Depression, Postpartum
Conditions
Brief summary
The proposed study aims to establish the feasibility of light therapy for postpartum depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).
Interventions
DEVICELight therapy
Light therapy glasses
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Within 6 months postpartum * Meet DSM-V diagnostic criteria for MDD * Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD).
Exclusion criteria
* current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V * past history of mania/hypomania, * chronic medical conditions associated with depression (e.g., thyroid conditions) * ocular or retinal pathology * history of seizures or epilepsy * color blindness * Lupus * currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks | After five weeks of light therapy | 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 From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks | After five weeks of light therapy | 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. |
| Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks | After five weeks of light therapy | Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Light Therapy Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Light therapy: Light therapy glasses | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Light Therapy |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks
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.
Time frame: After five weeks of light therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Light Therapy | Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks | Pre-Treatment (EPDS | 12.75 EPDS score | Standard Deviation 4.2 |
| Light Therapy | Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks | Post-Treatment (EPDS) | 7.75 EPDS score | Standard Deviation 7.5 |
p-value: 0.019t-test, 2 sided
Primary
Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks
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
Time frame: After five weeks of light therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Light Therapy | Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks | Pre-treatment | 24.75 SIGH-SAD score | Standard Deviation 4.83 |
| Light Therapy | Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks | Post-treatment | 12.88 SIGH-SAD score | Standard Deviation 7.88 |
p-value: 0.001t-test, 2 sided
Primary
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin
Time frame: After five weeks of light therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Therapy | Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks | -6 minutes | Standard Deviation 20 |
p-value: 0.502t-test, 2 sided