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临床试验/NCT03742960
NCT03742960已完成不适用

Sleep Subtypes in Adolescent Depression: Sleep Physiology and Treatment

University of Bern2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2019年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
2
主要终点
Change in self-reported mood assessed via the Multidimensional Mood Questionnaire

研究概览

简要总结

The purpose of this study is to compare sleep neurophysiology and behavior in adolescents with MDD with hypersomnia (MDD-HYP) and insomnia (MDD-INS) with healthy controls (HC). In addition, the investigators will test the efficacy of a simple behavioral sleep restriction on mood and sleep in their sample.

详细描述

The World Health Organization has identified depression as the leading cause of burden of disease amongst young people. Subjective sleep complaints are often a core symptom of depression and highly prevalent with 60-90% of depressed adolescents suffering from disrupted sleep. This sleep disruption often takes the form of insomnia (e.g., difficulty falling or staying asleep, or waking too early) or hypersomnia (prolonged sleep episodes or excessive daytime sleepiness). The aim of the trial is to examine the efficacy of a simple behavioral sleep restriction two weeks in duration on mood and sleep in adolescents ages 14 to 17 years with and without major depressive disorder. During this period sleep is objectively measured using actigraphy and monitor mood using self-report. The results of the study will inform whether a simple behavioral sleep restriction beneficially impacts mood and sleep.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • This study will recruit adolescents (ages 14 to 17 years) with major depressive disorder (MDD) with insomnia (MDD-INS) and with hypersomnia (MDD-HYP) and age and gender matched controls (HC).
  • Inclusion Criteria:
  • Key inclusion criteria for MDD Hypersomnia Group:
  • MDD as determined through the MINI-KID
  • Determination of hypersomnia as defined by excessive daytime sleepiness, or long sleep duration.
  • Written informed consent
  • Key inclusion criteria for MDD Insomnia Group:
  • MDD as determined through the MINI-KID
  • Determination of insomnia as defined by the insomnia severity index
  • Written informed consent

排除标准

  • Key exclusion criteria for all three groups include:
  • Current or lifetime experience of frank psychosis or mania
  • Presence of suicidal intent representing imminent risk as indicated during clinical interview
  • Medical or neurological condition that could impact brain functioning
  • History of physical brain injury or blow to the head resulting in loss of consciousness greater than 5 minutes
  • Do not meet criteria for substance or alcohol dependence in the last three months
  • Presence of an organic sleep disorder (e.g., narcolepsy, sleep apnea)
  • Additional exclusion criteria for healthy control group:
  • Presence of psychiatric disorder
  • Self-reported disrupted, short or ill-timed sleep
  • Additional exclusion criteria for MDD-INS and MDD-HYP:
  • No sleep difficulties

结局指标

主要结局

Change in self-reported mood assessed via the Multidimensional Mood Questionnaire

时间窗: Two weeks

Changes in self-reported mood will be measured via ecological momentary assessment. Participants will fill out the Multidimensional Mood Questionnaire four times a day (morning, after school, at dusk and 30 minutes before bedtime). The Multidimensional Mood Questionnaire assesses the state "happy/sad" on a visual analog scale from 0 to 100. The mean across the day will be calculated.

Change in self-reported sleep efficiency (defined as total sleep time divided by time in bed and thus expressed as a percentage) as assessed via sleep diary

时间窗: Two weeks

Changes in self-reported sleep efficiency will be measured via sleep diary. The data will be collected by ecological momentary assessment (EMA). Time in bed (TIB) is defined as the time between participants reporting going to bed and waking up. Total sleep time (TST) is defined as TIB minus the amount of time participants report taking to fall asleep (sleep onset latency; SOL) and the duration of waking after sleep onset (WASO).

次要结局

  • Change in Repetitive Negative Thinking (focus on problems) assessed by one question from the Response Style Questionnaire(Two weeks)
  • Change in depressive symptoms from 1 to 3 days prior to the sleep manipulation and the end of the manipulation (second to last or last day of sleep manipulation)(Two weeks)
  • Change in anxiety symptoms from 1 to 3 days prior to the sleep manipulation and the end of the manipulation (second to last or last day of sleep manipulation)(Two weeks)
  • Change in Repetitive Negative Thinking (focus on feelings) assessed by one question from the Response Style Questionnaire(Two weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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