Sleep in Psychiatric Care (SIP): Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)

Not Applicable

Recruiting

• Conditions: Delayed Sleep-Wake Phase Disorder; Sleep Disorder; Psychiatric Disorder
• Interventions: Behavioral: Group-based light therapy at gradually advanced timing for DSWPD; Other: 6-week wait list for sleep-school; Behavioral: Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses

• Registration Number: NCT05177055
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2022-01-04
• Study Start: 2022-05-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-11
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
n=15, sleep-school 6 weeks	Group-based light therapy at gradually advanced timing for DSWPD	Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep-school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.
n=30 Six-week wait list for sleep-school	6-week wait list for sleep-school	Patients receive treatment as usual in the psychiatric clinic while they wait for participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.
n=15, sleep-school 6 weeks and additive bb-glasses	Group-based light therapy at gradually advanced timing for DSWPD	Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.
n=15, sleep-school 6 weeks and additive bb-glasses	Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses	Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Changes in objective sleep onset latency (SOL)	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of minutes of average sleep onset latency.
Changes in Sleep efficiency (SE)	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by sleep diary; total sleep time/time in bed x 100= percentage SE
Changes in Time in bed (TIB)	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by sleep diary; time from bed-time to rise time
Changes in immediate sleepiness	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by the Karolinska Sleepiness Scale (KSS). The KSS measure subjective sleepiness at a specific time point (noon). The scale gives a number from 1-9 where 9 indicates "trouble staying awake" and is the worst outcome.
Changes in objective total sleep length/time asleep (TST)	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average total sleep time.
Work status	baseline and post intervention after 6 weeks, follow-up after 12 months	Status of employment/unemployment, percentage disability benefits received
Changes in objective early morning awakening (EMA)	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes early morning awakening.
Changes in well-being	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by the World Health Organisation Five Well-Being Index (WHO-5)
Changes in sleepiness	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by the Epworth Sleepiness Scale (ESS). The ESS is an 8-item scale where the respondent grades the likelihood of falling asleep or dozing off in different daily situations. The responses are graded on a 4-point likert scale 0=no likelihood to 3=very likely. A score of 11 or higher is considered an indication of excessive daytime sleepiness.
Changes in objective wake after sleep onset (WASO)	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes awake after sleep onset.
Changes in Total sleep length/time asleep (TST)	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by sleep diary; time in minutes from bed-time to estimated sleep onset
Changes in Early morning awakening (EMA)	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by sleep diary; minutes awake before rise time
Changes in objective sleep efficiency (SE)	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number from 0-100% that gives average sleep efficiency.
Changes in beliefs about sleep	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by Dysfunctional Beliefs About Sleep (DBAS-16). The DBAS-16 measures the degree of dysfunctional beliefs about sleep with 16 items. It has 4 subscales (1) sleep-related worry and helplessness; 2) beliefs about sleep medications; 3) expectations about sleep need; and 4) beliefs about the consequences/effects of insomnia and 1 total scale score. The higher the score, the more dysfunctional beliefs about sleep.
Changes in objective time in bed (TIB)	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by Genactive. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average time in bed.
Changes in Sleep onset latency (SOL)	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by sleep diary; time in minutes from bed-time to estimated sleep onset
Changes in fatigue	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by the Chalders Fatigue Scale (CFS)
Changes in Sleep quality (SQ)	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by sleep diary; subjective assesment of sleep quality on a scale from 1=very light to 5=very deep
Changes in Wake after sleep onset (WASO)	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by sleep diary; minutes awake before rise time
Changes in depression symptoms	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by The Beck Depression Inventory-2 (BDI-II). The BDI measure subjective symptoms of depression on a scale ranging from 0-63. The higher the score, the worse depression.
Suicide attempts and admittances in psychiatric wards	baseline and post intervention after 6 weeks, follow-up after 12 months	Whether or not suicide has been attempted, if applicable number og attempts and whether or nor the patient has been admitted to a psychitaric ward (voluntary/forced)
Changes in anxiety and depression	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by the Hospital anxiety and depression scale (HADS), Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI)
Changes in anxiety symptoms	baseline and post intervention after 6 weeks, follow-up after 12 months	Measured by The Beck Anxiety Inventory (BAI). The BAI measure subjective symptoms of anxiety on a scale ranging from 0-63. The higher the score, the worse the anxiety.
Changes in Daytime function (DF)	baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months	Measured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway