Sleep Subtypes in Adolescent Depression
1 other identifier
interventional
71
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable major-depressive-disorder
Started Apr 2019
Longer than P75 for not_applicable major-depressive-disorder
1 active site
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
CompletedFirst Posted
Study publicly available on registry
November 15, 2018
CompletedStudy Start
First participant enrolled
April 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedNovember 30, 2023
November 1, 2023
4.2 years
October 31, 2018
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
EXPERIMENTALParticipants 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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leila Tarokh, PhD
Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie
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