LiveWell: A Mobile Intervention for Bipolar Disorder

LiveWell：双相情感障碍的移动干预

• 批准号: 9165842
• 负责人: Evan H. Goulding
• 金额: $ 76.99万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-15 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9165842
• 关键词: Accountability; Accounting; Acute; Adherence; Adult; Algorithms; Behavior Therapy; Behavior monitoring; Behavioral; Bipolar Disorder; Bipolar I; Cellular Phone; Chicago; Clinical; Clinical Assessment Tool; Collection; Combined Modality Therapy; Computer software; Data; Data Collection; Databases; Development; Disease; Effectiveness; Enrollment; Evaluation; Feedback; Future; Goals; Health Status; Individual; Intervention; Interview; Life; Manic; Measures; Mediating; Mediator of activation protein; Mental Depression; Meta-Analysis; Modeling; Moods; Morbidity - disease rate; Online Systems; Outcome; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Phenotype; Population; Process; Provider; Psychiatrist; Psychotherapy; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Relapse; Research; Resources; Self Management; Severities; Single-Blind Study; Sleep; Specific qualifier value; Symptoms; System; Technology; Testing; Time; Training; Treatment outcome; Variant; Work; base; behavior change; care delivery; clinical practice; common symptom; design; evidence base; experience; field study; improved; improved outcome; individual patient; innovation; intervention effect; medication compliance; meetings; novel; patient stratification; primary outcome; programs; provider intervention; psychosocial; relapse prediction; response; secondary outcome; self reported behavior; severe mental illness; theories; therapy design; tool; treatment as usual; treatment program; treatment response; usability; user centered design

Goals: This R01 will deploy a smartphone based intervention for bipolar disorder to 1) reduce relapse and symptoms, 2) investigate targets mediating clinical outcomes, and 3) create a longitudinal feature-rich database to better understand illness trajectories and improve treatments. Background: Bipolar disorder is a severe and chronic mental illness. Combined treatment with medications and psychotherapy improves outcomes, but access to therapy is limited. Current therapies do not capture behavioral and other data that could improve our understanding of the disorder and its treatment. They also do not provide real-time feedback which could improve patient self-management and facilitate provider intervention. Finally, limited data exists specifying what behavioral targets mediate psychotherapy benefits. Significance: This study will use a smartphone to increase access to proven strategies that enhance patient self-management and provider intervention. Simultaneously, self-report, behavioral, and application usage data will be collected along with clinical status assessments creating a database for understanding intervention effects and elucidating phenotypes. Finally, changes in proposed targets mediating clinical outcomes will be specifically assessed with validated measures to understand intervention mechanisms. Innovation: 1) A theory-based approach organizes the intervention design and provides tools for investigating intervention mechanisms effecting change, 2) Use of a coach guided by the supportive accountability model will improve adherence and outcomes, 3) Highly personalized wellness plans and tailored feedback reactive to patient status will also improve outcomes, 4) The feature-rich data collected will facilitate understanding how the intervention works and elucidate bipolar disorder phenotypes leading to future improvements in treatment. Preliminary studies: Iterative user-centered design and usability testing elicited feedback on all aspects of the intervention from patients and psychiatrists. Daily self-monitoring and behavioral data collection was successfully tested in a field trial. All aspects of smartphone application design, content, and software are fully operational. Coach training and delivery materials as well as validated assessment tools for clinical outcomes, proposed targets and their determinants are fully developed. The complete intervention is being field tested. Design: A single blind, randomized controlled trial (N = 200, 2:3 ratio of usual care vs usual care and intervention) will be conducted in clinical practices around Chicago and Minneapolis. Population: Adult bipolar 1 disorder patients not experiencing a current mood episode with a history of two acute episodes in the last two years who are in treatment with a psychiatrist. Outcomes: The primary clinical outcomes will be time to relapse, and the secondary outcomes will be percent time symptomatic, symptom severity, and quality of life. Target outcomes will be medication adherence, sleep duration, routine regularity, and management of early warning signs.

目标：本R01将部署基于智能手机的双相情感障碍干预，以1）减少复发， 症状，2）调查介导临床结果的目标，以及3）创建纵向特征丰富的 数据库，以更好地了解疾病轨迹和改善治疗。 背景：双相情感障碍是一种严重的慢性精神疾病。药物联合治疗 心理治疗可以改善治疗效果，但获得治疗的机会有限。目前的治疗方法不能捕获 行为和其他数据，可以提高我们对疾病及其治疗的理解。他们也 不能提供实时反馈，这可以改善患者自我管理并促进提供者 干预最后，现有的数据有限，无法说明哪些行为目标介导心理治疗的益处。 意义：这项研究将使用智能手机来增加获得经证实的策略的机会， 自我管理和供应商干预。同时，自我报告、行为和应用程序使用数据 将与临床状态评估一起收集沿着，创建数据库以了解干预措施 影响和阐明表型。最后，建议的介导临床结局的靶点的变化将被 通过有效措施进行具体评估，以了解干预机制。 创新：1）以理论为基础的方法组织干预设计，并提供调查工具 影响变革的干预机制，2）在支持性问责制模式指导下使用教练 将提高依从性和结果，3）高度个性化的健康计划和定制的反馈反应， 患者状态也将改善结果，4）收集的功能丰富的数据将有助于了解如何 干预工作和阐明双相情感障碍的表型，导致未来的治疗改进。 初步研究：迭代的以用户为中心的设计和可用性测试引起了对 患者和精神科医生的干预。每日自我监测和行为数据收集是 在现场试验中获得成功。智能手机应用程序设计、内容和软件的各个方面都完全 操作。指导培训和交付材料以及经验证的临床结果评估工具， 拟议目标及其决定因素已充分拟订。目前正在实地测试全面干预措施。 设计：一项单盲、随机对照试验（N = 200，常规治疗与常规治疗的比例为2：3， 干预）将在芝加哥和明尼阿波利斯周围的临床实践中进行。 人群：未发生当前情绪发作且有2次情绪发作史的成人双相1型障碍患者 在过去的两年里，急性发作的人正在接受精神病医生的治疗。 结局：主要临床结局为复发时间，次要结局为百分比 出现症状的时间、症状严重程度和生活质量。目标结果将是药物依从性、睡眠 持续时间、日常规律和预警信号的管理。