A Wearable Morning Light Treatment for Postpartum Depression

Not Applicable

Recruiting

• Conditions: Post Partum Depression
• Interventions: Device: Bright Light Therapy; Device: Dim Light Therapy

• Registration Number: NCT04845347
• Lead Sponsor: University of Michigan

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-09
• Study First Posted: 2021-04-14
• Study Start: 2021-06-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bright Light Therapy	Bright Light Therapy	-
Dim Light Therapy	Dim Light Therapy	-

Primary Outcome Measures

Name	Time	Method
Change in score for the Structured interview guide score for the Hamilton Depression Rating Scale - Seasonal Affective Version (SIGH-SAD total score)	pre-treatment (baseline), post light therapy treatment (approximately week 5)	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.
Change in Phase angle difference	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
Epworth Sleepiness Scale (ESS) total score	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.
Social functioning as measured by the Postpartum Bonding Questionnaire (PBQ) total score	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.
Edinburgh Postnatal Depression Scale (EPDS) total score	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.
Patient Reported Outcomes Measurement Information System Sleep-related impairment (SRI) total score	up to 3 months	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States