The Sleep Clinic Outcome and Practice Study: The SUP-study
Phase: NA
Conditions: Insomnia Disorder, Circadian Rhythm Sleep Disorder
Sponsor: St. Olavs Hospital

The Sleep Clinic Outcome and Practice study: The SUP-study 
 
Outcome and practice of non-pharmacological treatment  
of sleep-wake disturbances at the Sleep Clinic, St. Olavs Hospital 
 
 
 
 
 
 
 
 
 
 
Authors: 
Cecilie Vestergaard1,2, Håvard Kallestad1,3, Daniel Vethe1,2, Knut Langsrud2 
 
 
1. Department of Mental Health, Norwegian University of Science and Technology, 
Trondheim, Norway 
2. Department of Østmarka, St. Olavs University Hospital, Trondheim, Norway 
3. Department of Research and Development, St. Olavs University Hospital, Trondheim, 
Norway. 
 
 
 
Declarations  
All authors declare that they have no competing interests in regard to this research 
project. 
 
 
 
Project leader: Knut Langsrud2 
 
 

Background 
Sleep-wake disturbances including insomnia disorder and sleep-wake rhythm disorders 
disables many aspects of life and is highly prevalent. As one of few treatment options for 
sleep-wake disturbances, the Sleep Clinic at St. Olavs Hospital offers clinical assessments 
and treatment for this patient group in Norway. Although the treatment of insomnia 
disorder is well-described and recommended, there is still a major subgroup that to not 
benefit from the treatment. Additionally, treatment and outcome of sleep-wake rhythm 
disorders is little described in clinical settings. A study of clinical practice and outcomes 
of the treatments in the Sleep Clinic, would give the possibility to illuminate these 
knowledge gaps. 
 
Aim  
Describe the practice (timing and duration) and outcomes of the sleep treatments 1) 
Cognitive Behavioral Therapy for Insomnia and 2) Chronotherapy for sleep-wake 
rhythm disorders at the Sleep Clinic at St. Olavs Hospital.  
 
Method  
All patients referred to the Sleep Clinic will be asked to participate before the first 
consultation with a clinician. Patients will be clinically assessed, diagnosed and given 
treatment as usual. Main outcomes will be self-report questionnaires at treatment 
termination and the use, timing and duration of specific sleep treatment components 
logged by the clinician during treatment.  
 
Potential impact 
The findings from this research project provides possibilities to improve treatment for 
sleep-wake disturbances by tailoring the treatment different to respective subgroups. 
The findings will also contribute to novel knowledge on how we treat patients with 
sleep-wake rhythm disorders and to what degree they benefit from the treatment in a 
sleep clinic.  
 
 
 
 
 

Background 
 
The Sleep Clinic at St. Olavs Hospital is part of the public psychiatric health care service 
in the central region of Norway. The Sleep Clinic is one of few treatment units for sleep-
wake disturbances in Norway. An underlying reason for this is that treatment for sleep-
wake disruption is not prioritized in Norwegian public health care. The treatment 
opportunities among private clinics are also few and ad hoc as the knowledge on sleep 
disorder treatments is generally low among clinicians, including psychologists and 
physicians, although almost one out of two patients in a general practitioner’s office 
report having a sleep-wake disruption1. Patients are typically referred to the Sleep Clinic 
by these general practitioners or other therapists working in the regional mental health 
care service. The mean waiting time from referral to the clinical assessment in the Sleep 
Clinic is over 12 months. During the recent years, the Sleep Clinic at St. Olavs Hospital 
has had three to six employed clinicians holding part-time positions and treated around 
225 patients every year. The numbers of patients treated the recent years have been 
affected by the Covid-19 pandemic: 
2018       
317 treated patients                                        
2019       
225 treated patients                                   
2020       
145 treated patients (Covid pandemic)                     
2021       
204 treated patients (Covid pandemic)                                       
 
The two main groups of sleep-wake disturbances referred to the Sleep Clinic are 
insomnia disorder and sleep-wake rhythm disorders. Hypersomnic disorders (like 
narcolepsy) and parasomnias (like REM sleep behavior disorder) are mainly assessed 
and treated at the Department of Neurology.  
 
Insomnia disorder 
Insomnia disorder is a major public health care concern that affects 10-12 % of the 
general population in Western countries 2-4 , and the prevalence is shown to be on the 
rise in Norway 2. Insomnia disorder involves subjective complaints of disturbed sleep 
and marked distress and/or daytime impairment 5 and is found to have strong 
correlations to both somatic and mental illness 6. The diagnostic criteria for insomnia in 
the ICD-10 are: inability to fall asleep, waking up during the night or too early in the 

morning for at least three nights a week for a month, and subsequent impairment in 
daytime functioning 5. Insomnia Severity Index (ISI) is a validated questionnaire used as 
the primary outcome measure in insomnia disorder research 7 and is shown to have 
good psychometric properties 8. 
 
Cognitive Behavioral. Therapy for Insomnia (CBT-I) is currently the best treatment 
option for insomnia disorder, recommended in several international reviews and 
subsequently acknowledged as the first-line treatment 9, 10, also when having somatic 
and mental comorbidities 11, 12. CBT-I is a multi-component treatment which focus on 
three main domains: education, behaviors, and cognitions. Specifically, the treatment 
usually consists of one or more of the following interventions: psychoeducation about 
sleep, sleep restriction therapy, stimulus control, and challenging beliefs and 
perceptions of sleep. The stimulus control and sleep restriction components have been 
recognized as the most efficacious therapy techniques 9, 13.   
 
More than 200 treatment studies have shown that on average CBT-I is a highly effective 
treatment for insomnia disorder 14, 15. On the one hand, a review of 48 treatment studies 
using psychological interventions showed that half of the patients had clinically 
significant outcomes, and one-third were considered “good sleepers” following 
treatment – a finding that remained consistent over time 9. On the other hand, when 
compared to control interventions such as sleep hygiene advice, 30-60% of individuals 
offered CBT-I do not demonstrate clinically significant benefits of the treatment 16, 17, 
suggesting there are subgroups of patients that do not respond to treatment.  
 
The treatment manual for CBT-I provides guidance to therapists regarding the content 
of treatment on a session-to-session basis18. However, individual adaptations of the 
treatment are often made to match the need of the patient, resulting in a certain level of 
inter-individual variation in which sub-components of the treatment patients will 
receive, and their order. Thus, there is a potential to explore the effectiveness of 
different variations of administering CBT-I. Our knowledge of the benefits of CBT-I 
currently exceeds our understanding of for whom and how the treatment works, and 
identifying the treatment components that generate change for different patient groups 
may also help develop and tailor the treatment to those with little or no effect of CBT-I.  

 
Sleep-wake rhythm disorders 
Sleep-wake rhythm disorders are also known as circadian rhythms disorders. Delayed 
sleep-wake rhythm disorder is the most common disorder and the prevalence among 
young Norwegian adults is estimated to be 3.3%19. However, the number of people 
seeking medical help is probably far lower. A proposed reason for this is that the 
knowledge of these disorders is low among both patients and health care professionals. 
A general feature of sleep-wake rhythm disorders is that the sleep-wake patterns are 
not in alignment with the societal rhythm, thus their sleep is out of sync with the 
majority of the public and they therefore experience major functional impairments from 
their condition. The patients with sleep-wake rhythm disorders referred to the Sleep 
Clinic are typically in their mid-twenties, making this population older than what is most 
often described in studies on sleep-wake rhythm disorders20, 21. The majority of these 
patients have not completed their education even at high school and have difficulties 
holding on to a job – something they typically have experienced over years. 
Subsequently, this group tends to drop out of education and working life from a young 
age.  
 
The human circadian system is composed of many interconnected circadian rhythms in 
tissue throughout the body which follow an approximately 24-hour rhythm. The 
circadian system is one of the major factors driving the sleep-wake rhythm, organizing 
sleep and wakefulness to nighttime and daytime22, 23. The timing of the circadian system 
is coordinated and regulated by the body´s central “internal clock”, the suprachiasmatic 
nucleus, which is located in the hypothalamus of the brain 24. For people with sleep-
wake rhythm disorders, the timing of circadian rhythms tends to be shifted either 
earlier or later compared with the general public, which results in interference with 
social, educational, or work schedules. In sleep-wake rhythm disorders there may be 
physiological deviations in the function of the internal clock or there may be external 
factors that drive the internal clock out of sync with the surroundings such as in jet lag 
disorders or shift work disorder. In the Sleep Clinic, we only treat internal sleep-wake 
rhythm disorders including 1) non-24-hour sleep-wake phase disorder, 2) irregular 
sleep-wake disorder, 3) advanced sleep-wake phase disorder (morning larks), but most 
common is 4) delayed sleep-wake phase disorder (night owls) (see figure 1). According 

to the American Academy of Sleep Medicine25, the diagnostic criteria for delayed sleep 
phase disorders are that the sleep phase is delayed relative to the desired or necessary 
time to fall asleep and to rise and that this pattern must have been present for at least 3 
months and is confirmed by sleep diaries or actigraphy for at least one week. There is 
also a criterion that sleep quality and quantity increases when patients self-select 
bedtimes and risetimes. The same diagnostic criteria apply for advanced sleep-wake 
phase disorder, except that with this disorder, the sleep phase is advanced relative to 
the desired or necessary time to fall asleep and rise in the morning. Non-24-hour sleep-
wake phase disorder, or free-running sleep-wake disruption, is characterized by a 
progressive delay in falling asleep and rising across weeks. Further, the symptoms of 
insomnia symptoms and sleepiness go into remission in periods when their sleep-wake 
cycle is in sync with their desired sleep phase. Irregular sleep-wake phase disorder is 
characterized by the lack of rhythm and length of sleep and wakefulness. In the most 
serious cases, sleep is very fragmented throughout the 24-hour period. The diagnostic 
criteria for this pattern of varying sleep and wakefulness is that the person experiences 
insomnia symptoms during the night and sleepiness during the day or both. The 
symptoms must have been present for at least three months.  
 
Figure 1, illustration from the Norwegian center of sleep medicine (SOVno)26. The three lines for 
each disorder represent three consecutive 24-hours. Black indicates sleep.  
 
Treatments for sleep-wake rhythm disorders are referred to as chronotherapy. These 
strategies aim to restore proper alignment of sleep-wake cycles by way of proper timed 

exposure to light such timed light exposure, blue-light blocking glasses, and chrono 
biotic medication such as the hormone melatonin27. In clinical practice these approaches 
are generally combined to provide the most effective treatment 28. Light therapy and 
blue-light blocking glasses are used as tools to either advance or delay circadian 
rhythms via suppression or stimulation of signals to the suprachiasmatic nucleus 
through the retina in the eye. The glasses block the blue light spectrum as these light 
frequencies have been shown to be the most potent for signals in the circadian clock 
pathway in the brain29. Blue blocking glasses have been shown to advance the timing 
and increase the production of pineal melatonin30-32. The past decade, there has been 
increasing evidence that sleep-wake rhythm disorders are both common and have major 
adverse impacts on daily function33. Despite published guidelines on the use of 
chronotherapy for these disorders26, 34, chronotherapeutic interventions are used to 
varying degrees in clinics, and when used the timing and combination of components 
vary. Moreover, there is to date no valid tool to evaluate the treatment effect of sleep-
wake rhythm disorders. This leads to a gap in knowledge concerning the effectiveness of 
each chronotherapy intervention on its own and in combination from clinical settings.  
 
Combined sleep disorders 
There are also patients whose sleep-wake patterns align with both insomnia disorder 
and a parallel sleep-wake rhythm disorder. This is little described in sleep literature, 
although it is recognized that the symptomatology is somewhat overlapping and that it 
is important to distinct between the two disorders. Our clinical experience is that many 
of our sleep-wake rhythm disorder-patients have developed dysfunctional believes and 
behavioral patterns and that some of them over time develops a parallel insomnia 
disorder. On the other hand, it is well-established that a major subgroup in populations 
with insomnia disorder have either morningness or eveningness chronotype preference 
which is shown to have less effect of CBT-I35. The timely question is whether these 
patients have been correctly diagnosed. In any case, this shows that it is always 
important to consider both disorders. For the patients where we assess that they have 
both an insomnia disorder and a sleep-wake rhythm disorder, a combination of CBT-I 
and chronotherapy is be offered in the Sleep Clinic. The clinical prevalence of such 
combined sleep-wake disturbances is largely unknown in sleep literature and even less 
is known about how this patient group is treated and their outcome of treatment.    

 
In the Sleep Clinic, we assess and treat the above-stated sleep-wake disturbances. We do 
not, however, have data on the use of each treatment component and the corresponding 
outcome of treatment, especially for those with sleep-wake rhythm disorders. Firstly, by 
collecting data on treatment as usual in the Sleep Clinic we can be able to improve the 
treatment outcomes by finding for instance patterns or timing of treatment components 
that are typically effective or not effective, making it possible to simplify the treatment 
and avoid unnecessary exertions for the patients. Another prospect with a collection of 
data in the Sleep Clinic is to identify moderators of treatment outcomes before 
treatment to identify subgroups that are most likely to attain positive outcomes. 
Moreover, we may identify subgroups that tend to have less favorable outcomes that 
may need tailored treatment regimes. Secondly, with data from the Sleep Clinic, we will 
be able to compare the treatment outcomes with other international studies and 
consider whether our treatment effects are in alliance with other published results. 
Additionally, it is a major gap in sleep literature of how to measure treatment outcome 
of chronotherapy, something that we can approach with data in the sleep Clinic. Thirdly, 
while the overall treatment approach tends to be well described in publications from 
sleep clinics, the timing and the duration of treatment components for sleep disorders 
are generally less documented, especially for sleep-wake rhythm disorders. Therefore, 
describing the practice and outcomes of treatment for sleep-wake rhythm disorders, will 
be a novel contribution to the sleep literature. 
 
Accordingly, the primary aims of the Sleep Clinic Outcome and Practice Study (SUP-
study) are to improve sleep treatments (CBT-I and chronotherapy for sleep-wake 
rhythm disorders) by describing the practice and outcomes - more specifically:  
1) the use, timing, and duration of specific sleep treatment components in a clinical 
setting 
a) CBT-I for insomnia disorder 
b) Chronotherapy for sleep-wake rhythm disorders 
2) clinical outcomes after sleep treatment 
a) CBT-I for insomnia disorder 
b) Chronotherapy for sleep-wake rhythm disorders, testing a method of 
operationalizing effects of chronotherapy. 

c) And a combination of CBT-I and chronotherapy for patients with both 
disorders 
 
The secondary aims are  
1) exploring the effectiveness of sleep treatment outcomes in different modes of 
treatment delivery:  
a) Group versus individual delivery of sleep treatment.  
b) Telemedicine versus face-to-face delivery of sleep treatment 
 

Methods 
 
Trial design and participants 
Patients will be recruited from the Sleep Clinic at St. Olavs Hospital. Patients are referred 
from regional general practitioners and other outpatient mental health care clinics. All 
patients referred to the Sleep Clinic will be asked to participate by an informational 
consent sent by mail before the first consultation with a clinician. In the first 
consultation, patients will be assessed through a standardized clinical sleep interview. 
The clinicians will carry out a diagnostic assessment and consider eligibility to 
participate in the study.  
 
Inclusion criteria  
1. Referred to the Sleep Clinic at St. Olavs Hospital for an assessment of a sleep-
wake disruption. 
2. Age >= 18 years.  
3. Willing and able to provide written informed consent.  
4. Meeting the diagnostic criteria for at least one of the following disorders: 
a. F51.0 Insomnia disorder 
b. G47.2 Sleep-wake rhythm disorders, considered being either:  
i. Delayed sleep-wake phase disorder 
ii. Advanced sleep-wake phase disorder 
iii. Non-24-hour sleep-wake disorder 
iv. Irregular sleep-wake disorder  
5. Desire non-pharmacological sleep treatment  
 
Exclusion criteria 
Individuals working night shifts or that otherwise have external conditions that result in 
inadequate sleep opportunity, such as caring for an infant or does not have permanent 
housing etc. Patients being blind or psychotic or having epilepsy or having an ongoing 
substance abuse will also be excluded. 
 
If the participant is considered eligible and has a signed consent, she/he will be included 
in the study. 

Interventions  
In the Sleep Clinic, either psychiatrists or clinical psychologists deliver the treatments.  
All patients considered being eligible will receive treatment as usual in the Sleep Clinic, 
one out of the two sleep-wake disorder treatments described underneath, or a 
combination of these. However, regardless which of the treatments they receive, there 
are common features in the treatment approach for all patients; 
a) All patients will be assessed as usual with a standardized assessment interview 
developed at the Sleep Clinic. Diagnoses is assessed, and in the case of difficult 
assessments, the clinician can discuss the patient in the clinicians weekly Sleep 
Clinic meetings.  
b) Step 1 in the treatment for all patients is psychoeducation about sleep, circadian 
rhythms and a description of the treatment adapted to their disorder. Everyone is 
sent a workbook that supports the content of the lesson. 
c) Step 2 in the treatment regardless of disorder is to stabilize the sleep-wake 
rhythm, hence aiming for relatively fixed rise times and bed times.  
d) In the last consultation the clinician and the patient summarize the treatment 
approaches used and the effect and benefits of these for the patients. It is also 
made strategies as preventive measures and a plan for what the patient can do if 
the sleep disorder relapses.   
 
After psychoeducation and stabilizing the sleep-wake rhythms, the specific treatment 
components is dependent of the sleep disorder: 
 
1) Cognitive Behavioral Therapy for Insomnia (CBT-I) 
CBT-I18 has several components and consists of the following interventions including 
psychoeducation about sleep: sleep hygiene, sleep restriction therapy, stimulus control, 
and challenging beliefs and perceptions of sleep. Special emphasis is placed on 
providing a rationale for behavior change as a primary means of improving sleep36 as 
well as addressing dysfunctional beliefs the patients may hold about sleep. During 
treatment, tapering sleep medication is not necessary. However, if the patients are 
motivated to do so, this is discussed and a plan for tapering is provided. Treatment 
duration is typically between 4 to 8 consultations over 1 to 4 months depending on the 
patients’ needs and progress during treatment.   

 
2) Chronotherapy for sleep-wake rhythm disorders 
Chronotherapy 27 aims to restore the proper circadian pattern of the sleep-wake cycle27 
through adequate sleep hygiene, timed light and dark exposure, and the use of 
melatonin, which affects the output phase of the circadian rhythm. The effect of 
chronotherapy depends on the timing of interventions in relation to the individual’s 
current internal circadian rhythms. The effect of light exposure follows a phase-
response curve where circadian phase advancement is strongest in the biological 
morning, whereas light in the biological evening/night may lead to a phase delay.  Light 
therapy is provided by 30 min light exposure using 10 000 lux light boxes. Clinical 
practice guidelines also recognize melatonin administrated in the evening as a 
treatment option for DSWPD37. In the Sleep Clinic melatonin 3 milligram (mg) is 
prescribed in tablet forms (not depot), usually 12 hours before the planned rise time. 
Additionally, blue-light-blocking glasses are used to block light exposure at night, which 
has been found to advance circadian rhythms in patients with DSWPD30. In the Sleep 
Clinic, patients are advised to wear their blue-blocking glasses 12 hours before rise time. 
Which chronotherapeutic interventions that are used, is considered individually by the 
clinicians in the Sleep Clinic, but often all three treatment components are used at the 
same time. Duration of chronotherapy given in the Sleep Clinic vary from 4 to 8 
consultations over 1 to 4 months depending on the patients’ needs and progress during 
treatment.   
 
Data management  
Primary and secondary outcomes of the study will be registered by the clinicians in 
eFORSK which is an electronic data collection solution. eFORSK was developed by 
HEMIT and is operated by Norsk Helsenett. A risk and vulnerability analyses has been 
carried out and the solution has been approved for use in national studies based in Helse 
Midt-Norge. A data processing agreement has been created and all processing of data 
will be in accordance with the requirements of the current regulations. Data extending 
primary outcomes will be retrieved from assessments in electronic hospital records. 
This data will be de-identified and the files will be stored on secure data servers.  
 
 

Withdrawal criteria 
An individual can decline to participate at any stage of the study 
 
Time frame 
The primary measure of the effect of chronotherapy will be based on a score of 12 
(summing 3 questions that are scored from 0 to 4). In a Norwegian study 38 the 
researchers found an effect size, Cohen’s d = 0.75, on the Bergen Insomnia Scale (BIS) 
after two weeks of treatment for delayed sleep phase syndrome with light therapy and 
melatonin. BIS is conceptually similar to ISI, and we assume a similar effect size. 
However, ISI measures the patient's assessment of the severity of their sleep difficulties 
over the past two weeks and how much it has hindered them in carrying out daily 
activities, which we believe aligns more closely with the treatment goals than BIS. 
Research at St. Olav's Hospital has also shown that ISI is the questionnaire that best 
predicts a diagnosis of sleep disorders 39. Participants in Saxvig et al.'s study had 
contacted the researchers themselves, were younger, and had a higher daily functioning 
level compared to patients referred to St. Olav's Hospital, Division of Mental Health Care, 
the Sleep Clinic. We therefore expect a somewhat lower effect in our population. 
We estimate that we will find an effect size of Cohen’s d = 0.6. Furthermore, we want an 
80% probability of detecting this difference. For this, approximately 45 patients who 
complete the measurements are needed. In other research and clinical settings, we see 
that about 50% of patients do not respond to questionnaires or drop out of treatment. 
We therefore assume about 50% dropout. Given these premises, we need to include 90 
patients in the study to have approximately 45 patients at the outcome measurement. 
We estimate that 200 patients will be included in the SUP-study annually. Of these, 
about 60 patients will be circadian rhythm patients and 140 would be pateints with 
insomnia disorders. We expect that about 50% will consent to participate in the study 
and that there will be about 50% dropout during the treatment period. These estimates 
mean that we will be able to collect data on 15 circadian rhythm patients annually, and 
to reach the number of 90 included patients, we will need to include patients over 6 
years. If the project starts on 01.01.2025, we plan to include patients until the end of 
2030 (31.12.2030). We estimate that data will be collected from 35 patients with 

insomnia disorder each year, resulting in a total of 210 patients insomnia disorder over 
the 6-year data collection period. 
 
Assessments 
See Table 1 for information about when in the study the various assessments are 
collected.  
 
Background assessments 
Patients will provide data on demographics; age, sex, socioeconomic status (marital 
status, children in household, educational level, and employment status), somatic 
diseases, mental illness, medication use and previous sleep medication used, lifestyle 
(use of alcohol and substances, use of caffeine, physical activity, number of days during a 
week where they have commitments outside the home).   
 
Sleep information 
a) The consensus sleep diary (CSD)  
The CSD40 estimates sleep and wakefulness (from the previous night). The diary was 
specifically developed for, and is widely used in insomnia research.41. The patients are 
sent the sleep diaries to log their sleep patterns every day for 14 consecutive days 
before their first consultation. The sleep diaries are used in the diagnostic assessment. 
The following sleep metrics are extracted from the CSD: bedtime (BT) in hh:mm, sleep 
onset latency (SOL) in minutes, wake after sleep onset (WASO) in minutes, and rise time 
(RT) in hh:mm. Time in bed (TIB) and total sleep time (TST) (in minutes) estimates 
were calculated from the other variables.  
 
b) Sleep-wake phase diary  
In clinical practice, St. Olavs Hospital have developed a sleep-wake phase diary that 
provides a visual estimate of sleep and wakefulness across weeks, focusing more on the 
sleep-wake cycle whilst sleep onset and offset times are somewhat less detailed 
compared with the CSD. This sleep-wake estimation is especially beneficial for patients 
where sleep-wake rhythm is a focus during treatment as the rhythm is easily assessed 
both by the patient and the clinician. The following sleep metrics are extracted from the 

sleep-wake phase diary: BT in hh:mm, SOL in minutes, WASO in minutes, and RT in 
hh:mm. TIB and TST (in minutes) estimates were calculated from the other variables.  
 
c) Revised Morningness Eveningness Questionnaire (rMEQ) 
The revised Morningness Eveningness Questionnaire42 is a reduced version of the 
Horne-Östberg Morningness-Eveningness Questionnaire containing five items. The 
score ranges from 4 to 25, with higher scores indicating greater preference for 
morningness. Individuals are classified as either evening type (those scoring from 4 to 
11), intermediate type (those scoring between 12 to 17), or morning type (those scoring 
between 18 and 25).  
 
Primary outcomes 
a) Timing and duration of treatment components 
The prescription, self-reported compliance, timing and duration of specific sleep 
treatment components will be logged by the clinician during treatment.  
i. 
Psychoeducation 
ii. 
Sleep restriction 
iii. 
Stimulus control 
iv. 
Cognitive restructuring / Experiments 
v. 
Sleep hygiene 
vi. 
Relaxation exercises 
vii. 
Tapering sleep medication 
viii. 
Melatonin 
ix. 
Blue-light blocking glasses 
x. 
Light therapy 
xi. 
Stabilizing sleep-wake rhythm 
xii. 
Sleep-phase advancement or delay 
 
b) Treatment effects:  
i. 
Insomnia Severity Index with additional question (ISI*) 
The Insomnia Severity Index (ISI)43 is recommended as a standard measure for 
insomnia symptoms in the assessment of sleep problems and outcome in RCTs.41 It 
comprises 7 items rating the severity of sleep-wake problems, impairment in daytime 

functioning, and concerns about sleep problems. Each item is rated on a 0 to 4 scale 
indicating its severity over the preceding 14 days and a higher total score indicates 
greater insomnia severity. An ISI score of 15 points is a recommended cut-off for 
clinical insomnia. Individuals who demonstrate an overall reduction in the ISI score >=8 
points are considered to show clinical response, whilst individuals with a total ISI score 
<= 7 are considered to show remission 8. 
 
For patients with sleep-wake rhythm disorder, there is no validated 
questionnaire to rate the severity of their sleep-wake disruption. As we want to measure 
how satisfied the patients are with their present sleep-wake rhythm and how much it 
affects their daily function, we will extract these questions from the ISI.  
“How satisfied/dissatisfied are you with your current sleep pattern?” and  
“To what extent do you consider your sleep problem to interfere with your daily 
functioning (e.g. daytime fatigue, mood, ability to function at work/daily chores, 
concentration, memory, mood, etc.) currently?”. Both questions are answered on a scale 
from 0 to 4. In addition, we will include a question that we consider relevant for those 
with delayed sleep-wake phase disorder: “On a score from 0 to 4, how difficult is it to 
rise in the morning?”. We will then combine these three questions to a sleep-wake 
rhythm severity index raging from 0 to 12, where higher score indicates a higher 
severity.  
 
ii. 
Clinical impression scale 
We will have a brief rating scale where the clinician’s impression is weighted. This will 
be similar to the well-used and validated Clinical Global Impression scale44, which was 
developed for clinical trials to provide a brief, stand-alone assessment of the clinician’s 
view of the patient’s global functioning prior to and after initiating a study medication. 
In our clinical impression scale, the clinician is asked to rate the treatment compliance, 
treatment response and daily function. Each question is rated from 0 to 10 with a higher 
number indicating a more improved outcome. By this, the study can compare the 
clinician impression with the patients self-reported (ISI*) effects of the treatment. Thus, 
it will strengthen our aim to test a method of operationalizing effects of chronotherapy.  
 
At baseline after first consultation:  

1. Based on your overall clinical experience with this patient group: How much benefit 
will the patient get from the treatment? 
2. Based on your overall clinical experience with this patient group: To what extent 
does the patient now have a circadian rhythm (if mainly insomnia: sleep-wake 
rhythm) that enables him/her to manage his/her daily tasks? 
3. Based on your overall clinical experience with this patient group: To what extent do 
you think the patient will comply with the treatment? 
4. How many years of clinical experience do you have with this patient group? 
 
Post treatment:  
1. Based on your overall clinical experience with this patient group: How useful has the 
treatment been for the patient? 
2. Based on your overall clinical experience with this patient group: To what extent 
does the patient now have a circadian rhythm (if mainly insomnia: sleep-wake 
rhythm) that enables him/her to manage his/her daily tasks? 
3. Based on your overall clinical experience with this patient group: To what extent has 
the patient complied with the treatment plan? 
 
Secondary outcomes 
Information about how the consultations are provided is logged 
a) individual or group therapy  
b) face-to-face therapy or telemedicine.  
 
 
 

Table 1: Timing of when various assessments are collected in the study.  
 
 
 
 
Funding 
The study is funded and grounded in the Department of Psychiatric, St. Olavs Hospital 
 
 
 
 
Baseline 
Under ongoing 
treatment 
Post 
treatment 
Background 
assessments 
 
X  
 
 
Sleep diaries  
 
X (2 weeks) 
X  
 
rMEQ 
 
X 
 
 
Timing and 
duration of 
treatment 
components 
 
 
X 
 
Clinical 
outcomes of 
treatment 
ISI* 
X  
 
X  
Clinical 
impression 
X  
 
X  
Information 
about how the 
consultations 
are provided 
 
X 
X 
 

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