NCT01603381已完成不适用
The Effect of Family History on Insomnia During Sobriety in Alcoholics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index total score
研究概览
简要总结
The investigators intend to assess the following:
- the efficacy of CBTi in treating insomnia during recovery,
- does a family history of alcoholism moderate the insomnia symptoms,
- does an improvement in insomnia lead to a decrease in impulsivity.
详细描述
The primary goals of this pilot study are the following:
a) to assess for the difference in improvement insomnia, after 8 weeks of treatment with recommended CBTi, in Veterans with alcohol dependence during early recovery,
The secondary goals include the following:
- to assess for any change in the alcohol consumption indices between the groups after 8 weeks of CBTi,
- to assess for change in psychiatric symptoms of mood and anxiety across the groups,
- to assess for differences in insomnia in subjects, with and without a first degree family history of alcohol dependence,
- to evaluate for any change in impulsivity-related measure with insomnia treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Presence of insomnia currently
- •DSM IV diagnosis of alcohol dependence within the past year
- •Not in acute alcohol withdrawal and within a year of sobriety from alcoholism
- •Patients with moderate-severe sleep apnea compliant on their PAP device
- •Can speak, understand and print in English.
- •Is capable of giving written informed consent.
排除标准
- •Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.
- •Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.
- •Unstable or serious medical/neurologic illness
- •Severe cognitive impairment
- •Untreated moderate - severe obstructive sleep apnea
结局指标
主要结局
Insomnia Severity Index total score
时间窗: 8 weeks.
There will be post-treatment follow up at 3 months and 6 months.
次要结局
- Time Line Follow Back measure(8 weeks.)
研究者
Subhajit Chakravorty
Staff Physician
Corporal Michael J. Crescenz VA Medical Center
研究点 (2)
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