Cognitive Behavioral Therapy for Insomnia in Patients with Schizophrenia
Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia - A Randomized Controlled Clinical Trial (SLEEPINS)
This study tests whether cognitive behavioral therapy for insomnia can help people with schizophrenia sleep better and feel healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki, Uusimaa) |
| Trial ID | NCT04144231 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) in improving sleep quality and overall well-being in patients with schizophrenia and schizoaffective disorder. Participants will be randomized into three groups: treatment as usual, internet-based CBT-I, and group CBT-I. The study will also assess various factors associated with sleep and well-being in these patients. By utilizing both individual and group therapy formats, the research seeks to provide accessible treatment options for insomnia in this population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with schizophrenia or schizoaffective disorder who experience sleep problems and are currently receiving psychiatric care.
Not a fit: Patients currently undergoing cognitive-behavioral psychotherapy or those with diagnosed sleep disorders like sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sleep quality and overall quality of life for patients with schizophrenia.
How similar studies have performed: Previous studies have shown that CBT-I can be effective for patients with major psychiatric disorders, but randomized clinical trials specifically for schizophrenia are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: To participate in the study, patients must meet the following criteria: 1. Have previously participated in the nationwide SUPER Finland study (www.superfinland.fi, a study on genetic mechanisms of psychotic disorders and a part of the Stanley Global Initiative) and have given permission for subsequent contact. 2. Be currently in psychiatric care at HUS 3. Be 18 years of age or older 4. Have a serious mental disorder (schizophrenia or schizoaffective disorder) 5. Have a stable medical condition 6. Have self-reported sleep problems: difficulty falling asleep, difficulty staying asleep, poor quality of sleep, or dissatisfaction with sleep 7. Have access to an electronic inquiry and treatment program and use of e-mail 8. Be able to participate in a sleep group if randomized. Exclusion Criteria: Exclusion criteria include: 1. ongoing cognitive-behavioral psychotherapy 2. diagnosed sleep disorder such as sleep apnea 3. insufficient Finnish language skills (insomnia interventions are produced in Finnish, so good Finnish language skills are required)
Where this trial is running
Helsinki, Uusimaa
- Helsinki University Central Hospital — Helsinki, Uusimaa, Finland (Recruiting)
Study contacts
- Principal investigator: Tiina M. Paunio, M.D., Ph.D. — Helsinki University Central Hospital
- Study coordinator: Tiina M. Paunio, M.D., Ph.D.
- Email: tiina.paunio@helsinki.fi
- Phone: +358503507936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.