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NCT Number: NCT05958940

BioClock: Bright Light Therapy for Depressive Disorders

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.

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Key information

Conditions

Depression, Unipolar Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Depression, Bipolar Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GGzE - Mental Health Institute of Eindhoven and the Kempen, Eindhoven, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65.
  • Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.)
  • A current depressive episode (a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR)
  • Sufficient knowledge of Dutch or English language to fill in questionnaires
  • Provided Informed consent

Exclusion criteria

  • A current (hypo)manic or mixed episode (as assessed with the M.I.N.I.)
  • Current psychotic episode (as assessed with the M.I.N.I.)
  • Prominent active suicidality (score 10 or higher on the M.I.N.I. module)
  • Antidepressant therapy (medication, psychotherapy or BLT, or other forms of specific treatments for depression) that started less than 2 months prior to study entry
  • participants with bipolar disorder should be in mood-stabilizing treatment for at least 1 month in a recommended dosage,
  • Use of melatonin or agomelatine in the last month
  • Current use of antibiotics
  • Current use of light sensitivity increasing medication
  • Travelled across more than 1 time zone during past month or during the treatment
  • Travelled to sunny holiday locations/winter sports during past month
  • pre-existing eye and skin disorders (retinitis pigmentosa, porphyria, chronic actinic dermatitis and sun-induced urticaria)
  • Systemic disorders with potential retinal involvement (rheumatoid arthritis and systemic lupus erythematosus)
  • Suffering from colour blindness (assessed by Ishihara colour plates)
  • Participated in night shift work in the last three months
  • (Retinal) blindness, severe cataract and glaucoma
  • Light-induced migraine or epilepsy
  • Pregnancy, or parents with a child younger than 18 months old

Treatment and study plan

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).

Blue Light Blocking Glasses

Device

Plastic, orange-coloured glasses that primarily block blue light. To be worn in the evening.

Primary outcomes

  1. Clinical Improvement

    Time frame: 2-5 weeks

    Difference between pre- and post-treatment assessment of the Montgomery Asberg Depression Rating Scale [MADRS]

Secondary outcomes

  1. Subjective change in depressive symptom severity

    Time frame: from baseline until follow-up, approximately 4 months

    Change in score on the Quick Inventory of Depressive Symptoms, Self Report (QIDS-SR)

  2. Remission rates, self assessed and clinician rated

    Time frame: 2-5 weeks for clinician rated. Up until 4 months after start treatment for self-assessed

    percentage of patients that after treatment have a score of <6 on the MADRS or QIDS-SR

  3. Response Rates, self assessed and clinician rated

    Time frame: 2-5 weeks for clinician rated, Up until 4 months after start treatment for self-assessed

    percentage of patients hat after treatment have at least 50% reduction in depressive symptom, measured using MADRS and QIDS-SR

  4. Time to remission

    Time frame: one, two or three weeks

    The time it takes to achieve remission, if remission is achieved. Measured with QIDS-SR

  5. Circadian phase

    Time frame: 2-5 weeks

    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)

  6. Circadian amplitude

    Time frame: 2-5 weeks

    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.

  7. Circadian Periodicity

    Time frame: 2-5 weeks

    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.

  8. Inter-daily stability

    Time frame: 2-5 weeks

    Constancy of the 24-h rhythmic pattern over days

  9. Intra-daily variability

    Time frame: 2-5 weeks

    rhythm fragmentation

  10. Chronotype

    Time frame: 1-3 months

    Chronotype changes as assessed with the Morningness-Eveningness Questionnaire(MEQ) and the Ultra-Short Version of the Munich Chronotype Questionnaire (µMCTQ)

  11. Sleep-Wake Pattern

    Time frame: 2-5 weeks

    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.

  12. Sleep Quality

    Time frame: 2-5 weeks for actigraphy, up until 4 months after the start of treatment for subjective 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.

  13. Severity of Insomnia Symptoms

    Time frame: up until 4 months after the starts of treatment

    Severity of Insomnia Symptoms as assessed with the Insomnia Severity Index

  14. Momentary Positive/Negative Affect

    Time frame: 2-5 weeks

    The EMA will consist of items from the Positive and Negative Affect Scale (PANAS) to assess momentary positive and negative affect

  15. Momentary Vitality

    Time frame: 2-5 weeks

    The EMA will contain 4 items concerning energy levels and alertness adapted from Activation-Deactivation Adjective Checklist

  16. Gray matter structure

    Time frame: 2-5 weeks

    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))

  17. Functional connectivity of the brain

    Time frame: 2-5 weeks

    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

Other outcomes

  1. Personal daily light exposure

    Time frame: 2-5 weeks

    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. Treatment expectations

    Time frame: baseline

    Treatment expectations will be assessed using the Credibility/expectancy Questionnaire

  3. Light Induced Melatonin suppression

    Time frame: Baseline

    Light Induced Melatonin suppression as assessed using the salivary melatonin assessments will give insight into light sensitivity of the participants.

  4. Treatment Adherence

    Time frame: 1-3 weeks

    Treatment adherence will be assessed subjectively using an item in the EMA and objectively using light logger devices.

  5. Side Effects

    Time frame: 1-3 weeks

    Side effects will be monitored with a questionnaire based on the Toronto Side Effects Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Luc Schlangen, PhD

CONTACT

Niki Antypa, PhD

CONTACT

[email protected]

+31 71 527 6677

Sponsors and collaborators

Lead sponsor

Universiteit Leiden

Other

Collaborators

  • Chrono@Work B.V.
  • Eindhoven University of Technology
  • Geestelijke Gezondheidszorg Eindhoven (GGzE)

Registry information

Official study title

BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2023
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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