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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Bright Light: An Adjunct Treatment for Combat PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701064
• Other study ID #: MHBA-008-08S
• Status: Completed
• Phase: N/A
• Start date: January 1, 2009
• Est. completion date: September 2, 2019

Study information

• Verified date: September 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2, 2019
• Est. primary completion date: November 21, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Bright Light Exposure
Administered via bright light box
• Negative Ion Generator
Administered via Negative Ion Generatore

Locations

Country	Name	City	State
United States	Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC	Columbia	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Mean change from baseline to post-treatment (5-6 weeks later)
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	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.	Baseline to following 4-week treatment