NCT06749444Recruiting
Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- 28 Nov 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Jimmi Nielsen
- Diseases
- Schizophrenia
- NCT number
- NCT06749444
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 28 Nov 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Psychiatric admission last six months (more than 1 week or resulted in significant changes in psychopharmacological treatment)
Other
- Substance abuse to a degree that will interfere with participation.
- Diagnoses of sleep apnea/CPAP use
Who the study is looking for
- Diagnosed with ICD-10 schizophrenia (DF20), chronic paranoid psychosis (DF22), schizo-affective disorder (DF25) or other non-organic psychosis (DF28-DF29)
- Treatment resistance according to TRRIP criteria
- Sleeping difficulties (minimum duration 3 months)
- ISI score \>14
- Stable psychopharmacological treatment the last month
- Only legal competent patient can participant
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mental Health Centre Glostrup Coordinator of this site? Confirm its status | Glostrup, Denmark | Denmark | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.