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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH121531-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light Therapy | Experimental |
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| Dim Light Therapy | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Light Therapy | Device | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in score for the Hamilton Depression Rating Scale (HAM-D total score) | 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. | pre-treatment (baseline), post light therapy treatment (approximately week 5) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in score for the structured interview guide score the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD total score) |
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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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 28, 2025 | Jul 31, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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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.
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| Dim Light Therapy | Device | 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. |
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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. |
| pre-treatment (baseline), post light therapy treatment (approximately week 5) |
| 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) |
| 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) |
| 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) |
| 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. | pre-treatment (baseline), post light therapy treatment (approximately week 5) |
| 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) |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |