Cognitive Behavioral Therapy Vs. Light Therapy for Preventing SAD Recurrence

描述（由申请人提供）：季节性情感障碍（SAD）是复发性抑郁症的一种亚型，涉及秋季和/或冬季的重度抑郁发作，在春季缓解。据估计，SAD影响了美国5%的人口。S.美国人口超过1450万。SAD管理中的中心公共卫生挑战是预防冬季抑郁症复发。已确立的最佳治疗方法是光疗法，可缓解53% SAD病例的急性症状。然而，长期遵守临床实践指南，建议从首次症状发作到每年秋冬季节的自发春季缓解期间每天使用灯箱。需要具有持久效果的有时限的替代治疗，以防止这些致残症状每年复发。我们的初步研究表明，一种新的，SAD量身定制的认知行为疗法（CBT）可能是有效的光疗法单独治疗急性SAD和CBT可能有上级结果在明年冬天光疗法。在研究治疗的最初冬季之后的下一个全新的冬季期间，随机分配到CBT（5.8%）或CBT联合光疗（5.2%）的参与者中抑郁复发的比例显著低于随机分配到单独光疗的参与者（39.2%）。作为干预研究的下一步，拟议项目的主要目的是进一步测试我们的CBT对SAD干预的有效性，在意向治疗（ITT）分析中使用所有随机参与者对下一个冬季结果进行更大，更明确的随机头对头比较。该项目旨在测试CBT和光疗在下一个冬天（主要结果）抑郁症复发方面的临床意义差异，从而有可能影响临床实践。 拟议的工作将在四个方面超越我们的试点研究：（1）这项研究将通过放宽纳入/排除标准以允许共病诊断，并通过证明培训经验丰富的社区治疗师以促进CBT组的可行性，来增强我们先前试点研究数据的普遍性。(2)我们将前瞻性地跟踪复发和可能影响结果的潜在干预变量（例如，新治疗，夏季缓解状态）。(3)本研究包括第二次年度冬季随访，以获得研究治疗最初冬季后两个冬季CBT与LT比较效果的初步数据。(4)我们将研究潜在的调节剂如何影响CBT与LT的效果，包括人口统计学变量;基线特征（例如，抑郁严重程度，合并症）;以及在此期间完全或不完全的夏季缓解状态。如果成功，这项工作将开发一种新的治疗方法，对预防冬季抑郁症具有重要的公共卫生意义。

DESCRIPTION (provided by applicant): Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. SAD affects an estimated 5% of the U. S. population, over 14.5 million Americans. The central public health challenge in the management of SAD is prevention of winter depression recurrence. The established and best available treatment, light therapy, remits acute symptoms in 53% of SAD cases. However, long-term compliance with clinical practice guidelines recommending daily use of a light box from onset of first symptom through spontaneous springtime remission during every fall/winter season is poor. Time-limited alternative treatments with durable effects are needed to prevent the annual recurrence of these disabling symptoms. Our preliminary studies suggest that a novel, SAD-tailored cognitive-behavioral therapy (CBT) may be as efficacious as light therapy alone for acute SAD treatment and that CBT may have superior outcomes to light therapy during the next winter. During the next wholly new winter season following the initial winter of study treatment, the proportion of depression recurrences was significantly smaller in participants randomized to CBT (5.8%) or to CBT combined with light therapy (5.2%) than in participants randomized to light therapy alone (39.2%). As the next step in this programmatic line of intervention studies, the primary aim of the proposed project is to further test the efficacy of our CBT for SAD intervention against light therapy in a larger, more definitive randomized head-to-head comparison on next winter outcomes in an intent-to-treat (ITT) analysis using all randomized participants. This project is seeking to test for a clinically meaningful difference between CBT and light therapy on depression recurrence in the next winter (the primary outcome), thereby having the potential to impact clinical practice. The proposed work will go beyond our pilot studies in four ways: (1) This study will augment the generalizability of our prior pilot study data by relaxing the inclusion/exclusion criteria to allow for comorbid diagnoses and by demonstrating the feasibility of training experienced community therapists to facilitate the CBT groups. (2) We will prospectively track recurrences and potential intervening variables that could affect outcome (e.g., new treatments, summer remission status) in the interim between treatment endpoint and the following winter. (3) This study includes a second annual winter follow-up to obtain preliminary data on the comparative effects of CBT vs. LT two winters after the initial winter of study treatment. (4) We will examine how potential modifiers influence the effects of CBT vs. LT, including demographic variables; baseline characteristics (e.g., depression severity, comorbidity); and complete or incomplete summer remission status in the interim. If successful, this work will develop a novel treatment with important public health implications for winter depression prevention.