NCT04463498 Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
| NCT ID | NCT04463498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Sleep Disorder; Insomnia Type |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-12-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-12-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The most common and best documented treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi). There is a great gap in the knowledge on how sleep disorders can be treated effectively in psychiatric care. In this project the investigators therefore seek to investigate the effect of non-pharmacological, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures. CBTi comprise of sleep education, sleep restriction, stimulus control and cognitive restructuring of dysfunctional thoughts about sleep.
Eligibility 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)
Contact & Investigator
Ane Wilhelmsen-Langeland, PhD
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT04463498 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Sleep Disorder; Insomnia Type. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04463498 currently recruiting?
Yes, NCT04463498 is actively recruiting participants. Contact the research team at ane.wilhelmsen-langeland@helse-bergen.no for enrollment information.
Where is the NCT04463498 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT04463498 clinical trial?
NCT04463498 is sponsored by Haukeland University Hospital. The principal investigator is Ane Wilhelmsen-Langeland, PhD at Haukeland University Hospital. The trial plans to enroll 60 participants.
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