Post Partum Depression
Conditions
Keywords
post partum, depression, light therapy
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.
Interventions
DEVICEBright 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.
DEVICEDim 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.
Sponsors
University of Michigan
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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 Hamilton Rating Scale for Depression score and parity.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D Total Score) at Week 5 | Post-treatment (approximately week 5) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Score on the Hamilton Depression Rating Scale-Seasonal Affective Version at Week 5 (SIGH-SAD Total Score) | Post-treatment (approximately week 5) | Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasional 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. |
| Edinburgh Postnatal Depression Scale (EPDS) Total Score at Week 5 | Post-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. |
| Epworth Sleepiness Scale (ESS) Total Score at Week 5 | Post-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. Total scores range from 0 to 24. |
| Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction With Participation in Social Roles (SPSR) Total Score at Week 5 | Post-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 total range of the scale was 14 - 60, with higher scores indicating more satisfaction. |
| Patient Reported Outcomes Measurement Information System Sleep-related Impairment (SRI) Total Score | Post-treatment (approximately week 5) | This is an 8 question scale from the Patient Reported Outcomes Measurement Information System (PROMIS) regarding sleep impairment where participants select items on a 5-point Likert scale not at all (1) to very much (5). The total range of the scale was 8 - 40, with higher scores indicating more impairment. |
| Phase Angle Difference at Week 5 | Post-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 per actigraphy. |
| Social Functioning as Measured by the Postpartum Bonding Questionnaire (PBQ) Total Score at Week 5 | Post-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, with higher scores indicating more impaired bonding. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeslie Swanson, Ph.D.
University of Michigan
Participant flow
Pre-assignment details
Protocol Enrollment number reflects the number of participants who were consented and were eligible to be enrolled in this trial.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30 Years STANDARD_DEVIATION 5 |
| Edinburgh Postnatal Depression Scale | 16.1 Units on a scale STANDARD_DEVIATION 4 |
| Epworth Sleepiness Scale | 7.9 Units on a scale STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hamilton Depression Rating Scale | 17.9 Units on a scale STANDARD_DEVIATION 4 |
| Hamilton Depression Rating Scale-Seasonal Affective Version | 25.5 Units on a scale STANDARD_DEVIATION 6 |
| Phase Angle Difference | 7.0 Hours STANDARD_DEVIATION 1 |
| Postpartum Bonding Questionnaire (PBQ) | 18.6 Units on a scale STANDARD_DEVIATION 17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 48 Participants |
| Satisfaction with Participation in Social Roles | 32.9 Units on a scale STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sleep-Related Impairment | 27.8 Units on a scale STANDARD_DEVIATION 7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 47 |
| other Total, other adverse events | 22 / 43 | 29 / 47 |
| serious Total, serious adverse events | 0 / 43 | 0 / 47 |
Outcome results
None listed