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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light Therapy | Experimental | Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light therapy | Device | Light therapy glasses |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After five weeks of light therapy |
| 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. | After five weeks of light therapy |
| 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 | After five weeks of light therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Swanson, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29603017 | Derived | Swanson LM, Burgess HJ, Zollars J, Todd Arnedt J. An open-label pilot study of a home wearable light therapy device for postpartum depression. Arch Womens Ment Health. 2018 Oct;21(5):583-586. doi: 10.1007/s00737-018-0836-z. Epub 2018 Mar 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Therapy | Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Therapy | Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | SIGH-SAD score | After five weeks of light therapy |
|
5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Light Therapy | Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks. Light therapy: Light therapy glasses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie Swanson | University of Michigan | 734-239-2248 | LMSwan@med.umich.edu |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | EPDS score | After five weeks of light therapy |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | minutes | After five weeks of light therapy |
|
|
|
|
| 0 |
| 10 |
| 5 |
| 10 |
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Eyestrain | Eye disorders | Systematic Assessment |
|
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |