Phototherapy in Young People With Depression

Study Overview
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Brief Summary
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Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered. The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.

Official Title
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Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms

Conditions
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Depression

Intervention / Treatment
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* Device: Phototherapy light-emitting glasses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Quick Inventory of Depressive Symptomatology score > 6; First episode of depression before age 25; Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic. Exclusion Criteria: Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction; Other primary psychiatric disorders aside from anxiety disorders; Significant alcohol or other substance dependence; Use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study); Use of medications that may interact with light to produce a photoallergic reaction; Eye or skin condition which may interact with bright light exposure; Regular shift-work within 60-days prior to entry into the study; Recent transmeridian travel.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phototherapy<br> | Device: Phototherapy light-emitting glasses<br>* The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m^2) upon awakening and progressive shift to earlier wake-up times. Participants are encouraged to complete the light exposure sessions for 60 min each day. Participants are also instructed to progressively shift their schedule 15 min earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7:30am is reached (in which case, participants keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they do the light exposure sessions upon awakening across the four weeks of the intervention. During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls.<br>* Other names: Re-timer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Depression | Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR) | Between baseline and post (4 weeks) intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Depression | Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR) | Score between baseline and follow up (8 weeks) | 
| Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression | Associations between changes in sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR) | Between baseline and post (4 weeks) intervention | 
| Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression | Associations between the initial sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR) | Baseline and post (4 weeks) intervention | 
| Subjective Sleep Quality | Change in Leeds Sleep Evaluation Questionnaire score | Between baseline and post (4 weeks) intervention | 
| Fatigue Severity | Change in Fatigue Severity Scale score | Between baseline and post (4 weeks) intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phototherapy, Light, Depression, Sleep and circadian disturbances, Youth