Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Launched by MENTAL HEALTH SERVICES IN THE CAPITAL REGION, DENMARK · Dec 18, 2024
Trial Information
Current as of July 04, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how cognitive behavioral therapy for insomnia (CBT-I) can help people with treatment-resistant schizophrenia who also struggle with sleep problems. The goal is to see if improving sleep can reduce psychotic symptoms and enhance overall quality of life. Participants will be randomly assigned to either receive 8-10 sessions of CBT-I focused on sleep issues or regular cognitive behavioral therapy that addresses their mental health in general.
To be eligible for this study, participants must be diagnosed with certain types of schizophrenia or related conditions, have had ongoing sleep difficulties for at least three months, and be on stable medication for at least a month. Those who have been hospitalized recently, have serious substance abuse issues, or use certain devices for sleep apnea won't be able to join. Over the course of 12 weeks, participants will attend weekly sessions and complete assessments to measure any changes in their sleep and mental health. This research aims to provide new insights into how addressing sleep problems can support individuals facing these challenging conditions.
Gender
ALL
Eligibility 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
About Mental Health Services In The Capital Region, Denmark
The Mental Health Services in the Capital Region of Denmark is a leading clinical trial sponsor dedicated to advancing psychiatric research and improving mental health care delivery. Operating within a robust healthcare framework, the organization focuses on innovative treatment methodologies and evidence-based practices, collaborating with multidisciplinary teams to conduct rigorous clinical trials. By prioritizing patient-centered outcomes and leveraging cutting-edge technology, the Mental Health Services aim to enhance therapeutic interventions and contribute to the global understanding of mental health disorders. Their commitment to research excellence fosters a culture of continuous improvement and collaboration, ultimately striving to elevate the standards of mental health services in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Glostrup, Denmark, , Denmark
Patients applied
Trial Officials
Jimmi Nielsen, MD
Study Director
Psykiatrisk Center Glostrup
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported