Cognitive Behavioral Therapy for Sleep Issues in Schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) in patients with treatment-resistant schizophrenia who also experience sleep disturbances. Participants will be randomly assigned to receive either CBT-I focused on sleep issues or standard cognitive behavioral therapy addressing their overall psychopathology. The study will assess changes in sleep quality, psychotic symptoms, and quality of life over a 12-week period. The primary analysis will compare the outcomes between the two groups using repeated measure ANOVA.

Why it matters

Who can join: the full rules

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

Where it's running

• Mental Health Centre Glostrup
  Glostrup, Denmark, Denmark Recruiting

Study contacts

• Study coordinator: Jeppe F Johansen (investigator), Psychologist
• Email: jeppe.feigenberg.johansen@regionh.dk
• Phone: +4538640885

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sequential Treatment Approaches for Treatment-Resistant Schizophrenia in Chinese Patients

  This trial tests whether clozapine-based drug therapy or neuromodulation with MECT or MST is better for adults in China who have treatment-resistant schizophrenia.

  Recruiting Phase 3 Shanghai Mental Health Center · Shanghai, Shanghai Municipality · NCT07918222

• Nitraria Retusa Infusion for Clozapine-Related Metabolic Side Effects in Treatment-Resistant Schizophrenia

  A daily Nitraria retusa leaf infusion is tested for 90 days to see if it helps with metabolic side effects in people with treatment-resistant schizophrenia who are taking clozapine.

  Recruiting Faculty of Medicine, Sousse · Sousse · NCT07817069

• Evenamide added to standard antipsychotic treatment for treatment-resistant schizophrenia

  This 12-week randomized, double-blind test will see if adding evenamide (15 mg twice daily) to a patient’s current antipsychotic helps adults with treatment-resistant schizophrenia improve symptoms compared with placebo.

  Recruiting at 10 sites Phase 3 Newron Pharmaceuticals SPA · Los Angeles, California and 18 other locations · NCT07184619

• Magnetic seizure therapy versus electroconvulsive therapy for treatment‑resistant schizophrenia

  This trial will test whether magnetic seizure therapy works as well as a specific form of electroconvulsive therapy for adults whose schizophrenia or schizoaffective disorder has not improved with medications.

  Recruiting at 2 sites Centre for Addiction and Mental Health · Vancouver, British Columbia and 1 other locations · NCT06672588

• Using maintenance electroconvulsive therapy for treatment-resistant schizophrenia

  This study is testing if adding maintenance electroconvulsive therapy to clozapine can help people with treatment-resistant schizophrenia stay well longer and improve their quality of life.

  Recruiting Central Institute of Mental Health, Mannheim · Aachen and 13 other locations · NCT06456983

• Reducing auditory-verbal hallucinations in schizophrenia using brain stimulation

  This study is testing a new brain stimulation method to see if it can help people with schizophrenia who hear voices and haven't found relief with regular medications.

  Recruiting Centre Hospitalier St Anne · Paris · NCT06361160

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.