Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Score from the insomnia severity index (ISI)
研究概览
简要总结
Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 months of abstinence
- •Planned enrollment into an abstinence-based treatment program
- •Meet probable DSM-5 criteria for chronic insomnia
- •Access to a video chat-capable device and reliable Wi-Fi network
排除标准
- •Diagnosis of, or high suspicion for, sleep disorders other than insomnia
- •Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (PTSD)
- •Terminal or progressive physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia), or presence of an unstable medical condition that is the specific cause of insomnia
- •Self-reported pregnancy or intention to become pregnant during the study
研究组 & 干预措施
Cognitive Behavioral Therapy for insomnia (CBTi)
CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.
干预措施: Cognitive Behavioral Therapy for insomnia (CBTi) (Behavioral)
Sleep Hygiene Education (SHE)
SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.
干预措施: Sleep Hygiene Education (SHE) (Behavioral)
结局指标
主要结局
Score from the insomnia severity index (ISI)
时间窗: Immediately post treatment
The ISI is a 7-item self-report assessment of the nature, severity and impact of insomnia. Scores range from 0-28 with higher scores suggesting more clinically significant insomnia.
Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)
时间窗: Immediately post treatment
The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.
次要结局
- Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale(Immediately post treatment)
研究者
J. Todd Arnedt
Associate Professor of Psychiatry
University of Michigan