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| Name | Class |
|---|---|
| Arizona State University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light Exposure | Experimental | Bright Light (30 min/day) |
|
| Negative Ion Generator | Placebo Comparator | Negative Ion Generator (30 min/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Light Exposure | Other | Administered via bright light box |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline severity to post-treatment (4 weeks later) Change |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to following 4-week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shawn D. Youngstedt, PhD | Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC | Columbia | Arizona | 29209 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bright Light Exposure | Bright Light (30 min/day) Bright Light Exposure: Administered via bright light box |
| FG001 | Negative Ion Generator | Negative Ion Generator (30 min/day) Negative Ion Generator: Administered via Negative Ion Generatore |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Veterans with PTSD
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| ID | Title | Description |
|---|---|---|
| BG000 | Bright Light Exposure | Bright Light (30 min/day) Bright Light Exposure: Administered via bright light box |
| BG001 | Negative Ion Generator | Negative Ion Generator (30 min/day) Negative Ion Generator: Administered via Negative Ion Generatore |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Separate analysis will be conducted to include drop-outs and exclusions. reported are end of study data | Posted | Mean | Standard Deviation | change in units on scale | Mean change from baseline to post-treatment (5-6 weeks later) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Bright Light Exposure | Bright Light (30 min/day) Bright Light Exposure: Administered via bright light box |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shawn Youngstedt | VA | 803-767-3208 | shawn.youngstedt@asu.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Negative Ion Generator |
| Other |
Administered via Negative Ion Generatore |
|
| initiated other PTSD treatment |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Clinician Administered PTSD Scale (CAPS2) | PTSD assessed by a skilled clinician, the CAPS2 is the most common clinical and experimental measure of PTSD severity. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD. Scores of 30 or more or 40 or more have been considered indicated of moderate severity PTSD. | Mean | Standard Deviation | units on a scale |
|
| Clinical Global Impression Scale (CGI) | Clinical judgement of the severity of one's condition at baseline (7 point scale: 1=normal; 4=moderately ill; 7= among the most severely ill) | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist (PCL) | A 17-item self-rated PTSD scale ranging from 17-105, with higher levels indicating more severe PTSD. The PCL correlates highly with the CAPS-2. | Mean | Standard Deviation | units on a scale |
|
| Pittsburgh Sleep Quality Inventory | A common instrument that assesses sleep quality over the previous month. The PSQI range is 0-21 with higher scores indicating worse sleep. Scores of > 5 have been considered indicative of a sleep problem. | Mean | Standard Deviation | units on a scale |
|
|
|
| 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 | Posted | Mean | Standard Error | units on scale | Baseline severity to post-treatment (4 weeks later) Change |
|
|
|
| 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. | Posted | Mean | Standard Error | decrease in units on scale | Baseline to following 4-week treatment |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Arm 2: Negative Ion Generator | Negative Ion Generator (30 min/day) Negative Ion Generator: Administered via Negative Ion Generatore | 0 | 32 | 0 | 32 | 0 | 32 |
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| D001519 | Behavior |