Clinical trial NCT05177055: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delayed Sleep-Wake Phase Disorder
Sleep Disorder
Psychiatric Disorder
Keywords: Sleep disorders
Delayed sleep-wake phase disorder
blue-blocking glasses
psychiatric disorders
group-based treatment for circadian rhythm sleep disorder
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2022-01-04
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
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 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.

Detailed description: The recommended treatment for Delayed Sleep-Wake phase disorder is bright light therapy (LT) at gradually advanced timing and/or melatonin administered in order to phase-advance the circadian rhythm. 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 advancing effect on the circadian rhythm. The investigators therefore also want to test bb-glasses as an additive treatment to LT at gradually advanced timing.

The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The DSWPD-group gets together every other Monday from 1 pm until 3 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 treatment, this often leads the group to function as a support for each other. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS in Bergen, Norway. Participants 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, hence the project has high ecological validity.

All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, sleep-diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based LT at gradually advanced timing. 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 6 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 on 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, hence both groups are in active treatment for their symptoms. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based LT at gradually advanced timing for 6 weeks or b) group-based group-based LT at gradually advanced timing for 6 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 DSWPD 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 DSWPD 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:

* Night work
* Patients that do not fulfil the DSM-V criteria for DSWPD 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: Changes (advancement) of sleep timing
timeFrame: baseline, post intervention after 6 weeks, follow-up after 12 months
Secondary outcomes:
measure: Changes in objective sleep onset latency (SOL)
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Sleep efficiency (SE)
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Time in bed (TIB)
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in immediate sleepiness
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in objective total sleep length/time asleep (TST)
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Work status
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Total sleep length/time asleep (TST)
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Early morning awakening (EMA)
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in objective sleep efficiency (SE)
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in objective early morning awakening (EMA)
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in well-being
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in sleepiness
timeFrame: baseline, bi-weekly assesment and post intervention after 6 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 beliefs about sleep
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Sleep onset latency (SOL)
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in objective time in bed (TIB)
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in fatigue
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Sleep quality (SQ)
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Wake after sleep onset (WASO)
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in anxiety symptoms
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in depression symptoms
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Daytime function (DF)
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
measure: Suicide attempts and admittances in psychiatric wards
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in anxiety and depression
timeFrame: baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months
Other outcomes:
measure: Changes in degree of experienced pain
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in self reported emotion regulation ability
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in vigilance
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in symptoms of inattention
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in symptoms of hypochondria
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in blood pressure
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in Heart rate variability (HRV)
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in work and social adjustment
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Changes in chronotype
timeFrame: baseline and post intervention after 6 weeks, follow-up after 12 months
measure: Client Satisfaction
timeFrame: post intervention after 6 weeks
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Tertnes
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Ane Wilhelmsen-Langeland, PhD
role: PRINCIPAL_INVESTIGATOR
References: