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- Ensayo clínico NCT02448433
Phototherapy in Young People With Depression
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rébecca Robillard, PhD
- Número de teléfono: 6279 +1 613 722 6521
- Correo electrónico: reb.robillard@gmail.com
Ubicaciones de estudio
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Suspendido
- Brain and Mind Research Insitute, The University of Sydney
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Ontario
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Ottawa, Ontario, Canadá, K1Z 7K4
- Reclutamiento
- Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
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Contacto:
- Rébecca Robillard, PhD
- Número de teléfono: 6279 +1 613 722 6521
- Correo electrónico: reb.robillard@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Phototherapy
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Severity of Depression
Periodo de tiempo: Between baseline and post (4 weeks) intervention
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Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
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Between baseline and post (4 weeks) intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Severity of Depression
Periodo de tiempo: Score between baseline and follow up (8 weeks)
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Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
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Score between baseline and follow up (8 weeks)
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Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression
Periodo de tiempo: Between baseline and post (4 weeks) intervention
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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)
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Between baseline and post (4 weeks) intervention
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Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression
Periodo de tiempo: Baseline and post (4 weeks) intervention
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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)
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Baseline and post (4 weeks) intervention
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Subjective Sleep Quality
Periodo de tiempo: Between baseline and post (4 weeks) intervention
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Change in Leeds Sleep Evaluation Questionnaire score
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Between baseline and post (4 weeks) intervention
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Fatigue Severity
Periodo de tiempo: Between baseline and post (4 weeks) intervention
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Change in Fatigue Severity Scale score
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Between baseline and post (4 weeks) intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015007
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