervention that combines in-person and smartphone-based cognitive behavior therapy (CBT) for experiential negative symptoms in schizophrenia called, Mobile-assisted CBT for Negative symptoms (mCBTn). mCBTn is a novel extraction and integration of the CBT components that target defeatist attitudes from our cognitive behavioral social skills training (CBSST) group therapy and mobile smartphone interventions from our prior clinical trials research. The primary aim of the project is to test whether mCBTn can reduce severity of a novel treatment target: defeatist performance attitudes. In a promising new model, Beck and colleagues proposed that defeatist attitudes (e.g., "Why bother, I always fail," "It's not worth the effort") contribute to experientil negative symptoms like amotivation and asociality, and ultimately poor functioning in schizophrenia, because defeatist attitudes lead to avoidance of effortful goal-directed activities. Our approach centers on the hypothesis that defeatist attitudes contribute to experiential negative symptoms, including diminished motivation and effort, which ultimately leads to poor functioning in schizophrenia. In addition, the field currently relies on symptom rating scales and subjective patient reports to measure motivation and effort; more objective measures are needed. The proposed project will determine whether pupillary responses can provide an objective psychophysiological biomarker of effort that is sensitive to change in a clinical trial fr negative symptoms. Greater pupil dilation indicates greater task effort allocation. We propose two sequential clinical trials of mCBTn in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms. In the R61 phase, we propose an open trial to determine whether mCBTn changes the defeatist attitude target and will identify the optimal dose to engage the target. In the R33 phase, we propose an RCT comparing mCBTn with a supportive contact control and will determine whether mCBTn produces greater reduction in defeatist attitudes that mediates improvement in experiential negative symptoms. Pupillary responses will be recorded as a secondary outcome in both trials to determine its potential as an end point in clinical trials of motivation and effort.

 描述（由申请人提供）：精神分裂症是人类已知的最具破坏性的疾病之一，是全球严重功能障碍的十大原因之一。精神分裂症的阴性症状是精神分裂症功能结局差的主要原因，并且在很大一部分患者中是未满足的治疗需求。我们建议使用一种实验治疗方法来测试一种新的心理社会干预，该干预将面对面和基于智能手机的认知行为疗法（CBT）结合起来，用于精神分裂症的经验性阴性症状，称为阴性症状的移动辅助CBT（mCBTn）。mCBTn是CBT成分的一种新的提取和整合，这些成分针对来自我们的认知行为社交技能训练（CBSST）团体治疗和来自我们先前临床试验研究的移动的智能手机干预的失败主义态度。该项目的主要目的是测试mCBTn是否可以降低一个新的治疗目标的严重程度：失败主义的表现态度。在一个有希望的新模型中，贝克和他的同事提出，失败主义的态度（例如，“为什么要烦恼，我总是失败，”“这不值得努力”）导致经验上的负面症状，如动机和社会性，并最终导致精神分裂症的功能低下，因为失败主义的态度导致避免努力的目标导向活动。 我们的研究方法基于这样一个假设：失败主义态度会导致体验性的负面症状，包括动机和努力的减少，最终导致精神分裂症的功能低下。此外，该领域目前依赖于症状评定量表和主观患者报告来衡量动机和努力;需要更客观的措施。该项目将确定瞳孔反应是否可以提供一个客观的心理生理学生物标志物的努力，是敏感的变化，在临床试验阴性症状。更大的瞳孔扩张表明更大的任务努力分配。我们提出了两个连续的临床试验mCBTn的消费者与精神分裂症谱系障碍持续中度至重度的经验阴性症状。在R61阶段，我们提出了一项开放试验，以确定mCBTn是否改变了失败主义的态度目标，并将确定最佳剂量，以从事目标。在R33阶段，我们提出了一项RCT，将mCBTn与支持性接触对照进行比较，并将确定mCBTn是否能更大程度地减少失败主义态度，从而介导经验性阴性症状的改善。瞳孔反应将被记录为两项试验的次要结局，以确定其作为动机和努力临床试验终点的潜力。