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Sleep Subtypes in Adolescent Depression

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Behavioral Sleep Restriction
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Leila TarokhRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Sleep Restriction

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
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).
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].
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).

Full Information

First Posted
October 31, 2018
Last Updated
May 17, 2022
Sponsor
University of Bern
Collaborators
University Hospital for Child and Adolescent Psychiatry and Psychotherapy Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03742960
Brief Title
Sleep Subtypes in Adolescent Depression
Official Title
Sleep Subtypes in Adolescent Depression: Sleep Physiology and Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
University Hospital for Child and Adolescent Psychiatry and Psychotherapy Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Sleep Restriction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Sleep Restriction
Intervention Description
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 Measure Information:
Title
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
Description
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).
Time Frame
Two weeks
Title
Change in self-reported mood assessed via the Multidimensional Mood Questionnaire
Description
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.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Change in Repetitive Negative Thinking (focus on problems) assessed by one question from the Response Style Questionnaire
Description
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).
Time Frame
Two weeks
Title
Change in Repetitive Negative Thinking (focus on feelings) assessed by one question from the Response Style Questionnaire
Description
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).
Time Frame
Two weeks
Title
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)
Description
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].
Time Frame
Two weeks
Title
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)
Description
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).
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Tarokh, PhD
Phone
0319328619
Email
leila.tarokh@upd.unibe.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Kaess, MD
Phone
0319328490
Email
michael.kaess@upd.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Tarokh, PhD
Organizational Affiliation
Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leila Tarokh
City
Bern
ZIP/Postal Code
3000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leila Tarokh, PhD
Phone
+41319328619
Email
leila.tarokh@upd.unibe.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sleep Subtypes in Adolescent Depression

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