RecruitingNot ApplicableNCT06749444

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

Sponsor

Jimmi Nielsen

Enrollment

60 participants

Start Date

Nov 28, 2024

Study Type

INTERVENTIONAL

Conditions

Treatment-Refractory Schizophrenia Treatment-resistant Schizophrenia

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing cognitive behavioral therapy for insomnia and sleep disruptions (CBT-I) — a structured, non-medication approach that helps people change the thoughts and behaviors contributing to poor sleep — in people with treatment-resistant schizophrenia or related psychotic disorders who also have significant sleep problems. **You may be eligible if...** - You have been diagnosed with schizophrenia, chronic paranoid psychosis, schizoaffective disorder, or a related non-organic psychosis - Your condition is considered treatment-resistant (not responding adequately to medications) - You have had sleeping difficulties lasting at least 3 months - Your insomnia is rated as moderate to severe on a standard scale (ISI score above 14) - Your psychiatric medications have been stable for at least one month - You are legally competent to consent **You may NOT be eligible if...** - You have been psychiatrically hospitalized in the last 6 months - You have a substance use disorder that would interfere with participation - You have been diagnosed with sleep apnea or use a CPAP machine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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