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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Arizona State University
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00701064
First received: June 17, 2008
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
The investigators 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

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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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


Enrollment: 71
Study Start Date: January 2009
Estimated Study Completion Date: December 2016
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bright Light Exposure
Bright Light (30 min/day)
Other: Bright Light Exposure
Administered via bright light box
Placebo Comparator: Negative Ion Generator
Negative Ion Generator (30 min/day)
Other: Negative Ion Generator
Administered via Negative Ion Generatore

Detailed 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
  Eligibility

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

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
  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, Arizona
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, Arizona, United States, 29209
Sponsors and Collaborators
VA Office of Research and Development
Arizona State University
Investigators
Principal Investigator: Shawn D. Youngstedt, PhD Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00701064     History of Changes
Other Study ID Numbers: MHBA-008-08S 
Study First Received: June 17, 2008
Results First Received: March 26, 2015
Last Updated: April 5, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
posttraumatic stress disorder
phototherapy
anxiety
depression
sleep
negative ion generator

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016