Condition: Treatment-refractory Schizophrenia · Treatment-resistant Schizophrenia · Sponsor: Jimmi Nielsen
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.
This description comes directly from the study's public registry record.
Jeppe F Johansen (investigator), Psychologist · +4538640885 · jeppe.feigenberg.johansen@regionh.dk
Jimmi Nielsen, (Sponsor), MD · +4531326403 · jimmi.nielsen@regionh.dk
Always discuss trial participation with your own doctor first.
| Mental Health Centre Glostrup | Glostrup, Denmark, Denmark | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06749444