Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CBT-I, CBT.
- Who it may be relevant to
- Registry conditions: Treatment-refractory Schizophrenia, Treatment-resistant Schizophrenia. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other CBT-I
Cognitive therapy tailored for insomnia symptoms. - Other CBT
Cognitive behavioral therapy for general psychopathology
Primary outcome measures
- Insomnia severity index [Time frame: Baseline, after 12-weeks and 24-weeks.]
Secondary outcome measures (10)
- Positive and negative syndrome scale (PANSS) [Time frame: Baseline, after 12-weeks and 24-weeks.]
- WHO well being index [Time frame: Baseline, after 12-weeks and 24-weeks.]
- Global Assessment of Functioning (GAF) [Time frame: Baseline, after 12-weeks and 24-weeks.]
- Functioning Assessment Short Test (FAST) [Time frame: Baseline, after 12-weeks and 24-weeks.]
- Personal and Social Performance scale [Time frame: Baseline, after 12-weeks and 24-weeks.]
- Process of recovery questionnaire (QPR) [Time frame: Baseline, after 12-weeks and 24-weeks.]
- Sleep onset latency (PSG) [Time frame: Baseline and after 12-weeks.]
- Sleep efficiency (PSG) [Time frame: Baseline and after 12-weeks.]
- Wake after sleep onset, number of awakenings (PSG) [Time frame: Baseline and after 12-weeks.]
- Wake after sleep onset, duration of wake periods (PSG) [Time frame: Baseline and after 12-weeks.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Mental Health Centre Glostrup — Glostrup, Denmark
Publications
- 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- PMID 26363701
- 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. PMID 29033618
- 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. PMID 30170114
- 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. PMID 30202909
- 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. PMID 30707986
- Johansen JF, Nielsen MO, Kragh M, Nielsen J. Cognitive behavioral therapy for insomnia vs. standard cognitive behavioral therapy for sleep and circadian disturbances in treatment-resistant schizophrenia: study protocol for the randomized controlled trial (COSTS). Trials. 2026 Apr 17;27(1):309. doi: 10.1186/s13063-026-09482-0. PMID 41998739
Identifiers
NCT: NCT06749444 · H-24002249 · 10.46540/3166-00056B