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

NCT03788993 | Completed

• 1 other identifier: 2017/916
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder

Keywords

Phototherapy; Hospitals, psychiatric; Emergency Services, Psychiatric

Outcome Measures

Primary Outcomes (1)

• Duration of admission

  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.

  Recorded at the date of discharge (range from 0 to about 150 days).

Secondary Outcomes (16)

• Total Sleep Time

  Daily throughout the admission (range form 0 to about 150 days).

• Bed time

  Recorded daily throughout the admission (range form 0 to about 150 days).

• Sleep onset

  Recorded daily throughout the admission (range form 0 to about 150 days).

• Nocturnal awakenings

  Recorded daily throughout the admission (range form 0 to about 150 days).

• Wake after sleep onset

  Recorded daily throughout the admission (range form 0 to about 150 days).

Study Arms (2)

Blue-depleted evening light condition

EXPERIMENTAL

Other: Blue-depleted evening light condition

Normal light condition

ACTIVE COMPARATOR

Other: Normal light condition

Interventions

Blue-depleted evening light condition OTHER

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.

Blue-depleted evening light condition

Normal light condition OTHER

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.

Normal light condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 years or older

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St. Olavs Hospital, Department Østmarka

Trondheim, 7040, Norway

Location

Related Publications (2)

• 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 BACKGROUND

• Kallestad H, Langsrud K, Simpson MR, Vestergaard CL, Vethe D, Kjorstad K, Faaland P, Lydersen S, Morken G, Ulsaker-Janke I, Saksvik SB, Scott J. Clinical benefits of modifying the evening light environment in an acute psychiatric unit: A single-centre, two-arm, parallel-group, pragmatic effectiveness randomised controlled trial. PLoS Med. 2024 Dec 6;21(12):e1004380. doi: 10.1371/journal.pmed.1004380. eCollection 2024 Dec.

  PMID: 39642162 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Håvard Kallestad, PhD

  St. Olavs Hospital, Department of Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 28, 2018
• Study Start: October 23, 2018
• Primary Completion: November 29, 2019
• Study Completion: December 1, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

NO (1)