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

1/3-通过在抗抑郁药中添加治疗失眠的 CBT 来改善抑郁症的结果

基本信息

批准号：
7808910
负责人：
RACHEL MANBER
金额：
$ 59.37万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-06-01 至 2014-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7808910
关键词：
Academy Acute Address Adherence Administrative Coordination Adverse event Affect Aging Algorithms American Antidepressive Agents Applications Grants Archives Attention Authorization documentation Behavior Therapy Behavioral Caring Charge Chronic Clinic Clinical Clinical Trials Cognitive Cognitive Therapy Communication Communities Comorbid Insomnia Conduct Clinical Trials Contracts Control Groups DSM-IV Data Data Analyses Data Collection Data Coordinating Center Data Reporting Databases Depressed mood Diagnostic Direct Costs Discipline Disease Disease remission Doctor of Medicine Doctor of Philosophy Early identification Early treatment Electronic Mail Elements Eligibility Determination Enrollment Ensure Equilibrium Equipment Escitalopram Ethnic Origin Event Failure Fostering Goals Grant Guidelines Hamilton Rating Scale for Depression Healthcare Systems Human Resources Individual Institution International Internet Intervention Interviewer Joints Lead Leadership Letters Longitudinal Studies Major Depressive Disorder Manuals Masks Measurement Measures Medical Medicine Mental Depression Methods Monitor Nerve Ophthalmology Outcome Outcome Measure Oxalates Participant Patients Pennsylvania Pharmaceutical Preparations Pharmacotherapy Phase Pilot Projects Placebos Population Preparation Primary Insomnia Principal Investigator Protocols documentation Psychiatry Psychological desensitization therapy Psychotherapy Public Health Publications Quality of life Race Randomized Controlled Trials Recruitment Activity Recurrence Relapse Relative (related person)Reporting Research Research Infrastructure Research Personnel Research Proposals Residual state Resolution Risk Factors Role Safety Sample Size Sampling Schedule Screening procedure Seminal Severities Severity of illness Site Sleep Sleep Disorders Sleeplessness Supervision Survival Analysis Symptoms Telephone Testing Time Training Treatment outcome Universities Voting Woman Work actigraphy alternative treatment base clinical research site clinically significant cost data integrity data management depressive symptoms design disability effective therapy efficacy testing experience follow-up functional outcomes hypnotic improved meetings men multi-site trial neurosurgery novel strategies operation outcome forecast primary outcome programs prospective psychologic response suicidal risk symposium transmission process treatment duration treatment strategy web site

项目摘要

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.

描述（由申请人提供）：拟议的研究的目的是通过结合最先进的抗抑郁药（MED）并经验支持的认知 - 行为疗法（CBTI）来改善重度抑郁症和合并症患者的抑郁症结果。失眠是抑郁症的重要方面，只有现有治疗方法才能完全解决。由于持续性失眠既是抑郁复发的危险因素，又是疾病严重程度和预后不良的更普遍的指标，因此对失眠症患者的抑郁症患者更有效的疗法具有公共健康意义。因此，我们提出了一项前瞻性，随机对照的研究，该研究将测试所提出的策略在重度抑郁症和合并症患者中的功效。与对照干预相比，主要目的是测试拟议的干预措施在治疗16周后是否会增加抑郁症的缓解率。第二个目的是测试所提出的干预措施是否通过减少相对于对照治疗的6个月随访阶段中复发的参与者的比例来增强长期结局。参与者将是300名男性和女性，这些男女来自3个研究地点，因此在种族和种族方面样本是多种多样的。参与者将符合主要抑郁症的DSM-IV标准，在17个项目的汉密尔顿抑郁评分量表（HRSD）上得分18或更高，并且难以发起或保持临床意义的睡眠（DSM-IV缺陷标准）。急性治疗阶段结束后，参与者将过渡到社区护理，并将进行6个月的跟进。主要结果指标是SCID-IV的HRSD和抑郁部分，由蒙面的评估者在基线时，在急性阶段每两周进行，在随访阶段每月一次。次要措施包括睡眠和功能结果的度量。相关性：实现和维持缓解是MDD所需的临床目标。拟议的研究通过评估将标准化抗抑郁药疗法与靶向失眠症（CBTI）的非药理治疗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具有临床意义的改善。失眠是严重抑郁症患者的常见问题，与对抑郁症治疗，抑郁症复发和自杀风险增加的反应不佳有关。这项研究将研究特定的心理行为治疗失眠症是否与最先进的抗抑郁药治疗相结合，改善了严重抑郁症和失眠症患者的结局。这项研究的结果可能提供了一种方法，可以改善重大抑郁症的治疗，而无需使用其他药物。