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| ID | Type | Description | Link |
|---|---|---|---|
| CET 129-2025 | Other Identifier | CET Lombardia 1 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Cognitive-Behavioral Therapy for Insomnia (dCBT-I) | Experimental | 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. |
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| standard face-to-face group-based Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Cognitive-Behavioral Therapy for Insomnia (dCBT-I) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether the benefits of dCBT-I are comparable with CBT-I treatment in standard group mode | Comparison at Insomnia Severity Index (ISI) questionnaire between the two groups evaluated at baseline and post-treatment. | Change from baseline to post-treatment (2 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Ferini Strambi, MD | Contact | +390226433363 | +390226433363 | ferinistrambi.luigi@hsr.it |
| Luigi Strambi, MD | Contact | +390226433363 | +390226433363 | ferinistrambi.luigi@hsr.it |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| standard face-to-face group-based Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Behavioral | 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. |
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| D001523 |
| Mental Disorders |