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临床试验/NCT04712968
NCT04712968终止不适用

Efficacy of Daylight as Adjunctive Treatment in Patients With Unipolar Depression - a Randomized Controlled Feasibility Study

University of Aarhus1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
Change in well-being

研究概览

简要总结

The aim of this study is to improve the treatment effect for outpatients with depression by adding regular daily morning daylight exposure to their treatment with antidepressants. Patients will wear a personal light tracker to keep them motivated. Our hypothesis is that patients daily exposed to morning daylight, as a supplement to standard treatment for depression, will achieve significantly higher antidepressant effect that patients receiving standard treatment alone. Furthermore, we hypothesize that they will experience improved well-being and sleep.

详细描述

Due to inadequate efficiency of existing medical and psychotherapeutic treatments for depression there is a need for investigating the efficacy of adjunctive treatments. Light therapy has proven efficient as an add-on treatment for depression, but some patients might prefer being outdoors rather than sitting in front of a light therapy screen. However, no high-quality studies, have so far investigated the antidepressant and other potential positive effects of regular exposure to morning daylight for patients with unipolar depression.

The aim of this study is to examine the efficacy of morning daylight as add-on to treatment as usual in patients with depression. Efficacy is measured as reduction of depressive symptoms, improvement of sleep quality, and improvement of well-being.

Methods and material: A randomized controlled trial comprising 150 patients diagnosed with unipolar depression aged 18-50 years will be conducted. Patients are included after giving informed consent and the study period is 6 weeks. A wearable Personal Light Tracker, measuring the amount off light received, will be provided for all participants. Participants will be randomized into the following groups:

Group 1: Daylight (outdoor daylight exposed stay for minimum 30 minutes per day before 1 pm). To motivate patients to go outside they will receive psychoeducation on the connection between exposure to morning daylight and a possible antidepressant effect, and they are introduced to potential options for outdoor activities. A detailed instruction to the personal light tracker and the matching app, for monitoring the amount of light received throughout the day, is provided.

Group 2: Control group receiving treatment as usual. Patients will wear a personal light tracker but they are not introduced to the light-monitoring-app.

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 (Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Fulfilling criteria for an ICD-10 diagnosis of unipolar depression (F. 32.0, F.32.1, F.32.2, F32.3, F. 32.
  • F.33.0, F.33.1, F.33.2, F. 33.3)
  • Hamilton Depression Score (HAM-D17) ≥ 12
  • In treatment with the same antidepressant medication 14 days prior to inclusion
  • The participant must have access to a smart phone

排除标准

  • Actual treatment with Electro Convulsive Therapy (ECT)
  • Seasonal Affective Disorder (SAD)
  • Known sleep disturbances (sleep-apnoea, narcolepsy, or "restless legs syndrome")
  • On lithium, agomelatine, melatonin and/or mirtazapine
  • Known eye disorders
  • Current alcohol- or drug abuse
  • Current user of Light therapy

结局指标

主要结局

Change in well-being

时间窗: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).

Measured on The WHO-5 Well-Being Index (WHO-5). A questionnaire which measures well-being. The scale ranges from 0 to 100, the higher the score the more well-being.

Change in depressive symptoms

时间窗: Participants will answer the questionnaire every fourth day in the 42 day studyperiod.

Measured on Hamilton Depression Scale: selfreported version (HAM-D6). A questionnaire measuring depressive symptoms. The scale ranges from 0-22, the higher the score the more depressed is the patient.

Change in sleep quality

时间窗: Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).

Measured by Pittsburgh Sleeping Quality Index (PSQI).The score is between 0 and 21 "0" indicating no difficulty and "21" indicating severe difficulties.

Change in insomnia severity

时间窗: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).

Measured by Insomnia Severity Index (ISI). Self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe insomnia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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