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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014