Actively Recruiting
Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Led by Jimmi Nielsen · Updated on 2026-01-20
60
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ICD-10 schizophrenia (DF20), chronic paranoid psychosis (DF22), schizo-affective disorder (DF25), or other non-organic psychosis (DF28-DF29)
- Meet treatment resistance according to TRRIP criteria
- Have sleep difficulties lasting at least 3 months
- Have an Insomnia Severity Index (ISI) score greater than 14
- Have had stable psychopharmacological treatment for at least one month
- Be legally competent to give consent and participate
You will not qualify if you...
- Psychiatric admission in the last six months lasting more than one week or causing significant medication changes
- Substance abuse that interferes with participation
- Diagnosis of sleep apnea or current use of CPAP therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mental Health Centre Glostrup
Glostrup, Denmark, Denmark
Actively Recruiting
Research Team
J
Jeppe F Johansen (investigator), Psychologist
CONTACT
J
Jimmi Nielsen, (Sponsor), MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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