Cognitive Behavioral Therapy Vs. Light Therapy for Preventing SAD Recurrence

描述(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，在春季缓解的秋季和/或冬季期间会出现严重的抑郁发作。据估计，美国有5%的人口受到SAD的影响，超过1,450万美国人。管理SAD的中心公共卫生挑战是防止冬季抑郁症复发。在53%的SAD病例中，公认的和最好的治疗方法--光疗法--缓解了急性症状。然而，长期遵守临床实践指南的建议，即在每个秋/冬季节从第一次症状出现到春季自发缓解期间每天使用灯箱的情况很差。需要具有持久效果的有时间限制的替代治疗，以防止这些致残症状每年再次出现。我们的初步研究表明，一种针对SAD量身定做的新型认知行为疗法(CBT)对急性SAD的治疗可能与光疗法一样有效，而且CBT在明年冬天可能会有比光疗法更好的结果。在研究治疗开始后的下一个全新的冬季，随机接受CBT(5.8%)或CBT联合光疗(5.2%)的参与者抑郁复发的比例明显低于随机接受光疗的参与者(39.2%)。作为这一干预研究计划性路线的下一步，拟议项目的主要目标是通过使用所有随机参与者的意向治疗(ITT)分析，通过更大、更明确的面对面随机比较，进一步测试我们的CBT对SAD干预相对于光疗法的有效性。该项目正在寻求测试CBT和光线疗法在明年冬天抑郁症复发方面的临床意义差异(主要结果)，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/排除标准以允许合并诊断，并展示培训经验丰富的社区治疗师以促进CBT小组的可行性，从而增强我们先前试点研究数据的概括性。(2)我们将前瞻性地跟踪在治疗终点和下一个冬季之间的过渡期间可能影响结果的复发和潜在的干预变量(例如，新的治疗方法、夏季缓解状况)。(3)本研究包括第二次冬季随访，以获得CBT和LT在研究治疗开始冬季后两个冬季的比较效果的初步数据。(4)我们将研究潜在的修饰物如何影响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)；以及在过渡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，对冬季抑郁症的预防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.