<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03788993</url>
  </required_header>
  <id_info>
    <org_study_id>2017/916</org_study_id>
    <nct_id>NCT03788993</nct_id>
  </id_info>
  <brief_title>Testing the Effectiveness of an Evening Blue-depleted Light Environment in an Acute Psychiatric Ward</brief_title>
  <official_title>A Pragmatic Effectiveness Randomized Controlled Trial of Duration of Psychiatric Hospitalization in a Trans-diagnostic Sample of Patients With Acute Mental Illness Admitted to a Ward With Either Blue Depleted Evening Lighting or Normal Lighting Conditions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is increasing recognition of the need to stabilize sleep-wake cycles in individuals&#xD;
      with major mental disorders. As such, clinicians and researchers advocate for the use of&#xD;
      interventions targeted at sleep and circadian dysrhythmias as an adjunct to the standard&#xD;
      treatments offered for acute illness episodes of a broad range of diagnoses. To determine the&#xD;
      trans-diagnostic generalizability of chronotherapy, the investigators will explore the&#xD;
      benefits of admitting individuals with major mental disorders to an acute psychiatric&#xD;
      inpatient unit where changes in light exposure are integrated into the therapeutic&#xD;
      environment.&#xD;
&#xD;
      A two-arm pragmatic effectiveness randomized controlled treatment trial, where individuals&#xD;
      admitted for inpatient psychiatric care will be allocated to a ward with blue depleted&#xD;
      evening light or to a ward with the same layout and facilities but lacking the new lighting&#xD;
      technology. The trial will test whether the experimental lighting conditions offer any&#xD;
      additional benefits beyond those associated with usual treatment in an acute psychiatric&#xD;
      inpatient unit.&#xD;
&#xD;
      The main objectives are to examine any differences between groups in the mean duration of&#xD;
      hospitalization in days. Additional analyses will compare groups differences in sleep,&#xD;
      functioning, symptoms, medication usage, and side-effects and whether length of stay is&#xD;
      associated with stability of sleep-wake cycles and circadian rhythms. Given this unique&#xD;
      research opportunity, ancillary investigations will determine any benefits according to&#xD;
      diagnostic subgroups and potential drawbacks such as any adverse effects on the well-being of&#xD;
      professionals working across both wards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent decades there has been increased attention to the impact of disturbed sleep on&#xD;
      general health. For example, sleep-wake cycle abnormalities linked with circadian&#xD;
      dysrhythmias are associated with physical disorders such as diabetes, metabolic&#xD;
      abnormalities, obesity, impaired functioning of the immune system, and a greater risk of&#xD;
      cancer. Given that light is a central zeitgeber of the circadian system, this had led to some&#xD;
      researchers exploring the benefits of photo- or chrono-therapies for selected medical&#xD;
      illnesses, especially in those individuals who have a concurrent comorbid mental disorder.&#xD;
      The latter is noteworthy as sleep problems are uniquely important in the field of mental&#xD;
      health. For instance, sleep abnormalities may be prodromal symptoms that precede the onset of&#xD;
      a first episode of a major mental disorder, sleep-wake cycle disruptions are criterion&#xD;
      symptoms of unipolar and bipolar disorders and circadian dysrhythmias may exacerbate suicidal&#xD;
      behaviours. In addition, research demonstrates that day-to-day variability in the sleep-wake&#xD;
      cycle is associated with longer duration of admission to an acute psychiatric inpatient unit&#xD;
      and frequency of aggressive behavior and violent incidents. Lastly, and importantly, sleep&#xD;
      problems are often the last clinical symptoms to resolve during recovery from an acute&#xD;
      episode of a mood or psychotic disorder. Overall, experimental and clinical research&#xD;
      emphasize the reciprocal relationship between sleep-wake disruptions and mental disorders&#xD;
      showing that they perpetuate and exacerbate each other and that improved sleep is associated&#xD;
      with improvements in mental state.&#xD;
&#xD;
      The observations noted above have increased awareness of the need to stabilize sleep-wake&#xD;
      cycles in individuals with major mental disorders and highlighted the importance of&#xD;
      incorporating therapeutic interventions targeted at circadian dysrhythmias as an adjunct to&#xD;
      other treatments offered for acute illness episodes. Psychological and pharmacological&#xD;
      interventions are efficacious approaches for sleep-wake cycle disturbances in adults without&#xD;
      comorbid mental disorders. However, their use in individuals with an acute exacerbation of a&#xD;
      major mental illness can be problematic, including attenuation of the benefit-to-risk ratio&#xD;
      for therapies or contra-indications to the use of some medications. Partly as a response to&#xD;
      these concerns, but also because of new research on circadian rhythms, attention has shifted&#xD;
      to the potential role of chronotherapeutic interventions based on controlled exposures to&#xD;
      environmental stimuli that act on biological rhythms. These strategies initially focused on&#xD;
      e.g. bright light therapy for seasonal affective disorders and for some sub-types of&#xD;
      depression; but more recently they have been extended to e.g. dark therapy (spending 14 hours&#xD;
      in darkness per day) or the use of blue blocking glasses in for patients who are hospitalized&#xD;
      for the treatment of acute mania. To date, clinical trials of all these interventions have&#xD;
      been targeted at small and/or homogeneous samples with a specified sleep or mood disorder&#xD;
      (e.g. delayed sleep phase syndrome or bipolar depression, etc.) and have required the study&#xD;
      participants to adhere to a protocol for the repeated use of equipment at specified times of&#xD;
      the day (sitting by a lamp, resting in forced darkness or wearing glasses, etc.).&#xD;
&#xD;
      The above represent interesting treatment advances. However, given the prevalence of&#xD;
      sleep-wake cycle disturbances in individuals with mental disorders, it is logical to extend&#xD;
      trials of the use of these types of interventions to broader trans-diagnostic populations.&#xD;
      Furthermore, to enhance the generalizability of interventions, it would be helpful to avoid&#xD;
      giving personal responsibility for following protocols regarding exposure to different&#xD;
      intensities or spectra of light to individuals who are acutely unwell. A pragmatic&#xD;
      alternative is to create a therapeutic environment for patients with major mental disorders&#xD;
      where changes in light exposure are regulated automatically and where programable lighting&#xD;
      conditions form an integral part of a hospital unit. This is an intriguing option as little&#xD;
      consideration has been given to how contemporary technology might be employed to augment any&#xD;
      benefits of acute treatment in an inpatient facility. Historically, acute psychiatric&#xD;
      admission units have offered asylum and a place of safety, and it is assumed that ward&#xD;
      routines and structured activities may reduce arousal, regularize sleep-wake cycle patterns&#xD;
      and improve confidence and self-esteem, etc. However, the focus is primarily on physical and&#xD;
      pharmacological treatments that reduce symptoms and suicidality, enhance social functioning&#xD;
      and sufficiently improves the individuals mental state to allow a timely return to outpatient&#xD;
      or community care. Less attention has been given to the creation of a state-of-the-art&#xD;
      inpatient milieu.&#xD;
&#xD;
      The investigators have been involved in the planning and design of a newly-built psychiatric&#xD;
      unit and this process has allowed the investigators to consider how the inpatient environment&#xD;
      might be modified to try to enhance recovery from acute illness. The unit comprises of two&#xD;
      wards: one ward incorporates state-of-the-art lighting technology while the other ward has an&#xD;
      identical layout and facilities but has normal lighting conditions. This unit offers a unique&#xD;
      opportunity to explore how exposure to different lighting conditions may modify sleep-wake&#xD;
      cycles and how any changes may impact on the clinical and functional outcomes of individuals&#xD;
      experiencing an acute episode of a severe mental disorder that requires inpatient care. The&#xD;
      findings could influence the future design of hospital units offering care to patients with&#xD;
      mental or physical disorders.&#xD;
&#xD;
      The investigators aim to recruit 400 individuals who give written informed consent to&#xD;
      participate in a two-arm pragmatic effectiveness randomized controlled clinical treatment&#xD;
      trial (RCT). However, based on projected admission rates, the investigators believe that this&#xD;
      sample size is at the lower limit of the estimated study population as they are permitted to&#xD;
      continue recruitment for at least six consecutive months.&#xD;
&#xD;
      Eligible individuals will be allocated to a ward with a lighting system that produces an&#xD;
      environment with blue depleted evening light or to a ward with the same layout and facilities&#xD;
      but lacking the new lighting technology. The trial will test whether the environment with&#xD;
      programmable lighting conditions offers any additional benefits beyond those associated with&#xD;
      usual treatment in an acute psychiatric inpatient unit. The main objectives are to examine if&#xD;
      there are any differences between groups in the mean duration of hospitalization. In&#xD;
      addition, the investigators will explore whether level of functioning, day-to-day symptom&#xD;
      ratings, episodes of suicidality or aggressive behavior, medication usage, and self-reported&#xD;
      side-effects differ between groups and whether shorter duration of admission is associated&#xD;
      with greater stability of sleep-wake cycles and circadian rhythms.&#xD;
&#xD;
      Given that this trail takes place in a unique setting, the investigators will undertake&#xD;
      several ancillary investigations to determine the range of benefits or adverse effects for&#xD;
      subpopulations of patients (e.g. different diagnostic subgroups) and examine any potential&#xD;
      benefits or drawbacks to the use of this new lighting system, including actigraphic&#xD;
      recordings of sleep-wake patterns of nurses and any self-reported effects on well-being that&#xD;
      are recorded by professionals who experience working in both wards.&#xD;
&#xD;
      Update March 8th, 2019&#xD;
&#xD;
      As noted in the original protocol, we aimed to recruit a minimum of 400 individuals who give&#xD;
      written informed consent to participate in a two-arm pragmatic effectiveness randomized&#xD;
      controlled clinical treatment trial (RCT), with the expectation that we would actually&#xD;
      include about 200-250 individuals per group. This recruitment target takes into account&#xD;
      'failure to complete randomization' (i.e. the patient is randomized to a specified lighting&#xD;
      condition, but is not admitted to the bed in the ward with the allocated lighting condition;&#xD;
      this may occur for a number of reasons that were listed in the original protocol) and the&#xD;
      delayed consent procedure (we note that the delay between randomization and consent is, on&#xD;
      average, about 14 days).&#xD;
&#xD;
      The recruitment period was about 6 months (Oct 23th 2018 until April 12th 2019), but we set a&#xD;
      limit on randomization to March 31st and for obtaining delayed consent of April 12th. This&#xD;
      time frame was selected as it corresponds to the winter period in this region of Norway.&#xD;
      After March 31st, daylight saving time changes and also we experience very different&#xD;
      environmental light exposure (long days, short nights, etc). This is relevant as it means&#xD;
      that any extension to the recruitment period needs to be delayed until the environmental&#xD;
      light exposure matches that experienced by individuals who entered the RCT at the start of&#xD;
      recruitment. As such, we agreed (in advance of starting the RCT) with the ethics committee&#xD;
      and trial steering group, that should we fall short of the target sample size after six&#xD;
      months or recruitment, then the recruitment process would be suspended and would be re-opened&#xD;
      in October 2019 (when the environmental light exposure would be the same as during the&#xD;
      original winter recruitment period).&#xD;
&#xD;
      Although our projected randomization rate is as expected (and we have randomized &gt;600&#xD;
      individuals by month 4-5 of the study), two issues have arisen with completion of&#xD;
      randomization. The first was totally unpredictable, namely that a regional electricity power&#xD;
      failure meant that we could not properly randomize admissions for a 72-hour weekend period&#xD;
      (during with &gt;15 admissions occurred). After discussion, it was agreed that the manual system&#xD;
      of randomization that was introduced over that weekend could not be regarded as equivalent to&#xD;
      the automated system, so these cases were immediately excluded from the RCT sample. Second,&#xD;
      the bed occupancy rate in January and February has been running at about 100%, meaning that&#xD;
      many randomizations cannot be completed (i.e. the patient is randomized but cannot then be&#xD;
      admitted to the lighting condition to which they were allocated).&#xD;
&#xD;
      We undertook modelling of the projected number of randomizations that would be completed&#xD;
      (i.e. admitted to the lighting condition allocated at randomization) and have given written&#xD;
      informed consent by April 12th. the projected admission rates, we believe that this sample&#xD;
      size is at the lower limit of the estimated study population (as we are permitted to continue&#xD;
      recruitment for at least six consecutive months). We modelled the best- and worst-case&#xD;
      scenario. The best-case scenario suggested we would achieve the target sample by April 12th&#xD;
      (&gt;400), but the worst-case scenario suggested we may only have randomized, completed correct&#xD;
      allocation and obtained the delayed consent in about 350-360 cases.&#xD;
&#xD;
      Given the above, and the pre-trial agreement that recruitment could be suspended and&#xD;
      re-opened in October 2019, this is course of action we have taken. As we do not break the&#xD;
      codes for randomization (completed as allocated or failed) or match these to which&#xD;
      individuals have given consent (via the deferred procedure), we cannot know the exact number&#xD;
      of trial participants we need to recruit in October. However, the original protocol stated we&#xD;
      would recruit 400-500 participants. With this in mind, we will re-open randomization for six&#xD;
      weeks, starting October 2019, and close the consent procedure by the end of November 2019.&#xD;
&#xD;
      Added October 7t,h 2021:&#xD;
&#xD;
      The Statistical Analytical Plan (SAP) has been written before anyone have performed any&#xD;
      analyses on data from the trial. Analyses of the data from the trial will start one week&#xD;
      after the SAP has been uploaded to https://register.clinicaltrials.gov.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2018</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a single-centre, unblinded, two-arm, parallel-group, pragmatic effectiveness RCT of differences in the mean duration of acute psychiatric hospitalization in days for individuals exposed to experimental lighting compared with normal lighting conditions.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of admission</measure>
    <time_frame>Recorded at the date of discharge (range from 0 to about 150 days).</time_frame>
    <description>The primary outcome measure will be mean duration of admission per individual. The date and time of admission and of discharge will be extracted from the electronic records for the Intention To Treat (ITT) analyses. For the per-protocol analyses discharge will be the date and time the patient left the light environment the patient was randomized to and was subsequently away from the unit for more than 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Sleep Time</measure>
    <time_frame>Daily throughout the admission (range form 0 to about 150 days).</time_frame>
    <description>Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.&#xD;
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate total sleep time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bed time</measure>
    <time_frame>Recorded daily throughout the admission (range form 0 to about 150 days).</time_frame>
    <description>Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.&#xD;
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate the time the patients went to bed (bed time).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep onset</measure>
    <time_frame>Recorded daily throughout the admission (range form 0 to about 150 days).</time_frame>
    <description>Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.&#xD;
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate the time for sleep onset.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nocturnal awakenings</measure>
    <time_frame>Recorded daily throughout the admission (range form 0 to about 150 days).</time_frame>
    <description>Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.&#xD;
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate number of nocturnal awakenings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake after sleep onset</measure>
    <time_frame>Recorded daily throughout the admission (range form 0 to about 150 days).</time_frame>
    <description>Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.&#xD;
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate the time a patient is awake after initial sleep onset.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep offset</measure>
    <time_frame>Recorded daily throughout the admission (range form 0 to about 150 days).</time_frame>
    <description>Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.&#xD;
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate the time of final awakening called sleep offset.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of clinical improvement</measure>
    <time_frame>Recorded daily throughout admission and at the date of discharge (range from 0 to about 150 days).</time_frame>
    <description>Clinical Global Impression, Improvement subscale (CGI-I): The investigators use the Improved version of the Clinical Global Improvement Scale (iCGI-I).28 Scores capture change over time with ratings ranging from -6 (maximum deterioration) to +6 (ideal improvement). The iCGI-I is used (a) to monitor day-to-day changes in mental state and functioning, and (b) to record overall change from admission to discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of illness severity</measure>
    <time_frame>First 0-24 hours of admission, last 24 hours of admission</time_frame>
    <description>Clinical Global Impression, Severity subscale (CGI-S): The CGI-S is a likert scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). These CGI-S ratings are benchmarked relative the total inpatient population (i.e. not according to diagnostic subgroups). It is scored on two occasions only: the morning after admission to the unit (based on observations for 0-24 hours since admission) and at discharge (based on information from the 24 hours preceding discharge).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicide risk</measure>
    <time_frame>Daily throughout the admission (range from 0 to about 150 days)</time_frame>
    <description>Suicide risk is assessed daily throughout the admission by a clinical psychologist or psychiatrist treating the patient. It is scored using one item assessing if the patient has elevated risk of suicide using a binary scale (yes/no) and one item assessing if there is need for continuous observation of the patient to reduce suicide risk (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aggressive behavior</measure>
    <time_frame>One score will be made 2 hours into each shift, a total of three times per day, every day, while the patient is admitted (range from 0 to about 150 days)</time_frame>
    <description>Risk of aggressive behaviour are assessed three times per 24 hours by nurses using the Brøset Violence Checklist (BVC). The BVC is a 6-item scale assessing the presence of six observable behaviours on a binary scale (1=present/0=not present). The BVC has with good psychometric properties and the sum score (range 0-6) indicates risk of violence (low=0, moderate =1-2, high &gt; 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aggressive incidents</measure>
    <time_frame>Aggressive incidents are not recorded at pre-specified time points, but the time and date are recorded if they occur throughout the duration of admission (range 0 to about 150 days).</time_frame>
    <description>Actual incidents of aggressive behaviour will be systematically recorded using the Staff Observation Aggression Scale-Revised (SOAS-R) and interventions employed will be recorded by the nurses. The items in the SOAS-R specifies the context of the aggressive incident and the severity of the aggressive incident on a 0 to 100 scale (0 = not severe, 100 = very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication use</measure>
    <time_frame>Daily throughout the admission (range from 0 to about 150 days)</time_frame>
    <description>Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual during admission will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission status</measure>
    <time_frame>Changes in admission status are not recorded at pre-specified times, but the time and date are recorded when they occur throughout the admission (range from 0 to about 150 days)</time_frame>
    <description>If a patient is admitted involuntarily, the investigators will estimate the time until their status is reclassified as voluntary (as a marker of improved insight and mental capacity). Similarly change from voluntary to involuntary status and time to this reclassification will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction and Benefit</measure>
    <time_frame>At the day of discharge (range 0 to about 150 days)</time_frame>
    <description>Mean levels of patient satisfaction with an admission are routinely assessed using the standard patient satisfaction questionnaire completed at discharge. The questionnaire was developed by Norwegian Institute of Public Health, is used throughout the Norwegian Health Care system and consists of 10 items scored on a 5-point Likert scale (1=low satisfaction). Some items are relevant to examining experiences of the different lighting conditions, (e.g. was the treatment was tailored to your situation?) Also, there are items related to side effects (see below). A specific item assesses the perceived benefit of the admission (1 = no benefit, 5 = very large benefit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of the light environment</measure>
    <time_frame>At the day of discharge (range 0 to about 150 days)</time_frame>
    <description>The frequency of any side effects or adverse events experienced by individuals admitted to each lighting condition will be examined. The assessment comprises of the Headache and Eye Strain Scale (HES) supplement by additional items developed specifically for this trial and setting (and incorporated into the satisfaction questionnaire), 22 items in total. The HES assesses eight symptoms each of which is rated on a 4-point scale (ranging from absent = 0, to severe = 3) and is sensitive to exposure to different lighting conditions. Study participants are asked to rate any HES symptoms experienced during the course of admission and 14 further items that may represent side effects of acute psychiatric treatment (e.g. dizziness, gastro-intestinal disturbances, daytime sleepiness, poor sleep quality, and restlessness, etc.) that will also be rated using the same 4-point scale. Range of scores is 0 to 66 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of the light environment</measure>
    <time_frame>Adverse effects are not recorded at pre specified times, but the time and date are recorded when they occur throughout the admission (range 0 to about 150 days)</time_frame>
    <description>To capture any putative adverse events experienced during the admission the investigators will record any serious or untoward incidents (such as non-accidental and accidental deaths, near fatal events, severe violence, etc.). Also, the investigators will note if any patients are transferred out of the blue-depleted light environment because clinical opinion suggests that it may be having a detrimental effect on the individual.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">475</enrollment>
  <condition>Mental Disorder</condition>
  <arm_group>
    <arm_group_label>Blue-depleted evening light condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal light condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blue-depleted evening light condition</intervention_name>
    <description>A 20-bedded ward with tunable light emitting diode (LED) lamps. At 18:00h the lighting undergoes a 30-minute transition during which the green and blue LEDs are dimmed to produce blue-depleted amber colored lighting. At 06:50h a new 10-minute transition changes the light color to ordinary indoor lighting. From 07:00h to 18:00h, there is ordinary indoor lighting (3000K colour temperature). The light intensity is dimmed to 20% of the maximum from 23:00h to 6:50h.&#xD;
Blue-blocking window filters are deployed also in the evening. All TV sets have permanent blue-blocking filters and individuals are provided with blue-blocking screens that can be attached to the front of personal electronic devices. If the patients leave the blue-depleted unit after 18:30 they are offered blue-blocking glasses to wear. The light spectrum in the ward was assessed prior to commencing the RCT and is well-matched to what has been shown in laboratory settings to minimally suppress melatonin.</description>
    <arm_group_label>Blue-depleted evening light condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal light condition</intervention_name>
    <description>The other half of the unit (20 patient rooms and their corresponding bathrooms and common areas) have ordinary indoor light installed (Glamox, Norway). This has a 3000K color temperature. The light is dimmed to 20% of max in the night, similar to the blue-depleted condition.&#xD;
The light in the normal light condition and the blue-depleted light condition have similar levels of photopic lux throughout the 24h cycle, but different levels of melanopic lux between 1830h and 0700h.</description>
    <arm_group_label>Normal light condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals aged 18 years or older&#xD;
&#xD;
          -  Admitted to the acute inpatient unit at St. Olavs University Hospital, Department&#xD;
             Østmarka, Trondheim, Norway during the inclusion period for the study.&#xD;
&#xD;
          -  Any patients who are re-admitted during the inclusion period for the study are&#xD;
             eligible for re-randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Post-randomization, there are four potential reasons for exclusion from the RCT:&#xD;
&#xD;
          -  Lack of availability of rooms (as allocated at randomization): acute wards operate at&#xD;
             high levels of bed occupancy, so on some occasions there will be no rooms available in&#xD;
             the ward to which the individual is allocated (i.e. the randomization process cannot&#xD;
             be completed).&#xD;
&#xD;
          -  Clinical imperative: on some occasions senior medical or nursing professionals may&#xD;
             decide that it is clinically inappropriate to admit an individual to a vacant room in&#xD;
             the ward to which they are randomized. The most frequent reasons for this to occur are&#xD;
             clinical concerns about (a) how this admission would affect the case mix within the&#xD;
             ward (e.g. it may be inappropriate to locate all the patients with an acute episode of&#xD;
             mania in one ward, etc.) and/or (b) completing the randomization process may&#xD;
             compromise the safety, care and treatment of current inpatients or of the individual&#xD;
             being admitted (e.g. it may not be possible to provide the appropriate&#xD;
             staff-to-patient ratio required for optimal treatment if all individuals with higher&#xD;
             levels of need are located in one ward, etc.).&#xD;
&#xD;
          -  The individual is unwilling to give written informed consent at any time during their&#xD;
             admission (when approached according to the deferred consent procedure) or is unable&#xD;
             to give informed consent for the duration of the study (i.e. they remain persistently&#xD;
             and severely ill and/or lack mental capacity).&#xD;
&#xD;
          -  The consent procedure was incomplete: an individual may be discharged early or have an&#xD;
             unplanned discharge (e.g. discharge against medical advice) which may mean they were&#xD;
             not approached about study participation or they had only given verbal, but not&#xD;
             written consent.&#xD;
&#xD;
        Withdrawal criteria:&#xD;
&#xD;
        As randomization occurs at the point of admission, all exclusions de facto occur&#xD;
        post-randomization, so the criteria described above represent the main reasons for study&#xD;
        withdrawal.&#xD;
&#xD;
        Additional withdrawal criteria:&#xD;
&#xD;
          -  A patient will be withdrawn from the study if they are absent for &gt;24 hours from the&#xD;
             ward to which they randomized (e.g. they may be transferred to a medical ward for&#xD;
             several days; the patient may request or the clinicians instigate transfer to another&#xD;
             ward; medical or nursing staff may decide the patient should be transferred to the&#xD;
             other ward at the unit because of patient need, case mix or staffing issues, etc.).&#xD;
&#xD;
          -  An individual can decline to participate at any stage of the study and/or a mental&#xD;
             health professional can recommend withdrawal of an inpatient from the RCT if they have&#xD;
             any clinical concerns regarding an individuals' participation (e.g. if there is a&#xD;
             belief that the patient has experienced an adverse event associated with exposure to&#xD;
             the blue-depleted light). In all instances a record will be kept of reasons for&#xD;
             withdrawal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Håvard Kallestad, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Olavs Hospital, Department of Research and Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Olavs Hospital, Department Østmarka</name>
      <address>
        <city>Trondheim</city>
        <zip>7040</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Scott J, Langsrud K, Vethe D, Kjorstad K, Vestergaard CL, Faaland P, Lydersen S, Vaaler A, Morken G, Torgersen T, Kallestad H. A pragmatic effectiveness randomized controlled trial of the duration of psychiatric hospitalization in a trans-diagnostic sample of patients with acute mental illness admitted to a ward with either blue-depleted evening lighting or normal lighting conditions. Trials. 2019 Aug 1;20(1):472. doi: 10.1186/s13063-019-3582-2.</citation>
    <PMID>31370871</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>February 19, 2022</last_update_submitted>
  <last_update_submitted_qc>February 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phototherapy</keyword>
  <keyword>Hospitals, psychiatric</keyword>
  <keyword>Emergency Services, Psychiatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03788993/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03788993
org study id: 2017/916
nct id: NCT03788993
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
There is increasing recognition of the need to stabilize sleep-wake cycles in individuals
      with major mental disorders. As such, clinicians and researchers advocate for the use of
      interventions targeted at sleep and circadian dysrhythmias as an adjunct to the standard
      treatments offered for acute illness episodes of a broad range of diagnoses. To determine the
      trans-diagnostic generalizability of chronotherapy, the investigators will explore the
      benefits of admitting individuals with major mental disorders to an acute psychiatric
      inpatient unit where changes in light exposure are integrated into the therapeutic
      environment.

      A two-arm pragmatic effectiveness randomized controlled treatment trial, where individuals
      admitted for inpatient psychiatric care will be allocated to a ward with blue depleted
      evening light or to a ward with the same layout and facilities but lacking the new lighting
      technology. The trial will test whether the experimental lighting conditions offer any
      additional benefits beyond those associated with usual treatment in an acute psychiatric
      inpatient unit.

      The main objectives are to examine any differences between groups in the mean duration of
      hospitalization in days. Additional analyses will compare groups differences in sleep,
      functioning, symptoms, medication usage, and side-effects and whether length of stay is
      associated with stability of sleep-wake cycles and circadian rhythms. Given this unique
      research opportunity, ancillary investigations will determine any benefits according to
      diagnostic subgroups and potential drawbacks such as any adverse effects on the well-being of
      professionals working across both wards.
In recent decades there has been increased attention to the impact of disturbed sleep on
      general health. For example, sleep-wake cycle abnormalities linked with circadian
      dysrhythmias are associated with physical disorders such as diabetes, metabolic
      abnormalities, obesity, impaired functioning of the immune system, and a greater risk of
      cancer. Given that light is a central zeitgeber of the circadian system, this had led to some
      researchers exploring the benefits of photo- or chrono-therapies for selected medical
      illnesses, especially in those individuals who have a concurrent comorbid mental disorder.
      The latter is noteworthy as sleep problems are uniquely important in the field of mental
      health. For instance, sleep abnormalities may be prodromal symptoms that precede the onset of
      a first episode of a major mental disorder, sleep-wake cycle disruptions are criterion
      symptoms of unipolar and bipolar disorders and circadian dysrhythmias may exacerbate suicidal
      behaviours. In addition, research demonstrates that day-to-day variability in the sleep-wake
      cycle is associated with longer duration of admission to an acute psychiatric inpatient unit
      and frequency of aggressive behavior and violent incidents. Lastly, and importantly, sleep
      problems are often the last clinical symptoms to resolve during recovery from an acute
      episode of a mood or psychotic disorder. Overall, experimental and clinical research
      emphasize the reciprocal relationship between sleep-wake disruptions and mental disorders
      showing that they perpetuate and exacerbate each other and that improved sleep is associated
      with improvements in mental state.

      The observations noted above have increased awareness of the need to stabilize sleep-wake
      cycles in individuals with major mental disorders and highlighted the importance of
      incorporating therapeutic interventions targeted at circadian dysrhythmias as an adjunct to
      other treatments offered for acute illness episodes. Psychological and pharmacological
      interventions are efficacious approaches for sleep-wake cycle disturbances in adults without
      comorbid mental disorders. However, their use in individuals with an acute exacerbation of a
      major mental illness can be problematic, including attenuation of the benefit-to-risk ratio
      for therapies or contra-indications to the use of some medications. Partly as a response to
      these concerns, but also because of new research on circadian rhythms, attention has shifted
      to the potential role of chronotherapeutic interventions based on controlled exposures to
      environmental stimuli that act on biological rhythms. These strategies initially focused on
      e.g. bright light therapy for seasonal affective disorders and for some sub-types of
      depression; but more recently they have been extended to e.g. dark therapy (spending 14 hours
      in darkness per day) or the use of blue blocking glasses in for patients who are hospitalized
      for the treatment of acute mania. To date, clinical trials of all these interventions have
      been targeted at small and/or homogeneous samples with a specified sleep or mood disorder
      (e.g. delayed sleep phase syndrome or bipolar depression, etc.) and have required the study
      participants to adhere to a protocol for the repeated use of equipment at specified times of
      the day (sitting by a lamp, resting in forced darkness or wearing glasses, etc.).

      The above represent interesting treatment advances. However, given the prevalence of
      sleep-wake cycle disturbances in individuals with mental disorders, it is logical to extend
      trials of the use of these types of interventions to broader trans-diagnostic populations.
      Furthermore, to enhance the generalizability of interventions, it would be helpful to avoid
      giving personal responsibility for following protocols regarding exposure to different
      intensities or spectra of light to individuals who are acutely unwell. A pragmatic
      alternative is to create a therapeutic environment for patients with major mental disorders
      where changes in light exposure are regulated automatically and where programable lighting
      conditions form an integral part of a hospital unit. This is an intriguing option as little
      consideration has been given to how contemporary technology might be employed to augment any
      benefits of acute treatment in an inpatient facility. Historically, acute psychiatric
      admission units have offered asylum and a place of safety, and it is assumed that ward
      routines and structured activities may reduce arousal, regularize sleep-wake cycle patterns
      and improve confidence and self-esteem, etc. However, the focus is primarily on physical and
      pharmacological treatments that reduce symptoms and suicidality, enhance social functioning
      and sufficiently improves the individuals mental state to allow a timely return to outpatient
      or community care. Less attention has been given to the creation of a state-of-the-art
      inpatient milieu.

      The investigators have been involved in the planning and design of a newly-built psychiatric
      unit and this process has allowed the investigators to consider how the inpatient environment
      might be modified to try to enhance recovery from acute illness. The unit comprises of two
      wards: one ward incorporates state-of-the-art lighting technology while the other ward has an
      identical layout and facilities but has normal lighting conditions. This unit offers a unique
      opportunity to explore how exposure to different lighting conditions may modify sleep-wake
      cycles and how any changes may impact on the clinical and functional outcomes of individuals
      experiencing an acute episode of a severe mental disorder that requires inpatient care. The
      findings could influence the future design of hospital units offering care to patients with
      mental or physical disorders.

      The investigators aim to recruit 400 individuals who give written informed consent to
      participate in a two-arm pragmatic effectiveness randomized controlled clinical treatment
      trial (RCT). However, based on projected admission rates, the investigators believe that this
      sample size is at the lower limit of the estimated study population as they are permitted to
      continue recruitment for at least six consecutive months.

      Eligible individuals will be allocated to a ward with a lighting system that produces an
      environment with blue depleted evening light or to a ward with the same layout and facilities
      but lacking the new lighting technology. The trial will test whether the environment with
      programmable lighting conditions offers any additional benefits beyond those associated with
      usual treatment in an acute psychiatric inpatient unit. The main objectives are to examine if
      there are any differences between groups in the mean duration of hospitalization. In
      addition, the investigators will explore whether level of functioning, day-to-day symptom
      ratings, episodes of suicidality or aggressive behavior, medication usage, and self-reported
      side-effects differ between groups and whether shorter duration of admission is associated
      with greater stability of sleep-wake cycles and circadian rhythms.

      Given that this trail takes place in a unique setting, the investigators will undertake
      several ancillary investigations to determine the range of benefits or adverse effects for
      subpopulations of patients (e.g. different diagnostic subgroups) and examine any potential
      benefits or drawbacks to the use of this new lighting system, including actigraphic
      recordings of sleep-wake patterns of nurses and any self-reported effects on well-being that
      are recorded by professionals who experience working in both wards.

      Update March 8th, 2019

      As noted in the original protocol, we aimed to recruit a minimum of 400 individuals who give
      written informed consent to participate in a two-arm pragmatic effectiveness randomized
      controlled clinical treatment trial (RCT), with the expectation that we would actually
      include about 200-250 individuals per group. This recruitment target takes into account
      'failure to complete randomization' (i.e. the patient is randomized to a specified lighting
      condition, but is not admitted to the bed in the ward with the allocated lighting condition;
      this may occur for a number of reasons that were listed in the original protocol) and the
      delayed consent procedure (we note that the delay between randomization and consent is, on
      average, about 14 days).

      The recruitment period was about 6 months (Oct 23th 2018 until April 12th 2019), but we set a
      limit on randomization to March 31st and for obtaining delayed consent of April 12th. This
      time frame was selected as it corresponds to the winter period in this region of Norway.
      After March 31st, daylight saving time changes and also we experience very different
      environmental light exposure (long days, short nights, etc). This is relevant as it means
      that any extension to the recruitment period needs to be delayed until the environmental
      light exposure matches that experienced by individuals who entered the RCT at the start of
      recruitment. As such, we agreed (in advance of starting the RCT) with the ethics committee
      and trial steering group, that should we fall short of the target sample size after six
      months or recruitment, then the recruitment process would be suspended and would be re-opened
      in October 2019 (when the environmental light exposure would be the same as during the
      original winter recruitment period).

      Although our projected randomization rate is as expected (and we have randomized >600
      individuals by month 4-5 of the study), two issues have arisen with completion of
      randomization. The first was totally unpredictable, namely that a regional electricity power
      failure meant that we could not properly randomize admissions for a 72-hour weekend period
      (during with >15 admissions occurred). After discussion, it was agreed that the manual system
      of randomization that was introduced over that weekend could not be regarded as equivalent to
      the automated system, so these cases were immediately excluded from the RCT sample. Second,
      the bed occupancy rate in January and February has been running at about 100%, meaning that
      many randomizations cannot be completed (i.e. the patient is randomized but cannot then be
      admitted to the lighting condition to which they were allocated).

      We undertook modelling of the projected number of randomizations that would be completed
      (i.e. admitted to the lighting condition allocated at randomization) and have given written
      informed consent by April 12th. the projected admission rates, we believe that this sample
      size is at the lower limit of the estimated study population (as we are permitted to continue
      recruitment for at least six consecutive months). We modelled the best- and worst-case
      scenario. The best-case scenario suggested we would achieve the target sample by April 12th
      (>400), but the worst-case scenario suggested we may only have randomized, completed correct
      allocation and obtained the delayed consent in about 350-360 cases.

      Given the above, and the pre-trial agreement that recruitment could be suspended and
      re-opened in October 2019, this is course of action we have taken. As we do not break the
      codes for randomization (completed as allocated or failed) or match these to which
      individuals have given consent (via the deferred procedure), we cannot know the exact number
      of trial participants we need to recruit in October. However, the original protocol stated we
      would recruit 400-500 participants. With this in mind, we will re-open randomization for six
      weeks, starting October 2019, and close the consent procedure by the end of November 2019.

      Added October 7t,h 2021:

      The Statistical Analytical Plan (SAP) has been written before anyone have performed any
      analyses on data from the trial. Analyses of the data from the trial will start one week
      after the SAP has been uploaded to https://register.clinicaltrials.gov.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a single-centre, unblinded, two-arm, parallel-group, pragmatic effectiveness RCT of differences in the mean duration of acute psychiatric hospitalization in days for individuals exposed to experimental lighting compared with normal lighting conditions.
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of admission
time frame: Recorded at the date of discharge (range from 0 to about 150 days).
description: The primary outcome measure will be mean duration of admission per individual. The date and time of admission and of discharge will be extracted from the electronic records for the Intention To Treat (ITT) analyses. For the per-protocol analyses discharge will be the date and time the patient left the light environment the patient was randomized to and was subsequently away from the unit for more than 24 hours.
measure: Total Sleep Time
time frame: Daily throughout the admission (range form 0 to about 150 days).
description: Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate total sleep time.
measure: Bed time
time frame: Recorded daily throughout the admission (range form 0 to about 150 days).
description: Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate the time the patients went to bed (bed time).
measure: Sleep onset
time frame: Recorded daily throughout the admission (range form 0 to about 150 days).
description: Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate the time for sleep onset.
measure: Nocturnal awakenings
time frame: Recorded daily throughout the admission (range form 0 to about 150 days).
description: Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate number of nocturnal awakenings.
measure: Wake after sleep onset
time frame: Recorded daily throughout the admission (range form 0 to about 150 days).
description: Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate the time a patient is awake after initial sleep onset.
measure: Sleep offset
time frame: Recorded daily throughout the admission (range form 0 to about 150 days).
description: Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.
Employing best available scoring algorithms, raw data from daily recordings will be used to estimate the time of final awakening called sleep offset.
measure: Level of clinical improvement
time frame: Recorded daily throughout admission and at the date of discharge (range from 0 to about 150 days).
description: Clinical Global Impression, Improvement subscale (CGI-I): The investigators use the Improved version of the Clinical Global Improvement Scale (iCGI-I).28 Scores capture change over time with ratings ranging from -6 (maximum deterioration) to +6 (ideal improvement). The iCGI-I is used (a) to monitor day-to-day changes in mental state and functioning, and (b) to record overall change from admission to discharge.
measure: Level of illness severity
time frame: First 0-24 hours of admission, last 24 hours of admission
description: Clinical Global Impression, Severity subscale (CGI-S): The CGI-S is a likert scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). These CGI-S ratings are benchmarked relative the total inpatient population (i.e. not according to diagnostic subgroups). It is scored on two occasions only: the morning after admission to the unit (based on observations for 0-24 hours since admission) and at discharge (based on information from the 24 hours preceding discharge).
measure: Suicide risk
time frame: Daily throughout the admission (range from 0 to about 150 days)
description: Suicide risk is assessed daily throughout the admission by a clinical psychologist or psychiatrist treating the patient. It is scored using one item assessing if the patient has elevated risk of suicide using a binary scale (yes/no) and one item assessing if there is need for continuous observation of the patient to reduce suicide risk (yes/no).
measure: Aggressive behavior
time frame: One score will be made 2 hours into each shift, a total of three times per day, every day, while the patient is admitted (range from 0 to about 150 days)
description: Risk of aggressive behaviour are assessed three times per 24 hours by nurses using the Brøset Violence Checklist (BVC). The BVC is a 6-item scale assessing the presence of six observable behaviours on a binary scale (1=present/0=not present). The BVC has with good psychometric properties and the sum score (range 0-6) indicates risk of violence (low=0, moderate =1-2, high > 2).
measure: Aggressive incidents
time frame: Aggressive incidents are not recorded at pre-specified time points, but the time and date are recorded if they occur throughout the duration of admission (range 0 to about 150 days).
description: Actual incidents of aggressive behaviour will be systematically recorded using the Staff Observation Aggression Scale-Revised (SOAS-R) and interventions employed will be recorded by the nurses. The items in the SOAS-R specifies the context of the aggressive incident and the severity of the aggressive incident on a 0 to 100 scale (0 = not severe, 100 = very severe).
measure: Medication use
time frame: Daily throughout the admission (range from 0 to about 150 days)
description: Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual during admission will be recorded.
measure: Admission status
time frame: Changes in admission status are not recorded at pre-specified times, but the time and date are recorded when they occur throughout the admission (range from 0 to about 150 days)
description: If a patient is admitted involuntarily, the investigators will estimate the time until their status is reclassified as voluntary (as a marker of improved insight and mental capacity). Similarly change from voluntary to involuntary status and time to this reclassification will be recorded.
measure: Patient Satisfaction and Benefit
time frame: At the day of discharge (range 0 to about 150 days)
description: Mean levels of patient satisfaction with an admission are routinely assessed using the standard patient satisfaction questionnaire completed at discharge. The questionnaire was developed by Norwegian Institute of Public Health, is used throughout the Norwegian Health Care system and consists of 10 items scored on a 5-point Likert scale (1=low satisfaction). Some items are relevant to examining experiences of the different lighting conditions, (e.g. was the treatment was tailored to your situation?) Also, there are items related to side effects (see below). A specific item assesses the perceived benefit of the admission (1 = no benefit, 5 = very large benefit).
measure: Side effects of the light environment
time frame: At the day of discharge (range 0 to about 150 days)
description: The frequency of any side effects or adverse events experienced by individuals admitted to each lighting condition will be examined. The assessment comprises of the Headache and Eye Strain Scale (HES) supplement by additional items developed specifically for this trial and setting (and incorporated into the satisfaction questionnaire), 22 items in total. The HES assesses eight symptoms each of which is rated on a 4-point scale (ranging from absent = 0, to severe = 3) and is sensitive to exposure to different lighting conditions. Study participants are asked to rate any HES symptoms experienced during the course of admission and 14 further items that may represent side effects of acute psychiatric treatment (e.g. dizziness, gastro-intestinal disturbances, daytime sleepiness, poor sleep quality, and restlessness, etc.) that will also be rated using the same 4-point scale. Range of scores is 0 to 66 points.
measure: Adverse effects of the light environment
time frame: Adverse effects are not recorded at pre specified times, but the time and date are recorded when they occur throughout the admission (range 0 to about 150 days)
description: To capture any putative adverse events experienced during the admission the investigators will record any serious or untoward incidents (such as non-accidental and accidental deaths, near fatal events, severe violence, etc.). Also, the investigators will note if any patients are transferred out of the blue-depleted light environment because clinical opinion suggests that it may be having a detrimental effect on the individual.
arm group label: Blue-depleted evening light condition
arm group type: Experimental
arm group label: Normal light condition
arm group type: Active Comparator
intervention type: Other
intervention name: Blue-depleted evening light condition
description: A 20-bedded ward with tunable light emitting diode (LED) lamps. At 18:00h the lighting undergoes a 30-minute transition during which the green and blue LEDs are dimmed to produce blue-depleted amber colored lighting. At 06:50h a new 10-minute transition changes the light color to ordinary indoor lighting. From 07:00h to 18:00h, there is ordinary indoor lighting (3000K colour temperature). The light intensity is dimmed to 20% of the maximum from 23:00h to 6:50h.
Blue-blocking window filters are deployed also in the evening. All TV sets have permanent blue-blocking filters and individuals are provided with blue-blocking screens that can be attached to the front of personal electronic devices. If the patients leave the blue-depleted unit after 18:30 they are offered blue-blocking glasses to wear. The light spectrum in the ward was assessed prior to commencing the RCT and is well-matched to what has been shown in laboratory settings to minimally suppress melatonin.
arm group label: Blue-depleted evening light condition
intervention type: Other
intervention name: Normal light condition
description: The other half of the unit (20 patient rooms and their corresponding bathrooms and common areas) have ordinary indoor light installed (Glamox, Norway). This has a 3000K color temperature. The light is dimmed to 20% of max in the night, similar to the blue-depleted condition.
The light in the normal light condition and the blue-depleted light condition have similar levels of photopic lux throughout the 24h cycle, but different levels of melanopic lux between 1830h and 0700h.
arm group label: Normal light condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Håvard Kallestad, PhD
role: Principal Investigator
affiliation: St. Olavs Hospital, Department of Research and Development
facility: 
country: Norway
citation: Scott J, Langsrud K, Vethe D, Kjorstad K, Vestergaard CL, Faaland P, Lydersen S, Vaaler A, Morken G, Torgersen T, Kallestad H. A pragmatic effectiveness randomized controlled trial of the duration of psychiatric hospitalization in a trans-diagnostic sample of patients with acute mental illness admitted to a ward with either blue-depleted evening lighting or normal lighting conditions. Trials. 2019 Aug 1;20(1):472. doi: 10.1186/s13063-019-3582-2.
PMID: 31370871
responsible party type: Sponsor
mesh term: Mental Disorders
provided document: 