Dynamic LED-light Versus Usual Care for Depressed Inpatient: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale 6 item version
研究概览
简要总结
Background: despite developments a substantial part of patients with depression will only recover slowly. Light therapy from light boxes has shown antidepressant effects but have several limitations: time consuming, only allowing a fixed spectral distribution, only delivered at a specific time-point, and often with inadequate light intensity delivered at the retina. Therefore, we developed a new dynamic lighting system using light fixtures that are built into the room and can change intensity and spectral distribution of light during the 24-hour day.
Objectives: the objective of this trial is to assess the beneficial and harmful effects of a newly developed dynamic lighting system using Light Emitting Diodes (LED) -light armatures aiming to mimic sunlight, when installed in the patient rooms of a psychiatric inpatient ward, compared with usual care.
Design: the design is a randomised controlled trial with two arms: an active dynamic light trial arm and a usual care arm with blinding of depression outcome, and data analyses. Randomisation will be 1:1.
Inclusion criteria: a current episode of a major depressive episode as part of a unipolar or bipolar disorder. Patients with bipolar depression should be in current and recent (minimum two months before admission) mood stabilising treatment, age > 18 years, informed consent.
Exclusion criteria: severe suicidality, abuse of alcohol and / or drugs, actual psychotic state, Young Mania Rating score above 7 or fulfilling diagnostic criteria for a current hypomanic or manic episode.
Interventions: the experimental intervention is a dynamic LED-light system in 10 separate patient single rooms with three dynamic lamps: a window jamb built-in light panel, two ceiling mounted lamps, and a wall mounted lamp. The usual care is constant standard LED-light.
Primary outcome: score on the Hamilton Depression Rating Scale 6 item version (HAM-D6) scale at week 3
Secondary outcomes: score on the Suicidal Ideation Attribution Scale (SIDAS ) scale at week 3, and score in the Hamilton. Depression Rating Scale 17 item version (HAM-D17) scale at week 3, and score on the World Health Organisation Quality Of Life questionaire abbreviated version (WHOQOL-BREF) at week 3.
Trial size: in total, 150 patients.
Time schedule: the trial will be submitted for regulatory approvals January 2019, the first participant will be included April 2019, the expected last follow-up of the last participant will be December 2020, the expected last follow-up after 6 months will be June 2021, data will be analysed from June 2021 till September 2021, manuscripts will be prepared from December 2020, and we expect to submit first manuscript December 2021.
详细描述
The participant population: depression is a common disorder with a prevalence of about 150,000 in Denmark. According to WHO depression is a leading cause of disability worldwide and is a major contributor to the global burden of disease. Society suffers large direct and indirect losses in terms of lost work, sickness and early retirements. In Denmark, the costs of depression alone amount to an estimated 14 billion DKK per year. Depression can affect an individual to the extent that everyday activities and chores are insurmountable, and can ultimately lead to despair, hopelessness, and suicidal behaviour.
Current treatment: the current treatment of a depressive episode, whether it is part of a Major Depressive Disorder (MDD) or of a Bipolar Disorder (BD), involves as first line treatment psychotherapy /psychoeducation, mood stabilisers, and antidepressants. Second line treatments include neurostimulation (Electroconvulsive treatment), and complementary options include exercise, chronotherapeutics (light therapy, sleep deprivation), neurostimulation and other therapies. Recent drug development has not been able to produce compounds with better antidepressant effect, and despite the ongoing development of new psychotherapeutic approaches, improvement from depression is often slow and with 10-25% ending up being treatment resistant. Relapse, readmission, and suicide are also major treatment challenges.
Trial interventions: the present efficacy trial investigates the possible antidepressant effect of a new form of dynamic lighting in the treatment of a major depressive episode either as part of a MDD or a BD. The Light-Emitting-Diode (LED) technology provides new potentials to adjust frequency distribution and intensity of light during the 24 hour-day. LED-lighting can be adjusted to supply light rich in the blue, short waved region of the spectral composition in the first part of the day, and warmer light with less blue later in the day and in the evening. This regulation should, according to our current chronobiological knowledge, entrain and regulate the sleep-wake cycle, and thereby improve and stabilize mood, providing an added non-pharmacological treatment of in-patients suffering from depression.
The experimental intervention specifically consists of implementation of a dynamic LED-light system in patient rooms with three modules:
- a dynamic "sunlight therapy LED-lighting" that mimics the spectral composition and intensity of daylight coming through a southeast (SE) facing window at equinox with 12 hours of sunlight and 12 hours of darkness. The fixture is built into the window jamb (vertical side of the window) and cannot be switched off.
- Two LED-lighting lamps mounted horizontally in the ceiling providing dynamic spectral composition and intensity dynamic. Can be switched on/off.
- A reading LED-light mounted vertically on the wall adjacent to the bed providing dynamic spectral composition and intensity. Can be switched on/off.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of depression severity assessment
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A current episode of a major depressive episode (DSM-5) as part of a unipolar or bipolar disorder.
- •Patients with bipolar depression should be in current and recent (minimum two months before admission) mood stabilizing treatment
- •Age > 18 years
- •Informed consent
- •Danish speaking.
排除标准
- •Severe suicidality
- •Abuse of alcohol and / or drugs
- •Actual psychotic state within last four weeks
- •Actual Young Mania Rating score above 7 or fulfilling diagnostic criteria for a current hypomanic or manic episode
- •Patient is subject to coercive measures of any kind.
研究组 & 干预措施
Dynamic light
The experimental intervention is the installation of a dynamic LED-light system in 10 separate patient single rooms. The system includes three elements: a window jamb built-in light panel, two ceiling mounted lamps, and a wall mounted lamp. All lamps will have a dynamic, time dependent frequency distribution and intensity of light.
干预措施: Dynamic Light (Device)
Usual care
The usual care is constant standard LED-light with two elements: two ceiling mounted lamps and a wall mounted lamp.
干预措施: Usual care (Device)
结局指标
主要结局
Hamilton Depression Rating Scale 6 item version
时间窗: Up to 3 weeks
A scale, consisting of 7 items from the Hamilton depression Rating Scale, measuring severity of depression. Total scores from zero (no depression) to 24 (most severe depression)
次要结局
- WHOQOL-BREF(Up to 3 weeks)
- Score on the SIDAS scale(Up to 3 weeks)
- Hamilton Depression Rating Scale 17 item version(Up to 3 weeks)
研究者
Klaus Martiny
Professor of Clinical Psychiatry
University Hospital Bispebjerg and Frederiksberg