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OpenTrials
Completed

NCT Number: NCT00701064

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

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

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Key information

Conditions

Posttraumatic Stress Disorder Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, Arizona, 29209, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bright Light Exposure

Other

Administered via bright light box

Negative Ion Generator

Other

Administered via Negative Ion Generatore

Primary outcomes

  1. Clinical Assessed PTSD Scale (CAPS-2)

    Time frame: 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.

  2. Clinical Global Impressions Scale (CGI)

    Time frame: 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 outcomes

  1. Posttraumatic Stress Disorder Checklist (PCL-M)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Arizona State University

Registry information

Official study title

Bright Light: An Adjunct Treatment for Combat PTSD

Important dates

Study start
2009
Primary completion
2012
Study completion
2019
First posted
Jun 19, 2008
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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