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| ID | Type | Description | Link |
|---|---|---|---|
| 10.46540/3166-00056B | Other Grant/Funding Number | DFF: Independent Research Fund Denmark |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for insomnia | Experimental | 8-10 sessions CBT-I tailored for insomnia symptoms |
|
| Cognitive Behavioral Therapy | Active Comparator | 8-10 sessions CBT tailored for general psychopathology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I | Other | Cognitive therapy tailored for insomnia symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and negative syndrome scale (PANSS) | 32-items clinician administered rating scale measuring psychopathology. Range of score 30-210. Higher scores indicate higher level of symptoms | Baseline, after 12-weeks and 24-weeks. |
| WHO well being index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeppe F Johansen (investigator), Psychologist | Contact | +4538640885 | jeppe.feigenberg.johansen@regionh.dk | |
| Jimmi Nielsen, (Sponsor), MD | Contact | +4531326403 | jimmi.nielsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jimmi Nielsen, MD | Psykiatrisk Center Glostrup | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Centre Glostrup | Recruiting | Glostrup, Denmark | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26363701 | Background | 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. | |
| 29033618 |
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| ID | Term |
|---|---|
| D000090663 | Schizophrenia, Treatment-Resistant |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Sleep laboratory employees
| CBT | Other | Cognitive behavioral therapy for general psychopathology |
|
|
5-five items patient-entered questionnaire. Measuring quality of life. Range of score 0-100. Higher scores indicate better quality of life.
| Baseline, after 12-weeks and 24-weeks. |
| Global Assessment of Functioning (GAF) | Rating scale measuring level of functioning. Clinician administered. Range of score 0-100. Higher scores indicate higher level of functioning. | Baseline, after 12-weeks and 24-weeks. |
| Functioning Assessment Short Test (FAST) | Clinician administered rating scale measuring level of functioning. Range of score 0-72. Higher scores indicate lower level of functioning. | Baseline, after 12-weeks and 24-weeks. |
| Personal and Social Performance scale | Semi-structured interview. Measuring level of functioning. Range of score 0-100. Higher scores indicate higher level of functioning. | Baseline, after 12-weeks and 24-weeks. |
| Process of recovery questionnaire (QPR) | Questionnaire. Range 0-60. Higher scores indicate better outcome. | Baseline, after 12-weeks and 24-weeks. |
| Sleep onset latency (PSG) | Time until sleep verified by polysomnography. Measured in minutes. Increasing number is associated with poorer sleep. | Baseline and after 12-weeks. |
| Sleep efficiency (PSG) | Time with verified sleep divided by Time spent in bed and multiplied by 100. Measured by polysomnography. Higher percentage is associated with better sleep quality. | Baseline and after 12-weeks. |
| Wake after sleep onset, number of awakenings (PSG) | Number of wake periods after initial onset of sleep. Measured in number of awakenings . Higher number is associated with poorer sleep quality. | Baseline and after 12-weeks. |
| Wake after sleep onset, duration of wake periods (PSG) | Duration of wake periods after initial onset of sleep. Measured in minutes of duration. Longer duration is associated with poorer sleep quality. | Baseline and after 12-weeks. |
| Background |
| 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. |
| 30170114 | Background | 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. |
| 30202909 | Background | 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. |
| 30707986 | Background | 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. |
| 41998739 | Derived | 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. |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |