Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

December 1, 2027

Study Completion Date

December 1, 2028

Conditions
Insomnia
Interventions
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.

All Listed Sponsors
lead

IRCCS San Raffaele

OTHER

NCT06939790 - Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial | Biotech Hunter | Biotech Hunter