Clinical trial NCT04845347: A Wearable Morning Light Treatment for Postpartum Depression
Official title: A Wearable Morning Light Treatment for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Depression
Keywords: post partum
depression
light therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-04-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in score for the Structured interview guide score for the Hamilton Depression Rating Scale - Seasonal Affective Version (SIGH-SAD total score)
timeFrame: pre-treatment (baseline), post light therapy treatment (approximately week 5)
measure: Change in Phase angle difference
timeFrame: pre-treatment (baseline), post light therapy treatment (approximately week 5)
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS) total score
timeFrame: pre-treatment (baseline), post light therapy treatment (approximately week 5)
measure: Epworth Sleepiness Scale (ESS) total score
timeFrame: pre-treatment (baseline), post light therapy treatment (approximately week 5)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction with Participation in Social Roles (SPSR) total score
timeFrame: pre-treatment (baseline), post light therapy treatment (approximately week 5)
measure: Patient Reported Outcomes Measurement Information System Sleep-related impairment (SRI) total score
timeFrame: up to 3 months
measure: Social functioning as measured by the Postpartum Bonding Questionnaire (PBQ) total score
timeFrame: pre-treatment (baseline), post light therapy treatment (approximately week 5)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Leslie Swanson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: