改变急性精神病病房夜间光照环境的临床益处:一项单中心、双臂、平行组、实用有效性随机对照试验

IF 15.8 1区 医学 Q1 Medicine PLoS Medicine Pub Date : 2024-12-06 eCollection Date: 2024-12-01 DOI:10.1371/journal.pmed.1004380
Håvard Kallestad, Knut Langsrud, Melanie Rae Simpson, Cecilie Lund Vestergaard, Daniel Vethe, Kaia Kjørstad, Patrick Faaland, Stian Lydersen, Gunnar Morken, Ingvild Ulsaker-Janke, Simen Berg Saksvik, Jan Scott
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引用次数: 0

摘要

背景:光暴露对心理健康的影响越来越被认识到。调整住院病人的夜间光照可能是一种低强度的精神障碍干预措施,但很少有随机对照试验(rct)存在。我们报告了一项大规模的实用有效性随机对照试验,探讨急性精神疾病患者是否从住院病房获得额外的益处,因为夜间光照的变化与治疗环境相结合。方法和研究结果:2018年10月25日至2019年3月29日,以及2019年10月1日至2019年11月15日,挪威特隆赫姆所有急性住院精神病患者(≥18岁)被随机分配到一个蓝色耗尽的夜间光环境病房或一个标准光环境病房。使用了提供延迟知情同意的个人的基线和结果数据。主要结局指标是每个患者的平均入院时间(以天为单位)。次要结局评估主要临床结局的平均差异:入院期间的改善(临床总体印象量表-改善,CGI-I)和出院时的疾病严重程度(CGI-S),入院期间的攻击行为(布罗塞特暴力检查表,BVC),暴力事件(工作人员观察攻击量表-修订,SOAS-R),副作用和患者满意度,自杀概率,因自杀而需要监督,以及从非自愿到自愿的转变。意向治疗样本包括476人(平均年龄37岁(标准差(SD) 13.3);男性193例(41%),女性283例(59%)。平均入院时间没有差异(暴露于蓝光减弱的夜间光环境的住院患者为7.1天,暴露于标准夜间光环境的住院患者为6.7天;估计平均差:0.4天(95%置信区间[-0.9,1.9]);P = 0.523)。在入院时,暴露于夜间蓝光不足的住院患者表现出更高的改善(CGI-I差0.28 (95% CI [0.02, 0.54];p = 0.035),临床有意义改善所需治疗数(NNT): 12);出院时疾病严重程度较低(CGI-S差-0.18)(95% CI [-0.34, -0.02];p = 0.029),轻度出院时NNT: 7);攻击行为水平较低(BVC预测每100天严重事件的差异:-2.98 (95% CI [-4.98, -0.99];p = 0.003), NNT: 9)。其他次要结局无差异。这项研究的性质意味着不可能使患者或临床工作人员对照明条件视而不见。结论:根据时间生物学原理改变急性精神病医院的夜间光照环境不会改变住院时间,但在不增加副作用、降低患者满意度或需要额外临床工作人员的情况下,可以获得显著的临床益处。试验注册:Clinicaltrials.gov NCT03788993;2018 (cristin id 602154)。
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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.

Background: The impact of light exposure on mental health is increasingly recognised. Modifying inpatient evening light exposure may be a low-intensity intervention for mental disorders, but few randomised controlled trials (RCTs) exist. We report a large-scale pragmatic effectiveness RCT exploring whether individuals with acute psychiatric illnesses experience additional benefits from admission to an inpatient ward where changes in the evening light exposure are integrated into the therapeutic environment.

Methods and findings: From 10/25/2018 to 03/29/2019, and 10/01/2019 to 11/15/2019, all adults (≥18 years of age) admitted for acute inpatient psychiatric care in Trondheim, Norway, were randomly allocated to a ward with a blue-depleted evening light environment or a ward with a standard light environment. Baseline and outcome data for individuals who provided deferred informed consent were used. The primary outcome measure was the mean duration of admission in days per individual. Secondary outcomes were estimated mean differences in key clinical outcomes: Improvement during admission (The Clinical Global Impressions Scale-Improvement, CGI-I) and illness severity at discharge (CGI-S), aggressive behaviour during admission (Broset Violence Checklist, BVC), violent incidents (Staff Observation Aggression Scale-Revised, SOAS-R), side effects and patient satisfaction, probabilities of suicidality, need for supervision due to suicidality, and change from involuntary to voluntary admission. The Intent to Treat sample comprised 476 individuals (mean age 37 (standard deviation (SD) 13.3); 193 (41%) were male, 283 (59%) were female). There were no differences in the mean duration of admission (7.1 days for inpatients exposed to the blue-depleted evening light environment versus 6.7 days for patients exposed to the standard evening light environment; estimated mean difference: 0.4 days (95% confidence interval (CI) [-0.9, 1.9]; p = 0.523). Inpatients exposed to the blue-depleted evening light showed higher improvement during admission (CGI-I difference 0.28 (95% CI [0.02, 0.54]; p = 0.035), Number Needed to Treat for clinically meaningful improvement (NNT): 12); lower illness severity at discharge (CGI-S difference -0.18 (95% CI [-0.34, -0.02]; p = 0.029), NNT for mild severity at discharge: 7); and lower levels of aggressive behaviour (difference in BVC predicted serious events per 100 days: -2.98 (95% CI [-4.98, -0.99]; p = 0.003), NNT: 9). There were no differences in other secondary outcomes. The nature of this study meant it was impossible to blind patients or clinical staff to the lighting condition.

Conclusions: Modifying the evening light environment in acute psychiatric hospitals according to chronobiological principles does not change duration of admissions but can have clinically significant benefits without increasing side effects, reducing patient satisfaction or requiring additional clinical staff.

Trial registration: Clinicaltrials.gov NCT03788993; 2018 (CRISTIN ID 602154).

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来源期刊
PLoS Medicine
PLoS Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
17.60
自引率
0.60%
发文量
227
审稿时长
4-8 weeks
期刊介绍: PLOS Medicine is a prominent platform for discussing and researching global health challenges. The journal covers a wide range of topics, including biomedical, environmental, social, and political factors affecting health. It prioritizes articles that contribute to clinical practice, health policy, or a better understanding of pathophysiology, ultimately aiming to improve health outcomes across different settings. The journal is unwavering in its commitment to uphold the highest ethical standards in medical publishing. This includes actively managing and disclosing any conflicts of interest related to reporting, reviewing, and publishing. PLOS Medicine promotes transparency in the entire review and publication process. The journal also encourages data sharing and encourages the reuse of published work. Additionally, authors retain copyright for their work, and the publication is made accessible through Open Access with no restrictions on availability and dissemination. PLOS Medicine takes measures to avoid conflicts of interest associated with advertising drugs and medical devices or engaging in the exclusive sale of reprints.
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