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: 10518396
• 负责人: TRACY G GLADSTONE
• 金额: $ 72.39万
• 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/10518396
• 关键词: 18 year old; Address; Adolescence; Adolescent; Adult; Affect; Behavioral; Cells; Characteristics; China; Clinical Trials; Clinical Trials Design; Cognitive; Cognitive Therapy; Communities; Complex; Depressive disorder; Developed Countries; Diagnosis; Disease; Dose; Dropout; Family; Geographic state; Health Status; Health system; Healthcare; Healthcare Systems; High School Student; Intervention; Mediating; Mediator; Mental Depression; Minor; Modeling; Mood Disorders; Morbidity - disease rate; National Institute of Mental Health; Outcome; PF4 Gene; Parents; Participant; Phase; Population; Preparation; Prevention; Preventive; Primary Care; Public Health; Randomized; Recommendation; Research Design; Resources; Risk; Rural; Selection for Treatments; Site; Symptoms; Technology; Testing; Time; Trauma; United States; United States Preventative Services Task Force; Vaccines; Work; Youth; associated symptom; collaboratory; cost; depression prevention; depressive symptoms; design; efficacy trial; experience; follow-up; functional status; 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; primary care practice; programs; protective factors; psychologic; randomized, clinical trials; recruit; resilience; resilience factor; rumination; satisfaction; single episode major depressive disorder; suburb

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，预防抑郁症 疾病已成为 NIMH 的首要任务。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（例如公共卫生影响）。为了满足这一需求，我们开发了多健康 系统“协作”来开发和评估基于初级保健的技术“行为疫苗”， 通过认知行为人文主义和人际疗法实现成年过渡（CATCH-IT） （14 个青少年模块，4 个家长模块）。利用这种卫生系统协作模型，CATCH-IT 证明了 美国三期临床试验显示其预防抑郁发作的功效证据 中国。然而，与许多“一揽子”干预措施一样，CATCH-IT 在功效方面变得更大、更复杂 试验。因此，青少年和家长不太愿意完成所有 18 个模块，这表明青少年剂量 “容忍度”问题（例如满意度、可接受性和资源使用、“时间即成本”）。同样，初级保健 实践存在“可扩展性”挑战（可接受性、可行性、资源利用、成本），导致 REACH（完成干预的高危青少年百分比）。为实施研究做好准备 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 预防抑郁症的大多数方法（指示性预防，即升高 抑郁症症状）在代表美国地理和人口的实践和卫生系统中。这 选择用于研究和优化的 CATCH-IT 的理论基础组件包括：行为激活、 认知治疗、人际心理治疗和家长计划。我们将完全使用 4 因子 (2x2x2x2) N=16 个单元格的交叉因子设计（每个单元格 20 个，15% 丢失）来评估每个单元格的贡献 成分。我们建议从每个卫生系统站点随机分配 N=378 (N=189)。处于危险中的青少年将 13 至 18 岁的高中生，目前没有情绪障碍，但患有亚综合征 抑郁症症状（中度至高风险）。使用有效的因子设计，我们可以评估 对每个组成部分的预防效力的贡献。因此，MOST 研究设计将使我们能够消除 非贡献成分，同时保持功效并通过增强耐受性来优化 CATCH-IT 通过减少“资源使用”来实现可扩展性。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铺平道路 认可以支持传播。因此，我们的首要问题是是否有一个组件，或者也许 二、可以在功效方面表现出与其他成分的组合相同的效果，同时还可以 在 12 个月的随访中展示了卓越的青少年/家庭耐受性可扩展性。