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

描述(申请人提供)：拟议研究的目的是通过结合最先进的抗抑郁算法(MED)和经验支持的失眠认知行为疗法(CBTI)来改善患有严重抑郁障碍和共病失眠的患者的抑郁结局。失眠是抑郁症的一个重要方面，只有现有的治疗方法才能完全解决这一问题。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一般指标，因此确定更有效的治疗抑郁症失眠患者的方法具有公共卫生意义。因此，我们提出了一项前瞻性的随机对照研究，将测试所提出的策略在患有严重抑郁障碍和共病失眠的个体中的有效性。主要目的是测试拟议的干预措施与对照干预措施相比，是否提高了16周治疗后抑郁症的缓解率。第二个目标是测试拟议的干预是否通过减少参与者在6个月随访阶段相对于对照治疗的复发比例来提高长期结果。参与者将是300名男性和女性，他们来自3个研究地点，因此样本在种族和民族方面是多样化的。参与者将达到严重抑郁障碍的DSM-IV标准，在17项汉密尔顿抑郁评定量表(HRSD)上得18分或更高，并难以开始或维持具有临床意义的睡眠(DSM-IV失眠标准)。在急性治疗阶段结束后，参与者将过渡到社区护理，并将被跟踪6个月。主要的结果衡量标准是HRSD和SCID-IV的抑郁部分，由蒙面评分员在基线、急性期每两周一次、后续阶段每月一次进行评估。次要措施包括睡眠和功能结果的衡量。相关性：实现并维持缓解是MDD的理想临床目标。通过评估标准化抗抑郁药物疗法与针对失眠的非药物疗法(CBTI)相结合的治疗策略的有效性，拟议的研究可能会对许多MDD和失眠患者的生活带来临床上有意义的改善。失眠是重度抑郁症患者的常见问题，与抑郁症治疗反应差、抑郁症复发和自杀风险增加有关。这项研究将检验针对失眠的特定心理行为治疗，结合最先进的抗抑郁药物治疗，是否可以改善患有严重抑郁症和失眠的患者的结果。这项研究的结果可能会为改善重度抑郁症的治疗提供一种方法，而不需要使用额外的药物。

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.