Antidepressant & CBT for Insomnia to Depression Outcome

描述（由申请人提供）： 内容：拟议的探索性/发展性R21补助金的目的是在伴有难以启动和/或维持睡眠的抑郁症患者中进行抗抑郁药物和失眠认知行为疗法（CBTi）的联合治疗的试点测试。所提出的联合方法针对患者的失眠，因为这种常见的抑郁症状通常与标准治疗的不良结果和复发风险增加有关。 具体目标：1）测试拟议的干预措施是否改善了对急性治疗的反应（12周），测量相对于对照治疗缓解的患者百分比和缓解的时间过程; 2）为了测试拟议的西酞普兰+ CBTI干预是否通过减少6个月随访期间复发的参与者比例来增强长期结果，相对于对照治疗。 研究设计和方法：在这项前瞻性、随机、对照研究中，参与者将随机接受为期12周的SSRI西酞普兰加CBTI或经验证的安慰剂失眠心理疗法的急性治疗。受试者将在急性治疗期结束后随访6个月。参与者将在第一个随访月期间过渡到社区护理。 参会人员：参与者将是58名年龄在18到65岁之间的男性和女性，他们1）符合DSM-IV的重度抑郁症标准; 2）在24项汉密尔顿抑郁评定量表（HRSD）的前17项中得分大于或等于14;（3）难以入睡（睡眠开始潜伏期> 30分钟）和/或维持睡眠（睡眠发作后醒来>每晚30分钟，每周至少3个晚上），通过一周的睡眠日记记录来确认。参与者还必须符合所有研究排除标准。样本的种族分布将代表旧金山弗朗西斯科湾区的种族分布。妇女与男子的比例预计为2：1，抑郁症也是如此。 主要结局指标：主要结局指标是HRSD和SCIDIV的抑郁部分，将在基线、急性期第1、2、4、8和12周结束时以及随访期第1、2、3和6个月结束时进行。其他重要的测量包括贝克抑郁量表（每周），睡眠测量（日记和手腕活动监测器，每周）以及提供者和患者期望，依从性和依从性的测量。 预期结果：我们假设，与接受西酞普兰和安慰剂心理治疗的失眠患者相比，接受西酞普兰和CBTI联合治疗的患者在急性治疗后的缓解率和部分缓解率较高，随访期间的复发率较低。本研究将评估两种治疗联合的可行性和可接受性，并将提供效应量和损耗率的估计值。拟议的试点研究的结果将为后续全规模随机对照试验的设计提供信息。

DESCRIPTION (provided by applicant): Context: The purpose of the proposed Exploratory/Developmental R21 Grant is to pilot test a combined treatment of an antidepressant medication and cognitive-behavioral therapy for insomnia (CBTi) in patients with depressive disorders who have concomitant difficulty initiating and/or maintaining sleep. The proposed combined approach targets the patients' insomnia, because this common depression symptom is often associated with less favorable outcome of standard treatment and with increased risk of relapse. Specific aims: 1) To test whether the proposed intervention improves response to acute treatment (12 weeks) for depression, as measured the percent of patients who remit and the time course to remission, relative to the control treatment; 2) To test whether the proposed citalopram + CBTI 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. Research Design and Method: In this prospective, randomized, controlled study, participants will be randomized to receive 12 weeks of acute treatment with the SSRI citalopram plus either CBTI or a validated, placebo psychotherapy for insomnia. Participants will be followed-up for 6 months after the end of acute treatment phase. Participants will be transitioned to community care during the first follow-up month. Participants: Participants will be 58 men and women ages 18 to 65 who 1) meet DSM-IV criteria for Major Depressive Disorder; 2) have a score greater than or equal to14 on the first 17 items of the 24-item Hamilton Depression Rating Scale (HRSD); 3) have difficulty initiating sleep (sleep onset latency > 30 minutes) and/or maintaining sleep (wake after sleep onset > 30 minutes per night at least 3 nights per week), to be confirmed by one week of sleep diary recording. Participants will also have to meet all study exclusion criteria. The ethnic distribution of the sample will be representative of the ethnic distribution in the San Francisco Bay Area. Women-to-men ratio is expected to be 2:1 as it is the case for depression. Main Outcome Measure(s): The primary outcome measures are the HRSD and the depression portion of the SCIDIV, to be administered at baseline, at the end of weeks 1, 2, 4, 8, and 12 of the acute phase, and at the end of 1, 2, 3, and 6 months of the follow-up phase. Other important measures include the Beck Depression Inventory (weekly), measures of sleep (diaries and wrist activity monitors, weekly) and measures of provider and patient expectations, adherence, and compliance. Expected Outcomes: We hypothesize that the group of patients who receive the combination of citalopram and CBTI will have higher remission and partial response rates following acute treatment and lower relapse rates during follow-up as compared to the group that receive citalopram and placebo psychotherapy for insomnia. The study will assess the feasibility and acceptability of the combination of the two treatments and will provide estimates of effect sizes, and attrition rate. The findings from the proposed pilot study will inform the design of a subsequent full-scale randomized controlled trial.