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

描述（由申请人提供）：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）来改善患有重度抑郁症和共病失眠的个体的抑郁结果。失眠是抑郁症的一个重要方面，现有的治疗方法无法完全解决失眠问题。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不良预后的更普遍指标，因此为抑郁症失眠患者确定更有效的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，将测试所提出的策略对患有重度抑郁症和共病失眠的个体的有效性。主要目的是测试与对照干预相比，在 16 周的治疗后，所提出的干预措施是否会提高抑郁症的缓解率。第二个目的是测试所提出的干预措施是否通过减少 6 个月随访阶段复发的参与者比例（相对于对照治疗）来增强长期结果。参与者将包括来自 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具有多样性。参与者将符合 DSM-IV 重度抑郁症标准，在 17 项汉密尔顿抑郁评定量表 (HRSD) 上得分 18 或更高，并且难以开始或维持有临床意义的睡眠（DSM-IV 失眠标准）。急性治疗阶段结束后，参与者将转入社区护理，并接受 6 个月的随访。主要结局指标是 HRSD 和 SCID-IV 的抑郁部分，由匿名评估者在基线、急性期每两周一次、随访阶段每月一次进行管理。次要测量包括睡眠和功能结果的测量。相关性：实现并维持缓解是 MDD 的理想临床目标。通过评估将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疗效，拟议的研究可能会为许多患有 MDD 和失眠的患者带来临床上有意义的生活改善。失眠是重度抑郁症患者的常见问题，与抑郁症治疗反应不佳、抑郁症复发和自杀风险增加有关。这项研究将探讨针对失眠的特定心理行为治疗与最先进的抗抑郁药物治疗相结合是否可以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无需使用额外药物即可改善重度抑郁症治疗的方法。

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.