Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial to Improve Cost-effectiveness and Treatment Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 60
- Primary Endpoint
- To assess whether the benefits of dCBT-I are comparable with CBT-I treatment in standard group mode
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: 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.
Intervention: standard face-to-face group-based Cognitive-Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
Outcomes
Primary Outcomes
To assess whether the benefits of dCBT-I are comparable with CBT-I treatment in standard group mode
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Luigi Ferini Strambi
Professor
IRCCS San Raffaele