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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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New South Wales
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Camperdown, New South Wales, Австралия, 2050
- Приостановленный
- Brain and Mind Research Insitute, The University of Sydney
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Ontario
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Ottawa, Ontario, Канада, K1Z 7K4
- Рекрутинг
- Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
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Контакт:
- Rébecca Robillard, PhD
- Номер телефона: 6279 +1 613 722 6521
- Электронная почта: reb.robillard@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Другой: 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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Severity of Depression
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Severity of Depression
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2015007
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Phototherapy light-emitting glasses
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Chang Gung Memorial HospitalNational Taipei University of Nursing and Health SciencesЗавершенныйУсталость | Качество сна | Гинекологические выжившие рак | Симптомы настроенияТайвань
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University of Alabama at BirminghamРекрутингСпать | Расстройство, связанное с употреблением опиоидов | Циркадные ритмы | фМРТ исследованияСоединенные Штаты