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Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Mental Health Centre Glostrup
RECRUITING
Glostrup, Denmark
Contact Information
Primary
Jeppe F Johansen (investigator), Psychologist
jeppe.feigenberg.johansen@regionh.dk
+4538640885
Backup
Jimmi Nielsen, (Sponsor), MD
jimmi.nielsen@regionh.dk
+4531326403
Time Frame
Start Date: 2024-11-28
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 60
Treatments
Experimental: Cognitive Behavioral Therapy for insomnia
8-10 sessions CBT-I tailored for insomnia symptoms
Active_comparator: Cognitive Behavioral Therapy
8-10 sessions CBT tailored for general psychopathology
Related Therapeutic Areas
Sponsors
Leads: Jimmi Nielsen

This content was sourced from clinicaltrials.gov