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

CBT-I 对酗酒者的功效

• 批准号: 8811012
• 负责人: Subhajit Chakravorty
• 金额: --
• 依托单位: PHILADELPHIA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8811012
• 关键词: Abate; Abstinence; Accounting; Address; Aftercare; Age of Onset; Alcohol dependence; Alcoholism; Alcohols; Anxiety; Back; Beck depression inventory; Biological Markers; Clinical; Cognitive Therapy; Cohort Studies; Data; Disease remission; Electroencephalography; Equipment and supply inventories; Evaluation; Exhibits; Family; Family history of; Fatigue; General Population; Generalized Anxiety Disorder; Genetic; Goals; Health; Heavy Drinking; Hour; Hygiene; Incidence; Individual; Intervention; Investigation; Laboratories; Lead; Maintenance; Measures; Military Personnel; Modality; Moods; Outcome; Outcome Measure; Participant; Patients; Performance at work; Pharmaceutical Preparations; Pharmacotherapy; Phenotype; Placebos; Population; Prevalence; Primary Health Care; Protocols documentation; Questionnaires; Randomized; Recording of previous events; Recovery; Recurrence; Regimen; Relapse; Relative (related person); Replacement Therapy; Research; Risk; Risk Factors; Sampling; Severities; Severity of illness; Sleep; Sleeplessness; Stimulus; Testing; Time; TimeLine; Training; Trazodone; Treatment outcome; Veterans; Withdrawal; alcohol craving; alcohol misuse; alcoholism therapy; anxiety symptoms; awake; base; binge drinking; clinical effect; clinically significant; craving; daily functioning; depressive symptoms; desensitization; design; diaries; drinking; effective therapy; experience; falls; follow-up; gabapentin; health related quality of life; improved; indexing; male; modifiable risk; post intervention; primary outcome; problem drinker; public health relevance; recidivism; sleep regulation; sobriety; targeted treatment; trait; treatment adherence; treatment effect; treatment response; trend

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.

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％ 退伍军人。滥用酒精的最新估计范围从OIF退伍军人的11.8％到OEF/OIF的21.8％ 男性退伍军人。据估计失眠症发生在约28％的现役军事人员中（来自 千年队列研究），在VHA初级保健经验中，多达77％的退伍军人在临床上看到 失眠的重要水平。在从酒精中毒中康复的患者中，失眠也很普遍 此类患者中，有多达70％的患者抱怨睡眠开始和/或维持问题。这些流行率 比率是普通人群的2-7倍。失眠的直接后果包括 嗜睡，疲劳，烦躁，工作表现降低和人际关系功能受损。长期 失眠的术语后遗症包括患有新的和经常性精神病的风险， 酒精中毒，酗酒强度更高，戒酒中戒酒的风险增加。现在， 有九项研究评估失眠是否代表了可修改的风险因素 酒精中毒（2个调查曲唑酮，3个研究加巴喷丁，1个研究拉梅尔特恩和3 研究一种修饰的失眠认知行为疗法[CBT-I]）。这些结果 研究是可变的。 CBT-I调查表明，在改善睡眠方面，最有希望 没有明确的证据表明改善睡眠具有防止病理饮酒的保护价值。因此，CBT-I （n = 30）将评估并将 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 分层为那些（n = 30）而没有（n = 30）的人具有一级酗酒的家族史。家族 酗酒被考虑在内，因为这可能代表了导致失眠严重程度的独特因素 和/或治疗结果。所有受试者将完成为期2周的基线记录期，然后每周 8周的CBT-I/QDT会议。 CBT-I将根据标准协议进行。每周1小时 会议（单个格式）将用于传递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[与睡眠有关的de胃化]）。将遵循治疗 在干预后3和6个月进行两次评估。所有受试者都将完成失眠的严重性 索引，每日睡眠日记和与酒精相关的措施为2周的基线，在干预期间， 并在3个月和6个月的治疗完成后进行两个随访间隔。主要结果度量 是失眠的严重程度（与ISI评估）和戒酒百分比（如使用 时间轴遵循后退措施）。此外，将使用短表格12（SF-12）跟踪健康和情绪 项目规模，BDI-II，PHQ9，Stai和Gad7。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过来的患者，并且 成功治疗失眠症将与与酒精中毒有关的更好的临床结局有关。 最后，将根据探索性评估家族史数据来评估基线失眠的差异 和客观的睡眠以及失眠，酒精中毒，治疗依从性和/或治疗的结果 结果。客观睡眠将通过七个受试者的定位多聚疗法来初步评估 有和没有家族性酗酒（n = 16）。假设戒酒中的CBT-1将导致1） 与QDT相比，与睡眠相关的结果明显优于较高 与荟萃分析规范相媲美，3）最多的天数至少趋势 减少复发，4）更好的整体健康和情绪。如果这些发现是实现和复制的，则 将暗示失眠治疗应该是酒精中毒管理的标准组成部分 CBT-I是这种合并症失眠的理想管理方法。