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

每年有超过13%的青少年被诊断为抑郁障碍，预防抑郁 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来 减少发病率和死亡率(例如对公共健康的影响)。为了满足这一需求，我们开发了一种多健康 开发和评估以初级保健为基础的技术“行为疫苗”的系统“协作”， 通过认知-行为人本主义和人际治疗(Catch-IT)实现合格的成年过渡 (14名青少年，4名家长模块)。使用该医疗系统协作模型，Catch-IT演示了 美国第三阶段临床试验中预防抑郁发作有效性的证据 中国。然而，像许多“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 “容忍度”问题(例如，满意度、可接受性和资源使用、“时间作为成本”)。同样，初级保健 实践存在“可伸缩性”挑战(可接受性、可行性、资源使用、成本)，导致下降 覆盖范围(完成干预的高危青年的百分比)。为实施研究做准备，并 在传播方面，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因素 随机临床试验设计，同时解决疗效、耐受性和可扩展性问题。我们将使用 用于预防抑郁症的优化捕获信息技术的MOST方法(指示预防，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。这个 选择用于研究和优化的Catch-IT的理论上的基础组件是：行为激活， 认知治疗、人际心理治疗和家长计划。我们将完全使用四因素(2x2x2x2) N=16个单元格(每个单元格20个，15%辍学)的交叉析因设计，以评估每个单元格的贡献 组件。我们建议从每个卫生系统站点随机抽取N=378(N=189)。处于危险中的年轻人将是 13至18岁的高中生，目前没有经历情绪障碍，但患有亚综合征 抑郁症状(中度至高度危险)。使用有效的析因设计，我们可以评估 每种成分对预防效果的贡献。因此，研究最多的设计将使我们能够消除 在保持有效性的同时保持非贡献组件，并通过增强耐受性来优化Catch-IT 和可伸缩性，通过减少“资源使用”。通过减少资源使用，我们期望获得满意度和可接受性 也将增加，为实施试验和最终美国预防服务工作组铺平道路 背书以支持传播。因此，我们的主要问题是，是否有一个组件，或者也许 第二，在功效方面，可以表现出与其他成分的组合相同的效果，同时还 在12个月的随访中表现出卓越的青少年/家庭耐受性和可扩展性。

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.