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，酒精中毒发生在约6.4％的退伍军人中。滥用酒精的最新估计范围从OIF退伍军人的11.8％到OEF/OIF男性退伍军人的21.8％。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具有重要水平的失眠水平。从酒精中毒中恢复过来的患者中，失眠也很普遍，其中多达70％的患者抱怨睡眠开始和/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嗜睡，疲劳，易怒，工作表现降低和人际关系功能受损。失眠的长期后遗症包括患有新发育和复发性精神病的风险，在酗酒，酗酒强度更高以及戒酒中戒酒的风险增加的背景下。目前，有九项研究评估失眠是否代表了酒精中毒复发的可修改危险因素（2个研究曲唑酮，3项研究加巴喷丁，1个研究了拉梅尔特，调查了Ramelteon和3个调查了一种修饰的认知 - 行为治疗的形式[CBT-ii [CBT-II] ]）。这些研究的结果是可变的。 CBT-I调查表明，在改善睡眠方面，最有希望的是，没有明确的证据表明改善的睡眠具有防止病理饮酒的保护价值。因此，将评估CBT-I（n = 30），并将其与已清醒至少一个月（但不到一年）的退伍军人样本中的准脱敏疗法（QDT）（QDT）（n = 30）进行比较。 。该研究队列将进一步分为那些（n = 30）并且没有（n = 30）具有一级酒精中毒的家族史。考虑到家族性酗酒，因为这可能代表了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，然后为8周举行每周的CBT-I/QDT课程。 CBT-I将根据标准协议进行。每周1小时的课程（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]）。治疗将在干预后3个月和6个月进行两次评估。所有受试者将在干预期间完成失眠严重程度指数，每日睡眠日记和与酒精相关的措施，并在干预期间进行两周的基线，并在3和6个月的治疗完成后进行两个随访间隔。主要的结果度量是失眠的严重程度（如ISI评估）和戒酒百分比（使用时间轴遵循措施评估）。此外，将使用简短的形式-12（SF-12）项目量表，BDI-II，PHQ9，STAI和GAD7跟踪健康和情绪。这些措施的组合有助于检验假设，即标准CBT-I可以成功地应用于酒精中毒的患者，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果有关。最后，将根据探索性评估家族史数据，以评估基线失眠和客观睡眠的差异，以及失眠，酒精中毒，治疗依从性和/或治疗结果的结果。客观睡眠将通过七个受试者有或没有家族性酒精中毒的七名受试者进行定位的多个多肌电图（n = 16）进行初步评估。假设戒酒中的CBT-I将导致1）与QDT相比，与超级睡眠相关的结果显着，2）2）与元分析规范相媲美的前至固定前治疗效果大小，3）节制的日子百分比至少朝着更少的复发趋势，以及4）更好的整体健康和情绪。如果这些发现得出并复制，这将表明失眠症治疗应该是酒精中毒管理的标准组成部分，并且CBT-I是这种合并症失眠症的理想管理方法。