Cognitive Behavioral Therapy for Sleep Issues in Schizophrenia
Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
This study tests if a special type of therapy for sleep problems can help people with schizophrenia who have trouble sleeping feel better and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 1 site (Glostrup, Denmark) |
| Trial ID | NCT06749444 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) in patients with treatment-resistant schizophrenia who also experience sleep disturbances. Participants will be randomly assigned to receive either CBT-I focused on sleep issues or standard cognitive behavioral therapy addressing their overall psychopathology. The study will assess changes in sleep quality, psychotic symptoms, and quality of life over a 12-week period. The primary analysis will compare the outcomes between the two groups using repeated measure ANOVA.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with treatment-resistant schizophrenia or related psychoses who have persistent sleep difficulties.
Not a fit: Patients with recent psychiatric admissions or those with substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and reduce psychotic symptoms in patients with treatment-resistant schizophrenia.
How similar studies have performed: Other studies have shown promising results using cognitive behavioral therapy for insomnia in various populations, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Glostrup, Denmark
- Mental Health Centre Glostrup — Glostrup, Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Jeppe F Johansen (investigator), Psychologist
- Email: jeppe.feigenberg.johansen@regionh.dk
- Phone: +4538640885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.