App-Enhanced CBT for Adolescents at High Risk for Severe Mood Disorders

项目摘要 K23职业发展奖将使候选人成为独立的临床研究人员 在应用移动的健康（mHealth）技术以改善心理社会临床试验方面具有专业知识 对于严重情绪障碍（SMD;即，双相I/II型障碍和复发性或持续性 严重抑郁症）。背景心理社会治疗（最显著的是认知行为疗法 （CBT））对SMD高危青少年的治疗显示出一定的疗效， 发作复发;然而，影响的大小范围从小到中等。的促成因素 可变效应大小是对CBT规定的治疗任务的依从率低（例如，认知 重新评价）。CBT的治疗变化机制取决于实践和实施 治疗任务之间的会议。然而，青少年通常报告动机低，健忘， 缺乏资源是完成CBT治疗任务的障碍。这就要求临床研究人员 设计更好的方法让病人参与到这些治疗任务中。具体目标。这项建议旨在 更好地让参与者参与治疗和过渡治疗，方法是：（1）调整和测试 现有移动的应用程序（app）的可接受性，该应用程序将加强会话内容，促进 治疗技巧，并允许参与者记录和监测的想法和症状;和（2）进行 一项随机对照试验（RCT），旨在测试应用程序增强的CBT对青少年（13-17岁）的有效性， SMD在提高参与者依从性方面的风险较高。训练候选人将实现短期目标 通过资源丰富的机构环境和连贯一致的培训计划，（1）规划、交付和 移动医疗技术的评估，（2）临床试验的进行，以及（3）统计方法， 通过使用功能数据分析来检查高维mHealth数据。导师制。的 候选人将得到一个跨学科专家团队的支持：大卫Miklowitz，博士（主要导师），邦妮 Zima，MD，MPH（共同导师），Catherine Sugar，PhD（共同导师），Armen Arevian MD，PhD（合作者），Eric Granholm博士（顾问）和Jill Escherich-May博士（顾问）。冲击与NIMH资助一致 优先事项，拟议的研究将回答有关（1）的可接受性和初步疗效的关键问题， 移动的应用程序在改善SMD高风险青少年的参与者依从性和可接受性方面的作用，以及（2） 开始揭示移动的应用程序影响参与者依从性的初始机制。而 最初的研究将集中在SMD高风险的青少年，预计候选人的培训和 研究将广泛应用于各种年龄人口和精神状况。通过这个 K23奖，候选人将获得必要的培训和初步数据，以申请更大的NIMH 确定移动的应用程序的哪些组件影响参与者依从性和测试参与者的临床试验 坚持精神和心理社会治疗结果的调解人。

PROJECT SUMMARY This K23 career development award will position the candidate to become an independent clinical researcher with expertise in the application of mobile health (mHealth) technologies to improve psychosocial clinical trials for youth at high risk for severe mood disorders (SMD; i.e., bipolar I/II disorder and recurrent or unremitting major depression). BACKGROUND. Psychosocial treatments (most notably cognitive-behavioral therapy (CBT)) for adolescents at high risk for SMD show some efficacy in reducing symptoms and rates of mood episode relapse; however, the size of the effects range from small to moderate. A contributing factor to the variable effect sizes is the low rates of adherence to CBT’s prescribed treatment tasks (e.g., cognitive reappraisal). CBT’s mechanisms of therapeutic change hinge upon practice and implementation of the treatment tasks between sessions. However, adolescents commonly report low motivation, forgetfulness, and a lack of resources as barriers to completing the CBT treatment tasks. This challenges clinical researchers to devise better methods of engaging patients in these treatment tasks. SPECIFIC AIMS. This proposal aims to better engage participants in treatment and bridge treatment sessions by (1) adapting and testing the acceptability of an existing mobile application (app) that will reinforce session content, facilitate practice of treatment skills, and allow participants to log and monitor thoughts and symptoms; and (2) conducting a randomized-controlled trial (RCT) to test the efficacy of an app-enhanced CBT for adolescents (ages 13-17) at high risk for SMD in improving participant adherence. TRAINING. The candidate will achieve short-term goals through a resource-rich institutional environment and a cohesive training plan in (1) the planning, delivery, and evaluation of mHealth technologies, (2) the conduct of clinical trials, and (3) statistical methodologies to examine high dimensional mHealth data through the use of functional data analysis. MENTORSHIP. The candidate will be supported by an expert interdisciplinary team: David Miklowitz, PhD (primary mentor), Bonnie Zima, MD, MPH (co-mentor), Catherine Sugar, PhD (co-mentor), Armen Arevian MD, PhD (collaborator), Eric Granholm, PhD (consultant), and Jill Ehrenreich-May, PhD (consultant). IMPACT. In line with NIMH funding priorities, the proposed research will answer critical questions about (1) the acceptability and initial efficacy of a mobile app in improving participant adherence and acceptability for adolescents at high risk for SMD and (2) begin to uncover the initial mechanisms by which a mobile app can influence participant adherence. While initial studies will focus on adolescents at high risk for SMD, it is anticipated that the candidate’s training and research will have broad applications to a range of age populations and psychiatric conditions. Through this K23 award, the candidate will gain the training and preliminary data necessary to apply for a larger NIMH clinical trial to determine what components of a mobile app affect participant adherence and test participant adherence as a mediator of psychiatric and psychosocial treatment outcomes.