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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.
Please note this project added a sub-study (HUM00235787, IRB approved on 7/31/2024) to the main study. However, the sub-study only applies to some of the participants and there are only exploratory outcomes, therefore, this will not affect the main study registration.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of Michigan
Ann Arbor, Michigan, United States
Start Date
June 23, 2021
Primary Completion Date
July 23, 2025
Completion Date
July 24, 2025
Last Updated
February 9, 2026
95
ACTUAL participants
Bright Light Therapy
DEVICE
Dim Light Therapy
DEVICE
Lead Sponsor
University of Michigan
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03856931