Trials / Not Yet Recruiting
Not Yet RecruitingNCT06939790
Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial
Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial to Improve Cost-effectiveness and Treatment Outcomes
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- IRCCS San Raffaele · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| 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. |
Timeline
- Start date
- 2025-06-01
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2025-04-23
- Last updated
- 2025-05-16
Source: ClinicalTrials.gov record NCT06939790. Inclusion in this directory is not an endorsement.