The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index - Total Score
研究概览
简要总结
Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking.
Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may be efficacious for insomnia during recovery.
The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if an improvement in the insomnia is associated with an improvement in the underling alcoholism and the daytime functioning. On an exploratory basis, the association of a first-degree family history of alcoholism with the insomnia severity and treatment response will also be evaluated.
详细描述
Eligible subjects will be Veterans with alcohol dependence during their first year of recovery, 21-65 years old, with ISI total score of 15 or more, medically and psychiatrically stable, and without dependence on other drugs (with the exception of nicotine and marijuana).
The proposed study will consist of a single-blind trial comparing CBT-I against a behavioral placebo intervention (Quasi-Desensitization Therapy, QDT).
Baseline assessments conducted over a month will comprehensively evaluate for the addiction, psychiatric, sleep and medical disorders, as well as for a family history of alcohol dependence.
Once the subject is seen to be eligible for the study he will be randomized to either the CBT-I or the QDT arm, and treated for the next weeks. The primary outcome measure for insomnia will be the Insomnia Severity Index. The primary outcome measure for alcohol dependence will be the percent days abstinent (on the Time Line Follow Back measure, TLFB), and the daytime symptoms will be assessed using the Short Form-12 item scale (SF-12, for self reported well-being), the Beck Depression Inventory (BDI, for depressive symptoms), and the State Trait Anxiety Inventory (STAI, for anxiety symptoms).
After completion of the treatment phase, subjects will be followed up 3 months and 6 months later, to assess for changes over time in their insomnia, alcohol use, and daytime functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Veterans between the ages of 21 and 70 years
- •DSM IV diagnosis of alcohol dependence over the past year (as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders [SCID-I])
- •Self-reported sleep latency or wake time after sleep onset >30 min on three or more nights per week for 1 month and a score of 15 or more on the Insomnia Severity Index (ISI)
- •No current alcohol withdrawal symptoms at baseline: CIWA score < 8 (CIWA is the Clinical Institute Withdrawal Assessment scale for alcohol withdrawal signs and symptoms)
- •Abstain for at least 4 weeks from heavy drinking, and < 12 months of abstinence from heavy drinking prior to the baseline study assessments, as assessed by subjective report or breathalyzer
- •Ability to speak, understand and print in English
- •Capacity to give written informed consent
排除标准
- •DSM-IV criteria for dependence on any other substance including benzodiazepines (and excluding nicotine dependence)
- •Positive urine drug screen for opioids, cocaine, or amphetamine (positive screen for Tetra Hydro Cannabinol is not considered an exclusion criteria)
- •Patient is currently in alcohol withdrawal as assessed by the Clinical Institute Withdrawal Assessment Scale (CIWA) total score of 8 or more
- •A lifetime DSM-IV diagnosis of Bipolar I or II disorder, Schizophrenia, or other psychotic disorder, as determined on the SCID-I, and current (past month) DSM-IV diagnosis of Major Depressive Disorder
- •Presence of unstable medical diagnosis e.g. congestive heart failure, leading to interference with sleep, as reported on history, examination, and/or review of clinical chart during baseline assessments
- •Current use of any medications that may influence the drinking behavior, e.g. naltrexone or acamprosate
- •Evidence of severe cognitive impairment as assessed by the Blessed Orientation-Memory-Concentration (BOMC) test weighted score
- •Untreated patients with the diagnosis of moderate-severe obstructive sleep apnea with Total Apnea-Hypopnea Index (AHI-T) of 15 events/hour of sleep
- •Subject's inability to give informed consent
结局指标
主要结局
Change in Insomnia Severity Index - Total Score
时间窗: 8 weeks, 3 months post-treatment, and 6 months post-treatment
Insomnia Severity Index (ISI): This 7-item (0-4 Likert scales) measure yields a total score of 28. The norms for the scale are as follows: 0-7 represents no clinically significant insomnia; 8-14 represents sub threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The scale provides a measure of severity of insomnia (overall), a measure of insomnia subtype, a measure of the diurnal effects of insomnia, and a measure of sleep "satisfaction". The ISI will be completed at baseline and for all the subsequent study-related visits.
Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure
时间窗: 8 weeks, 3 months post-treatment and 6-months post-treatment
Time Line Follow Back measure (TLFB): The TLFB provides assessment of drinking using a calendar format for the number of standard alcoholic beverages consumed per day. A standard drink, as defined by the National Institutes of Health, is 12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits (e.g. whiskey). Numerous indices may be derived from the TLFB, such as the Percent Days Abstinent (PDA) proposed in this study. The PDA is derived as the percentage of days an individual reports being abstinent from alcohol within a given assessment time period.
次要结局
未报告次要终点