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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05177055
Acronym
SIP
Enrollment
60
Registered
2022-01-04
Start date
2022-05-23
Completion date
2027-12-31
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sleep disorders, Delayed sleep-wake phase disorder, blue-blocking glasses, psychiatric disorders, group-based treatment for circadian rhythm sleep disorder

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.

Interventions

BEHAVIORALGroup-based light therapy at gradually advanced timing for DSWPD

Light therapy at gradually advanced timing, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques

BEHAVIORALGroup-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

OTHER6-week wait list for sleep-school

Treatment as usual in a psychiatric outpatient clinic

Sponsors

University of Bergen
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

All eligible participants will be informed that there may be a waitlist (length not specified) and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Changes (advancement) of sleep timingbaseline, post intervention after 6 weeks, follow-up after 12 monthsMeasured by sleep diaries, Genactiv actigraphy and saliva samples (intraindividual variation of rise time (IIV), dim light melatonin onset (DLMO), rise /wake up time)

Secondary

MeasureTime frameDescription
Changes in Early morning awakening (EMA)baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 monthsMeasured by sleep diary; minutes awake before rise time
Changes in Sleep onset latency (SOL)baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 monthsMeasured by sleep diary; time in minutes from bed-time to estimated sleep onset
Changes in objective time in bed (TIB)baseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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 fatiguebaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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 monthsMeasured 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 monthsMeasured by sleep diary; minutes awake before rise time
Changes in anxiety symptomsbaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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 depression symptomsbaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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.
Changes in Daytime function (DF)baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 monthsMeasured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor
Suicide attempts and admittances in psychiatric wardsbaseline and post intervention after 6 weeks, follow-up after 12 monthsWhether 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 depressionbaseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 monthsMeasured by the Hospital anxiety and depression scale (HADS), Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI)
Changes in objective sleep onset latency (SOL)baseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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 monthsMeasured 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 monthsMeasured by sleep diary; time from bed-time to rise time
Changes in immediate sleepinessbaseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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 monthsMeasured 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 statusbaseline and post intervention after 6 weeks, follow-up after 12 monthsStatus of employment/unemployment, percentage disability benefits received
Changes in Total sleep length/time asleep (TST)baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 monthsMeasured by sleep diary; time in minutes from bed-time to estimated sleep onset
Changes in objective sleep efficiency (SE)baseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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 objective early morning awakening (EMA)baseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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-beingbaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured by the World Health Organisation Five Well-Being Index (WHO-5)
Changes in sleepinessbaseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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 monthsMeasured 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 beliefs about sleepbaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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.

Other

MeasureTime frameDescription
Changes in vigilancebaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured by the Conners Continuous Performance (CPT) Test 3rd Edition™ (Conners CPT 3™)
Changes in symptoms of inattentionbaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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.
Changes in symptoms of hypochondriabaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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.
Changes in blood pressurebaseline and post intervention after 6 weeks, follow-up after 12 monthsWe will measure systolic and diastolic pressure by a digital blood pressure measurement machine.
Changes in Heart rate variability (HRV)baseline and post intervention after 6 weeks, follow-up after 12 months24 -hour HRV.
Changes in work and social adjustmentbaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured by the Work and Social Adjustment Scale (WSAS)
Changes in chronotypebaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured by the Munich Chrono Type Questionnaire (MCTQ)
Client Satisfactionpost intervention after 6 weeksMeasured 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.
Changes in self reported emotion regulation abilitybaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured 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.
Changes in degree of experienced painbaseline and post intervention after 6 weeks, follow-up after 12 monthsMeasured by a visual analogue scale (VAS Pain) ranging from 0 to 10. The higher the score, the worse the pain.

Countries

Norway

Contacts

Primary ContactAne Wilhelmsen-Langeland, PhD
ane.wilhelmsen-langeland@helse-bergen.no+47 55957000
Backup ContactBerge Osnes, PhD
berge.osnes@helse-bergen.no+47 55957000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026