Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial
Not Applicable
Not yet recruiting
- Conditions
- Insomnia
- Registration Number
- NCT06939790
- Lead Sponsor
- IRCCS San Raffaele
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Diagnosis of chronic insomnia Individuals aged 18 to 75 years Signed informed consent form (ICF) prior to study participation
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To assess whether the benefits of dCBT-I are comparable with CBT-I treatment in standard group mode 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.
- Secondary Outcome Measures
Name Time Method