Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial to Improve Cost-effectiveness and Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- To assess whether the benefits of dCBT-I are comparable with CBT-I treatment in standard group mode
研究概览
简要总结
The study investigates whether online Cognitive-Behavioral Therapy for insomnia is as effective as the standard in-person group treatment, using clinical and sleep-related outcomes in adult patients.
详细描述
This study aims to evaluate the effectiveness of digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in Italian, comparing it to the traditional face-to-face group-based CBT-I. Sixty adults with chronic insomnia will be randomized to one of the two interventions, with assessments conducted pre- and post-treatment through validated questionnaires and objective sleep monitoring.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic insomnia Individuals aged 18 to 75 years Signed informed consent form (ICF) prior to study participation
排除标准
- •Diagnosis of comorbid sleep disorder (e.g. obstructive sleep apnea) Diagnosis of mental disorder in comorbidity Physical problems that may alter and dysregulate sleep Pregnancy and breastfeeding
研究组 & 干预措施
Digital Cognitive-Behavioral Therapy for Insomnia (dCBT-I)
The digital CBT-I (dCBT-I) is a self-guided online program replicating the structure and content of standard face-to-face CBT-I, aiming to offer a more accessible treatment for chronic insomnia. It includes video lessons, interactive exercises, and relaxation techniques, with core components such as sleep education, sleep restriction, stimulus control and cognitive restructuring. Supervision is provided through periodic check-ins.
干预措施: Digital Cognitive-Behavioral Therapy for Insomnia (dCBT-I) (Behavioral)
standard face-to-face group-based Cognitive-Behavioral Therapy for Insomnia (CBT-I)
The control group will receive standard face-to-face group-based CBT-I, the current gold-standard treatment for chronic insomnia. Delivered by trained professionals, the intervention includes seven structured sessions covering core components such as sleep education, sleep restriction, stimulus control cognitive restructuring, and relaxation techniques. Sessions last about 90 minutes and aim to improve sleep quality through evidence-based strategies.
干预措施: standard face-to-face group-based Cognitive-Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
结局指标
主要结局
To assess whether the benefits of dCBT-I are comparable with CBT-I treatment in standard group mode
时间窗: Change from baseline to post-treatment (2 months)
Comparison at Insomnia Severity Index (ISI) questionnaire between the two groups evaluated at baseline and post-treatment.
次要结局
未报告次要终点
研究者
Luigi Ferini Strambi
Professor
IRCCS San Raffaele