N/A
Completed N=107
Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings
Source: ClinicalTrials.gov NCT04300218 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Insomnia Severity Index (ISI) — 10.0; 13.5; 11.3; 13.1 units on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) |
10.0; 13.5; 11.3; 13.1 | — |
| SECONDARY Sleep Onset Latency (SOL), |
28.2; 39.2; 33.3; 42.5 | — |
| SECONDARY Total Sleep Time (TST) |
6.9; 7.0; 7.3; 7.0 | — |
| SECONDARY Sleep Efficiency (SE) |
84.5; 81.9; 83.8; 80.2 | — |
| SECONDARY Wake After Sleep Onset (WASO) |
19.0; 28.0; 28.8; 29.3 | — |
| SECONDARY Fatigue Severity Scale (FSS) |
35.1; 40.6; 33.3; 38.3 | — |
| SECONDARY Short-form Survey (SF-12 Version 1.0) |
34.7; 33.1; 33.7; 32.8 | — |
| SECONDARY Epworth Sleepiness Scale (ESS) |
4.4; 4.1; 3.9; 4.0 | — |
| SECONDARY Beck Anxiety Inventory (BAI) |
7.0; 9.8; 8.3; 9.3 | — |
| SECONDARY Beck Depression Inventory (BDI-II) |
6.7; 10.2; 8.0; 10.3 | — |
| SECONDARY Sleep Hygiene Index (SHI) |
51.9; 49.8; 27.7; 28.5 | — |
| SECONDARY Sleep Locus of Control Questionnaire (SLC) |
38.5; 38.6; 39.8; 40.1 | — |
| SECONDARY Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) |
75.3; 95.8; 76.1; 99.3 | — |
| SECONDARY Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
2.43; 2.62 | — |
| SECONDARY Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption |
16500; 4896; 6263; 5959 | — |
| SECONDARY Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ) |
2449; 7238; 1196; 2853 | — |
| SECONDARY Success Expectancy |
6.3; 6.2 | — |
| SECONDARY User Satisfaction |
3.7; 5.0 | — |
| SECONDARY System Usability Scale (SUS) |
32.8; 10 | — |
| SECONDARY Number of Completed Modules |
6.54; 4.93 | — |
| SECONDARY Total Time Spent on the iCBT-I Website |
— | — |
| SECONDARY Time Spent on Each Module |
— | — |
| SECONDARY Number of Completed Sleep Diaries |
6.54; 4.93 | — |
| SECONDARY Usage of the Support |
9.44; 7.74 | — |
| SECONDARY Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
2.24; 2.04 | — |
| SECONDARY Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.26; 1.33 | — |
| SECONDARY Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.49; 1.57 | — |
| SECONDARY Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.23; 1.43 | — |
| SECONDARY Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
2.10; 2.27 | — |
| SECONDARY Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.67; 1.62 | — |
| SECONDARY Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.70; 1.79 | — |
| SECONDARY Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.65; 1.56 | — |
| SECONDARY Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.75; 2.01 | — |
| SECONDARY Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.69; 1.63 | — |
| SECONDARY Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.70; 1.82 | — |
| SECONDARY Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.34; 1.35 | — |
| SECONDARY Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.65; 1.65 | — |
| SECONDARY Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.16; 1.14 | — |
| SECONDARY Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
2.08; 2.24 | — |
| SECONDARY Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.91; 2.13 | — |
| SECONDARY Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
2.21; 2.28 | — |
| SECONDARY Risk Taking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.50; 1.52 | — |
| SECONDARY Separation Insecurity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
2.24; 2.49 | — |
| SECONDARY Submissiveness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
2.17; 2.16 | — |
| SECONDARY Suspiciousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.58; 1.57 | — |
| SECONDARY Unusual Beliefs Experience From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.24; 1.13 | — |
| SECONDARY Withdrawal From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.81; 2.08 | — |
| SECONDARY Anhedonia From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement |
1.69; 1.89 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT04300218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.