Morning Light Treatment for Postpartum Depression

Overseen By Kelley DuBuc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Photosensitizing, Melatonin, NSAIDs, Beta-blockers

Disqualifiers: PTSD, OCD, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a light therapy device called Re-Timer to determine if it improves mood and sleep in women with postpartum depression. The study will compare the effects of bright light therapy to dim light, which serves as a placebo. Women who are 26 weeks or less postpartum, experiencing major depression, and not receiving other depression treatments may qualify to participate. Participants will use the light device for 5 weeks and complete various assessments, including sleep tracking and questionnaires. The study also monitors the sleep of participating mothers' infants, as this may influence the mothers' mood and sleep patterns.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance postpartum depression treatment options.

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.

What prior data suggests that the Re-Timer light therapy device is safe for postpartum depression treatment?

Research has shown that bright light therapy, like the Re-Timer device used in this study, is generally safe and well-tolerated for treating depression. A study published in JAMA Psychiatry found it to be an effective additional treatment for various types of depression. Users of bright light therapy often report few side effects. When side effects occur, they might include mild issues like eye strain or headaches, which usually resolve on their own.

In a small study examining wearable light therapy for postpartum depression, participants did not report any serious problems. This finding suggests that the Re-Timer device is safe for home use. However, individual reactions can vary, so monitoring one's own response during treatment is important.

Prospective trial participants can feel confident that researchers will closely monitor participants to ensure safety and promptly address any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Re-Timer light therapy for postpartum depression because it offers a non-invasive approach by using light exposure to help regulate mood. Unlike traditional treatments like antidepressants, which can take weeks to show effectiveness and have potential side effects, bright light therapy can potentially provide quicker mood improvements with fewer risks. The Re-Timer device is designed to mimic natural sunlight, which may help reset the body's internal clock, potentially improving mood and sleep patterns in new mothers. This innovative approach could offer a valuable alternative or complement to existing treatments for postpartum depression.

What evidence suggests that the Re-Timer light therapy device is effective for postpartum depression?

This trial will compare Bright Light Therapy with Dim Light Therapy for postpartum depression. Research has shown that Bright Light Therapy, which participants in this trial may receive, can help individuals with postpartum depression. Studies have found that it improves mood and reduces symptoms of depression. One study found that it can positively affect the body's internal clock, influencing mood and energy levels. Bright Light Therapy has proven effective in treating various types of depression, not just seasonal. This treatment offers hope for helping mothers feel better and manage their daily lives more effectively. ^{1 2 3 5 6}

Who Is on the Research Team?

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.

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?

Group I: Bright Light Therapy Experimental Treatment 1 Intervention

Group II: Dim Light Therapy Placebo Group 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morning light therapy for postpartum depression. Corral, M., Wardrop, AA., Zhang, H., et al.[2016]

In a pilot trial involving 22 women with perinatal depression, those receiving bright light therapy (BLT) showed a 73% remission rate compared to only 27% in the dim red light group, indicating BLT's effectiveness in treating PND.

The study demonstrated that BLT was well-tolerated with no major side effects reported, suggesting it is a safe and viable treatment option for women experiencing depression during the perinatal period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial. Garbazza, C., Cirignotta, F., D'Agostino, A., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label pilot study of a home wearable light therapy device for postpartum depression. Swanson, LM., Burgess, HJ., Zollars, J., et al.[2019]

Bright light therapy (BLT) significantly improved response rates in women with perinatal depression, with 75% of participants showing improvement compared to only 18.2% in the placebo group after 3 weeks.

BLT was found to be safe, with no significant differences in treatment-related side effects between the BLT and placebo groups, suggesting it could be a viable treatment option for perinatal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of bright light therapy in perinatal depression: A randomized, double-blind, placebo-controlled study. Donmez, M., Yorguner, N., Kora, K., et al.[2022]

Listening Visits (LV) delivered by U.S. home visitors resulted in a significant reduction in depression symptoms and improved life satisfaction among 19 postpartum women with depressive symptoms.

The intervention was found to be acceptable to the participants, indicating its potential as an effective treatment for maternal depression, which affects about one in five women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening visits: an evaluation of the effectiveness and acceptability of a home-based depression treatment. Segre, LS., Stasik, SM., O'Hara, MW., et al.[2021]

Light therapy has been found to be effective in reducing depression and improving sleep disturbances in pregnant and postnatal women, with a moderate effect size (SMD = 0.34 for depression and SMD = 0.64 for sleep) based on a meta-analysis of eight studies.

The analysis showed no serious adverse effects associated with light therapy, suggesting it is a safe treatment option for this population, although more high-quality studies with larger sample sizes are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of light therapy on depression and sleep in women during pregnancy or the postpartum period: A systematic review and meta-analysis. Li, X., Fang, L., Guan, L., et al.[2023]

In a study involving 20 healthy participants, a new bright light therapy (BLT) cabin showed no reports of headaches, which are a common side effect of conventional BLT devices.

While some participants experienced blurring of vision (21.1% prevalence), the absence of headaches suggests that this new technology may improve patient adherence to treatment for seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. Leichtfried, V., Kantner-Rumplmair, W., Bartenbach, C., et al.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of light therapy for perinatal depression: a review. Crowley, SK., Youngstedt, SD.[2021]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04845347

A Wearable Morning Light Treatment for Postpartum ... 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 ...

3. psychiatry.org psychiatry.org/news-room/apa-blogs/bright-light-therapy-beyond-seasonal-depression

Bright Light Therapy: Growing Evidence Beyond Seasonal ... ... late 2024, found that bright light therapy was an effective supplementary treatment for depressive disorders other than seasonal depression.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6234841/

An Open-Label Pilot Study of a Home Wearable Light ... We sought to establish the feasibility and preliminary effects of home wearable light therapy for postpartum depression, and its effects on circadian ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124005882

Efficacy of bright light therapy improves outcomes ... This study indicates a beneficial impact of BLT on perinatal depression, subgroup analysis finds no significant mediation effects of different parameters.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3518242/

Efficacy of light therapy for perinatal depression: a review - PMC Perinatal depression refers to depressive syndromes with onset during pregnancy or within 12 months after delivery [ · The prevalence of postpartum depression ( ...