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Morning Light Treatment for Postpartum Depression

N/A

Recruiting

Led By Leslie Swanson, Ph.D.

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Not currently receiving treatment for depression (for example, prescription medications or psychotherapy)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Study Summary

This trial will test whether a consumer health light therapy device can help improve postpartum depression symptoms in women. The study will involve questionnaires, sleep monitoring, and wearing an actigraph watch. Additionally, the sleep of participants' infants will also be monitored.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed for this trial's interventions, typical reactions to bright light therapy may include eyestrain, headache, irritability, nausea and sleep disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not currently being treated for depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Phase angle difference

Change in score for the Structured interview guide score for the Hamilton Depression Rating Scale - Seasonal Affective Version (SIGH-SAD total score)

Secondary outcome measures

Edinburgh Postnatal Depression Scale (EPDS) total score

Epworth Sleepiness Scale (ESS) total score

Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction with Participation in Social Roles (SPSR) total score

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bright Light TherapyExperimental Treatment1 Intervention

Group II: Dim Light TherapyPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bright Light Therapy

2010

Completed Early Phase 1

~60

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,018 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,579 Total Patients Enrolled

24 Trials studying Postpartum Depression

8,023 Patients Enrolled for Postpartum Depression

Leslie Swanson, Ph.D.Principal Investigator - University of Michigan

University of Michigan

3 Previous Clinical Trials

83 Total Patients Enrolled

Media Library

Re-Timer Clinical Trial Eligibility Overview. Trial Name: NCT04845347 — N/A

Postpartum Depression Research Study Groups: Bright Light Therapy, Dim Light Therapy

Postpartum Depression Clinical Trial 2023: Re-Timer Highlights & Side Effects. Trial Name: NCT04845347 — N/A

Re-Timer 2023 Treatment Timeline for Medical Study. Trial Name: NCT04845347 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate objective of this clinical investigation?

"To measure the efficacy of light therapy over a pre-treatment and post-treatment timespan, this trial will observe Change in Phase angle difference. Additionally, Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction with Participation in Social Roles (SPSR), Sleep-related impairment (SRI), and Postpartum Bonding Questionnaire (PBQ) total scores are being analysed as secondary outcomes; these measurements range from 0 to 5 on Likert scales or up to 125 points respectively."

Answered by AI

How many participants are being accepted into this medical experiment?

"Indeed, clinicaltrials.gov data confirms that this medical investigation is still recruiting patients. The trial was initially posted on June 23rd 2021 and updated most recently on September 20th 2022; now needing 120 people from a single location to participate."

Answered by AI

Are there any open opportunities for volunteers to participate in this experiment?

"Clinicaltrials.gov reports that this trial is open to recruitment, having been first announced on June 23rd 2021 and most recently revised September 20th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Wearable Morning Light Treatment for Postpartum Depression

Leslie Swanson 2021. "A Wearable Morning Light Treatment for Postpartum Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04845347.