AzTrials
AzTrials

DepressionNCT07599124

Effectiveness of Light Therapy Across Seasons

An observational study of Depression and Unipolar Depression, run by Geestelijke Gezondheidszorg Eindhoven (GGzE) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bright Light Therapy
Type of treatment
Medical device
How many people
212 participants
Where
1 siteNetherlands
Study dates
1 Jan 2021to 23 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • GGzE

    Eindhoven, 5626ND

Other trials in Netherlands

About this study

Official title: 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.

Read more

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.

Being tested
Bright Light Therapy
Keywords
Depression, Bright Light Therapy, Chronotherapy, Sleep
Medical subject headings
Depression, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bright Light TherapyDevice

    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).

Study groups in NCT07599124
Study groupRoleWhat they receive
Spring/summerPatients 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.
Receives: Device: Bright Light Therapy
Autumn/winterPatients 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.
Receives: Device: Bright Light Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in depressive symptom severity (QIDS-SR)

    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.

    Measured: Baseline to end of treatment (approximately 1-3 weeks after initiation of light therapy)

Secondary outcomes (5)
  1. Sustained change in depressive symptoms (QIDS-SR follow-up)

    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.

    Measured: End of treatment to 6 weeks and 3 months post-treatment

  2. Change in sleep quality (PSQI)

    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.

    Measured: Baseline to 6 weeks and 3 months post-treatment

  3. Chronotype (MEQ)

    Chronotype is assessed using the Morningness-Eveningness Questionnaire (MEQ). This outcome examines whether baseline chronotype moderates changes in depressive symptom severity following light therapy.

    Measured: Baseline (chronotype assessment), end of treatment (1-3 weeks after initiation of light therapy), 6 weeks post-treatment, and 3 months post-treatment

  4. Adverse Events and Side Effects

    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).

    Measured: At the end of each treatment week, up to 3 weeks

  5. Change in Sleep-Wake Pattern during treatment

    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).

    Measured: Twice weekly during treatment, up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study start1 Jan 2021
  3. Primary completion7 Oct 2022
  4. Study completion23 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07599124
Sponsor's protocol ID
ILB/2020038
Status last verified
May 2026
First submitted
12 May 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Unipolar Depression, run by Geestelijke Gezondheidszorg Eindhoven (GGzE) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depressive symptom severity (QIDS-SR) (time frame: Baseline to end of treatment (approximately 1-3 weeks after initiation of light therapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in