A Wearable Morning Light Treatment for Postpartum Depression

University of Michigan

Status

Enrolling

Conditions

Post Partum Depression

Treatments

Device: Dim Light Therapy

Device: Bright Light Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04845347

1R01MH121531-01A1 (U.S. NIH Grant/Contract)

HUM00190163

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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