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Testing the Effectiveness of an Evening Blue-depleted Light Environment in an Acute Psychiatric Ward

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ClinicalTrials.gov Identifier: NCT03788993
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mental Disorder Other: Blue-depleted evening light condition Other: Normal light condition Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : November 19, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Blue-depleted evening light condition Other: Blue-depleted evening light condition

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.


Active Comparator: Normal light condition Other: Normal light condition

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.





Primary Outcome Measures :
  1. Duration of admission [ Time Frame: Recorded at the date of discharge (range from 0 to about 150 days). ]
    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.


Secondary Outcome Measures :
  1. Total Sleep Time [ Time Frame: Daily throughout the admission (range form 0 to about 150 days). ]

    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.


  2. Bed time [ Time Frame: Recorded daily throughout the admission (range form 0 to about 150 days). ]

    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).


  3. Sleep onset [ Time Frame: Recorded daily throughout the admission (range form 0 to about 150 days). ]

    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.


  4. Nocturnal awakenings [ Time Frame: Recorded daily throughout the admission (range form 0 to about 150 days). ]

    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.


  5. Wake after sleep onset [ Time Frame: Recorded daily throughout the admission (range form 0 to about 150 days). ]

    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.


  6. Sleep offset [ Time Frame: Recorded daily throughout the admission (range form 0 to about 150 days). ]

    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.


  7. Level of clinical improvement [ Time Frame: Recorded daily throughout admission and at the date of discharge (range from 0 to about 150 days). ]
    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.

  8. Level of illness severity [ Time Frame: First 0-24 hours of admission, last 24 hours of admission ]
    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).

  9. Suicide risk [ Time Frame: Daily throughout the admission (range from 0 to about 150 days) ]
    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).

  10. 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) ]
    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).

  11. 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). ]
    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).

  12. Medication use [ Time Frame: Daily throughout the admission (range from 0 to about 150 days) ]
    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.

  13. 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) ]
    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.

  14. Patient Satisfaction and Benefit [ Time Frame: At the day of discharge (range 0 to about 150 days) ]
    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).

  15. Side effects of the light environment [ Time Frame: At the day of discharge (range 0 to about 150 days) ]
    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.

  16. 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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals aged 18 years or older
  • Admitted to the acute inpatient unit at St. Olavs University Hospital, Department Østmarka, Trondheim, Norway during the inclusion period for the study.
  • Any patients who are re-admitted during the inclusion period for the study are eligible for re-randomization.

Exclusion Criteria:

Post-randomization, there are four potential reasons for exclusion from the RCT:

  • Lack of availability of rooms (as allocated at randomization): acute wards operate at high levels of bed occupancy, so on some occasions there will be no rooms available in the ward to which the individual is allocated (i.e. the randomization process cannot be completed).
  • Clinical imperative: on some occasions senior medical or nursing professionals may decide that it is clinically inappropriate to admit an individual to a vacant room in the ward to which they are randomized. The most frequent reasons for this to occur are clinical concerns about (a) how this admission would affect the case mix within the ward (e.g. it may be inappropriate to locate all the patients with an acute episode of mania in one ward, etc.) and/or (b) completing the randomization process may compromise the safety, care and treatment of current inpatients or of the individual being admitted (e.g. it may not be possible to provide the appropriate staff-to-patient ratio required for optimal treatment if all individuals with higher levels of need are located in one ward, etc.).
  • The individual is unwilling to give written informed consent at any time during their admission (when approached according to the deferred consent procedure) or is unable to give informed consent for the duration of the study (i.e. they remain persistently and severely ill and/or lack mental capacity).
  • The consent procedure was incomplete: an individual may be discharged early or have an unplanned discharge (e.g. discharge against medical advice) which may mean they were not approached about study participation or they had only given verbal, but not written consent.

Withdrawal criteria:

As randomization occurs at the point of admission, all exclusions de facto occur post-randomization, so the criteria described above represent the main reasons for study withdrawal.

Additional withdrawal criteria:

  • A patient will be withdrawn from the study if they are absent for >24 hours from the ward to which they randomized (e.g. they may be transferred to a medical ward for several days; the patient may request or the clinicians instigate transfer to another ward; medical or nursing staff may decide the patient should be transferred to the other ward at the unit because of patient need, case mix or staffing issues, etc.).
  • An individual can decline to participate at any stage of the study and/or a mental health professional can recommend withdrawal of an inpatient from the RCT if they have any clinical concerns regarding an individuals' participation (e.g. if there is a belief that the patient has experienced an adverse event associated with exposure to the blue-depleted light). In all instances a record will be kept of reasons for withdrawal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788993


Contacts
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Contact: Håvard Kallestad, PhD +47 93027262 havard.kallestad@ntnu.no
Contact: Terje Torgersen, MD PhD terje.torgerson@ntnu.no

Locations
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Norway
St. Olavs Hospital, Department Østmarka Recruiting
Trondheim, Norway, 7040
Contact: Daniel Vethe, cand.psychol    99373876    daniel.vethe@ntnu.no   
Contact: Patrick Faaland, cand.psychol       patrick.faaland@ntnu.no   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Håvard Kallestad, PhD St. Olavs Hospital, Department of Research and Development

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03788993     History of Changes
Other Study ID Numbers: 2017/916
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
Phototherapy
Hospitals, psychiatric
Emergency Services, Psychiatric

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders