Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Effectiveness of Light Therapy Across Seasons

18 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

212

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Holandia
      • Eindhoven, Holandia, 5626ND
        • GGzE

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Urządzenie: 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.
Urządzenie: 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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in depressive symptom severity (QIDS-SR)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sustained change in depressive symptoms (QIDS-SR follow-up)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Geestelijke Gezondheidszorg Eindhoven (GGzE)

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2021

Zakończenie podstawowe (Rzeczywisty)

7 października 2022

Ukończenie studiów (Rzeczywisty)

23 grudnia 2022

Daty rejestracji na studia

Pierwszy przesłany

12 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 maja 2026

Pierwszy wysłany (Rzeczywisty)

20 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ILB/2020038

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Bright Light Therapy

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Guinea

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj