Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

IRCCS San Raffaele

Conditions:

Insomnia

Eligibility:

All Genders

18-75 years

Phase:

NA

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 wit...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

June 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06939790

Start Date

June 1 2025

End Date

December 1 2028

Last Update

May 16 2025

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