Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD) - Full Text View

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

This study is not yet open for participant recruitment.
Verified by Department of Veterans Affairs, June 2008

Sponsors and Collaborators:	Department of Veterans Affairs University of South Carolina
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00701064

Purpose

We are testing a novel treatment for combat PTST: bright light exposure.

Condition	Intervention	Phase
Posttraumatic Stress Disorder Phototherapy	Other: Bright Light Exposure	Phase I Phase II

MedlinePlus related topics:

Anxiety Post-Traumatic Stress Disorder Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Bright Light: An Adjunct Treatment for Combat PTSD

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:	October 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bright Light (45 min/day)	Other: Bright Light Exposure Administered via bright light box
2: Placebo Comparator Inactivated Negative Ion Generator (45 min/day)	Other: Bright Light Exposure Administered via bright light box

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 placebo inactivated 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

Contacts


Contact: Shawn D Youngstedt, PhD	(803) 777-9929	syoungstedt@sc.edu

Locations


United States, South Carolina
	WJB Dorn Veterans Hospital, Columbia
	Columbia, South Carolina, United States, 29209

Sponsors and Collaborators

Department of Veterans Affairs

University of South Carolina

Investigators


Principal Investigator:	Shawn D. Youngstedt, PhD	WJB Dorn Veterans Hospital, Columbia

More Information

Responsible Party:	Department of Veterans Affairs ( Youngstedt, Shawn - Principal Investigator )
Study ID Numbers:	MHBA-008-08S
First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00701064
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

posttraumatic stress disorder

phototherapy

anxiety

depression

sleep

Study placed in the following topic categories:

Depression

Anxiety Disorders

Mental Disorders

Stress Disorders, Post-Traumatic

Stress

Depressive Disorder

Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 24, 2008