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

CBT-I 对酗酒者的功效

• 批准号: 9240571
• 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/9240571
• 关键词: Abate; Abstinence; Address; Aftercare; Age of Onset; Alcohol dependence; Alcoholism; Alcohols; Anxiety; Back; Beck depression inventory; Biological Markers; Clinical; Cognitive Therapy; Cohort Studies; Comorbidity; Data; Disease remission; Drowsiness; Electroencephalography; Equipment and supply inventories; Evaluation; Exhibits; Family; Family history of; Fatigue; General Population; Generalized Anxiety Disorder; Genetic; Goals; Health; Heavy Drinking; Hour; Hygiene; Impairment; Incidence; Individual; Intervention; Investigation; Laboratories; Maintenance; Measures; Mental disorders; Military Personnel; Modality; Moods; Neurobiology; Outcome; Outcome Measure; Participant; Pathologic; Patients; Performance at work; Pharmaceutical Preparations; Pharmacotherapy; Phenotype; Placebos; Population; Prevalence; Primary Health Care; Protocols documentation; Psychophysiological Insomnia; Questionnaires; Randomized; Recording of previous events; Recovery; Recurrence; Regimen; Relapse; 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; 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; relapse risk; secondary analysis; sobriety; targeted treatment; trait; treatment adherence; treatment effect; treatment response; trend

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.

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，大约6.4%的退伍军人会发生酒精中毒。最近对酒精滥用的估计从退伍军人的11.8%到退伍军人/退伍军人男性的21.8%不等。据估计，约28%的现役军人发生失眠(来自千年队列研究)，在VHA初级保健中，高达77%的退伍军人经历了临床上严重的失眠。失眠在从酒精中毒中恢复的患者中也非常普遍，多达70%的这类患者抱怨睡眠启动和/或维持问题。这些患病率是普通人群的2-7倍。失眠的直接后果包括困倦、疲倦、易怒、工作表现下降和人际功能受损。失眠的长期后遗症包括新发和复发的精神疾病的风险，在酒精中毒的背景下，戒酒者酗酒的程度更高，复发的风险增加。目前，有9项研究评估失眠是否代表酒精中毒复发的可改变的危险因素(2项研究曲唑酮，3项研究加巴喷丁，1项研究Ramelteon，3项研究一种改进的失眠认知行为疗法[CBT-I])。这些研究的结果各不相同。CBT-I的调查显示，在改善睡眠方面最有希望，但没有明确的证据表明，改善睡眠对防止病理性饮酒有保护作用。因此，CBT-I(n=30)将在戒酒至少一个月(但不到一年)的退伍军人样本中进行评估，并与准脱敏疗法(QDT)(n=30)进行比较。研究队列将进一步分成有(n=30)和没有(n=30)有一级家族酗酒史的人。家族性酗酒被考虑在内，因为这可能是影响失眠严重程度和/或治疗结果的一个独特因素。所有受试者将完成为期两周的基线记录期，然后每周进行为期8周的CBT-I/QDT训练。CBT-I将根据标准协议进行。每周1小时的课程(个人形式)将用于教授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[睡眠相关的去灾变])。治疗将在干预后3个月和6个月进行两次评估。所有受试者都将完成失眠严重指数、每日睡眠日记和酒精相关测量，包括两周的基线、干预期和治疗结束后3个月和6个月的两次随访间隔。主要结果指标是失眠严重程度(用ISI评估)和戒断天数百分比(用时间线追踪测量评估)。此外，健康和情绪将使用短表-12(SF-12)项目量表、BDI-II、PHQ9、STAI和GAD7进行跟踪。这些措施的组合用来检验这样的假设，即标准CBT-I可以成功地应用于酒精中毒康复患者，成功治疗失眠将与酒精中毒相关的更好的临床结果相关。最后，将在探索性的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/或治疗结果的差异。目的对16例家族性酒精中毒患者(n=16)进行实验室内多导睡眠图的初步睡眠评估。它假设戒酒患者的CBT-I将导致：1)与QDT相比，CBT-I的睡眠相关结果显著改善；2)治疗前后的效果大小与荟萃分析标准相当；3)戒酒天数百分比增加，至少有减少复发的趋势；4)整体健康和情绪更好。如果这些发现得到实现和重复，将表明失眠治疗应该成为酒精中毒治疗的标准组成部分，而CBT-I是这种共病失眠的理想治疗方法。