An interventional study of Bright Light Exposure and Negative Ion Generator in Posttraumatic Stress Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-09-24.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.
Seventy Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with posttraumatic stress disorders (PTSD) will be randomly assigned to one of two 4-week treatments (45 min/day): (1) bright light exposure or (2) a negative ion generator. Clinical assessments ,as well as self-reported measures of PTSD, anxiety, depression, and sleep will be assessed
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 71 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bright Light (30 min/day)
Other: Bright Light Exposure
Negative Ion Generator (30 min/day)
Other: Negative Ion Generator
Administered via bright light box
Administered via Negative Ion Generatore
Clinical Assessed PTSD Scale (CAPS-2)
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.
Time frame: Mean change from baseline to post-treatment (5-6 weeks later)
Clinical Global Impressions Scale (CGI)
The 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
Time frame: Baseline severity to post-treatment (4 weeks later) Change
Posttraumatic Stress Disorder Checklist (PCL-M)
Self-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.
Time frame: Baseline to following 4-week treatment
| Milestone | Bright Light Exposure | Negative Ion Generator |
|---|---|---|
| Started | 35 | 36 |
| Completed | 31 | 32 |
| Not completed | 4 | 4 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Initiated other ptsd treatment | 2 | 2 |
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.
| change in units on scale | Arm 1: Bright Light | Arm 2: Placebo Negative Ion Generator |
|---|---|---|
| Clinical Assessed PTSD Scale (CAPS-2) | 20.10 ± 18.63 | 8.84 ± 17.89 |
The 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
| units on scale | Arm 1: Bright Light | Arm 2: Placebo Negative Ion Generator |
|---|---|---|
| Clinical Global Impressions Scale (CGI) | 2.61 ± 0.18 | 3.16 ± 0.17 |
Self-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.
| decrease in units on scale | Arm 1: Bright Light | Arm 2: Placebo Negative Ion Generator |
|---|---|---|
| Posttraumatic Stress Disorder Checklist (PCL-M) | 11.03 ± 1.93 | 6.25 ± 1.61 |
Collected over At the end of baseline period and weekly during the 4-week intervention, we monitored the subjects for suicidal thoughts with the Beck Suicide Scale.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Bright Light Exposure | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Arm 2: Negative Ion Generator | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
Veterans with PTSD
| Age, Categorical(Participants) | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 36 | 71 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| Mean | 37.5 ± 9.3 | 36.0 ± 8.0 | 36.7 ± 8.6 |
| Sex: Female, Male(Participants) | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 27 | 28 | 55 |
| Ethnicity (NIH/OMB)(Participants) | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 32 | 32 | 64 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 11 | 24 |
| White | 21 | 23 | 44 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| United States | 35 | 36 | 71 |
| Clinician Administered PTSD Scale (CAPS2)(units on a scale) | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| Mean | 63.0 ± 20.2 | 62.3 ± 26.6 | 62.6 ± 23.5 |
| Clinical Global Impression Scale (CGI)(units on a scale) | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| Mean | 4.3 ± 0.9 | 4.2 ± 1.6 | 4.3 ± 1.3 |
2 further baseline measures are reported on the registry.
Plan to share: No
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