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

NCT06939790 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-12-01
Completion
2028-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939790 on ClinicalTrials.gov