Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (Total), Change From Baseline to Follow-up
研究概览
简要总结
The purposes of this study is to examine the feasibility of implementing an internet-based treatment for insomnia among veterans with substance use disorders, some with co-morbid serious mental illness, and to develop potential methods to support and encourage veterans while they self-administer this treatment. Our hypotheses are that the implementation of an internet-based therapy will be feasible and that a method of support can be devised, and tested in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inability to sleep within 30 minutes of going to bed or awakening during the night for 30 minutes for greater than or equal to 3 days per week
- •Above Criteria occurring every week for greater than or equal to 3 months
- •At least one symptom of daytime impairment: (reduced motivation, sleepiness, fatigue, lack of concentration, performance at home, work, social life, relationships impaired)
- •Able to provide valid consent
- •Willing to participate in an internet-based cognitive behavioral therapy for insomnia
- •English speaking
排除标准
- •Self-reported or provider diagnosed sleep apnea or related nighttime respiratory problem, restless legs syndrome or related nighttime movement disorder
- •Acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation)
- •Current treatment or treatment within the last month for opiate addiction with methadone maintenance or buprenorphine.
- •Has a conservator E. Shift work interfering with the establishment of regular sleep patterns F. Previous or ongoing cognitive behavioral therapy for insomnia
结局指标
主要结局
Insomnia Severity Index (Total), Change From Baseline to Follow-up
时间窗: pre-intervention, intervention completion (expected average of 7 weeks)
Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks) The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia.
Completion of All 7 Modules of the Intervention
时间窗: on average 7 weeks
Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable). The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program.
次要结局
未报告次要终点
研究者
Robert Rosenheck
Senior Health Serivces Investigator
VA Connecticut Healthcare System