Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)
1 other identifier
interventional
71
1 country
1
Brief Summary
The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2012
CompletedResults Posted
Study results publicly available
April 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2019
CompletedSeptember 24, 2019
September 1, 2019
3.9 years
June 17, 2008
March 26, 2015
September 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Assessed PTSD Scale (CAPS-2)
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.
Mean change from baseline to post-treatment (5-6 weeks later)
Clinical Global Impressions Scale (CGI)
The CGI assesses baseline severity on a 7-point scale, and change on 7-point scale. (1=normal; 4=moderately ill; 7= among the most severely ill). Change: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse
Baseline severity to post-treatment (4 weeks later) Change
Secondary Outcomes (1)
Posttraumatic Stress Disorder Checklist (PCL-M)
Baseline to following 4-week treatment
Study Arms (2)
Bright Light Exposure
EXPERIMENTALBright Light (30 min/day)
Negative Ion Generator
PLACEBO COMPARATORNegative Ion Generator (30 min/day)
Interventions
Eligibility Criteria
You may qualify if:
- Veteran of Operation Iraqi Freedom or Operation Enduring Freedom with Posttraumatic Stress Disorder
- receiving other treatment or stopped other treatment prior to study
You may not qualify if:
- bipolar disorder
- psychosis
- alcohol/drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Arizona State Universitycollaborator
Study Sites (1)
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, Arizona, 29209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shawn Youngstedt
- Organization
- VA
Study Officials
- PRINCIPAL INVESTIGATOR
Shawn D. Youngstedt, PhD
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 19, 2008
Study Start
January 1, 2009
Primary Completion
November 21, 2012
Study Completion
September 2, 2019
Last Updated
September 24, 2019
Results First Posted
April 29, 2015
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share