NCT06749444

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jimmi Nielsen · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Treatment-refractory Schizophrenia
• Treatment-resistant Schizophrenia

Interventions

Type	Name	Description
OTHER	CBT-I	Cognitive therapy tailored for insomnia symptoms.
OTHER	CBT	Cognitive behavioral therapy for general psychopathology

Timeline

• Start date: 2024-11-28
• Primary completion: 2026-06-30
• Completion: 2027-04-30
• First posted: 2024-12-27
• Last updated: 2026-01-20

Locations

1 site across 1 country: Denmark