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Effectiveness of Light Therapy Across Seasons

18 de maio de 2026 atualizado por: Claudia Simons, Geestelijke Gezondheidszorg Eindhoven (GGzE)

Is the Antidepressant Effect of Light Therapy for People With a Depressive Disorder Comparable in the Spring/Summer vs Autumn/Winter?

This study investigates whether the antidepressant effects of bright light therapy (BLT) differ between the spring/summer season and the autumn/winter season in adults with depressive disorders. While BLT is an established treatment for seasonal affective disorder, increasing evidence suggests it may also be effective for non-seasonal depression. However, it remains unclear whether its effectiveness depends on seasonal variation in natural daylight exposure.

In this prospective study conducted in a routine clinical care setting, patients referred for depressive symptoms and a score of > 6 on the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) receive BLT in a structured "Light Café" environment. Participants undergo daily morning light therapy sessions (30 minutes at 10,000 lux) for at least one week, with possible extension up to three weeks based on treatment response. A delayed-start design is used, where a subset of participants begins treatment two weeks later, allowing comparison with the natural course of depressive symptoms.

Depressive symptoms are assessed using the QIDS-SR at baseline, during treatment, and at follow-up (6 weeks and 3 months post-treatment). Sleep quality, chronotype, circadian timing, and side effects are also measured.

The primary objective is to compare the effectiveness of BLT across seasons. Secondary objectives include evaluating the persistence of treatment effects, assessing the change in sleep quality and day-to-day sleep-wake pattern, and exploring whether outcomes vary by chronotype, circadian phase, and patient characteristics.

This study aims to inform whether BLT should be considered a year-round treatment option for depressive disorders and to better understand factors influencing individual treatment response.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Real)

212

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Holanda
      • Eindhoven, Holanda, 5626ND
        • GGzE

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

The study population consists of patients with depression who are referred for treatment of depressive symptoms within a mental health care setting (GGzE, Eindhoven, The Netherlands), where bright light therapy is offered in a structured "Light Café" environment as part of routine clinical care.

Descrição

Inclusion Criteria:

  • Adults aged 18 years or older
  • Diagnosis of a depressive disorder (unipolar or bipolar), including both seasonal and non-seasonal depression
  • Currently indicated for bright light therapy
  • QIDS-SR score ≥ 6 at baseline
  • Able to provide informed consent
  • Sufficient proficiency in Dutch or English to complete questionnaires

Exclusion Criteria:

  • Current (hypo)manic or mixed episode
  • Current psychotic episode
  • Severe suicidal ideation requiring immediate intervention
  • Diagnosis of dementia
  • QIDS-SR score ≤ 5 at baseline
  • Age < 18 years
  • Inability to provide informed consent
  • Insufficient language proficiency to complete study questionnaires
  • Initiation, dose change, or switch of antidepressant medication within 3 weeks before or during light therapy
  • Long-term use of agomelatine

Relative Contraindications (require consultation with treating physician before participation):

  • Pregnancy (first trimester)
  • Diabetes or other systemic vascular diseases
  • Eye conditions associated with increased light sensitivity
  • Epilepsy

Medication-Related Considerations:

  • Participants are advised not to start antibiotics during light therapy (existing courses should be completed prior to participation)
  • Participants are advised to discontinue use of photosensitizing medications or topical agents during treatment
  • Participants are asked to discontinue melatonin use during light therapy
  • A wash-out period of 1 month is required after discontinuation of melatonin or short-term agomelatine use before starting light therapy

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Spring/summer
Patients with a depression who received bright light therapy as part of routine clinical care. For the purpose of the analyses, participants were categorized based on the season of treatment initiation, with this cohort including those who started treatment during the spring and summer seasons.
Dispositivo: Bright Light Therapy
Bright Light Therapy (BLT) will be administered according to Dutch depression guidelines, using Innolux LED light lamp (3800K, 10,000 lux). BLT will be given for one work week (Mon-Fri), 7:30-10:30 AM, 30 mins/session. Patients can have breakfast, read, or use devices. Treatment effectiveness will be evaluated using Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). If remission is achieved (QIDS-SR < 6), no additional treatment is given. If response is insufficient (QIDS-SR ≥ 6), 5 more sessions will be added in the following week, with maximum two extensions (1-3 weeks total).
Autumn/winter
Patients with a depression who received bright light therapy as part of routine clinical care. For the purpose of the analyses, participants were categorized based on the season of treatment initiation, with this cohort including those who started treatment during the autumn and winter seasons.
Dispositivo: Bright Light Therapy
Bright Light Therapy (BLT) will be administered according to Dutch depression guidelines, using Innolux LED light lamp (3800K, 10,000 lux). BLT will be given for one work week (Mon-Fri), 7:30-10:30 AM, 30 mins/session. Patients can have breakfast, read, or use devices. Treatment effectiveness will be evaluated using Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). If remission is achieved (QIDS-SR < 6), no additional treatment is given. If response is insufficient (QIDS-SR ≥ 6), 5 more sessions will be added in the following week, with maximum two extensions (1-3 weeks total).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in depressive symptom severity (QIDS-SR)
Prazo: Baseline to end of treatment (approximately 1-3 weeks after initiation of light therapy)
Depressive symptom severity is assessed using the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR), a validated 16-item questionnaire with total scores ranging from 0 to 27 (higher scores indicating greater symptom severity). The primary outcome is the change in QIDS-SR score from baseline (pre-treatment) to end of light therapy. The analysis compares changes between participants treated in the spring/summer season and those treated in the autumn/winter season, while accounting for the delayed-start control condition.
Baseline to end of treatment (approximately 1-3 weeks after initiation of light therapy)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sustained change in depressive symptoms (QIDS-SR follow-up)
Prazo: End of treatment to 6 weeks and 3 months post-treatment
Depressive symptom severity is assessed using the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR), a validated 16-item questionnaire with total scores ranging from 0 to 27 (higher scores indicating greater symptom severity). This secondary outcome evaluates the persistence of treatment effects by comparing post-treatment scores to follow-up scores.
End of treatment to 6 weeks and 3 months post-treatment
Change in sleep quality (PSQI)
Prazo: Baseline to 6 weeks and 3 months post-treatment
Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI), a validated self-report questionnaire with total scores ranging from 0 to 21 (higher scores indicating poorer sleep quality). The outcome reflects change in sleep quality following light therapy.
Baseline to 6 weeks and 3 months post-treatment
Chronotype (MEQ)
Prazo: Baseline (chronotype assessment), end of treatment (1-3 weeks after initiation of light therapy), 6 weeks post-treatment, and 3 months post-treatment
Chronotype is assessed using the Morningness-Eveningness Questionnaire (MEQ). This outcome examines whether baseline chronotype moderates changes in depressive symptom severity following light therapy.
Baseline (chronotype assessment), end of treatment (1-3 weeks after initiation of light therapy), 6 weeks post-treatment, and 3 months post-treatment
Adverse Events and Side Effects
Prazo: At the end of each treatment week, up to 3 weeks
Side effects are assessed using a self-report questionnaire capturing the presence and severity of common light therapy-related symptoms (e.g., headache, eye irritation, sleep disturbances).
At the end of each treatment week, up to 3 weeks
Change in Sleep-Wake Pattern during treatment
Prazo: Twice weekly during treatment, up to 3 weeks
Sleep timing, duration, quality and fragmentation, are assessed using a shortened sleep diary based on the Consensus Sleep Diary. This outcome evaluates changes in sleep patterns during light therapy and their relation to treatment response. Participants completed the diaries in the clinic on Mondays and Fridays, reporting retrospectively on their sleep during the preceding nights (i.e., Friday-Sunday nights for Monday entries and Monday-Thursday nights for Friday entries).
Twice weekly during treatment, up to 3 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Geestelijke Gezondheidszorg Eindhoven (GGzE)

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2021

Conclusão Primária (Real)

7 de outubro de 2022

Conclusão do estudo (Real)

23 de dezembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

20 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ILB/2020038

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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