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Sleep Subtypes in Adolescent Depression

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ClinicalTrials.gov Identifier: NCT03742960
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
University Hospital for Child and Adolescent Psychiatry and Psychotherapy Bern
Information provided by (Responsible Party):
University of Bern

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE April 24, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Change in Repetitive Negative Thinking (focus on problems) assessed by one question from the Response Style Questionnaire [ Time Frame: Two weeks ]
    Change in repetitive negative thinking will be measured via ecological momentary assessment. Participants will answer the question about "focus on problems" on a scale from 0 [not at all] to 100 [very much]) once a day (evening).
  • Change in Repetitive Negative Thinking (focus on feelings) assessed by one question from the Response Style Questionnaire [ Time Frame: Two weeks ]
    Participants will answer the question about "focus on feelings" on a scale from 0 [not at all] to 100 [very much]) once a day (evening).
  • 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) [ Time Frame: Two weeks ]
    The 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) will be measured via Center for Epidemiological Studies-Depression (CES-D; measures symptoms associated with depression), Strengths & Difficulties Questionnaires (SDQ; measures strengths and difficulties in general) and the Assessment of Snaith-Hamilton Pleasure Scale (SHAPS; assesses the presence of anhedonia [the inability to experience pleasure].
  • 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) [ Time Frame: Two weeks ]
    The 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) will be measured via Screen for Child Anxiety-Related Emotional Disorders (SCARED; screens anxiety disorder categories).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • Change in Repetitive Negative Thinking (focus on problems) assessed by one question from the Response Style Questionnaire [ Time Frame: Two weeks ]
    Change in repetitive negative thinking will be measured via ecological momentary assessment. Participants will answer the question about "focus on problems" on a scale from 0 [not at all] to 100 [very much]) once a day (evening).
  • Change in Repetitive Negative Thinking (focus on feelings) assessed by one question from the Response Style Questionnaire [ Time Frame: Two weeks ]
    Participants will answer the question about "focus on feelings" on a scale from 0 [not at all] to 100 [very much]) once a day (evening).
  • 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) [ Time Frame: Two weeks ]
    The 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 manpulation) will be measured via Center for Epidemiological Studies-Depression (CES-D; measures symptoms associated with depression), Strengths & Difficulties Questionnaires (SDQ; measures strengths and difficulties in general) and the Assessment of Snaith-Hamilton Pleasure Scale (SHAPS; assesses the presence of anhedonia [the inability to experience pleasure].
  • 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) [ Time Frame: Two weeks ]
    The 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 manpulation) will be measured via Screen for Child Anxiety-Related Emotional Disorders (SCARED; screens anxiety disorder categories).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Subtypes in Adolescent Depression
Official Title  ICMJE Sleep Subtypes in Adolescent Depression: Sleep Physiology and Treatment
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Behavioral: Behavioral Sleep Restriction
Participants will be instructed to go to bed 30 minutes later than their usual bedtime. On the other hand, wake up time will be unchanged resulting a nightly sleep restriction of 30 minutes. This protocol will be followed for two weeks.
Study Arms  ICMJE Experimental: Behavioral Sleep Restriction
Participants will be required to go to sleep half an hour later than their usual bedtime. Wake up time will be determined via their usual wake time.
Intervention: Behavioral: Behavioral Sleep Restriction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Additional exclusion criteria for MDD-INS and MDD-HYP:

• No sleep difficulties

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Leila Tarokh, PhD 0319328619 leila.tarokh@upd.unibe.ch
Contact: Michael Kaess, MD 0319328490 michael.kaess@upd.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03742960
Other Study ID Numbers  ICMJE Sleep Subtypes
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Bern
Study Sponsor  ICMJE University of Bern
Collaborators  ICMJE University Hospital for Child and Adolescent Psychiatry and Psychotherapy Bern
Investigators  ICMJE
Principal Investigator: Leila Tarokh, PhD Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie
PRS Account University of Bern
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP