Trial Outcomes & Findings for A Wearable Morning Light Treatment for Postpartum Depression (NCT NCT04845347)
NCT ID: NCT04845347
Last Updated: 2026-08-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
Post-treatment (approximately week 5)
Results posted on
2026-08-11
Participant Flow
Protocol Enrollment number reflects the number of participants who were consented and were eligible to be enrolled in this trial.
Participant milestones
| Measure |
Bright Light Therapy
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
COMPLETED
|
41
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Bright Light Therapy
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Overall Study
Started exclusionary treatment after randomization
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Wearable Morning Light Treatment for Postpartum Depression
Baseline characteristics by cohort
| Measure |
Bright Light Therapy
n=47 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=48 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 Years
STANDARD_DEVIATION 5 • n=54 Participants
|
30 Years
STANDARD_DEVIATION 5 • n=54 Participants
|
30 Years
STANDARD_DEVIATION 5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=54 Participants
|
48 Participants
n=54 Participants
|
95 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=54 Participants
|
38 Participants
n=54 Participants
|
68 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=54 Participants
|
45 Participants
n=54 Participants
|
87 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=54 Participants
|
48 Participants
n=54 Participants
|
95 Participants
n=27 Participants
|
|
Hamilton Depression Rating Scale
|
17.9 Units on a scale
STANDARD_DEVIATION 4 • n=54 Participants
|
16.5 Units on a scale
STANDARD_DEVIATION 4.3 • n=54 Participants
|
17.2 Units on a scale
STANDARD_DEVIATION 4.2 • n=27 Participants
|
|
Phase Angle Difference
|
6.8 Hours
STANDARD_DEVIATION 1 • n=54 Participants
|
7.0 Hours
STANDARD_DEVIATION 1 • n=54 Participants
|
6.9 Hours
STANDARD_DEVIATION 1 • n=27 Participants
|
|
Hamilton Depression Rating Scale-Seasonal Affective Version
|
26 Units on a scale
STANDARD_DEVIATION 5 • n=54 Participants
|
24.9 Units on a scale
STANDARD_DEVIATION 6 • n=54 Participants
|
25.5 Units on a scale
STANDARD_DEVIATION 6 • n=27 Participants
|
|
Edinburgh Postnatal Depression Scale
|
14.7 Units on a scale
STANDARD_DEVIATION 4 • n=54 Participants
|
16.1 Units on a scale
STANDARD_DEVIATION 4 • n=54 Participants
|
15.4 Units on a scale
STANDARD_DEVIATION 4 • n=27 Participants
|
|
Satisfaction with Participation in Social Roles
|
34.8 Units on a scale
STANDARD_DEVIATION 11 • n=54 Participants
|
31.2 Units on a scale
STANDARD_DEVIATION 10 • n=54 Participants
|
32.9 Units on a scale
STANDARD_DEVIATION 11 • n=27 Participants
|
|
Sleep-Related Impairment
|
27 Units on a scale
STANDARD_DEVIATION 6 • n=54 Participants
|
27.8 Units on a scale
STANDARD_DEVIATION 7 • n=54 Participants
|
27.4 Units on a scale
STANDARD_DEVIATION 6 • n=27 Participants
|
|
Postpartum Bonding Questionnaire (PBQ)
|
16.8 Units on a scale
STANDARD_DEVIATION 12 • n=54 Participants
|
18.6 Units on a scale
STANDARD_DEVIATION 17 • n=54 Participants
|
17.7 Units on a scale
STANDARD_DEVIATION 15 • n=27 Participants
|
|
Epworth Sleepiness Scale
|
7.5 Units on a scale
STANDARD_DEVIATION 5 • n=54 Participants
|
7.9 Units on a scale
STANDARD_DEVIATION 4 • n=54 Participants
|
7.7 Units on a scale
STANDARD_DEVIATION 4 • n=27 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (approximately week 5)Population: Only those participants who completed the study were included in the analyses.
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.
Outcome measures
| Measure |
Bright Light Therapy
n=41 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=46 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D Total Score) at Week 5
|
6.8 score on a scale
Standard Deviation 5.5
|
9.5 score on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Post-treatment (approximately week 5)Population: Only those participants who completed the study were included in the analyses. Among those who completed the study, the phase angle difference could not be calculated for 9 participants in the bright light therapy group and 9 participants in the dim light therapy group due to missing actigraphy data or missing dim light melatonin onset data at one or both of the time points. Missing data will not be collected at a later date.
Phase angle difference is calculated as the time interval between the time of dim light melatonin onset and the midpoint of sleep per actigraphy.
Outcome measures
| Measure |
Bright Light Therapy
n=32 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=37 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Phase Angle Difference at Week 5
|
7.2 Hours
Standard Deviation 1
|
6.8 Hours
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Post-treatment (approximately week 5)Population: Only those participants who completed the study were included in the analyses.
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.
Outcome measures
| Measure |
Bright Light Therapy
n=41 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=46 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Total Score on the Hamilton Depression Rating Scale-Seasonal Affective Version at Week 5 (SIGH-SAD Total Score)
|
11.1 score on a scale
Standard Deviation 8
|
14.7 score on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Post-treatment (approximately week 5)Population: Only those participants who completed the study were included in the analyses.
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.
Outcome measures
| Measure |
Bright Light Therapy
n=41 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=46 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS) Total Score at Week 5
|
7.4 score on a scale
Standard Deviation 5
|
8.5 score on a scale
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Post-treatment (approximately week 5)Population: Only participant who completed the study were included in this analysis.
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.
Outcome measures
| Measure |
Bright Light Therapy
n=41 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=46 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS) Total Score at Week 5
|
6.4 score on a scale
Standard Deviation 3
|
6.3 score on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Post-treatment (approximately week 5)Population: Only those participants who completed the study were included in the analyses.
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.
Outcome measures
| Measure |
Bright Light Therapy
n=41 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=46 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction With Participation in Social Roles (SPSR) Total Score at Week 5
|
45.8 score on a scale
Standard Deviation 13
|
41.0 score on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Post-treatment (approximately week 5)Population: Only participants who completed the study are included in the analyses.
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.
Outcome measures
| Measure |
Bright Light Therapy
n=41 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=46 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System Sleep-related Impairment (SRI) Total Score
|
21.9 score on a scale
Standard Deviation 8
|
21.8 score on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bright Light Therapy
n=41 Participants
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=46 Participants
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Social Functioning as Measured by the Postpartum Bonding Questionnaire (PBQ) Total Score at Week 5
|
8.8 score on a scale
Standard Deviation 7
|
10.7 score on a scale
Standard Deviation 14
|
Adverse Events
Bright Light Therapy
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Dim Light Therapy
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bright Light Therapy
n=43 participants at risk
Bright Light Therapy: Participants were provided with active, unaltered Re-Timer glasses that were worn in the morning daily for 60 minutes for 5 weeks on study.
|
Dim Light Therapy
n=47 participants at risk
Dim Light Therapy: Participants on this arm wore the placebo version of the Re-Timer fitted with neutral density filters. These were worn in the morning daily for 60 minutes for 5 weeks on study.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
23.3%
10/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
29.8%
14/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
14.0%
6/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
12.8%
6/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Psychiatric disorders
Anxiety
|
18.6%
8/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
21.3%
10/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
3/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
6.4%
3/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Gastrointestinal disorders
Flatulence
|
7.0%
3/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
12.8%
6/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Nervous system disorders
Headahces
|
20.9%
9/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
34.0%
16/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Psychiatric disorders
Irritability
|
14.0%
6/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
25.5%
12/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
4/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
6.4%
3/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
7.0%
3/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
0.00%
0/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
3/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
0.00%
0/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
6.4%
3/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/43 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
6.4%
3/47 • 5 weeks
The number of participants at risk in each group are those participants who started the treatment. Four participants in the Bright Light Therapy group withdrew from the study before starting the treatment and 1 participant in the Dim Light Therapy group withdrew from the study before starting the treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place