---
title: Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings
nct_id: NCT04300218
overall_status: COMPLETED
phase: NA
sponsor: I.M. Sechenov First Moscow State Medical University
study_type: INTERVENTIONAL
primary_condition: Chronic Insomnia
countries: Russia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04300218.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04300218"
ct_last_update_post_date: 2026-01-07
last_seen_at: "2026-05-12T06:52:59.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings

**NCT ID:** [NCT04300218](https://clinicaltrials.gov/study/NCT04300218)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 107
- **Lead Sponsor:** I.M. Sechenov First Moscow State Medical University
- **Collaborators:** University of Bern
- **Conditions:** Chronic Insomnia
- **Start Date:** 2020-03-05
- **Completion Date:** 2023-09-01
- **CT.gov Last Update:** 2026-01-07

## Brief 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

## Detailed Description

Application of internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) is a perspective method that can fill the gap created by the discrepancy between insomnia cases and the number of trained professionals. Although the effectiveness of this method was proven in multiple studies conducted in research settings, it is unclear if iCBT-I outperforms pharmacotherapy which remains a widely used alternative of cognitive-behavior therapy of insomnia (CBT-I). Predictors, mediators, and moderators of treatment effect remain uncertain since previous studies often give contradictory results. The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual (CAU) among patients with chronic insomnia (CI) recruited from clinical settings. Baseline data will be further analyzed to find predictors of treatment outcome

For these purposes, a parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition was designed. 110 participants will be referred from the medical doctors in Moscow. Both groups will have access to CAU, treatment prescribed by the referred doctor. Patients of the first group will additionally get access to the iCBT-I program with the opportunity to contact a specialist within the program (guidance on request) in a secured environment. The primary outcome is insomnia severity change from pre- to posttreatment and to post-follow-up. Secondary outcomes include change subjective sleep characteristics, daytime symptoms, comorbid affective disorders, dysfunctional cognitions and behavior, healthcare consumption, and productivity losses. Predictors analysis will include baseline scores of the aforementioned outcomes along with treatment expectancies, personality traits

To the best of our knowledge, the present study is the first study of iCBT-I to be conducted in clinical settings. We expect that this approach lets us determine the target group more precisely and exclude health problems that may interfere with treatment. It is also expected that patients, referred to iCBT-I from the doctor's office will be more motivated to finish the treatment course that will reduce the drop out rate. CAU as control condition let us reconstruct clinical situation facing practicing doctor. On the other hand, CAU may result in a loss of power to detect a meaningful difference. Limitation of our study is in the impossibility of blinding participants to the treatment condition

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Sleep disorder matching chronic insomnia criteria (International Classification of Sleep Disorders-3) - assessed by clinical judgement
* Ability to follow the procedures of the study, fluent Russian language, Good access to internet - assessed by self-report

Exclusion Criteria:

* Presence of dementia (identified by history or a score \< 25 on the Folstein Mini Mental Status Exam) - assessed by clinical judgement
* Severe depression or severe anxiety as measured with the Beck Depression Inventory (BDI-II; score \> 28 ) and the Beck Anxiety Inventory (BAI; score \> 26) - assessed by the questionnaires
* History of severe psychiatric comorbidities other than anxiety and depression (bipolar disorders, psychotic disorders) or substance use disorder - assessed by self-report and clinical history
* Untreated severe obstructive sleep apnea syndrome (apnea-hypopnea index (AHI) \> 15), restless legs syndrome (movement index with arousal \> 15 per hour) or other sleep disorders affecting night sleep - assessed by clinical judgement and clinical history
* pregnancy, lactation - assessed by self-report
* having a serious somatic condition or brain disorders (stroke, Parkinson's disease…) preventing further participation - assessed by self-report
* Having high suicidality risk - assessed by clinical judgement, high total BDI-II score (\> 29) or score \>1 on a BDI-II of suicidality subscale
```

## Arms

- **iCBT-I + CAU** (EXPERIMENTAL) — Participants of this arm will get access to the course of the online cognitive-behavioral therapy for insomnia (iCBT-I) for 2 months along with the treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment
- **CAU** (ACTIVE_COMPARATOR) — Participants of this arm will get a treatment prescribed by a consulting doctor (care as usual - CAU). After the 2-month course participants will pass the post-treatment assessment followed by the 3-month follow-up and post-follow-up assessment. Then provided completion of all the assessments and satisfying eligibility criteria participants of this arm will get tha access to the 2-month iCBT-I course followed by the post-treatment assessment

## 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

## Primary Outcomes

- **Insomnia Severity Index (ISI)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_ — Change of ISI from pre- to post-treatment and post-follow-up. Change is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of insomnia severity.

The ISI is a seven-item insomnia assessment tool. The 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28)

## Secondary Outcomes

- **Sleep Onset Latency (SOL),** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Total Sleep Time (TST)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Sleep Efficiency (SE)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Wake After Sleep Onset (WASO)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Fatigue Severity Scale (FSS)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Short-form Survey (SF-12 Version 1.0)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Epworth Sleepiness Scale (ESS)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Beck Anxiety Inventory (BAI)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Beck Depression Inventory (BDI-II)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Sleep Hygiene Index (SHI)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Sleep Locus of Control Questionnaire (SLC)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ)** _(time frame: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)_
- **Success Expectancy** _(time frame: Once at baseline assessment)_
- **User Satisfaction** _(time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)_
- **System Usability Scale (SUS)** _(time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)_
- **Number of Completed Modules** _(time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)_
- **Total Time Spent on the iCBT-I Website** _(time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)_
- **Time Spent on Each Module** _(time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)_
- **Number of Completed Sleep Diaries** _(time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)_
- **Usage of the Support** _(time frame: After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)_
- **Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Risk Taking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Separation Insecurity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Submissiveness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Suspiciousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Unusual Beliefs Experience From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Withdrawal From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_
- **Anhedonia From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement** _(time frame: Once at baseline assessment)_

## Locations (3)

- Sleep medicine department, University clinical hospital 3, I.M.Sechenov First Moscow Medical University, Moscow, Moscow, Russia
- Stavropol regional somnological center, Stavropol, Stavropol Kray, Russia
- Kuzbass clinical veterans hospital, Kemerovo, Russia

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sleep medicine department, university clinical hospital 3, i.m.sechenov first moscow medical university|moscow|moscow|russia` — added _(2026-05-12)_
- `locations.stavropol regional somnological center|stavropol|stavropol kray|russia` — added _(2026-05-12)_
- `locations.kuzbass clinical veterans hospital|kemerovo||russia` — added _(2026-05-12)_

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