Trial Outcomes & Findings for Behavioral Study of Effects of Low-Level Light Therapy on Mood and Reaction Time (NCT NCT02390076)
NCT ID: NCT02390076
Last Updated: 2019-05-08
Results Overview
The CES-D (Radloff, 1977) is a 20-item, self-report scale designed to assess the presence and severity of depressive symptoms over the past week. The total range is 0-80, with higher scores reflecting more severe depression symptoms. Outcome measure data table reflects clinical symptoms at 2 week follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
At baseline, session 1, session 2, 1 week follow-up, and 2 week follow-up.
Results posted on
2019-05-08
Participant Flow
Participant milestones
| Measure |
Left Active LLLT
Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy
Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Right Active LLLT
Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy
Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Sham LLLT
Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
15
|
|
Overall Study
COMPLETED
|
16
|
17
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
Left Active LLLT
Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy
Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Right Active LLLT
Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy
Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Sham LLLT
Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
4
|
Baseline Characteristics
Behavioral Study of Effects of Low-Level Light Therapy on Mood and Reaction Time
Baseline characteristics by cohort
| Measure |
Left Active LLLT
n=18 Participants
Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy
Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Right Active LLLT
n=18 Participants
Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy
Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Sham LLLT
n=15 Participants
Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.22 years
STANDARD_DEVIATION 1.48 • n=5 Participants
|
18.72 years
STANDARD_DEVIATION 0.89 • n=7 Participants
|
20.33 years
STANDARD_DEVIATION 5.29 • n=5 Participants
|
19.37 years
STANDARD_DEVIATION 3.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baseline, session 1, session 2, 1 week follow-up, and 2 week follow-up.The CES-D (Radloff, 1977) is a 20-item, self-report scale designed to assess the presence and severity of depressive symptoms over the past week. The total range is 0-80, with higher scores reflecting more severe depression symptoms. Outcome measure data table reflects clinical symptoms at 2 week follow-up.
Outcome measures
| Measure |
Left Active LLLT
n=18 Participants
Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy
Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Right Active LLLT
n=18 Participants
Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy
Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Sham LLLT
n=15 Participants
Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response.
|
|---|---|---|---|
|
Presence and Severity of Depressive Symptoms Assessed by Center for Epidemiologic Studies - Depression Scale (CES-D)
|
21.93 units on a the CESD scale
Standard Deviation 10.15
|
22.5 units on a the CESD scale
Standard Deviation 9.77
|
21.75 units on a the CESD scale
Standard Deviation 8.45
|
SECONDARY outcome
Timeframe: Measure was administered at the beginning of session 1 and end of session 2.This task measures biased attention for emotional stimuli. In this task, two stimuli are presented at the same time. The investigators plan to present two words concurrently; one emotionally valenced word (positive or negative) and one neutral word. Two words appear on the screen for 1000 ms; the location of the emotional and neutral word varies randomly. Following the offset of the words, a subsequent target (i.e., O or Q) appears; the location of the target is randomized with the constraint that it must appear an equal number of times behind the emotional and neutral words. Each iteration of the dot probe task will include 96 trials, and will last approximately 7 minutes. Behavioral reaction times are recorded via a button push on the response box. Change in negative bias is calculated as mean bias value from the dot probe task at the end of session 2 minus the mean bias value calculated at the beginning of session 1.
Outcome measures
| Measure |
Left Active LLLT
n=18 Participants
Active LLLT targeting the left forehead Attention Bias Modification Left low level light therapy
Left Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Right Active LLLT
n=18 Participants
Active LLLT targeting the left forehead Attention Bias Modification Right low level light therapy
Right Low Level Light Therapy: Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the right forehead.
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
|
Sham LLLT
n=15 Participants
Sham LLLT targeting the right forehead Attention Bias Modification Sham low level light therapy
Attention bias modification: The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. Latency and accuracy of the button press responses are recorded by the computer.
Sham Low Level Light Therapy: Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary to elicit a physiological response.
|
|---|---|---|---|
|
Biased Attention for Emotional Stimuli Measured by the Dot Probe Task
|
-24.15 change in negative bias (ms)
Standard Deviation 67.66
|
4.28 change in negative bias (ms)
Standard Deviation 31.43
|
-3.08 change in negative bias (ms)
Standard Deviation 25.64
|
Adverse Events
Left Active LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Right Active LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place