Overview

This trial is active, not recruiting.

Condition posttraumatic stress disorder
Treatments bright light exposure, negative ion generator
Phase phase 1
Sponsor Department of Veterans Affairs
Collaborator Arizona State University
Start date January 2009
End date November 2012
Trial size 71 participants
Trial identifier NCT00701064, MHBA-008-08S

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Bright Light (30 min/day)
bright light exposure
Administered via bright light box
(Placebo Comparator)
Negative Ion Generator (30 min/day)
negative ion generator
Administered via Negative Ion Generatore

Primary Outcomes

Measure
Clinical Assessed PTSD Scale (CAPS-2) and Clinical Global Impression (CGI)
time frame: Mean change from baseline to post-treatment (5-6 weeks later)

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Bright Light: An Adjunct Treatment for Combat PTSD
Principal investigator Shawn D. Youngstedt, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.