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Phototherapy in Young People With Depression

14 mei 2015 bijgewerkt door: Rébecca Robillard, University of Ottawa

Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms

Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered.

The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.

Studie Overzicht

Toestand

Onbekend

Conditie

Depressie

Interventie / Behandeling

Apparaat: Phototherapy light-emitting glasses

Studietype

Ingrijpend

Inschrijving (Verwacht)

Fase

Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Australië
- New South Wales
  - Camperdown, New South Wales, Australië, 2050
    - Geschorst
    - Brain and Mind Research Insitute, The University of Sydney
Canada
- Ontario
  - Ottawa, Ontario, Canada, K1Z 7K4
    - Werving
    - Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
    - Contact:
      
      Rébecca Robillard, PhD
      
      Telefoonnummer: 6279 +1 613 722 6521
      
      E-mail: reb.robillard@gmail.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 30 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Quick Inventory of Depressive Symptomatology score > 6;
First episode of depression before age 25;
Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic.

Exclusion Criteria:

Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;
Other primary psychiatric disorders aside from anxiety disorders;
Significant alcohol or other substance dependence;
Use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study);
Use of medications that may interact with light to produce a photoallergic reaction;
Eye or skin condition which may interact with bright light exposure;
Regular shift-work within 60-days prior to entry into the study;
Recent transmeridian travel.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: NVT
Interventioneel model: Opdracht voor een enkele groep
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Ander: Phototherapy	Apparaat: Phototherapy light-emitting glasses The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m^2) upon awakening and progressive shift to earlier wake-up times. Participants are encouraged to complete the light exposure sessions for 60 min each day. Participants are also instructed to progressively shift their schedule 15 min earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7:30am is reached (in which case, participants keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they do the light exposure sessions upon awakening across the four weeks of the intervention. During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls. Andere namen: Re-timer

Deelnemersgroep / Arm

Interventie / Behandeling

Ander: Phototherapy

Apparaat: Phototherapy light-emitting glasses

The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m^2) upon awakening and progressive shift to earlier wake-up times.

Participants are encouraged to complete the light exposure sessions for 60 min each day. Participants are also instructed to progressively shift their schedule 15 min earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7:30am is reached (in which case, participants keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they do the light exposure sessions upon awakening across the four weeks of the intervention.

During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls.

Andere namen:

Re-timer

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Severity of Depression Tijdsspanne: Between baseline and post (4 weeks) intervention	Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)	Between baseline and post (4 weeks) intervention

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Severity of Depression Tijdsspanne: Score between baseline and follow up (8 weeks)	Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)	Score between baseline and follow up (8 weeks)
Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression Tijdsspanne: Between baseline and post (4 weeks) intervention	Associations between changes in sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)	Between baseline and post (4 weeks) intervention
Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression Tijdsspanne: Baseline and post (4 weeks) intervention	Associations between the initial sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)	Baseline and post (4 weeks) intervention
Subjective Sleep Quality Tijdsspanne: Between baseline and post (4 weeks) intervention	Change in Leeds Sleep Evaluation Questionnaire score	Between baseline and post (4 weeks) intervention
Fatigue Severity Tijdsspanne: Between baseline and post (4 weeks) intervention	Change in Fatigue Severity Scale score	Between baseline and post (4 weeks) intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Ottawa

Medewerkers

University of Sydney

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2015

Primaire voltooiing (Verwacht)

1 april 2017

Studieregistratiedata

Eerst ingediend

14 mei 2015

Eerst ingediend dat voldeed aan de QC-criteria

14 mei 2015

Eerst geplaatst (Schatting)

19 mei 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

19 mei 2015

Laatste update ingediend die voldeed aan QC-criteria

14 mei 2015

Laatst geverifieerd

1 mei 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

2015007

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Phototherapy in Young People With Depression