Sleep in Psychiatric Care (SIP): Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHaukeland University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Group-based light therapy at gradually advanced timing for DSWPD
BehavioralLight 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
BehavioralLight therapy (LT) at gradually advanced timing, bb-glasses 12 hrs after LT, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques
6-week wait list for sleep-school
Other interventionTreatment as usual in a psychiatric outpatient clinic
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: n=15, sleep-school 6 weeksExperimental treatment 1 intervention
Group B: n=15, sleep-school 6 weeks and additive bb-glassesExperimental treatment 2 interventions
Group C: n=30 Six-week wait list for sleep-schoolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
baseline, post intervention after 6 weeks, follow-up after 12 monthsSecondary outcomes
1
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.
Time frame
baseline and post intervention after 6 weeks, follow-up after 12 months2
Changes in Sleep efficiency (SE)
Measured by sleep diary; total sleep time/time in bed x 100= percentage SE
Time frame
baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months3
Changes in Time in bed (TIB)
Measured by sleep diary; time from bed-time to rise time
Time frame
baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months4
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.
Time frame
baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 monthsOther outcomes
1
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.
Time frame
baseline and post intervention after 6 weeks, follow-up after 12 months2
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.
Time frame
baseline and post intervention after 6 weeks, follow-up after 12 months3
Changes in vigilance
Measured by the Conners Continuous Performance (CPT) Test 3rd Edition™ (Conners CPT 3™)
Time frame
baseline and post intervention after 6 weeks, follow-up after 12 months4
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.
Time frame
baseline and post intervention after 6 weeks, follow-up after 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Haukeland University Hospital
Lead sponsor
University of Bergen
Collaborator
Source ClinicalTrials.gov