120 Participants Needed

Morning Light Treatment for Postpartum Depression

KD
Overseen ByKelley DuBuc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock).Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re-Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results.The hypotheses regarding the bright light versus the placebo dim light of the study are:* morning bright light therapy will produce greater improvement from pre- to post-treatment on the Hamilton Rating Scale for Depression* morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms.* morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes those currently using photosensitizing medications, exogenous melatonin, and medications that may interfere with melatonin measurement, such as daily NSAIDs and beta-blockers.

Is morning light therapy safe for humans?

Morning light therapy, also known as bright light therapy, has been tested in several studies and is generally well tolerated. Some studies report minor side effects like blurring, but no serious safety concerns have been identified.12345

How is morning light treatment with Re-Timer different from other treatments for postpartum depression?

Morning light treatment with Re-Timer is unique because it uses a wearable light therapy device that can be used at home, offering a non-drug option for postpartum depression. This treatment is appealing as it has fewer side effects compared to medications and can be easily integrated into daily routines.12367

What data supports the effectiveness of the treatment Re-Timer, Re-Timer, Bright Light Therapy, Light Therapy Device for postpartum depression?

Research shows that home-wearable light therapy devices can significantly improve depression symptoms in postpartum women. Bright light therapy, which is part of this treatment, has been shown to have antidepressant effects and is considered a promising option for perinatal depression due to its low cost and minimal side effects.12368

Who Is on the Research Team?

LS

Leslie Swanson, Ph.D.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for women up to 26 weeks postpartum with major depressive disorder, not currently treated for depression. Excluded are those with PTSD, certain disorders outside the perinatal period, sleep-related issues, retinal pathology or eye surgery history, use of photosensitizing meds or melatonin affecting drugs, conditions contraindicating bright light therapy like epilepsy, nightshift workers or current pregnancy.

Inclusion Criteria

Less or equal (≤) to 26 weeks postpartum
I am not currently being treated for depression.
Meet criteria for current major depressive disorder per the Structured Clinical Interview for Diagnostic (SCID) and Statistical Manual of Mental Disorders version 5 (DSM-V)

Exclusion Criteria

I do not have conditions like epilepsy that make bright light therapy unsafe for me.
I have had eye surgery or retinal problems.
I have or am at high risk for sleep issues like insomnia or restless leg syndrome.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Re-Timer light therapy device for 5 weeks, complete questionnaires, record sleep information, wear an actigraph watch, and provide saliva samples.

5 weeks
Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of sleep-related impairment and depression symptoms.

up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Re-Timer
Trial Overview The study tests a wearable light therapy device (Re-Timer) on women with postpartum depression. Participants will be randomly assigned to receive either morning bright light therapy or dim light (placebo). They'll track mood changes and sleep patterns using questionnaires and devices over five weeks to see if it improves their depression symptoms and adjusts their body clock.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bright Light TherapyExperimental Treatment1 Intervention
Group II: Dim Light TherapyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

A study involving eight women within 6 months postpartum showed that home-wearable light therapy for 60 minutes daily over 5 weeks was well tolerated and feasible.
Participants experienced significant improvements in both self-reported and clinician-rated depression symptoms, suggesting that this therapy may be a promising treatment for postpartum depression.
An open-label pilot study of a home wearable light therapy device for postpartum depression.Swanson, LM., Burgess, HJ., Zollars, J., et al.[2019]
In a 6-week trial involving 15 women with postpartum depression, both bright light therapy (10,000 lux) and dim red light (600 lux) resulted in significant improvements in depression symptoms, as measured by self-report scales and clinician ratings.
There was no significant difference in effectiveness between the bright light and dim red light conditions, suggesting that both types of light exposure may be beneficial for women with postpartum depression.
Morning light therapy for postpartum depression.Corral, M., Wardrop, AA., Zhang, H., et al.[2016]
Bright light therapy is a promising treatment for perinatal depression, which affects 10% to 20% of childbearing women, due to its low cost, home-based application, and minimal side effects compared to traditional medications.
The review highlights established antidepressant effects of bright light and suggests it could be effective for perinatal depression, warranting further investigation into its use during pregnancy and lactation.
Efficacy of light therapy for perinatal depression: a review.Crowley, SK., Youngstedt, SD.[2021]

Citations

An open-label pilot study of a home wearable light therapy device for postpartum depression. [2019]
Morning light therapy for postpartum depression. [2016]
Efficacy of light therapy for perinatal depression: a review. [2021]
Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial. [2023]
Listening visits: an evaluation of the effectiveness and acceptability of a home-based depression treatment. [2021]
Efficacy of bright light therapy in perinatal depression: A randomized, double-blind, placebo-controlled study. [2022]
Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]
The effects of light therapy on depression and sleep in women during pregnancy or the postpartum period: A systematic review and meta-analysis. [2023]
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