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RecruitingNCT04463498

Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia

Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Haukeland University Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGroup-based cognitive behavioral therapy for insomniaSleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques
BEHAVIORALGroup-based cognitive behavioral therapy for insomnia and additive bb-glassesSleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.
OTHER8-week wait list for sleep-schoolTreatment as usual in a psychiatric outpatient clinic

Timeline

Start date
2021-12-17
Primary completion
2026-12-31
Completion
2027-12-31
First posted
2020-07-09
Last updated
2024-06-18

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT04463498. Inclusion in this directory is not an endorsement.