Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
概览
- 阶段
- 不适用
- 干预措施
- Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I
- 疾病 / 适应症
- Insomnia
- 发起方
- Brigham and Women's Hospital
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
- 状态
- 进行中(未招募)
- 最后更新
- 3个月前
概览
简要总结
Insomnia is an important public health problem and the most common sleep disorder in the general population. Up to 20% of adults in the United States suffer from insomnia disorder, and it has been associated with increased morbidity, mortality, and healthcare costs. Cognitive behavioral therapy for insomnia (CBT-I) is the initial recommended treatment approach for insomnia. Combined therapy with CBT-I and medication has shown no advantage over CBT-I alone. CBT-I is not always accessible to patients, however, due to cost and availability of trained healthcare professionals. Web-based CBT-I is an inexpensive and effective self-management tool for treatment of insomnia.
This pilot study would test the efficacy of a new digital CBT-I application called Stellar Sleep, a cost effective and user-friendly version of wCBT-I, in patients with insomnia. This is the first digital CBT-I app that allows automatic entry of sleep diary data from wearable devices that track sleep (such as the Mi Band 5 or a FitBit, for instance). Testing the efficacy of this application will provide the preliminary data necessary for larger trials to further validate the application and determine its role for future patients. Use of this application can help bridge the gap in providing care to insomnia patients with transportation and cost barriers and to accommodate the long wait times for traditional in-person CBT-I. It will also be the first web-based CBT-I application that can directly upload data from a wearable device.
研究者
Sogol Javaheri
Principal Investigator
Brigham and Women's Hospital
入排标准
入选标准
- •18 years or older
- •Daily access to a computer or smartphone with reliable internet connection
排除标准
- •Currently pregnant or planning to become pregnant in the next year
- •Visual impairment that prevents use of a computer
- •Serious health conditions that will prevent taking part in the study over the next 3 - 6 months, such as severe medical or psychiatric disease, such as treatments for cancer or congestive heart failure, OR a condition that may require hospitalization or surgery
- •Self-reported history of drowsy driving or fallen asleep while driving
- •Night shift worker
- •Prior exposure to Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
- •Insomnia severity index score \< 12
研究组 & 干预措施
Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I) with general sleep education
干预措施: Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I
General Sleep Education
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 6-8 weeks
Mean change in Insomnia Severity Index (ISI) score from baseline to end of intervention. Score ranges from 0 to 28, with higher scores indicating a worse outcome.