Interventional Recruiting
NCT05177055 on ClinicalTrials.gov
Sleep in Psychiatric Care (SIP): Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)
Official title: Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)
- Sponsor: Haukeland University Hospital
- Collaborators: University of Bergen
- Enrollment: 60 (Estimated)
- Study start: 2022-05-23 (Actual)
- Primary completion: 2026-12-31 (Estimated)
- Study completion: 2027-12-31 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Single (Participant)
- PrimaryPurpose: Treatment
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 recommended treatment for Delayed Sleep-Wake phase disorder is light therapy at gradually advanced timing and/or melatonin administered in order to help phase-advance the circadian rhythm. There is a great gap in the knowledge on how sleep disorders can be treated effectively when they occur comorbid to moderate and severe psychiatric illness. In this project the we therefore seek to investigate the effect of psychological and behavioural, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures.
Conditions
- Delayed Sleep-Wake Phase Disorder
- Sleep Disorder
- Psychiatric Disorder
Intervention / Treatment
- Behavioral: Group-based light therapy at gradually advanced timing for DSWPD
- Behavioral: Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses
- Other: 6-week wait list for sleep-school
Primary Outcome Measures
-
Changes (advancement) of sleep timing
(baseline, post intervention after 6 weeks, follow-up after 12 months)
Measured by sleep diaries, Genactiv actigraphy and saliva samples (intraindividual variation of rise time (IIV), dim light melatonin onset (DLMO), rise /wake up time)
Countries
Norway
Locations and Investigators
-
Haukeland University Hospital, Bergen, Norway (Recruiting)
- Ane Wilhelmsen-Langeland, PhD
- Veronika A VÃ¥genes, BA
-
Haukeland University Hospital, Bergen, Norway (Recruiting)
- Ane Wilhelmsen-Langeland, PhD
- Berge Osnes, PhD
Study Officials
- Ane Wilhelmsen-Langeland, PhD (Principal Investigator) — Haukeland University Hospital