Digital Cognitive-behavioral Therapy for Insomnia: a Randomized Controlled Trial (DCBT-I)

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Insomnia

Treatments: Behavioral: standard face-to-face group-based Cognitive-Behavioral Therapy for Insomnia (CBT-I); Behavioral: Digital Cognitive-Behavioral Therapy for Insomnia (dCBT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT06939790

CET 129-2025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Digital Cognitive-Behavioral Therapy for Insomnia (dCBT-I)

Experimental group

Description:

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.

Treatment:

Behavioral: Digital Cognitive-Behavioral Therapy for Insomnia (dCBT-I)

standard face-to-face group-based Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Active Comparator group

Description:

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.

Treatment:

Behavioral: standard face-to-face group-based Cognitive-Behavioral Therapy for Insomnia (CBT-I)