NCT03742960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 24, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

4.2 years

First QC Date

October 31, 2018

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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).

    Two weeks

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

    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.

    Two weeks

Secondary Outcomes (4)

  • Change in Repetitive Negative Thinking (focus on problems) assessed by one question from the Response Style Questionnaire

    Two weeks

  • Change in Repetitive Negative Thinking (focus on feelings) 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

Study Arms (1)

Behavioral Sleep Restriction

EXPERIMENTAL

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

Interventions

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.

Behavioral Sleep Restriction

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- 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).
  • MDD as determined through the MINI-KID
  • Determination of hypersomnia as defined by excessive daytime sleepiness, or long sleep duration.
  • Written informed consent
  • MDD as determined through the MINI-KID
  • Determination of insomnia as defined by the insomnia severity index
  • Written informed consent

You may not qualify if:

  • 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)
  • Presence of psychiatric disorder
  • Self-reported disrupted, short or ill-timed sleep
  • No sleep difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leila Tarokh

Bern, 3000, Switzerland

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Leila Tarokh, PhD

    Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 15, 2018

Study Start

April 24, 2019

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations