Trial Outcomes & Findings for Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD) (NCT NCT00701064)
NCT ID: NCT00701064
Last Updated: 2019-09-24
Results Overview
The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Mean change from baseline to post-treatment (5-6 weeks later)
Results posted on
2019-09-24
Participant Flow
Participant milestones
| Measure |
Bright Light Exposure
Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box
|
Negative Ion Generator
Negative Ion Generator (30 min/day)
Negative Ion Generator: Administered via Negative Ion Generatore
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
|
Overall Study
COMPLETED
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Bright Light Exposure
Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box
|
Negative Ion Generator
Negative Ion Generator (30 min/day)
Negative Ion Generator: Administered via Negative Ion Generatore
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
initiated other PTSD treatment
|
2
|
2
|
Baseline Characteristics
Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Bright Light Exposure
n=35 Participants
Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box
|
Negative Ion Generator
n=36 Participants
Negative Ion Generator (30 min/day)
Negative Ion Generator: Administered via Negative Ion Generatore
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Clinician Administered PTSD Scale (CAPS2)
|
63.0 units on a scale
STANDARD_DEVIATION 20.2 • n=5 Participants
|
62.3 units on a scale
STANDARD_DEVIATION 26.6 • n=7 Participants
|
62.6 units on a scale
STANDARD_DEVIATION 23.5 • n=5 Participants
|
|
Clinical Global Impression Scale (CGI)
|
4.3 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
PTSD Checklist (PCL)
|
45.3 units on a scale
STANDARD_DEVIATION 10.1 • n=5 Participants
|
47.2 units on a scale
STANDARD_DEVIATION 15.2 • n=7 Participants
|
46.3 units on a scale
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Pittsburgh Sleep Quality Inventory
|
10.3 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 4.2 • n=7 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Mean change from baseline to post-treatment (5-6 weeks later)Population: Separate analysis will be conducted to include drop-outs and exclusions. reported are end of study data
The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.
Outcome measures
| Measure |
Arm 1: Bright Light
n=31 Participants
Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box
|
Arm 2: Placebo Negative Ion Generator
n=31 Participants
Negative Ion Generator (30 min/day)
Inactivated Negative Ion Generator: Administered via Negative Ion Generator
|
|---|---|---|
|
Clinical Assessed PTSD Scale (CAPS-2)
|
20.10 change in units on scale
Standard Deviation 18.63
|
8.84 change in units on scale
Standard Deviation 17.89
|
PRIMARY outcome
Timeframe: Baseline severity to post-treatment (4 weeks later) ChangeThe CGI assesses baseline severity on a 7-point scale, and change on 7-point scale. (1=normal; 4=moderately ill; 7= among the most severely ill). Change: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse
Outcome measures
| Measure |
Arm 1: Bright Light
n=31 Participants
Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box
|
Arm 2: Placebo Negative Ion Generator
n=31 Participants
Negative Ion Generator (30 min/day)
Inactivated Negative Ion Generator: Administered via Negative Ion Generator
|
|---|---|---|
|
Clinical Global Impressions Scale (CGI)
|
2.61 units on scale
Standard Error 0.18
|
3.16 units on scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline to following 4-week treatmentSelf-rated PTSD scale with 17 items (rated 1-5) with range of 17-85. Higher score = worse severity of PTSD. Reported are decreases from baseline to end-of-study.
Outcome measures
| Measure |
Arm 1: Bright Light
n=31 Participants
Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box
|
Arm 2: Placebo Negative Ion Generator
n=31 Participants
Negative Ion Generator (30 min/day)
Inactivated Negative Ion Generator: Administered via Negative Ion Generator
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist (PCL-M)
|
11.03 decrease in units on scale
Standard Error 1.93
|
6.25 decrease in units on scale
Standard Error 1.61
|
Adverse Events
Arm 1: Bright Light Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Negative Ion Generator
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