Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Subtypes in Adolescent Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03742960
Recruitment Status : Not yet recruiting
First Posted : November 15, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie
Information provided by (Responsible Party):
University of Bern

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Behavioral Sleep Restriction Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleep Subtypes in Adolescent Depression: Sleep Physiology and Treatment
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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].

  4. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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

• No sleep difficulties


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742960


Contacts
Layout table for location contacts
Contact: Leila Tarokh, PhD 0319328619 leila.tarokh@upd.unibe.ch
Contact: Michael Kaess, MD 0319328490 michael.kaess@upd.ch

Locations
Layout table for location information
Switzerland
Leila Tarokh Not yet recruiting
Bern, Switzerland, 3000
Contact: Leila Tarokh, PhD    +41319328619    leila.tarokh@upd.unibe.ch   
Sponsors and Collaborators
University of Bern
Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie
Investigators
Layout table for investigator information
Principal Investigator: Leila Tarokh, PhD Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie

Layout table for additonal information
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03742960     History of Changes
Other Study ID Numbers: Sleep Subtypes
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders