CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 107 enrolled
Drug / intervention
internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04300218
NCT04300218N/ACompleted

Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings

I.M. Sechenov First Moscow State Medical University·interventional·Posted Mar 9, 2020·Updated Jan 7, 2026

In Brief

A clinical study evaluating internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) and Care as usual (CAU) for Chronic Insomnia. Completed, enrolled 107 participants across 3 sites.

Detailed Summary

The proposed parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition will let us investigate the effectiveness and cost-effectiveness of iCBT-I. Analysis of baseline characteristics of the participants aims to find predictors of outcome

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia
CollaboratorsUniversity of Bern

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 9, 2020
Enrollment StartMar 5, 2020
Primary CompletionJul 1, 2023
Study CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.3 years ago

Interventions

internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I)behavioral

The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures. The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings. All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study.

Care as usual (CAU)other

Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers. All concurrently applied treatments will be assessed repeatedly by self-report