Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness

描述（由申请人提供）：该项目响应RFA MH 13-260“利用先进的健康技术推动心理健康改善”，由一名新/早期研究者领导。双相情感障碍（BD）和精神分裂症（SZ）是导致残疾的主要原因，也是严重精神疾病中治疗成本最高的疾病。充分的证据表明，以证据为基础的心理疗法，如认知行为疗法（CBT），对双相障碍和SZ的症状有显著的临床改善，但社区中只有5%的患者能够获得这些治疗。由于训练有素的提供者数量有限，这些治疗的资源强度有限，以及许多公共精神卫生系统中心理服务的报销停止，严重精神疾病获得CBT的机会受到限制。我们在过去五年中对BD和SZ的研究表明，手机可以提供自动化但个性化的认知行为干预，这种干预是可行的、可接受的，并且与症状、药物依从性和社会化的改善有关。我们的干预措施称为CBT2go，将生态瞬时评估与在症状和相关经历发生时提供的个性化干预相结合。我们已经开发了一个创新的平台，可以在各种屏幕类型、操作系统或数据访问技术上运行，我们已经开始将创新功能纳入CBT2go，包括基于位置的数据和个性化预测建模，这可能会导致变革性的移动干预。我们提出了一项研究，其总体目标是评估CBT2go的有效性，收集必要的数据以完善其创新特征，并检查其成本，促进因素和在公共精神卫生系统中实施的障碍。我们提出了一项随机对照试验，分为三组：1)CBT2go, 2)生态瞬时评估条件，以控制自我监测和设备接触，3)标准护理。共有255名患有BD或SZ的参与者将从一个大型公共精神卫生系统中招募，该系统几乎没有获得CBT。参与者将在基线、6周（治疗中期）、12周（治疗后）和24周（随访）时进行评估。该研究的主要结果将是临床医生评定的全球精神病理学，次要结果将包括药物依从性、社会功能和心理健康服务的利用。认识到并非所有参与者都将受益，我们建议在亚组中检查不同的有效性。我们还将研究变化的机制，为移动干预设计提供信息，重点关注CBT2go对认知洞察力和功能失调态度的影响，这是传统交付CBT变化的两个中介。根据实施研究的经验，我们将采用混合方法，从消费者、技术专家、管理人员和一线临床医生的角度评估采用CBT2go的促进因素、障碍和成本。这项研究将为CBT2go在医疗保健环境中进行高保真调整和实施奠定基础。

DESCRIPTION (provided by applicant): This project responds to RFA MH 13-260 "Harnessing Advanced Health Technologies to Drive Mental Health Improvement," and is led by a New/Early Stage Investigator. Bipolar disorder (BD) and Schizophrenia (SZ) are leading causes of disability and are the costliest disorders to treat among serious mental illnesses. Ample evidence exists that evidence-based psychotherapies such as cognitive behavioral therapy (CBT) produce clinically significant improvements in symptoms of BD and SZ, and yet only 5% of patients in the community can access these treatments. Access to CBT for serious mental illnesses is limited by the restricted pool of trained providers, the resource intensity of these treatments, and cessation of reimbursement for psychological services in many public mental health systems. Our research in BD and SZ over the past five years indicates that mobile phones can provide automated yet personalized cognitive behavioral intervention that is feasible, acceptable, and associated with improvements in symptoms, medication adherence and socialization. Our intervention, called CBT2go, integrates ecological momentary assessment with personalized interventions delivered in the moment that symptoms and related experiences occur. We have developed an innovative platform that functions on various screen types, operating system, or data access technologies, and we have begun to incorporate innovative features into CBT2go, including location-based data and personalized predictive modeling, that can potentially lead to transformative mobile interventions. We propose a research study with the overarching aims of evaluating the effectiveness of CBT2go, gathering necessary data to refine its innovative features, and examining its costs, facilitators, and barries to implementation in a public mental health system. We propose a randomized controlled trial with three arms: 1) CBT2go, 2) an ecological momentary assessment only condition to control for self-monitoring and device contact, and 3) standard care. A total of 255 participants with either BD or SZ will be recruited from a large public mental health system that has minimal access to CBT. Participants will be assessed at baseline, 6 weeks (mid-treatment), 12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome of the study will be clinician rated global psychopathology, and secondary outcomes will include medication adherence, social functioning, and mental health service utilization. Recognizing that not all participants wil benefit, we propose to examine differential effectiveness in sub-groups. We will also examine mechanisms of change to inform mobile intervention design, focusing on the impact of CBT2go on cognitive insight and dysfunctional attitudes, which are two mediators of change in traditionally delivered CBT. Drawing from experience in implementation research, we will employ a mixed methods approach to assessing the facilitators, barriers, and costs of adoption of CBT2go from perspectives of consumers, technology experts, administrators and front-line clinicians. This study will lay the groundwork for CBT2go to be adapted and implemented with high fidelity in healthcare settings.