Clinical trial NCT06749444: Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Official title: Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment-refractory Schizophrenia
Treatment-resistant Schizophrenia
Keywords: Cognitive
CBT
Therapy
Insomnia
polysomnography
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Insomnia severity index
timeFrame: Baseline, after 12-weeks and 24-weeks.
Secondary outcomes:
measure: Positive and negative syndrome scale (PANSS)
timeFrame: Baseline, after 12-weeks and 24-weeks.
measure: WHO well being index
timeFrame: Baseline, after 12-weeks and 24-weeks.
measure: Global Assessment of Functioning (GAF)
timeFrame: Baseline, after 12-weeks and 24-weeks.
measure: Functioning Assessment Short Test (FAST)
timeFrame: Baseline, after 12-weeks and 24-weeks.
measure: Personal and Social Performance scale
timeFrame: Baseline, after 12-weeks and 24-weeks.
measure: Process of recovery questionnaire (QPR)
timeFrame: Baseline, after 12-weeks and 24-weeks.
measure: Sleep onset latency (PSG)
timeFrame: Baseline and after 12-weeks.
measure: Sleep efficiency (PSG)
timeFrame: Baseline and after 12-weeks.
measure: Wake after sleep onset (PSG)
timeFrame: Baseline and after 12-weeks.
Other outcomes:
Locations:
city: Glostrup, Denmark
country: Denmark
facility: Mental Health Centre Glostrup
Study officials:
affiliation: Psykiatrisk Center Glostrup
name: Jimmi Nielsen, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.