Is Insomnia a Modifiable Risk Factor for MDD?

描述（由申请人提供）：最近的研究表明，失眠可能是重性抑郁症（MDD）的一个脆弱因素。这些发现表明，如果复发性MDD的缓解患者接受失眠治疗，这种干预可能会预防或延迟复发/复发，或至少减少后续发作的强度。我们建议评估这一假设进行了初步研究的行为治疗失眠缓解复发性抑郁症患者的临床过程中的影响。 具体来说，我们建议将45例复发性抑郁症缓解患者随机分配到两个条件之一，即失眠行为治疗组（n=30）或合同对照监测组（n=15），选择行为治疗，因为这种治疗方式已证明对失眠有效，但不太可能有直接的抗抑郁作用。 在治疗开始前（3-4周）、活性治疗期间（8周）和长达33个月的时间内，将每周监测一次睡眠和抑郁症状。监测将要求受试者完成每日睡眠日记、每周贝克抑郁量表（BDI）和每月临床访谈。BDI将用于确定受试者何时表现出抑郁症状恶化，并将作为临床评价的提示，以确定是否有复发/再发。每周日记将用于确定1）失眠治疗的急性效应，2）行为干预的长期疗效，以及3）睡眠相关主诉是前驱至新发发作的程度。每月访谈将用于监测和确认临床状态。此外，将在治疗前后采集多导睡眠图（PSG）数据。这些数据将用于排除隐匿性睡眠障碍（例如，睡眠呼吸暂停和PLM），客观评估治疗前后失眠症状的严重程度，并初步探索睡眠结构变量（例如，减少的REM潜伏期）独立预测治疗结果、临床过程和/或这些测量如何与自我报告睡眠连续性测量相互作用的程度。 假设对MDD缓解患者的失眠进行行为治疗将与缓解期间抑郁症状减少、缓解期延长、新发发作严重程度降低以及对复发发作治疗的反应更好相关。将使用这些假设的数据计算效应量并进行把握度估计。 如果这些分析提供了良好的可行性数据，则将用作R 01级应用的基础。最终，如果这些假设中的一个或多个在更大的随访研究中得到证实，这将强烈表明：1）失眠的CBT可能是管理复发性MDD的重要策略; 2）失眠不仅是MDD的症状，也是疾病发展的一个因素。

DESCRIPTION (provided by applicant): Recent studies have shown that insomnia may represent a vulnerability factor for Major Depression (MDD). These findings suggest that if remitted patients with recurrent MDD received treatment for their insomnia, this intervention might prevent or delay relapse/recurrence, or at least diminish the intensity of subsequent episodes. We propose to evaluate this hypothesis by undertaking a preliminary study on the effects of Behavioral treatment for insomnia on the clinical course of patients with remitted recurrent MDD. Specifically, we propose to randomly assign 45 patients with remitted recurrent Major Depression to one of two conditions behavioral treatment for insomnia (n=30) or to a contract control monitor only group (n=15) behavior therapy was selected because this treatment modality has demonstrated efficacy with respect to insomnia yet is not likely to have direct antidepressant effects. Sleep and depression symptoms will be monitored on a weekly basis prior to treatment initiation (3-4 weeks), during active treatment (8 weeks), and for a period of up to 33 months. Monitoring will require that subjects complete daily sleep diaries, weekly Beck Depression Inventories (BDI), and monthly clinical interviews. The BDI will be used to ascertain when subjects exhibit a worsening of their depressive symptoms and will serve as a prompt for a clinical evaluation to determine whether there has been a relapse/recurrence. Weekly diaries will be used to determine 1) the acute effects of the insomnia treatment, 2) the long term efficacy of the behavioral intervention, and 3) the extent to which sleep related complaints are prodromal to new onset episodes. Monthly interviews will be used to monitor and confirm clinical state. In addition, polysomnographic (PSG) data will be acquired prior to and following treatment. These data will be used to rule out occult sleep disorders (e.g., sleep apnea and PLMs), to objectively assess severity of insomnia symptoms prior to and following treatment, and to explore, in a preliminary way, the extent to which sleep architecture variables (e.g. reduced REM latency) independently predict treatment outcome, clinical course, and/or how these measures interact with self report sleep continuity measures. It is hypothesized that behavioral treatment for insomnia in patients with remitted MDD will be associated with less depressive symptomatology during remission, longer periods of remission, less severe new onset episodes and better responses to treatment for recurrent episodes Data for each of these hypotheses will be used to calculate effect sizes and to conduct power estimates. These analyses, if they provide good feasibility data, will be used as the foundation for a R01 level application. Ultimately, If one or more of these hypotheses are borne out in the larger follow up study, this will strongly suggest that 1) CBT for insomnia may be an important strategy for the management of recurrent MDD, and 2) insomnia is not only a symptom of MDD, but also a factor in the development of the disease.