Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
COSTS
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2024
CompletedFirst Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
January 20, 2026
August 1, 2025
1.6 years
December 12, 2024
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia severity index
Patient-entered questionnaire measuring sleep difficulties. Seven items. Range of score 0-28. Higher scores indicate more severe insomnia.
Baseline, after 12-weeks and 24-weeks.
Secondary Outcomes (10)
Positive and negative syndrome scale (PANSS)
Baseline, after 12-weeks and 24-weeks.
WHO well being index
Baseline, after 12-weeks and 24-weeks.
Global Assessment of Functioning (GAF)
Baseline, after 12-weeks and 24-weeks.
Functioning Assessment Short Test (FAST)
Baseline, after 12-weeks and 24-weeks.
Personal and Social Performance scale
Baseline, after 12-weeks and 24-weeks.
- +5 more secondary outcomes
Study Arms (2)
Cognitive Behavioral Therapy for insomnia
EXPERIMENTAL8-10 sessions CBT-I tailored for insomnia symptoms
Cognitive Behavioral Therapy
ACTIVE COMPARATOR8-10 sessions CBT tailored for general psychopathology
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jimmi Nielsenlead
Study Sites (1)
Mental Health Centre Glostrup
Glostrup, Denmark, Denmark
Related Publications (5)
Freeman D, Waite F, Startup H, Myers E, Lister R, McInerney J, Harvey AG, Geddes J, Zaiwalla Z, Luengo-Fernandez R, Foster R, Clifton L, Yu LM. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial. Lancet Psychiatry. 2015 Nov;2(11):975-83. doi: 10.1016/S2215-0366(15)00314-4. Epub 2015 Sep 9.
PMID: 26363701BACKGROUNDKaskie RE, Graziano B, Ferrarelli F. Schizophrenia and sleep disorders: links, risks, and management challenges. Nat Sci Sleep. 2017 Sep 21;9:227-239. doi: 10.2147/NSS.S121076. eCollection 2017.
PMID: 29033618BACKGROUNDNucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment resistant schizophrenia: Clinical, biological, and therapeutic perspectives. Neurobiol Dis. 2019 Nov;131:104257. doi: 10.1016/j.nbd.2018.08.016. Epub 2018 Aug 29.
PMID: 30170114BACKGROUNDReeve S, Sheaves B, Freeman D. Sleep Disorders in Early Psychosis: Incidence, Severity, and Association With Clinical Symptoms. Schizophr Bull. 2019 Mar 7;45(2):287-295. doi: 10.1093/schbul/sby129.
PMID: 30202909BACKGROUNDRobertson I, Cheung A, Fan X. Insomnia in patients with schizophrenia: current understanding and treatment options. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jun 8;92:235-242. doi: 10.1016/j.pnpbp.2019.01.016. Epub 2019 Jan 29.
PMID: 30707986BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jimmi Nielsen, MD
Psykiatrisk Center Glostrup
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Sleep laboratory employees
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 12, 2024
First Posted
December 27, 2024
Study Start
November 28, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
January 20, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share