The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse

描述（由申请人提供）： 酗酒和失眠在退伍军人中非常普遍。据估计，酗酒发生在大约6.4%的退伍军人。最近估计，OIF退伍军人滥用酒精的比例为11.8%，OEF/OIF男性退伍军人为21.8%。据估计，大约28%的现役军人（来自千年队列研究）和高达77%的退伍军人在VHA初级保健中出现临床显著的失眠水平。失眠在从酒精中毒中恢复的患者中也非常普遍，多达70%的此类患者抱怨睡眠开始和/或维持问题。这些流行率比一般人口高2-7倍。失眠的直接后果包括嗜睡、疲劳、易怒、工作表现下降和人际交往功能受损。失眠的长期后遗症包括新发和复发性精神疾病的风险，以及在酒精中毒的情况下，酒精中毒的强度更大，戒酒者复发的风险增加。目前，有9项研究评估失眠是否是酒精中毒复发的可改变的风险因素（2项研究曲唑酮，3项研究加巴喷丁，1项研究雷美替酮，3项研究失眠的认知行为疗法的改良形式[CBT-I]）。这些研究的结果是可变的。CBT-I研究显示，改善睡眠最有希望，但没有明确的证据表明改善睡眠对病理性饮酒具有保护价值。因此，将在清醒至少一个月（但不到一年）的退伍军人样本中评价CBT-I（n = 30）并与准脱敏疗法（QDT）（n=30）进行比较。研究队列将进一步分层为有（n=30）和无（n=30）一级酗酒家族史的患者。考虑到家族性酗酒，因为这可能是导致失眠严重程度和/或治疗结果的独特因素。所有受试者将完成为期2周的基线记录期，然后每周进行一次CBT-I/QDT治疗，持续8周。CBT-I将根据标准方案进行。每周1小时的会议（个人格式）将用于提供CBT-I的四个组成部分（睡眠限制，刺激控制，睡眠卫生和认知治疗[睡眠相关的去灾难化]）。治疗将在干预后3个月和6个月进行两次评估。所有受试者将在2周基线、干预期以及治疗完成后3个月和6个月的两个随访间隔内完成失眠严重程度指数、每日睡眠日记和酒精相关测量。主要结果测量是失眠严重程度（如ISI评估）和禁欲天数百分比（如使用时间轴随访测量评估）。此外，将使用简明健康量表-12（SF-12）项目量表、BDI-II、PHQ 9、STAI和GAD 7跟踪健康和情绪。这些措施的组合用于测试的假设，标准CBT-I可以成功地应用于从酒精中毒中恢复的患者，成功治疗失眠症将与酒精中毒相关的更好的临床结果。最后，将在探索性基础上评估家族史数据，以评估基线失眠和客观睡眠的差异，以及失眠、酗酒、治疗依从性和/或治疗结局的结局。客观睡眠将进行初步评估，在实验室多导睡眠图的7名受试者有和没有家族性酒精中毒（n=16）。据推测，CBT-I在戒酒者中将导致1）与QDT相比显著优于睡眠相关的结果，2）与荟萃分析规范相当的治疗前后效应大小，3）更大比例的戒酒天数，至少有更少的复发趋势，以及4）更好的整体健康和情绪。如果这些发现得到实现和复制，这将表明失眠治疗应该是酒精中毒管理的标准组成部分，CBT-I是这种共病失眠的理想管理方法。

DESCRIPTION (provided by applicant): Alcoholism and insomnia are highly prevalent in Veterans. Alcoholism is estimated to occur in about 6.4% of Veterans. More recent estimates of alcohol misuse range from 11.8% in OIF Veterans to 21.8% in OEF/OIF male Veterans. Insomnia is estimated to occur in about 28% of active duty military personnel (from the Millennium Cohort Study), and up to 77% of Veterans seen in a VHA primary care experience clinically significant levels of insomnia. Insomnia is also highly prevalent in patients recovering from alcoholism with as many as 70% of such patients complaining of sleep initiation and/or maintenance problems. These prevalence rates are 2-7 times higher than that of the general population. The direct consequences of insomnia include sleepiness, fatigue, irritability, diminished work performance and impaired interpersonal functioning. The long- term sequelae of insomnia include risk for new-onset and recurrent psychiatric illness, and in the context of alcoholism, greater intensity of alcoholism and increased risk for relapse in abstinent alcoholics. At present, there are nine studies which evaluate whether insomnia represents a modifiable risk factor for relapse of alcoholism (2 investigating trazodone, 3 investigating gabapentin, 1 investigating ramelteon, and 3 investigating a modified form of cognitive-behavioral therapy for insomnia [CBT-I]). The results from these studies are variable. The CBT-I investigations show the most promise in terms of improved sleep, but there is no clear evidence that improved sleep has protective value against pathological drinking. Accordingly, CBT-I (n=30) will be evaluated and compared to the Quasi-Desensitization Therapy (QDT) (n=30) in a sample of veterans who have been sober for at least one month (but less than one year). The study cohort will be further stratified into those who do (n=30) and do not (n=30) have a first-degree family history of alcoholism. Familial alcoholism is taken into account, as this may represent a unique factor that contributes to insomnia severity and/or treatment outcome. All subjects will complete a 2-week baseline recording period followed by weekly CBT-I/QDT sessions for 8-weeks. CBT-I will be conducted according to a standard protocol. Weekly 1-hour sessions (individual format) will be used to deliver the four components of CBT-I (Sleep Restriction, Stimulus Control, Sleep Hygiene, and Cognitive therapy [sleep-related de-catastrophization]). Treatment will be followed up with two evaluations at 3 and 6 months post-intervention. All subjects will complete the Insomnia Severity Index, daily sleep diaries, and the alcohol-related measures for a 2-week baseline, for the intervention period, and for two follow-up intervals after treatment completion at 3 and 6 months. The primary outcome measures are insomnia severity (as assessed with the ISI) and percentage days abstinent (as assessed using the Timeline Follow Back measure). In addition, health and mood will be tracked using the Short Form-12 (SF-12) item scale, the BDI-II, PHQ9, STAI, and the GAD7. The combination of these measures serve to test the hypotheses that standard CBT-I can be applied successfully in patients recovering from alcoholism and that successful treatment of insomnia will be associated with better clinical outcomes in relation to alcoholism. Finally, family history data will be assessed on an exploratory basis to assess differences in baseline insomnia and objective sleep, as well as outcomes for the insomnia, alcoholism, treatment adherence, and/or treatment outcome. Objective sleep will be preliminarily assessed with in-laboratory polysomnograms of seven subjects with and without familial alcoholism (n=16). It is hypothesized that CBT-I in abstinent alcoholics will lead to 1) significantly superio sleep-related outcomes as compared to QDT, 2) pre-to-post treatment effect sizes that are comparable to the meta-analytic norms, 3) a larger percentage of days abstinent with at least a trend toward fewer relapses, and 4) better overall health and mood. If these findings are achieved and replicated, it will suggest that insomnia treatment should be a standard component in the management of alcoholism and that CBT-I is an ideal management approach for this co-morbid insomnia.