The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression

Study Overview
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Brief Summary
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The proposed study aims to establish the feasibility of light therapy for postpartum depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).

Official Title
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The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression

Conditions
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Depression, Postpartum

Intervention / Treatment
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* Device: Light therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Within 6 months postpartum Meet DSM-V diagnostic criteria for MDD Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD). Exclusion Criteria: current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V past history of mania/hypomania, chronic medical conditions associated with depression (e.g., thyroid conditions) ocular or retinal pathology history of seizures or epilepsy color blindness Lupus currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light Therapy<br>Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. | Device: Light therapy<br>* Light therapy glasses<br>* Other names: Re-Timer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks | Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) (29 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 -73, where 0 means no depression, and 73 is the greatest possible depression. Generally scores of 20 or higher represent clinical depression | After five weeks of light therapy | 
| Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks | Self-report of depression symptoms. The Edinburgh Postnatal Depression scale is scored from 0 to 30 where 0 is no depression and 30 is most severe depression. | After five weeks of light therapy | 
| Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks | Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin | After five weeks of light therapy |