Sleep Subtypes in Adolescent Depression

Major Depressive Disorder Clinical Trial

Official title:

Sleep Subtypes in Adolescent Depression: Sleep Physiology and Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742960
• Other study ID #: Sleep Subtypes
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Leila Tarokh	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	University Hospital for Child and Adolescent Psychiatry and Psychotherapy Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Repetitive Negative Thinking (focus on problems) assessed by one question from the Response Style Questionnaire	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).	Two weeks
Secondary	Change in Repetitive Negative Thinking (focus on feelings) assessed by one question from the Response Style Questionnaire	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).	Two weeks
Secondary	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)	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].	Two weeks
Secondary	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)	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).	Two weeks