Light Therapy to Improve Symptoms in Pregnant Women With Major Depressive Disorder

Study Overview
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Brief Summary
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This study will investigate the effectivenss of bright light therapy(10000 lux white)on pregnant women with major depression disorder.

Detailed Description
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Depression during pregnancy is a common and high impact disease.Children who are exposed to maternal depression during pregnancy have a higher risk of adverse birth outcomes, such as low birth weight, and more often show cognitive, emotional and behavioral problems.Therefore, early detection and prompt treatment of depression during pregnancy can benefit both mother and child.However, the window of opportunity in pregnancy is small and from the perspective of the child postponement is in fact non-treatment. Psychotherapy might take a long time to be effective and do not work for all people. Further, the safety of pharmacological treatment for pregnant women with depression is still a big concern .Psychiatric medication use for depression in pregnancy may also pose a risk of fetal growth retardation and preterm delivery, as well as withdrawal symptoms in the new born. Therefore, investigating non-pharmacological approaches to treating depression during pregnancy is urgent and relevant, for both mother and child. Preliminary evidence shows that bright light therapy (BLT) is an effective treatment for pregnant women with depression based on several theoretical and clinical considerations, with effect size around 0.45 and without adverse effects to the new born. In this study we aim to investigate the effectiveness of BLT on pregnant women with major depression.

Official Title
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Bright Light Therapy in Pregnant Women With Major Depressive Disorder: a Randomized, Double-blind, Placebo-Controlled Study

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: bright light
* Device: dim red light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women; 18 45 years of age; medically healthy, with normal ocular function; 13 28 weeks pregnancy; DSM-V diagnosis of major depressive disorder HAMD score ≥18 Exclusion Criteria: DSM-V defined bipolar disorder、schizophrenia、schizoaffective disorder,anxiety disorders; substance Use Disorders; substance use within the last 6 months; suicidal ideation, suicidal attempt, suicide behavior, and attempted suicide; being treated by the light therapy; with antidepressant in recent 2 months; Multiple pregnancy; Any obstetrical care or medications for physical disorders that might confound treatment results; current use of β-adrenergic blockers, melatonin, or St. John's wort; thyroid function test results inconsistent with normal pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bright light group<br>treat patients with bright light (10000 lux) | Device: bright light<br>* treat patients with bright light, 30 min per day, 7 times per week, over 6 weeks<br>|
| Placebo Comparator: dim red light group<br>treat patients with dim red light (100 lux) | Device: dim red light<br>* treat patients with dim red light, 30 min per day, 7 times per week, over 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive symptoms from baseline | Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD) | Week2;Week6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in anxious symptoms from baseline | anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA) | week 2; week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Light therapy; Major Depressive Disorder; Pregnancy