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New treatment option for Treatment-refractory Schizophrenia
Official title Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
ClinicalTrials.gov ID: NCT06749444
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Diagnosed with ICD-10 schizophrenia (DF20), chronic paranoid psychosis (DF22), schizo-affective disorder (DF25) or other non-organic psychosis...
- Treatment resistance according to TRRIP criteria
- Sleeping difficulties (minimum duration 3 months)
- ISI score \>14
- Stable psychopharmacological treatment the last month
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup, Denmark, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup, Denmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.