Trial Outcomes & Findings for Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity (NCT NCT04117347)
NCT ID: NCT04117347
Last Updated: 2024-12-27
Results Overview
Participants completed the Emotional Faces Assessment Task (EFAT) during the fMRI scan. The average blood-oxygen-level-dependent (BOLD) signal change between the display of negative faces versus display of shapes was derived for the left and right amygdala separately. Higher levels indicate greater amygdala reactivity to negative faces versus display of shapes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline and treatment week 2 and treatment week 4
Results posted on
2024-12-27
Participant Flow
Four participants withdrew after study enrollment but before randomization.
Participant milestones
| Measure |
Light Therapy A Via the Re-Timer®
-15 minutes/day
Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy B Via the Re-Timer®
-30 minutes/day
Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy C Via the Re-Timer®
-60 minutes/day
Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
16
|
|
Overall Study
COMPLETED
|
14
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Light Therapy A Via the Re-Timer®
-15 minutes/day
Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy B Via the Re-Timer®
-30 minutes/day
Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy C Via the Re-Timer®
-60 minutes/day
Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
No time for study
|
0
|
2
|
0
|
|
Overall Study
Family emergency
|
1
|
0
|
0
|
Baseline Characteristics
Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
Baseline characteristics by cohort
| Measure |
Light Therapy A Via the Re-Timer®
n=15 Participants
-15 minutes/day
Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy B Via the Re-Timer®
n=15 Participants
-30 minutes/day
Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy C Via the Re-Timer®
n=16 Participants
-60 minutes/day
Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.10 years
STANDARD_DEVIATION 12.03 • n=15 Participants
|
36.45 years
STANDARD_DEVIATION 10.58 • n=15 Participants
|
30.69 years
STANDARD_DEVIATION 8.85 • n=16 Participants
|
33.68 years
STANDARD_DEVIATION 10.57 • n=46 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=15 Participants
|
12 Participants
n=15 Participants
|
10 Participants
n=16 Participants
|
34 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
6 Participants
n=16 Participants
|
12 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=16 Participants
|
4 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
15 Participants
n=16 Participants
|
42 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=16 Participants
|
3 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=46 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=15 Participants
|
12 Participants
n=15 Participants
|
13 Participants
n=16 Participants
|
37 Participants
n=46 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=46 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
16 Participants
n=16 Participants
|
46 Participants
n=46 Participants
|
|
fMRI BOLD signal change in amygdala
fMRI BOLD signal change in left amygdala
|
0.1311 beta weight
STANDARD_DEVIATION 0.0816 • n=15 Participants • Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
|
0.1410 beta weight
STANDARD_DEVIATION 0.0822 • n=14 Participants • Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
|
0.2065 beta weight
STANDARD_DEVIATION 0.1333 • n=14 Participants • Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
|
0.1589 beta weight
STANDARD_DEVIATION 0.1047 • n=43 Participants • Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
|
|
fMRI BOLD signal change in amygdala
fMRI BOLD signal change in right amygdala
|
0.1611 beta weight
STANDARD_DEVIATION 0.1577 • n=15 Participants • Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
|
0.1800 beta weight
STANDARD_DEVIATION 0.0936 • n=14 Participants • Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
|
0.1858 beta weight
STANDARD_DEVIATION 0.0812 • n=14 Participants • Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
|
0.1753 beta weight
STANDARD_DEVIATION 0.1147 • n=43 Participants • Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute).
|
PRIMARY outcome
Timeframe: Baseline and treatment week 2 and treatment week 4Population: Four participants discontinued the study after randomization: 2 no time for study (Light Therapy B group -30 minute), 1 family emergency (Light Therapy A group - 15 minute), 1 light-triggered headaches (Light Therapy C group - 60 minute). Some participants were not scanned at week 2 due to various reasons (e.g. weather, available funding).
Participants completed the Emotional Faces Assessment Task (EFAT) during the fMRI scan. The average blood-oxygen-level-dependent (BOLD) signal change between the display of negative faces versus display of shapes was derived for the left and right amygdala separately. Higher levels indicate greater amygdala reactivity to negative faces versus display of shapes.
Outcome measures
| Measure |
Light Therapy A Via the Re-Timer®
n=14 Participants
-15 minutes/day
Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy B Via the Re-Timer®
n=12 Participants
-30 minutes/day
Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy C Via the Re-Timer®
n=13 Participants
-60 minutes/day
Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
|---|---|---|---|
|
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
After 4 weeks of light treatment (right amygdala)
|
0.1087 beta weights
Standard Deviation 0.1159
|
0.1107 beta weights
Standard Deviation 0.1141
|
0.1303 beta weights
Standard Deviation 0.0905
|
|
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
Baseline (left amygdala)
|
0.1287 beta weights
Standard Deviation 0.0842
|
0.1532 beta weights
Standard Deviation 0.0828
|
0.2134 beta weights
Standard Deviation 0.1362
|
|
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
After 2 weeks of light treatment (left amygdala)
|
0.1048 beta weights
Standard Deviation 0.0770
|
0.1248 beta weights
Standard Deviation 0.0855
|
0.0806 beta weights
Standard Deviation 0.1582
|
|
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
After 4 weeks of light treatment (left amygdala)
|
0.1155 beta weights
Standard Deviation 0.0927
|
0.1191 beta weights
Standard Deviation 0.1047
|
0.1375 beta weights
Standard Deviation 0.1399
|
|
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
Baseline (right amygdala)
|
0.1437 beta weights
Standard Deviation 0.1480
|
0.1969 beta weights
Standard Deviation 0.0882
|
0.1899 beta weights
Standard Deviation 0.0830
|
|
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
After 2 weeks of light treatment (right amygdala)
|
0.1104 beta weights
Standard Deviation 0.0715
|
0.1176 beta weights
Standard Deviation 0.1042
|
0.1012 beta weights
Standard Deviation 0.0716
|
Adverse Events
Light Therapy A Via the Re-Timer®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Light Therapy B Via the Re-Timer®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Light Therapy C Via the Re-Timer®
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Light Therapy A Via the Re-Timer®
n=15 participants at risk
-15 minutes/day
Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy B Via the Re-Timer®
n=15 participants at risk
-30 minutes/day
Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
Light Therapy C Via the Re-Timer®
n=16 participants at risk
-60 minutes/day
Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
|
|---|---|---|---|
|
General disorders
Light-triggered headache
|
0.00%
0/15 • 4 weeks
|
0.00%
0/15 • 4 weeks
|
6.2%
1/16 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place