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Major Depressive DisorderNCT03742960

Sleep Subtypes in Adolescent Depression

A study testing Behavioral Sleep Restriction in people with Major Depressive Disorder, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Major Depressive Disorder
What is being tested?
Behavioral Sleep Restriction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteSwitzerland
Study dates
24 Apr 2019to 1 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Leila Tarokh

    Bern, 3000

Other trials in Switzerland

About this study

Official title: Sleep Subtypes in Adolescent Depression: Sleep Physiology and Treatment

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.

Read the 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.

Being tested
Behavioral Sleep Restriction
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Sleep RestrictionBehavioural

    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.

Study groups in NCT03742960
Study groupRoleWhat they receive
Behavioral Sleep RestrictionExperimentalParticipants 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.
Receives: Behavioral: Behavioral Sleep Restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Two weeks

  2. 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.

    Measured: Two weeks

Secondary outcomes (4)

  1. 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).

    Measured: Two weeks

  2. 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).

    Measured: Two weeks

  3. 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].

    Measured: Two weeks

  4. 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).

    Measured: Two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start24 Apr 2019
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742960
Sponsor's protocol ID
Sleep Subtypes
Status last verified
Nov 2023
First submitted
31 Oct 2018
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Sleep Restriction in people with Major Depressive Disorder, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03742960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

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