NCT03328585已完成不适用
Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in ISI scores
研究概览
简要总结
Cognitive behavioral therapy for insomnia (CBT-I) has been the 'gold standard' for the treatment of insomnia. There is a need to increase access to treatment, particularly for patients in more rural locations where providers may be scarce. One solution is to utilize telemedicine which is "the use of electronic communications to provide and support health care when distance separates the provider from the patient." So the purpose of the study is to determine if receiving CBT-I by video teleconferencing works just as well as in-person 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet current DSM5 criteria for Insomnia Disorder as determined by clinician interview
- •ISI score greater than 14, with self-reported duration of insomnia of at least 3 months
- •Ability to read and speak English
- •Own a personal computer with an internet connection sufficient to utilize the SleepTM and REDCap platform
- •BMI less than 30
- •Between the ages of 21-50
排除标准
- •Unable or unwilling to provide informed consent
- •Individuals with an untreated sleep disorder other than insomnia (Individuals with sleep apnea who are adherent with CPAP treatment (average 4 hours use per night) will be eligible to participate)
- •A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months
- •Individuals with substance abuse/dependence, bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia, and other psychotic disorders
- •Individuals with prominent current suicidal or homicidal ideation
- •Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing, or cognitive impairment
- •Any use of medications or OTC products that might impact sleep or metabolism
结局指标
主要结局
Change in ISI scores
时间窗: Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later
Total score on the Insomnia Severity Index (0-28)
次要结局
- Change in actigraphic sleep efficiency(Patients will wear the wristband for a week during sleep baseline assessment and again for a week at follow-up, approximately 8 weeks later)
研究者
研究点 (2)
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