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- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New South Wales
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Camperdown, New South Wales, Austrália, 2050
- Suspenso
- Brain and Mind Research Insitute, The University of Sydney
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Ontario
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Ottawa, Ontario, Canadá, K1Z 7K4
- Recrutamento
- Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
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Contato:
- Rébecca Robillard, PhD
- Número de telefone: 6279 +1 613 722 6521
- E-mail: reb.robillard@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Severity of Depression
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Severity of Depression
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2015007
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