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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Other: Bright Light Exposure; Other: Negative Ion Generator

• Registration Number: NCT00701064
• Lead Sponsor: VA Office of Research and Development

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

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Study Start: 2009-01-01
• Primary Completion: 2012-11-21
• Results First Submitted: 2015-03-26
• Results First Submitted QC: 2015-04-08
• Results First Posted: 2015-04-29
• Status Verified: 2019-09
• Study Completion: 2019-09-02
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bright Light Exposure	Bright Light Exposure	Bright Light (30 min/day)
Negative Ion Generator	Negative Ion Generator	Negative Ion Generator (30 min/day)

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC; 🇺🇸 Columbia, Arizona, United States