Post Partum DepressionNCT04845347
A Wearable Morning Light Treatment for Postpartum Depression
A study testing Bright Light Therapy and Dim Light Therapy in people with Post Partum Depression, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Bright Light Therapy and Dim Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 24 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Post Partum Depression
- Being tested
- Bright Light Therapy, Dim Light Therapy
- Keywords
- post partum, depression, light therapy
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light TherapyDevice
Also called Re-Timer
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.
Dim Light TherapyDevice
Also called Re-Timer- (placebo version)
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.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Therapy | Experimental | Not described Receives: Device: Bright Light Therapy |
| Dim Light Therapy | Sham comparator | Not described Receives: Device: Dim Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D Total Score) at 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.
Measured: Post-treatment (approximately week 5)
Secondary outcomes (7)
Phase Angle Difference at 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.
Measured: Post-treatment (approximately week 5)
Total Score on the Hamilton Depression Rating Scale-Seasonal Affective Version at Week 5 (SIGH-SAD Total Score)
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.
Measured: Post-treatment (approximately week 5)
Edinburgh Postnatal Depression Scale (EPDS) Total Score at 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.
Measured: Post-treatment (approximately week 5)
Epworth Sleepiness Scale (ESS) Total Score at 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.
Measured: Post-treatment (approximately week 5)
Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction With Participation in Social Roles (SPSR) Total Score at 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.
Measured: Post-treatment (approximately week 5)
Patient Reported Outcomes Measurement Information System Sleep-related Impairment (SRI) Total Score
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.
Measured: Post-treatment (approximately week 5)
Social Functioning as Measured by the Postpartum Bonding Questionnaire (PBQ) Total Score at 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.
Measured: Post-treatment (approximately week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start23 Jun 2021
- Primary completion23 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Leslie Swanson, University of Michigan
- Investigators
- Leslie Swanson, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845347
- Sponsor's protocol ID
- HUM00190163
- Other IDs
- 1R01MH121531-01A1
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2021
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable Morning Light Treatment for Postpartum Depression
- ClinicalTrials.gov ID
- NCT04845347
- Acronym / sponsor ID
- HUM00190163
- Conditions
- Post Partum Depression
- Keywords
- post partum, depression, light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Posted 11 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bright Light Therapy | Experimental | Device: Bright Light Therapy |
| Dim Light Therapy | Sham comparator | Device: Dim Light Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light TherapyAlso: Re-TimerParticipants 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. | Device | Bright Light Therapy |
| Dim Light TherapyAlso: Re-Timer- (placebo version)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. | Device | Dim Light Therapy |
Primary outcome
Hamilton Depression Rating Scale (HAM-D Total Score) at Week 5
Time frame: 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.
7 secondary outcomes
Phase Angle Difference at Week 5
Time frame: Post-treatment (approximately week 5)
Total Score on the Hamilton Depression Rating Scale-Seasonal Affective Version at Week 5 (SIGH-SAD Total Score)
Time frame: Post-treatment (approximately week 5)
Edinburgh Postnatal Depression Scale (EPDS) Total Score at Week 5
Time frame: Post-treatment (approximately week 5)
Epworth Sleepiness Scale (ESS) Total Score at Week 5
Time frame: Post-treatment (approximately week 5)
Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction With Participation in Social Roles (SPSR) Total Score at Week 5
Time frame: Post-treatment (approximately week 5)
Patient Reported Outcomes Measurement Information System Sleep-related Impairment (SRI) Total Score
Time frame: Post-treatment (approximately week 5)
Social Functioning as Measured by the Postpartum Bonding Questionnaire (PBQ) Total Score at Week 5
Time frame: Post-treatment (approximately week 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Swanson, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Therapy and Dim Light Therapy in people with Post Partum Depression, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D Total Score) at Week 5 (time frame: Post-treatment (approximately week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.