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BioClock: Bright Light Therapy for Depressive Disorders

Primary Purpose

Depression, Unipolar, Depression, Bipolar

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bright Light Therapy
Blue Light Blocking Glasses
Sponsored by
Universiteit Leiden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Unipolar focused on measuring Depression, Bright Light Therapy, Chronotherapy, Circadian Rhythm, Sleep, Life Style, Ecological Momentary Assessment, Actigraphy, Dim light melatonin onset, Response predictors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GGzE - Mental Health Institute of Eindhoven and the Kempen
  • Leids Universitair Behandel- en Expertise Centrum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Light@Home

LightCafé

LightCafé+

Arm Description

Standard Care - BLT in the home environment

BLT will be administered in a specialized cafe, under the supervision of clinical staff, promoting lifestyle changes and social interaction.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective change in depressive symptom severity
Change in score on the Quick Inventory of Depressive Symptoms, Self Report (QIDS-SR)
Remission rates, self assessed and clinician rated
percentage of patients that after treatment have a score of <6 on the MADRS or QIDS-SR
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 to remission
The time it takes to achieve remission, if remission is achieved. Measured with QIDS-SR
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)
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.
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.
Inter-daily stability
Constancy of the 24-h rhythmic pattern over days
Intra-daily variability
rhythm fragmentation
Chronotype
Chronotype changes as assessed with the Morningness-Eveningness Questionnaire(MEQ) and the Ultra-Short Version of the Munich Chronotype Questionnaire (µMCTQ)
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.
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.
Severity of Insomnia Symptoms
Severity of Insomnia Symptoms as assessed with the Insomnia Severity Index
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
Momentary Vitality
The EMA will contain 4 items concerning energy levels and alertness adapted from Activation-Deactivation Adjective Checklist
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))
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

Full Information

First Posted
July 7, 2023
Last Updated
July 14, 2023
Sponsor
Universiteit Leiden
Collaborators
Eindhoven University of Technology, Geestelijke Gezondheidszorg Eindhoven (GGzE), Chrono@Work B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05958940
Brief Title
BioClock: Bright Light Therapy for Depressive Disorders
Official Title
BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Leiden
Collaborators
Eindhoven University of Technology, Geestelijke Gezondheidszorg Eindhoven (GGzE), Chrono@Work B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Unipolar, Depression, Bipolar
Keywords
Depression, Bright Light Therapy, Chronotherapy, Circadian Rhythm, Sleep, Life Style, Ecological Momentary Assessment, Actigraphy, Dim light melatonin onset, Response predictors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
231 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Light@Home
Arm Type
Active Comparator
Arm Description
Standard Care - BLT in the home environment
Arm Title
LightCafé
Arm Type
Experimental
Arm Description
BLT will be administered in a specialized cafe, under the supervision of clinical staff, promoting lifestyle changes and social interaction.
Arm Title
LightCafé+
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Bright Light Therapy
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Blue Light Blocking Glasses
Intervention Description
Plastic, orange-coloured glasses that primarily block blue light. To be worn in the evening.
Primary Outcome Measure Information:
Title
Clinical Improvement
Description
Difference between pre- and post-treatment assessment of the Montgomery Asberg Depression Rating Scale [MADRS]
Time Frame
2-5 weeks
Secondary Outcome Measure Information:
Title
Subjective change in depressive symptom severity
Description
Change in score on the Quick Inventory of Depressive Symptoms, Self Report (QIDS-SR)
Time Frame
from baseline until follow-up, approximately 4 months
Title
Remission rates, self assessed and clinician rated
Description
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
Title
Response Rates, self assessed and clinician rated
Description
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
Title
Time to remission
Description
The time it takes to achieve remission, if remission is achieved. Measured with QIDS-SR
Time Frame
one, two or three weeks
Title
Circadian phase
Description
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
Title
Circadian amplitude
Description
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
Title
Circadian Periodicity
Description
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
Title
Inter-daily stability
Description
Constancy of the 24-h rhythmic pattern over days
Time Frame
2-5 weeks
Title
Intra-daily variability
Description
rhythm fragmentation
Time Frame
2-5 weeks
Title
Chronotype
Description
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
Title
Sleep-Wake Pattern
Description
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
Title
Sleep Quality
Description
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
Title
Severity of Insomnia Symptoms
Description
Severity of Insomnia Symptoms as assessed with the Insomnia Severity Index
Time Frame
up until 4 months after the starts of treatment
Title
Momentary Positive/Negative Affect
Description
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
Title
Momentary Vitality
Description
The EMA will contain 4 items concerning energy levels and alertness adapted from Activation-Deactivation Adjective Checklist
Time Frame
2-5 weeks
Title
Gray matter structure
Description
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
Title
Functional connectivity of the brain
Description
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
Other Pre-specified Outcome Measures:
Title
Personal daily light exposure
Description
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.
Time Frame
2-5 weeks
Title
Treatment expectations
Description
Treatment expectations will be assessed using the Credibility/expectancy Questionnaire
Time Frame
baseline
Title
Light Induced Melatonin suppression
Description
Light Induced Melatonin suppression as assessed using the salivary melatonin assessments will give insight into light sensitivity of the participants.
Time Frame
Baseline
Title
Treatment Adherence
Description
Treatment adherence will be assessed subjectively using an item in the EMA and objectively using light logger devices.
Time Frame
1-3 weeks
Title
Side Effects
Description
Side effects will be monitored with a questionnaire based on the Toronto Side Effects Questionnaire
Time Frame
1-3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niki Antypa, PhD
Phone
+31 71 527 6677
Email
nantypa@fsw.leidenuniv.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Luc Schlangen, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niki Antypa, PhD
Organizational Affiliation
Leiden University
Official's Role
Principal Investigator
Facility Information:
Facility Name
GGzE - Mental Health Institute of Eindhoven and the Kempen
City
Eindhoven
ZIP/Postal Code
5626 ND
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Visser, MSc
Phone
+31622143145
Email
e.visser1@tue.nl
Facility Name
Leids Universitair Behandel- en Expertise Centrum
City
Leiden
ZIP/Postal Code
5626 ND
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niki Antypa, PhD
Phone
+31 71 527 6677
Email
nantypa@fsw.leidenuniv.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data underlying a publication can be shared upon request.
IPD Sharing Time Frame
Data will be available after publication of the analyses
IPD Sharing Access Criteria
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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BioClock: Bright Light Therapy for Depressive Disorders

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