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

Not Applicable

Recruiting

• Conditions: Treatment-refractory Schizophrenia; Treatment-resistant Schizophrenia

• Registration Number: NCT06749444
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-06-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia severity index	Baseline, after 12-weeks and 24-weeks.	Patient-entered questionnaire measuring sleep difficulties. Seven items. Range of score 0-28. Higher scores indicate more severe insomnia.

Secondary Outcome Measures

Name	Time	Method
Positive and negative syndrome scale (PANSS)	Baseline, after 12-weeks and 24-weeks.	32-items clinician administered rating scale measuring psychopathology. Range of score 30-210. Higher scores indicate higher level of symptoms
WHO well being index	Baseline, after 12-weeks and 24-weeks.	5-five items patient-entered questionnaire. Measuring quality of life. Range of score 0-100. Higher scores indicate better quality of life.
Global Assessment of Functioning (GAF)	Baseline, after 12-weeks and 24-weeks.	Rating scale measuring level of functioning. Clinician administered. Range of score 0-100. Higher scores indicate higher level of functioning.
Functioning Assessment Short Test (FAST)	Baseline, after 12-weeks and 24-weeks.	Clinician administered rating scale measuring level of functioning. Range of score 0-72. Higher scores indicate lower level of functioning.
Personal and Social Performance scale	Baseline, after 12-weeks and 24-weeks.	Semi-structured interview. Measuring level of functioning. Range of score 0-100. Higher scores indicate higher level of functioning.
Process of recovery questionnaire (QPR)	Baseline, after 12-weeks and 24-weeks.	Questionnaire. Range 0-60. Higher scores indicate better outcome.
Sleep onset latency (PSG)	Baseline and after 12-weeks.	Time until sleep verified by polysomnography. Measured in minutes. Increasing number is associated with poorer sleep.
Sleep efficiency (PSG)	Baseline and after 12-weeks.	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.
Wake after sleep onset (PSG)	Baseline and after 12-weeks.	Number and duration of wake periods after initial onset of sleep. Measured in number of awakenings and minutes of duration. Higher of each is associated with poorer sleep quality.

Trial Locations

Locations (1)

Mental Health Centre Glostrup; 🇩🇰 Glostrup, Denmark, Denmark