Trial Outcomes & Findings for The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression (NCT NCT02769858)
NCT ID: NCT02769858
Last Updated: 2021-04-22
Results Overview
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
COMPLETED
NA
10 participants
After five weeks of light therapy
2021-04-22
Participant Flow
Participant milestones
| Measure |
Light Therapy
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Light therapy: Light therapy glasses
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Light Therapy
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Light therapy: Light therapy glasses
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
Baseline characteristics by cohort
| Measure |
Light Therapy
n=10 Participants
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Light therapy: Light therapy glasses
|
|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: After five weeks of light therapyClinician-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
Outcome measures
| Measure |
Light Therapy
n=8 Participants
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Light therapy: Light therapy glasses
|
|---|---|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: After five weeks of light therapySelf-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 |
Light Therapy
n=8 Participants
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Light therapy: Light therapy glasses
|
|---|---|
|
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
|
|
Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks
Post-Treatment (EPDS)
|
7.75 EPDS score
Standard Deviation 7.50
|
PRIMARY outcome
Timeframe: After five weeks of light therapyOnset 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
Outcome measures
| Measure |
Light Therapy
n=8 Participants
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Light therapy: Light therapy glasses
|
|---|---|
|
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks
|
-6 minutes
Standard Deviation 20
|
Adverse Events
Light Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Light Therapy
n=10 participants at risk
Participants will use commercially-available light therapy glasses (Re-Timer) daily for 60 minutes for five weeks.
Light therapy: Light therapy glasses
|
|---|---|
|
Nervous system disorders
Headache
|
50.0%
5/10 • 5 weeks
|
|
Psychiatric disorders
Irritability
|
40.0%
4/10 • 5 weeks
|
|
Eye disorders
Eyestrain
|
20.0%
2/10 • 5 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place