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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright Light Exposure
Negative Ion Generator
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder, phototherapy, anxiety, depression, sleep, negative ion generator

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright Light Exposure

Negative Ion Generator

Arm Description

Bright Light (30 min/day)

Negative Ion Generator (30 min/day)

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Posttraumatic Stress Disorder Checklist (PCL-M)
Self-rated PTSD scale with 17 items (rated 1-5) with range of 17-85. Higher score = worse severity of PTSD. Reported are decreases from baseline to end-of-study.

Full Information

First Posted
June 17, 2008
Last Updated
September 11, 2019
Sponsor
VA Office of Research and Development
Collaborators
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT00701064
Brief Title
Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)
Official Title
Bright Light: An Adjunct Treatment for Combat PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
November 21, 2012 (Actual)
Study Completion Date
September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
posttraumatic stress disorder, phototherapy, anxiety, depression, sleep, negative ion generator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright Light Exposure
Arm Type
Experimental
Arm Description
Bright Light (30 min/day)
Arm Title
Negative Ion Generator
Arm Type
Placebo Comparator
Arm Description
Negative Ion Generator (30 min/day)
Intervention Type
Other
Intervention Name(s)
Bright Light Exposure
Intervention Description
Administered via bright light box
Intervention Type
Other
Intervention Name(s)
Negative Ion Generator
Intervention Description
Administered via Negative Ion Generatore
Primary Outcome Measure Information:
Title
Clinical Assessed PTSD Scale (CAPS-2)
Description
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.
Time Frame
Mean change from baseline to post-treatment (5-6 weeks later)
Title
Clinical Global Impressions Scale (CGI)
Description
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
Time Frame
Baseline severity to post-treatment (4 weeks later) Change
Secondary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist (PCL-M)
Description
Self-rated PTSD scale with 17 items (rated 1-5) with range of 17-85. Higher score = worse severity of PTSD. Reported are decreases from baseline to end-of-study.
Time Frame
Baseline to following 4-week treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D. Youngstedt, PhD
Organizational Affiliation
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
City
Columbia
State/Province
Arizona
ZIP/Postal Code
29209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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