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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)

Conditions
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Delayed Sleep-Wake Phase Disorder, Sleep Disorder, Psychiatric Disorder

Intervention / Treatment
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* Behavioral: Group-based light therapy at gradually advanced timing for DSWPD
* Behavioral: Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses
* Other: 6-week wait list for sleep-school


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: n=15, sleep-school 6 weeks<br>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. | Behavioral: Group-based light therapy at gradually advanced timing for DSWPD<br>* Light therapy at gradually advanced timing, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques<br>* Other names: Group-LT at gradually advanced timing;|
| Experimental: n=15, sleep-school 6 weeks and additive bb-glasses<br>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. | Behavioral: Group-based light therapy at gradually advanced timing for DSWPD<br>* Light therapy at gradually advanced timing, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques<br>* Other names: Group-LT at gradually advanced timing;Behavioral: Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses<br>* Light therapy (LT) at gradually advanced timing, bb-glasses 12 hrs after LT, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques<br>* Other names: Group-LT at gradually advanced timing & bb-glasses;|
| Active Comparator: n=30 Six-week wait list for sleep-school<br>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. | Other: 6-week wait list for sleep-school<br>* Treatment as usual in a psychiatric outpatient clinic<br>* Other names: Treatment as usual (TAU);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes (advancement) of sleep timing | Measured by sleep diaries, Genactiv actigraphy and saliva samples (intraindividual variation of rise time (IIV), dim light melatonin onset (DLMO), rise /wake up time) | baseline, post intervention after 6 weeks, follow-up after 12 months | 
| Changes in anxiety and depression | Measured by the Hospital anxiety and depression scale (HADS), Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI) | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in objective sleep onset latency (SOL) | 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. | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in Sleep efficiency (SE) | Measured by sleep diary; total sleep time/time in bed x 100= percentage SE | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in Time in bed (TIB) | Measured by sleep diary; time from bed-time to rise time | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in immediate sleepiness | 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. | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in objective total sleep length/time asleep (TST) | 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. | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Work status | Status of employment/unemployment, percentage disability benefits received | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in Total sleep length/time asleep (TST) | Measured by sleep diary; time in minutes from bed-time to estimated sleep onset | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in Early morning awakening (EMA) | Measured by sleep diary; minutes awake before rise time | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in objective sleep efficiency (SE) | 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. | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in objective early morning awakening (EMA) | 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. | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in sleepiness | 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. | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in objective wake after sleep onset (WASO) | 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. | baseline and post intervention after 8 weeks, follow-up after 12 months | 
| Changes in beliefs about sleep | 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. | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in objective time in bed (TIB) | 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. | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in Sleep onset latency (SOL) | Measured by sleep diary; time in minutes from bed-time to estimated sleep onset | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in Sleep quality (SQ) | Measured by sleep diary; subjective assesment of sleep quality on a scale from 1=very light to 5=very deep | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in Wake after sleep onset (WASO) | Measured by sleep diary; minutes awake before rise time | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in anxiety symptoms | 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. | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Changes in depression symptoms | Measured by The Beck Depression Inventory (BDI). The BDI measure subjective symptoms of depression on a scale ranging from 0-63. The higher the score, the worse depression. | baseline and post intervention after 6 weeks, follow-up after 12 months | 
| Client Satisfaction | Measured by the Client Satisfaction Questionnaire (CSQ8). The CSQ-8 is an 8-item questionnaire that measures patient satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very high satisfaction). The total score ranges from 8 to 32, with higher scores indicating higher degrees of satisfaction. | post intervention after 6 weeks | 
| Changes in Daytime function (DF) | Measured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor | baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months | 
| Suicide attempts and admittances in psychiatric wards | 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) | baseline and post intervention after 6 weeks, follow-up after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep disorders, Delayed sleep-wake phase disorder, blue-blocking glasses, psychiatric disorders, group-based treatment for circadian rhythm sleep disorder