Antidepressant & CBT for Insomnia to Depression Outcome

描述(由申请人提供)： 背景：拟议的探索性/发展性R21赠款的目的是试行抗抑郁药物和认知行为疗法联合治疗失眠(CBTi)的抑郁症患者，这些患者有启动和/或维持睡眠的伴随困难。建议的联合治疗针对的是患者的失眠，因为这种常见的抑郁症状通常与标准治疗的不利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抑郁症患者对急性治疗(12周)的反应，与对照治疗相比，患者的缓解率和缓解时间；2)测试拟议的西酞普兰+CBTI干预措施是否通过降低参与者在6个月随访期内的复发比例(相对于对照治疗)来提高长期结果。 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或有效的安慰剂失眠心理疗法的急性治疗。在急性治疗阶段结束后，对参与者进行为期6个月的随访。参与者将在第一个月的后续行动中过渡到社区护理。 参与者：参与者为58名年龄在18岁至65岁之间的男性和女性，他们1)符合DSM-IV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(入睡潜伏期30分钟)和/或维持睡眠(入睡后每晚30分钟醒来，每周至少3晚)，通过一周的睡眠日记记录得到确认。参与者还必须满足所有研究排除标准。样本的种族分布将代表旧金山湾区的种族分布。与抑郁症的情况一样，女性与男性的比例预计为2：1。 主要结果测量(S)：主要结果测量是HRSD和SCIDIV的抑郁部分，在基线、急性期的1、2、4、8和12周末，以及随访阶段的1、2、3和6个月末进行。其他重要的衡量标准包括Beck抑郁症清单(每周)、睡眠测量(每周的日记和手腕活动监测器)以及提供者和患者的期望、依从性和遵从性的测量。 预期结果：我们假设，与接受西酞普兰和安慰剂心理疗法治疗失眠的患者组相比，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应答率更高，而在随访期间的复发率更低。这项研究将评估两种治疗方法组合的可行性和可接受性，并将提供效果大小和流失率的估计。拟议的试点研究的结果将为随后的全面随机对照试验的设计提供参考。

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.