A Wearable Morning Light Treatment for Postpartum Depression

Post Partum Depression Clinical Trial

Official title:

A Wearable Morning Light Treatment for Postpartum Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845347
• Other study ID #: HUM00190163
• Secondary ID: 1R01MH121531-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Kelley DuBuc
• Phone: 734-764-2256
• Email: dubuck[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post Partum Depression

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)