Sleep-Focused Talk Therapy Tested in Treatment-Resistant Schizophrenia
Tests a sleep-focused talk therapy against standard talk therapy in people with schizophrenia.
Plain-language title generated from the registry record
Registry title: Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Key facts
- Where
- Glostrup, Denmark, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT06749444, who can take part
Where in Denmark
- Mental Health Centre GlostrupGlostrup, Denmark, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jimmi Nielsen
- Trial code
- NCT06749444
- Record updated
- 20 January 2026
- Original description
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.Read full original descriptionShow less
Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
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.
Inclusion: 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.
Exclusion: Psychiatric admission last six months (more than 1 week or resulted in significant changes in psychopharmacological treatment); Substance abuse to a degree that will interfere with participation; Diagnoses of sleep apnea/CPAP use.