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

项目总结 K23职业发展奖将使候选人成为一名独立的临床研究人员 在应用移动健康(MHealth)技术方面具有专业知识，以改善心理社会临床试验 对于严重情绪障碍(SMD)的高危青少年；即双相I/II障碍和反复发作或持续存在 严重抑郁症)。背景资料。心理社会治疗(最显著的是认知-行为治疗 (CBT))对于SMD的高危青少年在减少症状和心境发生率方面显示出一定的效果 发病复发；然而，影响的大小从小到中等不等。一个促成因素是 可变效应大小是指对CBT处方治疗任务的低依从率(例如，认知 重新评估)。CBT的治疗变化机制取决于实践和实施 疗程间歇的治疗任务。然而，青少年通常报告动力不足、健忘和 缺乏资源是完成CBT治疗任务的障碍。这对临床研究人员提出了挑战 设计更好的方法让患者参与到这些治疗任务中来。明确的目标。这项建议旨在 通过以下方式更好地让参与者参与治疗和桥梁治疗：(1)调整和测试 现有移动应用程序(APP)的可接受性，这将加强会话内容，促进实践 治疗技能，并允许参与者记录和监测想法和症状；以及(2)进行 随机对照试验(RCT)，以测试APP增强的CBT对青少年(13-17岁)的疗效 SMD在提高参与者遵从性方面的高风险。训练。候选人将实现短期目标 通过资源丰富的制度环境和连贯的培训计划(1)规划、交付和 评估移动健康技术，(2)进行临床试验，以及(3)统计方法，以 通过使用功能数据分析来检查高维mHealth数据。师徒关系。这个 候选人将得到跨学科专家团队的支持：David Miklowitz，博士(主要导师)，Bonnie 齐马，医学博士，公共卫生硕士(共同导师)，凯瑟琳·苏格，博士(共同导师)，阿门·阿雷维安医学博士，博士(合作者)，Eric Granholm博士(顾问)和Jill Ehrenreich-May博士(顾问)。冲击力。与NIMH的资金一致 作为优先事项，拟议的研究将回答以下关键问题：(1)可接受性和初步疗效 移动APP在提高SMD高危青少年参与者依从性和接受度方面的作用和(2) 开始揭示移动应用程序影响参与者忠诚度的初始机制。而当 初步研究将侧重于SMD的高危青少年，预计候选人的培训和 这项研究将广泛应用于各种年龄、人群和精神疾病。通过这件事 K23奖项，候选人将获得申请更大NIMH所需的培训和初步数据 临床试验，以确定移动应用程序的哪些组件会影响参与者的依从性并测试参与者 坚持作为精神和心理社会治疗结果的中介者。

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.