1/3-Improving Depression Outcome by Adding CBT for Insomnia to Antidepressants

描述（由申请人提供）：本研究的目的是通过结合最先进的抗抑郁算法（MED）和经验支持的失眠认知行为疗法（CBTI），改善重度抑郁症和共病失眠患者的抑郁结局。失眠是抑郁症的一个重要方面，现有的治疗方法只是不完全解决。由于持续失眠既是抑郁症复发的危险因素，也是疾病严重程度和预后不良的更一般的指标，因此确定更有效的抑郁症失眠患者治疗方法具有公共卫生意义。因此，我们提出了一项前瞻性，随机对照研究，以测试所提出的策略在重度抑郁症和合并症失眠患者中的有效性。主要目的是测试与对照干预相比，在16周的治疗后，拟议的干预是否增加了抑郁症的缓解率。第二个目的是测试与对照治疗相比，拟议的干预是否通过减少6个月随访期间复发的参与者比例来提高长期结果。参与者将是来自3个研究地点的300名男性和女性，因此样本在种族和民族方面是多样化的。参与者将符合DSM-IV重度抑郁症的标准，在17项汉密尔顿抑郁评定量表（HRSD）中得分为18分或更高，并且难以开始或维持具有临床意义的睡眠（DSM-IV失眠标准）。急性治疗阶段结束后，参与者将被转移到社区护理，并将随访6个月。主要结局指标是HRSD和SCID-IV的抑郁部分，在基线时由蒙面评分者给予，急性期每两周给予一次，随访期每月给予一次。次要测量包括睡眠和功能结果的测量。相关性：达到并维持缓解是重度抑郁症的理想临床目标。通过评估将标准化抗抑郁药物治疗与针对失眠（CBTI）的非药物治疗相结合的治疗策略的疗效，该研究可能会导致许多重度抑郁症和失眠患者的生活在临床上有意义的改善。失眠是重度抑郁症患者的常见问题，与抑郁症治疗效果差、抑郁症复发和自杀风险增加有关。本研究将检验一种特殊的心理行为治疗失眠，结合最先进的抗抑郁药物治疗，是否能改善重度抑郁症和失眠患者的预后。这项研究的结果可能提供一种方法，以改善治疗重度抑郁症，而不使用额外的药物。

DESCRIPTION (provided by applicant): The purpose of the proposed study is to improve depression outcome for individuals with major depressive disorder and co-morbid insomnia by combining state-of-the-art antidepressant algorithm (MED) and empirically supported cognitive-behavioral therapy for insomnia (CBTI). Insomnia is an important aspect of depression and is only incompletely addressed by existing treatments. As persistent insomnia is both a risk factor for depressive relapse and a more general indicator of disease severity and poor prognosis, identification of more effective therapies for depressed patients with insomnia has public health significance. Therefore, we propose a prospective, randomized controlled study that will test the efficacy of the proposed strategy in individuals with major depressive disorder and comorbid insomnia. The primary aim is to test whether the proposed intervention increases rates of remission from depression following 16 weeks of treatment compared with a control intervention. A secondary aim is to test whether the proposed intervention enhances longer-term outcome by reducing the proportion of participants who relapse during a 6-months follow-up phase, relative to the control treatment. Participants will be 300 men and women, drawn from 3 study sites, so that the sample is diverse with respect to race and ethnicity. Participants will meet DSM-IV criteria for Major Depressive Disorder, score 18 or higher on the 17-item Hamilton Depression Rating Scale (HRSD) and have difficulty initiating or maintaining sleep that is clinically significant (DSM-IV criteria for insomnia). After the end of the acute treatment phase, participants will be transitioned to community care and will be followed-up for 6 months. The primary outcome measures are the HRSD and the depression portion of the SCID-IV, to be administered by masked raters at baseline, biweekly during the acute phase, and monthly during the follow-up phase. Secondary measures include measures of sleep and functional outcome. Relevance: Achieving and maintaining remission is the desired clinical goal for MDD. By evaluating the efficacy of a treatment strategy that combines a standardized antidepressant pharmacotherapy with a non- pharmacological therapy that targets insomnia (CBTI), the proposed study, could lead to clinically meaningful improvement in the lives of many patients with MDD and insomnia. Insomnia is a common problem in patients with major depression, and is associated with poor response to depression treatment, recurrence of depression, and increased risk for suicide. This study will examine whether a specific psychological-behavioral treatment for insomnia, in conjunction with state-of-the-art antidepressant medication treatment, improves the outcomes of patients with major depression and insomnia. The results of this study may offer a method for improving the treatment of major depression without the use of additional medication.