Group-based treatment for insomnia in psychiatric patients
Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
This study is testing a group therapy program for insomnia to see if it helps people with sleep problems and mental health issues feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen) |
| Trial ID | NCT04463498 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a group-based cognitive behavioral therapy for insomnia (CBTi) program for patients with comorbid insomnia and psychiatric disorders. Participants will receive education on sleep regulation and hygiene, and will be randomly assigned to either the CBTi group or a group receiving CBTi with the addition of blue-blocking glasses. The program is conducted at the sleep-school at Bjørgvin District Psychiatric Hospital, where patients meet bi-weekly for treatment. The primary outcomes measured will be improvements in sleep and psychiatric symptoms.
Who should consider this trial
Good fit: Ideal candidates are patients referred to the sleep-school who meet DSM-V criteria for insomnia comorbid with moderate to severe psychiatric illness.
Not a fit: Patients who work night shifts or do not meet the DSM-V criteria for insomnia comorbid with psychiatric illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall mental health for patients with insomnia and psychiatric disorders.
How similar studies have performed: Other studies have shown promising results for group-based CBTi in similar populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital * Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the International Statistical Classification of Diseases and Related Health Problems (ICD-11) diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school) Exclusion Criteria: * Nightwork * Patients that do not fulfil the DSM-V criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
Where this trial is running
Bergen
- Haukeland University Hospital — Bergen, Norway (Recruiting)
Study contacts
- Principal investigator: Ane Wilhelmsen-Langeland, PhD — Haukeland University Hospital
- Study coordinator: Ane Wilhelmsen-Langeland, PhD
- Email: ane.wilhelmsen-langeland@helse-bergen.no
- Phone: +47 55957000
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.