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NCT04463498: SIP
Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
NA trial testing Group-based cognitive behavioral therapy for insomnia in Sleep Disorder; Insomnia Type in 60 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Haukeland University Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 17 December 2021 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Group-based cognitive behavioral therapy for insomnia
- Group-based cognitive behavioral therapy for insomnia and additive bb-glasses
- 8-week wait list for sleep-school
Conditions studied
- Sleep Disorder; Insomnia Type — all drugs for Sleep Disorder; Insomnia Type →
- Psychiatric Disorders — all drugs for Psychiatric Disorders →
Sponsor
Haukeland University Hospital
Who can join
Adults 18 to 80, any sex, with Sleep Disorder; Insomnia Type or Psychiatric Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Blue-light filtering spectacle lenses for visual performance, sleep, and macular health in adults.
Singh S, Keller PR, Busija L, McMillan P, et al · · 2023 · cited 23× · PMID 37593770 · DOI 10.1002/14651858.cd013244.pub2 -
Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial.
Wilhelmsen-Langeland A, Saxvig IW, Gradisar M, Vågenes VA, et al · · 2025 · PMID 40250874 · DOI 10.1136/bmjopen-2024-090997
Verify or expand the search:
- PubMed search for NCT04463498
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04463498 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Haukeland University Hospital
- Last refreshed: 18 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04463498.
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