A Wearable Morning Light Treatment for Postpartum Depression

NCT04845347 | Completed DMC

• 2 other identifiers: HUM001901631R01MH121531-01A1
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Partum Depression

Keywords

post partum; depression; light therapy

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (7)

• Change in Phase angle difference

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

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

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

• Edinburgh Postnatal Depression Scale (EPDS) total score

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

• Epworth Sleepiness Scale (ESS) total score

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

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

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

Study Arms (2)

Bright Light Therapy

EXPERIMENTAL

Device: Bright Light Therapy

Dim Light Therapy

SHAM COMPARATOR

Device: Dim Light Therapy

Interventions

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.

Also known as: Re-Timer

Bright Light Therapy

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.

Also known as: Re-Timer- (placebo version)

Dim Light Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Depression

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Leslie Swanson, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 14, 2021
• Study Start: June 23, 2021
• Primary Completion: July 23, 2025
• Study Completion: July 24, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)