A Wearable Morning Light Treatment for Postpartum Depression

Purpose

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.

Condition

  • Post Partum Depression

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • less or equal (≤) to 26 weeks postpartum - 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) - not currently receiving treatment for depression (for example, prescription medications or psychotherapy).

Exclusion Criteria

  • Current diagnosis of Posttraumatic stress disorder (PTSD), obsessive compulsive disorder if the onset is outside of the perinatal period, eating disorder, substance abuse or dependence, lifetime history of mania/hypomania or thought disorder per SCID. - current diagnosis of, or high risk for, sleep-disordered breathing, insomnia disorder, restless leg syndrome, and/or narcolepsy. - retinal pathology or history of eye surgery - current use of photosensitizing medications, - current use of exogenous melatonin or medications that may interfere with the measurement of melatonin (nonsteroidal anti-inflammatory drugs (NSAIDs) if used daily, and beta-blockers) - medical conditions for which bright light therapy is contraindicated (for example, epilepsy/seizures). - nightshift work - currently pregnant

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized using the minimization method. The study team will balance assignment to group based on the following baseline characteristics: baseline Structured Interview Guide For The Hamilton Depression Rating Scale (SIGH-SAD) score, maternal age, parity, and infant age.
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bright Light Therapy
  • Device: Bright Light Therapy
    Participants will be provided with active, unaltered Re-Timer glasses that will be worn in the morning daily for 60 minutes for 5 weeks on study.
    Other names:
    • Re-Timer
Sham Comparator
Dim Light Therapy
  • Device: Dim Light Therapy
    Participants on this arm will wear the placebo version of the Re-Timer fitted with neutral density filters. These will be worn in the morning daily for 60 minutes for 5 weeks on study.
    Other names:
    • Re-Timer- (placebo version)

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Kelley DuBuc
734-764-2256
dubuck@umich.edu

Detailed Description

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.