Primary Care Based Depression Prevention in Adolescents: Intervention Optimization in Preparation for Implementation Study

基于初级保健的青少年抑郁症预防：实施研究准备中的干预优化

• 批准号: 10308543
• 负责人: TRACY G GLADSTONE
• 金额: $ 73.56万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10308543
• 关键词: 18 year old; Address; Adolescence; Adolescent; Adult; Advisory Committees; Affect; Behavioral; Cells; Characteristics; China; Clinical Trials; Clinical Trials Design; Cognitive; Cognitive Therapy; Communities; Complex; Depressive disorder; Developed Countries; Diagnosis; Disease; Dose; Dropout; Family; Health Status; Health system; Healthcare; Healthcare Systems; High School Student; Intervention; Mediating; Mediator of activation protein; Mental Depression; Minor; Modeling; Mood Disorders; Morbidity - disease rate; National Institute of Mental Health; Outcome; PF4 Gene; Parents; Participant; Phase; Preparation; Prevention; Preventive; Preventive service; Primary Health Care; Public Health; Randomized; Randomized Clinical Trials; Recommendation; Research Design; Resources; Risk; Rural; Site; Symptoms; Technology; Testing; Time; Trauma; United States; Vaccines; Work; Youth; associated symptom; base; collaboratory; cost; depression prevention; depressive symptoms; design; efficacy trial; experience; follow-up; functional status; geographic population; high risk; high risk population; implementation determinants; implementation study; implementation trial; improved outcome; indicated prevention; interpersonal therapy; mental disorder prevention; model design; mortality; multiphase optimization strategy; peer; population based; preservation; prevent; preventive intervention; programs; protective factors; psychologic; recruit; resilience; rumination; satisfaction; single episode major depressive disorder; suburb; vaccine efficacy

With more than 13% of adolescents diagnosed with depressive disorders each year, prevention of depressive disorders has become a key priority for the NIMH. Unfortunately, we have no widely available interventions to reduce morbidity and mortality (e.g. public health impact). To address this need, we developed a multi-health system “collaboratory” to develop and evaluate the primary care based-technology “behavioral vaccine,” Competent Adulthood Transition with Cognitive-Behavioral Humanistic and Interpersonal Therapy (CATCH-IT) (14 adolescent, 4 parent modules). Using this health-system collaboratory model, CATCH-IT demonstrated evidence of efficacy in prevention of depressive episodes in phase-three clinical trials in the United States and China. However, like many “package” interventions, CATCH-IT became larger and more complex across efficacy trials. Thus, adolescents and parents were less willing to complete all 18 modules, suggesting adolescent dose “tolerability” issues (e.g. satisfaction, acceptability and resource use, “time as cost”). Similarly, primary care practices have “scalability” challenges (acceptability, feasibility, resource use, cost), resulting in declining REACH (percent of at-risk youth who complete intervention). To prepare for implementation studies and dissemination, we need to address adolescent tolerability and practice/health system scalability, while preserving efficacy. Multiphase Optimization Strategy (MOST) uses a systematic analytic approach and a factorial randomized clinical trial design to address efficacy, tolerability, and scalability, simultaneously. We will use a MOST approach to optimize CATCH-IT for the prevention of depression (indicated prevention, i.e., elevated symptoms of depression) in practices and health systems representative of US geography and population. The theoretically grounded components of CATCH-IT selected for study and optimization are: behavioral activation, cognitive therapy, interpersonal psychotherapy, and parent program. We will use a 4-factor (2x2x2x2) fully crossed factorial design with N=16 cells (20 per cell, 15% dropout) to evaluate the contribution of each component. We propose to randomize N=378 (N=189) from each health system site. The at-risk youth will be high school students 13 through 18 years old, not currently experiencing a mood disorder, but with subsyndromal symptoms of depression (moderate to high risk). Using the efficient factorial design, we can assess the contribution to prevention efficacy of each component. Thus, the MOST study design will enable us to eliminate non-contributing components while preserving efficacy and to optimize CATCH-IT by strengthening tolerability and scalability by reducing “resource use.” By reducing resource use, we anticipate satisfaction and acceptability will also increase, preparing the way for an implementation trial and eventual US Preventive Services Task Force endorsement to support dissemination. Thus, our primary question is whether one component, or perhaps two, can demonstrate an equivalent effect to combinations of other components in terms of efficacy, whilst also demonstrating superior adolescent/family tolerability scalability over a 12-month follow-up.

每年有超过13%的青少年被诊断患有抑郁症， 疾病已经成为NIMH的一个关键优先事项。不幸的是，我们没有广泛可用的干预措施， 降低发病率和死亡率（例如对公共卫生的影响）。为了满足这一需求，我们开发了一个多健康 系统“合作实验室”，以开发和评估基于初级保健技术的“行为疫苗”， 胜任成人过渡与认知行为人文和人际关系治疗（CATCH-IT） (14青少年，4个家长模块）。CATCH-IT利用这一卫生系统合作实验室模型， 在美国进行的三期临床试验中， 中国然而，与许多“一揽子”干预措施一样，CATCH-IT在疗效方面变得更大、更复杂。 审判因此，青少年和父母不太愿意完成所有18个模块，这表明青少年剂量 “耐受性”问题（如满意度、可接受性和资源使用、“时间即成本”）。同样，初级保健 实践具有“可扩展性”挑战（可接受性、可行性、资源使用、成本），导致 REACH（完成干预的高危青年百分比）。筹备实施研究， 传播，我们需要解决青少年的耐受性和实践/卫生系统的可扩展性，同时保持 功效多阶段优化策略（MOST）使用系统分析方法和阶乘 随机临床试验设计，同时解决疗效，耐受性和可扩展性。我们将使用一个 优化CATCH-IT预防抑郁症的MOST方法（指示性预防，即，升高 抑郁症的症状）的做法和卫生系统代表美国的地理和人口。的 选择用于研究和优化的CATCH-IT的理论基础组件是：行为激活， 认知疗法，人际心理疗法，和家长计划。我们将完全使用4因子（2x2 x2 x2） 交叉析因设计，N=16个细胞（每个细胞20个，15%脱落），以评价每个细胞的贡献 成分我们建议从每个卫生系统站点随机分配N=378（N=189）。高危青少年将 高中学生13至18岁，目前没有经历情绪障碍，但有亚综合征 抑郁症状（中度至高度风险）。使用有效析因设计，我们可以评估 每个组成部分对预防效力的贡献。因此，MOST研究设计将使我们能够消除 非贡献成分，同时保持疗效，并通过增强耐受性来优化CATCH-IT 和可伸缩性，减少“资源使用”。通过减少资源使用，我们预期满意度和可接受性 也将增加，为实施试验和最终的美国预防服务工作组做好准备 支持传播。因此，我们的主要问题是，是否有一个组成部分，或者也许 第二，就功效而言，可以证明与其他组分的组合具有等同的效果，同时还 在12个月的随访中显示出上级青少年/家庭耐受性的可扩展性。