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

Sleep Disorder Clinical Trial

— SIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177055
• Other study ID #: 66304-2
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Haukeland University Hospital
• Contact: Ane Wilhelmsen-Langeland, PhD
• Phone: +47 55957000
• Email: ane.wilhelmsen-langeland[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delayed Sleep-Wake Phase Disorder
• Mental Disorders
• Parasomnias
• Problem Behavior
• Psychiatric Disorder
• Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Behavioral:
• Group-based light therapy at gradually advanced timing for DSWPD
Light therapy at gradually advanced timing, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques
• Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses
Light therapy (LT) at gradually advanced timing, bb-glasses 12 hrs after LT, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques

Other:
• 6-week wait list for sleep-school
Treatment as usual in a psychiatric outpatient clinic

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Tertnes
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in degree of experienced pain	Measured by a visual analogue scale (VAS Pain) ranging from 0 to 10. The higher the score, the worse the pain.	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	Changes in self reported emotion regulation ability	Measured by Difficulties in Emotion Regulation Scale (DERS) which is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores suggest greater problems with emotion regulation.	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	Changes in vigilance	Measured by the Conners Continuous Performance (CPT) Test 3rd Edition™ (Conners CPT 3™)	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	Changes in symptoms of inattention	Measured by the Adult attention deficit hyperactivity disorder (ADHD) Self-Rating Scale (ASRS). The scale contains the 18 symptoms of inattention, hyperactivity, and impulsivity defining ADHD according to the DSM-IV-TR and DSM-5. The severity of the symptoms are reported on a 5-point Likert-type scale (0-4 = never, rarely, sometimes, often, to very often), with a total range of 0-72. The higher the score, the more symptoms of inattention.	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	Changes in symptoms of hypochondria	Measured by the The Whiteley Index (WI). The 14-item WI measures assess health anxiety on a likert-scale from 1="not at all" to "5=very much". The higher the score, the more severe health anxiety.	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	Changes in blood pressure	We will measure systolic and diastolic pressure by a digital blood pressure measurement machine.	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	Changes in Heart rate variability (HRV)	24 -hour HRV.	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	Changes in work and social adjustment	Measured by the Work and Social Adjustment Scale (WSAS)	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	Changes in chronotype	Measured by the Munich Chrono Type Questionnaire (MCTQ)	baseline and post intervention after 6 weeks, follow-up after 12 months
Other	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Work status	Status of employment/unemployment, percentage disability benefits received	baseline and post intervention after 6 weeks, follow-up after 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in well-being	Measured by the World Health Organisation Five Well-Being Index (WHO-5)	baseline and post intervention after 6 weeks, follow-up after 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in fatigue	Measured by the Chalders Fatigue Scale (CFS)	baseline and post intervention after 6 weeks, follow-up after 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in depression symptoms	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.	baseline and post intervention after 6 weeks, follow-up after 12 months
Secondary	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
Secondary	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
Secondary	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