Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia (COSTS)

Jimmi Nielsen

Status: Enrolling

Conditions: Treatment-resistant Schizophrenia; Treatment-refractory Schizophrenia

Treatments: Other: CBT; Other: CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT06749444

H-24002249

10.46540/3166-00056B (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Cognitive Behavioral Therapy for insomnia

Experimental group

Description:

8-10 sessions CBT-I tailored for insomnia symptoms

Treatment:

Other: CBT-I

Cognitive Behavioral Therapy

Active Comparator group

Description:

8-10 sessions CBT tailored for general psychopathology

Treatment:

Other: CBT