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Completed

NCT Number: NCT04845347

A Wearable Morning Light Treatment for Postpartum Depression

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.

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Key information

Conditions

Post Partum Depression Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bright Light Therapy

Device

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

Dim Light Therapy

Device

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)

Primary outcomes

  1. Change in score for the Hamilton Depression Rating Scale (HAM-D total score)

    Time frame: pre-treatment (baseline), post light therapy treatment (approximately week 5)

    Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale (HAM-D) (17 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 - 52, where 0 means no depression, and 52 is the greatest possible depression. Generally, scores of 8 or higher represent clinical depression.

Secondary outcomes

  1. Change in Phase angle difference

    Time frame: pre-treatment (baseline), post light therapy treatment (approximately week 5)

    Phase angle difference is calculated as the time interval between the time of dim light melatonin onset and the midpoint of sleep.

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

    Time frame: pre-treatment (baseline), post light therapy treatment (approximately week 5)

    Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasional Affective Version (SIGH-SAD) (29 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 -73, where 0 means no depression, and 73 is the greatest possible depression. Generally scores of 20 or higher represent clinical depression.

  3. Edinburgh Postnatal Depression Scale (EPDS) total score

    Time frame: pre-treatment (baseline), post light therapy treatment (approximately week 5)

    Self-report of depression symptoms. The Edinburgh Postnatal Depression scale is scored from 0 to 30 where 0 is no depression and 30 is most severe depression.

  4. Epworth Sleepiness Scale (ESS) total score

    Time frame: pre-treatment (baseline), post light therapy treatment (approximately week 5)

    Participants complete this 8 item scale and select response from would never doze (0), to high chance of dozing (3). A score of ≥ 10 indicates excessive daytime sleepiness on the ESS.

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

    Time frame: pre-treatment (baseline), post light therapy treatment (approximately week 5)

    This is 14 questions regarding social roles where participants select items on a 5-point Likert scale (1) to very much (5). The higher the score the more satisfaction.

  6. Patient Reported Outcomes Measurement Information System Sleep-related impairment (SRI) total score

    Time frame: pre-treatment (baseline), post light therapy treatment (approximately week 5)

    This is an 8 question scale regarding sleep impairment where participants select items on a 6-point Likert scale not at all (0) to very much (5). The higher the score the more impairment.

  7. Social functioning as measured by the Postpartum Bonding Questionnaire (PBQ) total score

    Time frame: pre-treatment (baseline), post light therapy treatment (approximately week 5)

    The PBQ is a is a 25 question self-report measure of maternal-infant bonding. Items are scored on a 6-point Likert scale ranging from 0 (always) to 5 (never), sum score ranging from 0 to 125; high = problematic.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2021
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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