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: * Optimize the administration of BLT for patients with depressive episodes. * Gain a deeper understanding of the treatment mechanisms. * Determine which patients benefit the most from the treatment. The specific objectives are as follows: * Investigate whether additional treatments and interventions related to lifestyle and the biological clock can enhance the effects of BLT. * Examine how BLT influences the body's internal clock and sleep quality, and how these factors contribute to the outcomes. * Identify patient characteristics and behaviours that can predict treatment outcomes. * Develop a brain model to better understand the impact of BLT on the brain. 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: * Home - Patients will receive BLT at home, following the standard guidelines for light therapy in the Netherlands. * LightCafé, fixed time: Patients will receive BLT in a café-like setting called the LightCafé, where the focus is not only on symptom improvement but also lifestyle enhancements and fostering social connections. The treatment time will be the same every day. * LightCafé, varying time: Patients will also receive BLT at the LightCafé, with treatment timing varying each day. Additionally, this group will wear glasses in the evening that filter blue light. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
231
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).
Plastic, orange-coloured glasses that primarily block blue light. To be worn in the evening.
GGzE - Mental Health Institute of Eindhoven and the Kempen
Eindhoven, Netherlands
RECRUITINGLeids Universitair Behandel- en Expertise Centrum
Leiden, Netherlands
RECRUITINGClinical Improvement
Difference between pre- and post-treatment assessment of the Montgomery Asberg Depression Rating Scale \[MADRS\]
Time frame: 2-5 weeks
Subjective change in depressive symptom severity
Change in score on the Quick Inventory of Depressive Symptoms, Self Report (QIDS-SR)
Time frame: from baseline until follow-up, approximately 4 months
Remission rates, self assessed and clinician rated
percentage of patients that after treatment have a score of \<6 on the MADRS or QIDS-SR
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 2-5 weeks
Inter-daily stability
Constancy of the 24-h rhythmic pattern over days
Time frame: 2-5 weeks
Intra-daily variability
rhythm fragmentation
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 2-5 weeks
Momentary Vitality
The EMA will contain 4 items concerning energy levels and alertness adapted from Activation-Deactivation Adjective Checklist
Time frame: 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))
Time frame: 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
Time frame: 2-5 weeks
Luc Schlangen, PhD
CONTACT
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