NCT01603381已完成不适用
The Effect of Family History on Insomnia During Sobriety in Alcoholics
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 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
研究组 & 干预措施
CBT-I
Experimental
Cognitive Behavioral Therapy for Insomnia
干预措施: Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
Monitor Only (M.O.)
No Intervention
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 (1)
Loading locations...
相似试验
已完成
不适用
Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple SclerosisInsomniaNCT03216889University of Kansas Medical Center43
招募中
不适用
Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia(SLEEPINS)SchizophreniaInsomniaSchizoaffective DisorderNCT04144231Helsinki University Central Hospital120
Unknown
不适用
Effect of Clinical Insomnia and Sleep Deprivation on Maternal-fetal Outcome Among Egyptian Females in 3rd TrimesterEffect of Insomnia and Sleep Deprivation in 3rdtrimesterNCT04612361Dr. Osman Hospital750
已完成
不适用
Cognitive Behavioral Therapy for the Treatment of Depression-Related InsomniaDepressionNCT00255905University of Rochester45
Unknown
不适用
Do People With Insomnia Sleep Better After Psychological Treatment?InsomniaNCT00170391NHS Greater Glasgow and Clyde