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NCT06749444 · ClinicalTrials.gov record · last posted 2026-01-20

Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia

Study acronym: COSTS
StatusRecruiting
PhaseNot applicable
Started2024-11-28
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 20, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
Using a randomized controlled design, the project aims to test if cognitive behavioral therapy interventions specifically targeting sleep disorders can significantly lessen the burden of the disrupted sleep in patients with treatment resistant schizophrenia (TRS) and by proxy lead to a reduction in psychotic symptoms and improvement in quality of life. We are including treatment-resistant patients with schizophrenia other nonorganic and chronic psychoses and in addition meeting the criteria of a sleep or circadian disorder. Included patients will be block randomized to either 8-10 sessions of CBT-I (active treatment) with a specific focus on sleep or 8-10 sessions of regularCBT with a specific focus on patients' psychopathology (treatment as usual) approx.1 session/week. After 12 weeks the full battery of assessments will be repeated forboth groups. Primary analyses will be to identify group-difference in changes using repeated measure ANOVA.

Amendment record 2 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 2 times since 2024-12-18; most recent amendment 2026-01-16. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT06749444
Lead Sponsor Jimmi Nielsen
Conditions Treatment-refractory Schizophrenia, Treatment-resistant Schizophrenia
Enrollment 60 participants
Start Date 2024-11-28
Primary Completion 2026-06-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-20