Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Sleep Disorder; Insomnia Type, Psychiatric Disorders. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
Overview
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.
Detailed description
The recommended treatment for insomnia is CBTi. Recent research has proven that dark therapy, or blocking light in wavelengths \<530 nm by the use of for example orange blue-blocking glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to darkness and to have an additive effect in the treatment of insomnia. The investigators therefore also want to test bb-glasses as an additive treatment to CBTi for insomnia.
The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The insomnia-group gets together every other Monday from noon until 2 pm. The group is open, which means that participants start at different dates and meet people in the group that might be at the end of their CBTi treatment. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS. Participant have been referred to the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on the same structure for the group for participants that are recruited to the RCT.
All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based CBTi treatment. In a randomized manner, they will be allocated to the sleep-school group and start the treatment on the next possible date or to a 8 week wait-list and receive a date the treatment starts. All eligible participants will be informed that there may be a waitlist and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for their psychiatric problems parallel to either sleep-school or waitlist. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based CBTi 8 weeks or b) group-based CBTi 8 weeks and bb-glasses. All participant will be followed up after 12 months.
Interventions
- Behavioral Group-based cognitive behavioral therapy for insomnia
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques - Behavioral Group-based cognitive behavioral therapy for insomnia and additive bb-glasses
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime. - Other 8-week wait list for sleep-school
Treatment as usual in a psychiatric outpatient clinic
Primary outcome measures
- Insomnia symptoms [Time frame: baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months]
Secondary outcome measures (12)
- Changes in insomnia diagnosis [Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months]
- Changes in insomnia severity [Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months]
- Changes in Time in bed (TIB) [Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
- Changes in objective early morning awakening (EMA) [Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months]
- Changes in objective wake after sleep onset (WASO) [Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months]
- Changes in Early morning awakening (EMA) [Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
- Changes in objective time in bed (TIB) [Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months]
- Changes in objective sleep efficiency (SE) [Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months]
- Changes in objective total sleep length/time asleep (TST), [Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months]
- Changes in Total sleep length/time asleep (TST) [Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
- Changes in Sleep quality (SQ) [Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
- Changes in Daytime function (DF) [Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Haukeland University Hospital — Bergen
Publications
- Wilhelmsen-Langeland A, Saxvig IW, Gradisar M, Vagenes VA, Pallesen S, Sorensen L, Fasmer OB, Koenig J, Bjorvatn B, Osnes B. 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. BMJ Open. 2025 Apr 17;15(4):e090997. doi: 10.1136/bmjopen-2024-090997. PMID 40250874
Identifiers
NCT: NCT04463498 · 66304