2/3-Improving Depression Outcome by Adding CBT for Insomnia to Antidepressants

描述（由申请方提供）：拟议研究的目的是通过结合最先进的抗抑郁算法（MED）和经验支持的失眠症认知行为治疗（CBTI），改善重度抑郁症和共病失眠患者的抑郁结局。抑郁症是抑郁症的一个重要方面，现有的治疗方法只能不完全解决。由于持续性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普遍指标，因此确定更有效的治疗抑郁症患者失眠的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，将测试所提出的策略在患有重度抑郁症和共病失眠症的个体中的疗效。主要目的是测试与对照干预相比，拟议的干预措施是否会增加16周治疗后抑郁症的缓解率。次要目的是测试相对于对照治疗，拟议的干预措施是否通过降低6个月随访期间复发的参与者比例来增强长期结局。受试者为300名男性和女性，来自3个研究中心，因此样本在人种和种族方面具有多样性。受试者将符合DSM-IV重度抑郁症标准，17项汉密尔顿抑郁评定量表（HRSD）评分为18分或更高，并且难以启动或维持具有临床意义的睡眠（DSM-IV失眠标准）。急性治疗期结束后，参与者将过渡到社区护理，并将接受6个月的随访。主要结局指标是HRSD和SCID-IV的抑郁部分，由设盲的评估者在基线时、急性期每两周一次和随访期每月一次进行评估。次要指标包括睡眠和功能结果。相关性：实现和维持缓解是MDD的预期临床目标。通过评估标准化抗抑郁药物治疗与针对失眠症的非药物治疗（CBTI）相结合的治疗策略的疗效，拟议的研究可能会导致许多MDD和失眠症患者的生活出现具有临床意义的改善。抑郁症是抑郁症患者的常见问题，与抑郁症治疗反应差、抑郁症复发和自杀风险增加有关。这项研究将检查失眠症的特定心理行为治疗，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症患者的预后。这项研究的结果可能会提供一种方法来改善治疗抑郁症，而无需使用额外的药物。

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.