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

酗酒和失眠在退伍军人中非常普遍。据估计，酒精中毒发生在约6.4%的 老兵最近估计，滥用酒精的比例从法语国家组织退伍军人的11.8%到法语国家组织/法语国家组织的21.8%不等。 男性退伍军人据估计，约28%的现役军人（来自 千禧年队列研究），高达77%的退伍军人在VHA初级保健经验的临床 严重失眠酒精中毒患者在酒精中毒恢复期也很普遍， 多达70%的这类患者抱怨睡眠开始和/或维持问题。这些流行病 死亡率比一般人口高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功能受损。很长的- 失眠的长期后遗症包括新发和复发性精神疾病的风险， 酒精中毒，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复发的可改变的风险因素， 酒精中毒（曲唑酮组2例，加巴喷丁组3例，雷美替酮组1例， 研究失眠症的认知行为疗法的改良形式[CBT-I]）。结果从这些 研究是可变的。CBT-I调查显示，在改善睡眠方面， 没有明确的证据表明改善睡眠对病理性饮酒有保护作用。因此，CBT-I （n=30）进行评价，并与准脱敏疗法（QDT）（n=30）进行比较， 已清醒至少一个月（但不到一年）的退伍军人。研究队列将进一步 分层为有一级酗酒家族史者（n=30）和无一级酗酒家族史者（n=30）。家族性 酒精中毒被考虑在内，因为这可能是导致失眠严重程度的一个独特因素 和/或治疗结果。所有受试者将完成为期2周的基线记录期，随后每周 CBT-I/QDT课程，为期8周。CBT-I将根据标准方案进行。每周1小时 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，睡眠卫生和认知疗法[睡眠相关的去灾难化]）。治疗将遵循 在干预后3个月和6个月进行了两次评估。所有受试者均将填写不良反应严重程度 指数，每日睡眠日记，以及2周基线的酒精相关指标，在干预期间， 并在治疗完成后3个月和6个月进行两次随访。主要结局指标 是失眠严重程度（用ISI评估）和禁欲天数百分比（用 时间轴跟随返回测量）。此外，将使用简明健康调查表（SF-12）跟踪健康和情绪 项目量表、BDI-II、PHQ 9、STAI和GAD 7。这些措施的结合有助于测试 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， 失眠症的成功治疗将与酒精中毒相关的更好的临床结果相关。 最后，将在探索性基础上评估家族史数据，以评估基线失眠的差异 以及失眠、酗酒、治疗依从性和/或治疗的结果。 结果。客观睡眠将初步评估与在实验室多导睡眠图的七个主题 有和无家族性酒精中毒（n=16）。假设CBT-I在戒酒者中会导致1） 显著优于QDT的上级睡眠相关结局，2）治疗前后效应量， 与荟萃分析规范相当，3）更大比例的禁欲天数至少有一种趋势 更少的复发，以及4）更好的整体健康和情绪。如果这些发现得到实现和推广， 将建议失眠治疗应该是酗酒管理的标准组成部分， CBT-I是治疗这种共病失眠症的理想方法。

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 superior 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.