Status:
COMPLETED
Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Collaborating Sponsors:
University of Bern
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18-80 years
Phase:
NA
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 iCB...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04300218
Start Date
March 5 2020
End Date
September 1 2023
Last Update
January 7 2026
Active Locations (3)
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1
Sleep medicine department, University clinical hospital 3, I.M.Sechenov First Moscow Medical University
Moscow, Moscow, Russia, 119021
2
Stavropol regional somnological center
Stavropol, Stavropol Kray, Russia
3
Kuzbass clinical veterans hospital
Kemerovo, Russia