Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.

Detailed Description
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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

Official Title
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Bright Light: An Adjunct Treatment for Combat PTSD

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Other: Bright Light Exposure
* Other: Negative Ion Generator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright Light Exposure<br>Bright Light (30 min/day) | Other: Bright Light Exposure<br>* Administered via bright light box<br>|
| Placebo Comparator: Negative Ion Generator<br>Negative Ion Generator (30 min/day) | Other: Negative Ion Generator<br>* Administered via Negative Ion Generatore<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttraumatic stress disorder, phototherapy, anxiety, depression, sleep, negative ion generator