Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gaia AG
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual [CAU]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.
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
- Single (Outcomes Assessor)
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
- •diagnosis of chronic insomnia
- •impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
排除标准
- 未提供
研究组 & 干预措施
somnovia
somnovia is a digital health application for people with Insomnia Disorder. Content is continuously adapted to patients' concerns and needs. somnovia is a comprehensive program, which is conceptually and substantially based on the Cognitive Behavioral Therapy for Insomnia (CBT-I) used in patients with Insomnia Disorder. It contains interactive dialogues that can be accessed via computer or smartphone, illustrations, audio recordings and motivating text messages. Techniques to cope with insomnia symptoms (e.g., psychoeducation about causes and basic emotional needs in addition to relevant strategies to improve sleep quality) are conveyed in interactive sequences that are accompanied by audio recordings, illustrations, and worksheets. Patients are also prompted to regularly complete brief symptom severity self-monitoring questionnaires. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration.
干预措施: somnovia (Behavioral)
Care as Usual
Care as Usual: In the CAU control group, participants are free to continue to engage with any treatment they require. However, they will be offered access to somnovia after 6 months post-baseline.
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 3 months after randomization
The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem).
次要结局
- Insomnia Severity Index (ISI)(6 months after randomization)
- Patient Health Questionnaire (PHQ-9)(3 months and 6 months after randomization)
- Responder Rate on Insomnia Severity Index(3 months after randomization)
- Remission Rate on Insomnia Severity Index(3 months after randomization)
- Generalized Anxiety Disorder Assessment (GAD-7)(3 months and 6 months after randomization)
- Work and Social Assessment Scale (WSAS)(3 months and 6 months after randomization)