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来推动心理健康改善”，并由新的/早期研究人员领导。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费用最高的疾病。有充分的证据表明，循证心理疗法，如认知行为疗法（CBT），在BD和SZ的症状方面产生了临床显著的改善，但社区中只有5%的患者可以获得这些治疗。严重精神疾病患者接受CBT治疗的机会受到以下因素的限制：训练有素的提供者人数有限，这些治疗的资源密集度，以及许多公共精神卫生系统停止报销心理服务。我们过去五年在BD和SZ的研究表明，移动的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，并与症状、药物依从性和社会化的改善相关。我们的干预措施称为CBT 2go，它将生态瞬时评估与症状和相关经历发生时提供的个性化干预措施相结合。我们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CBT 2go，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的干预。我们提出了一项研究，其总体目标是评估CBT 2go的有效性，收集必要的数据以完善其创新功能，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）CBT 2go，2）仅用于控制自我监测和器械接触的生态学瞬时评估条件，3）标准护理。共有255名BD或SZ参与者将从一个大型公共精神卫生系统中招募，该系统几乎无法获得CBT。将在基线、6周（治疗中期）、12周（治疗后）和24周（随访）对受试者进行评估。研究的主要结局将是临床医生评定的总体精神病理学，次要结局将包括药物依从性、社会功能和精神卫生服务利用。认识到并非所有参与者都将受益，我们建议审查分组的差异有效性。我们还将研究改变的机制，为移动的干预设计提供信息，重点关注CBT 2go对认知洞察力和功能失调态度的影响，这是传统CBT中改变的两个中介。借鉴实施研究的经验，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CBT 2go的促进因素、障碍和成本。这项研究将为CBT 2go在医疗保健环境中以高保真度进行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.