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Chronotherapy for Perinatal Depression

N/A

Waitlist Available

Led By Samantha Meltzer-Brody, MD

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Preexisting eye/skin disorders contraindicating light therapy

Use of photosensitizing medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if adding light exposure and a set sleep routine to regular care can reduce depression and anxiety in pregnant women. It targets women aged 18-40 in late pregnancy who have depression. The treatment aims to adjust the body's natural rhythms and stabilize sleep patterns to improve mood. Light exposure is a promising treatment for depression during pregnancy, being easily accessible, effective, affordable, and safe for both mother and child.

Who is the study for?

This trial is for pregnant women aged 18-45 with major depressive disorder, as diagnosed by a specific clinical interview and having a certain depression score. It's not for those with seizure disorders, night shift workers, substance abuse issues, high-risk pregnancies or other primary mental health diagnoses. Participants must speak and read English.

What is being tested?

The study tests Personalized Integrated Chronotherapy (PIC) plus usual care against usual care alone in treating perinatal depression. PIC includes bright light therapy, sleep phase advance, and sleep stabilization/restriction tailored to each patient's circadian rhythm.

What are the potential side effects?

Potential side effects of PIC may include increased risk of seizures if predisposed, mania in individuals with bipolar disorder history (excluded from the trial), eye strain or skin issues due to light therapy, and headaches or migraines triggered by bright light or lack of sleep.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have eye or skin conditions that prevent me from undergoing light therapy.

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I am taking medication that increases my sensitivity to light.

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I have a condition that causes seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Depressive Symptoms

Secondary study objectives

Change in Circadian Phase

Change in Sleep Timing

Infant sleep behavior

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Personalize Integrated ChronotherapyExperimental Treatment1 Intervention

Women in the integrated chronotherapy group receive usual care (medications and/or talk therapy, as above) and also receive a bright light box to sit with every morning for up to 60 minutes as prescribed by the study doctor.

Group II: Usual CareActive Control1 Intervention

Women in the usual care group receive medications and/or talk therapy. Sleep and light levels are monitored at home with wrist actigraphy during 3rd trimester of pregnancy (weeks 28-40) and weeks 2-6 and18 after the baby is born (postpartum weeks 2-6 and 18).

0 / 3Eligibility criteria met