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Clinical Trials/NCT03742960
NCT03742960
Completed
Not Applicable

Sleep Subtypes in Adolescent Depression: Sleep Physiology and Treatment

University of Bern1 site in 1 country71 target enrollmentApril 24, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
University of Bern
Enrollment
71
Locations
1
Primary Endpoint
Change in self-reported mood assessed via the Multidimensional Mood Questionnaire
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 24, 2019
End Date
July 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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).

Secondary Outcomes

  • 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)

Study Sites (1)

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