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

NCT06939790 | Not Yet Recruiting DMC

• 1 other identifier: CET 129-2025
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Keywords

Sleep; Insomnia; Cognitive-Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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.

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

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.

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

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic insomnia Individuals aged 18 to 75 years Signed informed consent form (ICF) prior to study participation

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Luigi Ferini Strambi, MD

CONTACT

+390226433363; ferinistrambi.luigi@hsr.it

Luigi Strambi, MD

CONTACT

+390226433363; ferinistrambi.luigi@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share