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

This study has been completed.
Sponsor:
Collaborator:
University of South Carolina
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00701064
First received: June 17, 2008
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Posttraumatic Stress Disorder
Other: Bright Light Exposure
Other: Negative Ion Generator
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Bright Light: An Adjunct Treatment for Combat PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Clinical Assessed PTSD Scale (CAPS-2) and Clinical Global Impression (CGI) [ Time Frame: Change from baseline to post-treatment (5-6 weeks later) ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Bright Light (30 min/day)
Other: Bright Light Exposure
Administered via bright light box
Placebo Comparator: Arm 2
Negative Ion Generator (30 min/day)
Other: Negative Ion Generator
Administered via Negative Ion Generatore

Detailed Description:

Seventy OIF/OEF veterans with 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • veteran of OIF/OEF with PTSD
  • receiving other treatment

Exclusion Criteria:

  • bipolar disorder
  • psychosis
  • alcohol/drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701064

Locations
United States, South Carolina
WJB Dorn Veterans Hospital, Columbia
Columbia, South Carolina, United States, 29209
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Shawn D. Youngstedt, PhD WJB Dorn Veterans Hospital, Columbia
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00701064     History of Changes
Other Study ID Numbers: MHBA-008-08S
Study First Received: June 17, 2008
Last Updated: January 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
posttraumatic stress disorder
phototherapy
anxiety
depression
sleep
negative ion generator

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014