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Phototherapy in Young People With Depression

14 mai 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

La dépression

Intervention / Traitement

Dispositif: Phototherapy light-emitting glasses

Type d'étude

Interventionnel

Inscription (Anticipé)

Phase

N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

13 ans à 30 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: N / A
Modèle interventionnel: Affectation à un seul groupe
Masquage: Aucun (étiquette ouverte)

Nombre de bras

Armes et Interventions

Groupe de participants / Bras	Intervention / Traitement
Autre: Phototherapy	Dispositif: 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. Autres noms: Re-timer

Groupe de participants / Bras

Intervention / Traitement

Autre: Phototherapy

Dispositif: 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.

Autres noms:

Re-timer

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Severity of Depression Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Severity of Depression Délai: 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 Délai: 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 Délai: 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 Délai: Between baseline and post (4 weeks) intervention	Change in Leeds Sleep Evaluation Questionnaire score	Between baseline and post (4 weeks) intervention
Fatigue Severity Délai: Between baseline and post (4 weeks) intervention	Change in Fatigue Severity Scale score	Between baseline and post (4 weeks) intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Ottawa

Collaborateurs

University of Sydney

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2015

Achèvement primaire (Anticipé)

1 avril 2017

Dates d'inscription aux études

Première soumission

14 mai 2015

Première soumission répondant aux critères de contrôle qualité

14 mai 2015

Première publication (Estimation)

19 mai 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 mai 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 mai 2015

Dernière vérification

1 mai 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

2015007

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Phototherapy in Young People With Depression