Posttraumatic Stress Disorder
Conditions
Keywords
posttraumatic stress disorder, phototherapy, anxiety, depression, sleep, negative ion generator
Brief summary
The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.
Detailed description
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
Interventions
Administered via bright light box
Administered via Negative Ion Generatore
Sponsors
Arizona State University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Veteran of Operation Iraqi Freedom or Operation Enduring Freedom with Posttraumatic Stress Disorder * receiving other treatment or stopped other treatment prior to study
Exclusion criteria
* bipolar disorder * psychosis * alcohol/drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Assessed PTSD Scale (CAPS-2) | Mean change from baseline to post-treatment (5-6 weeks later) | 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. |
| Clinical Global Impressions Scale (CGI) | Baseline severity to post-treatment (4 weeks later) Change | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Checklist (PCL-M) | Baseline to following 4-week treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bright Light Exposure Bright Light (30 min/day)
Bright Light Exposure: Administered via bright light box | 35 |
| Negative Ion Generator Negative Ion Generator (30 min/day)
Negative Ion Generator: Administered via Negative Ion Generatore | 36 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | initiated other PTSD treatment | 2 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Bright Light Exposure | Negative Ion Generator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 36 Participants | 71 Participants |
| Age, Continuous | 37.5 years STANDARD_DEVIATION 9.3 | 36.0 years STANDARD_DEVIATION 8 | 36.7 years STANDARD_DEVIATION 8.6 |
| Clinical Global Impression Scale (CGI) | 4.3 units on a scale STANDARD_DEVIATION 0.9 | 4.2 units on a scale STANDARD_DEVIATION 1.6 | 4.3 units on a scale STANDARD_DEVIATION 1.3 |
| Clinician Administered PTSD Scale (CAPS2) | 63.0 units on a scale STANDARD_DEVIATION 20.2 | 62.3 units on a scale STANDARD_DEVIATION 26.6 | 62.6 units on a scale STANDARD_DEVIATION 23.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 32 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Pittsburgh Sleep Quality Inventory | 10.3 units on a scale STANDARD_DEVIATION 3.4 | 10.4 units on a scale STANDARD_DEVIATION 4.2 | 10.4 units on a scale STANDARD_DEVIATION 3.8 |
| PTSD Checklist (PCL) | 45.3 units on a scale STANDARD_DEVIATION 10.1 | 47.2 units on a scale STANDARD_DEVIATION 15.2 | 46.3 units on a scale STANDARD_DEVIATION 12.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 11 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 23 Participants | 44 Participants |
| Region of Enrollment United States | 35 Participants | 36 Participants | 71 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 27 Participants | 28 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 0 / 31 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
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)
Population: Separate analysis will be conducted to include drop-outs and exclusions. reported are end of study data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Bright Light | Clinical Assessed PTSD Scale (CAPS-2) | 20.10 change in units on scale | Standard Deviation 18.63 |
| Arm 2: Placebo Negative Ion Generator | Clinical Assessed PTSD Scale (CAPS-2) | 8.84 change in units on scale | Standard Deviation 17.89 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Bright Light | Clinical Global Impressions Scale (CGI) | 2.61 units on scale | Standard Error 0.18 |
| Arm 2: Placebo Negative Ion Generator | Clinical Global Impressions Scale (CGI) | 3.16 units on scale | Standard Error 0.17 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Bright Light | Posttraumatic Stress Disorder Checklist (PCL-M) | 11.03 decrease in units on scale | Standard Error 1.93 |
| Arm 2: Placebo Negative Ion Generator | Posttraumatic Stress Disorder Checklist (PCL-M) | 6.25 decrease in units on scale | Standard Error 1.61 |