Clinical trial NCT03742960: Sleep Subtypes in Adolescent Depression
Official title: Sleep Subtypes in Adolescent Depression: Sleep Physiology and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University Hospital for Child and Adolescent Psychiatry and Psychotherapy Bern
First posted: 2018-11-15
Enrollment: 71
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.

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

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

• No sleep difficulties

Primary outcomes:
measure: 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
timeFrame: Two weeks
measure: Change in self-reported mood assessed via the Multidimensional Mood Questionnaire
timeFrame: Two weeks
Secondary outcomes:
measure: Change in Repetitive Negative Thinking (focus on problems) assessed by one question from the Response Style Questionnaire
timeFrame: Two weeks
measure: Change in Repetitive Negative Thinking (focus on feelings) assessed by one question from the Response Style Questionnaire
timeFrame: Two weeks
measure: 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)
timeFrame: Two weeks
measure: 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)
timeFrame: Two weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Leila Tarokh
Study officials:
affiliation: Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie
name: Leila Tarokh, PhD
role: PRINCIPAL_INVESTIGATOR
References: