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.

Study Overview

• Status: Recruiting
• Conditions: Post Partum Depression
• Intervention / Treatment: Device: Bright Light Therapy; Device: Dim Light Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelley DuBuc; Phone Number: 734-764-2256; Email: dubuck@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Kelley DuBuc; Phone Number: 734-764-2256; Email: dubuck@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score for the Structured interview guide score for the Hamilton Depression Rating Scale - Seasonal Affective Version (SIGH-SAD total score)	Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasonal 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.	pre-treatment (baseline), post light therapy treatment (approximately week 5)
Change in Phase angle difference	Phase angle difference is calculated as the time interval between the time of dim light melatonin onset and the midpoint of sleep.	pre-treatment (baseline), post light therapy treatment (approximately week 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale (EPDS) total score	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.	pre-treatment (baseline), post light therapy treatment (approximately week 5)
Epworth Sleepiness Scale (ESS) total score	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.	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	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.	pre-treatment (baseline), post light therapy treatment (approximately week 5)
Patient Reported Outcomes Measurement Information System Sleep-related impairment (SRI) total score	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.	up to 3 months
Social functioning as measured by the Postpartum Bonding Questionnaire (PBQ) total score	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.	pre-treatment (baseline), post light therapy treatment (approximately week 5)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Leslie Swanson, Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: depression; post partum; light therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: HUM00190163; 1R01MH121531-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No