Clinical trial NCT04463498: Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
Official title: Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disorder; Insomnia Type
Psychiatric Disorders
Keywords: sleep disorders
insomnia
psychiatric disorders
bb-glasses
group-based cognitive behavioural therapy for insomnia
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2020-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: 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 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.

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)

Primary outcomes:
measure: Insomnia symptoms
timeFrame: baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months
Secondary outcomes:
measure: Changes in insomnia diagnosis
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in insomnia severity
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in Time in bed (TIB)
timeFrame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in objective early morning awakening (EMA)
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in objective wake after sleep onset (WASO)
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in Early morning awakening (EMA)
timeFrame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in objective time in bed (TIB)
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in objective sleep efficiency (SE)
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in objective total sleep length/time asleep (TST),
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in Total sleep length/time asleep (TST)
timeFrame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in Sleep quality (SQ)
timeFrame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in Daytime function (DF)
timeFrame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in objective sleep onset latency (SOL)
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in beliefs and attitudes about sleep
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in depression
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in anxiety
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in fatigue
timeFrame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
measure: Work status
timeFrame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
measure: Well-being
timeFrame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
Other outcomes:
measure: Changes in symptoms of inattention
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in vigilance
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in self reported emotion regulation ability
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in degree of experienced pain
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in symptoms of hypochondria
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in executive functions
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in blood pressure
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in Heart rate variability (HRV)
timeFrame: baseline and post intervention after 8 weeks, follow-up after 12 months
measure: Client Satisfaction
timeFrame: post intervention after 8 weeks
measure: Changes in sleepiness
timeFrame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
measure: Changes in immediate sleepiness
timeFrame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
measure: Suicide attempts and admittances in psychiatric wards
timeFrame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Ane Wilhelmsen-Langeland, PhD
role: PRINCIPAL_INVESTIGATOR
References: