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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701064
First Posted: June 19, 2008
Last Update Posted: May 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Arizona State University
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 17, 2008
First Posted: June 19, 2008
Results First Submitted: March 26, 2015
Results First Posted: April 29, 2015
Last Update Posted: May 10, 2016
Last Verified: April 2016

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