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

基本信息

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
项目类别：
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

项目摘要

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％的青少年被诊断出患有抑郁症，预防抑郁症疾病已成为NIMH的关键优先事项。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，公共卫生影响）。为了满足这一需求，我们开发了多种健康系统“协作”以开发和评估基于初级保健技术的“行为疫苗”，通过认知行为人文主义和人际疗法（catch-it）的胜任成年过渡（14个青少年，4个父模块）。使用此健康系统协作模型，Catch-It证明了在美国的第三阶段临床试验中预防抑郁发作效率的证据中国。但是，像许多“包装”干预措施一样，Catch-IT在效率上变得更大，更复杂试验。那是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 “容忍性”问题（例如，满意度，可接受性和资源使用，“时间为成本”）。同样，初级保健实践面临“可伸缩性”挑战（可接受性，可行性，资源使用，成本），导致下降达到（完成干预的高危青年百分比）。为实施研究做准备传播，我们需要解决青少年的耐受性和实践/卫生系统的可伸缩性，同时保持效率。多相优化策略（大多数）使用系统的分析方法和阶乘简单地解决效率，耐受性和可伸缩性的随机临床试验设计。我们将使用一个大多数优化捕获的方法以预防抑郁症（指示的预防，即提高抑郁症状）在代表美国地理和人口的实践和卫生系统中。这理论上选择用于研究和优化的Catchit的组成部分是：行为激活，认知疗法，人际心理治疗和父母计划。我们将完全使用4因子（2x2x2x2） n = 16个单元格（每个细胞20，15％辍学）的跨阶乘设计，以评估每个细胞的贡献成分。我们建议从每个卫生系统站点中随机化n = 378（n = 189）。处于危险的青年将是高中生13至18岁，目前尚未患有情绪障碍，而是次龙族抑郁症状（中度至高风险）。使用高效的阶乘设计，我们可以评估对每个组件的预防效率的贡献。这是研究最多的设计，使我们能够消除非限制组件，同时保持效率并通过增强耐受性来优化捕获和可扩展性通过减少“资源使用”。通过减少资源的使用，我们预计满意和可接受性还将增加，为实施试验和最终的美国预防服务工作组做准备认可以支持传播。那是我们的主要问题是一个组件，还是第二，在效率方面可以证明与其他组件的组合相同的效果在12个月的随访中证明了上山/家庭的耐受性可伸缩性。