Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
NCT ID: NCT06749444
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-11-28
2027-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive Behavioral Therapy for insomnia
8-10 sessions CBT-I tailored for insomnia symptoms
CBT-I
Cognitive therapy tailored for insomnia symptoms.
Cognitive Behavioral Therapy
8-10 sessions CBT tailored for general psychopathology
CBT
Cognitive behavioral therapy for general psychopathology
Interventions
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CBT-I
Cognitive therapy tailored for insomnia symptoms.
CBT
Cognitive behavioral therapy for general psychopathology
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Substance abuse to a degree that will interfere with participation.
* Diagnoses of sleep apnea/CPAP use
18 Years
64 Years
ALL
No
Sponsors
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Jimmi Nielsen
OTHER
Responsible Party
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Jimmi Nielsen
Professor
Principal Investigators
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Jimmi Nielsen, MD
Role: STUDY_DIRECTOR
Psykiatrisk Center Glostrup
Locations
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Mental Health Centre Glostrup
Glostrup, Denmark, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Kaskie 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.
Nucifora 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.
Reeve 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.
Robertson 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.
Other Identifiers
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10.46540/3166-00056B
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-24002249
Identifier Type: -
Identifier Source: org_study_id
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