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| Name | Class |
|---|---|
| Eindhoven University of Technology | OTHER |
| Geestelijke Gezondheidszorg Eindhoven (GGzE) | OTHER |
| Chrono@Work B.V. | UNKNOWN |
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Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response.
This clinical trial has three main goals:
The specific objectives are as follows:
In this study, patients will receive BLT with a light intensity of 10,000 lux for 30 minutes each morning over 5 consecutive days. The treatment duration will range from one to three weeks, depending on the improvement of depressive symptoms. Participants will be randomly assigned to one of three groups:
The study includes a baseline phase of up to two weeks, a treatment phase of up to three weeks, and a three-month follow-up phase. Patients will wear a motion watch to assess sleep-wake behaviour and physical activity during the day. Additionally, they will wear a broach that measures their personal light exposure throughout the day. Eight one-minute questionnaires per day will be sent to the participants' smartphones to assess vitality, sleep, and mood during the treatment. Predictors of treatment response, such as clinical characteristics, sleep measures, circadian parameters, and light-related behaviours, will be evaluated at baseline. In a small group of patients, salivary melatonin curves will be assessed before and after treatment. MRI scans will provide insights into functional and structural brain changes following light therapy treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light@Home | Active Comparator | Standard Care - BLT in the home environment |
|
| LightCafé | Experimental | BLT will be administered in a specialized cafe, under the supervision of clinical staff, promoting lifestyle changes and social interaction. |
|
| LightCafé+ | Experimental | Treatment will be identical to the second arm but now complemented with the use of blue-light blocking glasses in the evening and the adoption of personalized BLT timing based on sleep-wake patterns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Light Therapy | Procedure | In this study, 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement | Difference between pre- and post-treatment assessment of the Montgomery Asberg Depression Rating Scale [MADRS] | 2-5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective change in depressive symptom severity | Change in score on the Quick Inventory of Depressive Symptoms, Self Report (QIDS-SR) | from baseline until follow-up, approximately 4 months |
| Remission rates, self assessed and clinician rated |
| Measure | Description | Time Frame |
|---|---|---|
| Personal daily light exposure | the percentage of time exposed to light above the threshold of 300 lux will be calculated from light sensor data as well as the mean timing thereof (MLiT100). Additional parameter might be extracted from the light exposure data based on state of the art procedures. | 2-5 weeks |
| Treatment expectations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niki Antypa, PhD | Contact | +31 71 527 6677 | nantypa@fsw.leidenuniv.nl | |
| Luc Schlangen, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Niki Antypa, PhD | Leiden University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GGzE - Mental Health Institute of Eindhoven and the Kempen | Recruiting | Eindhoven | 5626 ND | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41088238 | Derived | Visser E, Rus-Oswald OG, van der Does AJW, Gordijn MCM, Marcelis MC, de Kort YAW, Oomen PP, Schlangen LJM, Seetsen T, Simons CJP, Antypa N. BioClock-optimizing Bright Light Therapy for adults with depression: a study protocol for a multicenter randomized clinical trial on treatment strategies, response predictors, and chronobiological and neurobiological mechanisms. Trials. 2025 Oct 14;26(1):411. doi: 10.1186/s13063-025-08984-7. |
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All data underlying a publication can be shared upon request.
Data will be available after publication of the analyses
Access may be granted to researchers who intend to conduct secondary analyses or meta-analyses using individual participant data. Additionally, researchers with a valid scientific research question or hypothesis that aligns with the objectives of the original study may be considered for IPD access.
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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|
| Blue Light Blocking Glasses | Device | Plastic, orange-coloured glasses that primarily block blue light. To be worn in the evening. |
|
percentage of patients that after treatment have a score of <6 on the MADRS or QIDS-SR
| 2-5 weeks for clinician rated. Up until 4 months after start treatment for self-assessed |
| Response Rates, self assessed and clinician rated | percentage of patients hat after treatment have at least 50% reduction in depressive symptom, measured using MADRS and QIDS-SR | 2-5 weeks for clinician rated, Up until 4 months after start treatment for self-assessed |
| Time to remission | The time it takes to achieve remission, if remission is achieved. Measured with QIDS-SR | one, two or three weeks |
| Circadian phase | Changes in circadian phase will be compared between groups as assessed using the DLMO (calculated from the melatonin assessments) and complemented with actigraphy data (using sleep onset timing, least active 5h period and most active 10h period) | 2-5 weeks |
| Circadian amplitude | Changes in the circadian amplitude will be compared between groups. The amplitude can be estimated from actigraphy data by the difference in activity between the most active 10h and the least active 5h normalized for total activity. | 2-5 weeks |
| Circadian Periodicity | Changes in circadian periodicity will be compared between groups. Circadian periodicity is a period of an oscillating rhythm assessed via periodogram analysis of the activity time-course of actigraphy data. The deviation between the maximum period of the periodogram and the normal daily period of 24h reflects pattern variability in normal entrainment conditions. | 2-5 weeks |
| Inter-daily stability | Constancy of the 24-h rhythmic pattern over days | 2-5 weeks |
| Intra-daily variability | rhythm fragmentation | 2-5 weeks |
| Chronotype | Chronotype changes as assessed with the Morningness-Eveningness Questionnaire(MEQ) and the Ultra-Short Version of the Munich Chronotype Questionnaire (µMCTQ) | 1-3 months |
| Sleep-Wake Pattern | Actigraphy and questions from The Consensus Sleep Diary will provide sleep onset time, sleep offset time, midsleep time, total sleep time, sleep onset latency, number of awakenings and time awake during the night. | 2-5 weeks |
| Sleep Quality | Fragmentation index (degree of movement during the night), sleep efficiency (total sleep time expressed as a percentage of time in bed) will be calculated using actigraphy data. The Pittsburgh Sleep Quality Index (PSQI) will provide a subjective measure of sleep quality. | 2-5 weeks for actigraphy, up until 4 months after the start of treatment for subjective sleep quality |
| Severity of Insomnia Symptoms | Severity of Insomnia Symptoms as assessed with the Insomnia Severity Index | up until 4 months after the starts of treatment |
| Momentary Positive/Negative Affect | The EMA will consist of items from the Positive and Negative Affect Scale (PANAS) to assess momentary positive and negative affect | 2-5 weeks |
| Momentary Vitality | The EMA will contain 4 items concerning energy levels and alertness adapted from Activation-Deactivation Adjective Checklist | 2-5 weeks |
| Gray matter structure | Properties of gray matter structure (thickness, volume, surface area and gyrification) of the whole brain as well as of the white matter structure (integrity of main white matter fiber tracts-fractional anisotropy (FA)) | 2-5 weeks |
| Functional connectivity of the brain | Functional connectivity of the brain under resting state condition - the communication of specific brain regions which work as a network without conducting a specific task | 2-5 weeks |
Treatment expectations will be assessed using the Credibility/expectancy Questionnaire |
| baseline |
| Light Induced Melatonin suppression | Light Induced Melatonin suppression as assessed using the salivary melatonin assessments will give insight into light sensitivity of the participants. | Baseline |
| Treatment Adherence | Treatment adherence will be assessed subjectively using an item in the EMA and objectively using light logger devices. | 1-3 weeks |
| Side Effects | Side effects will be monitored with a questionnaire based on the Toronto Side Effects Questionnaire | 1-3 weeks |
| Leids Universitair Behandel- en Expertise Centrum | Recruiting | Leiden | 5626 ND | Netherlands |
|
| D001519 |
| Behavior |