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

September 11, 2019 updated by: VA Office of Research and Development

Bright Light: An Adjunct Treatment for Combat PTSD

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Columbia, Arizona, United States, 29209
        • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Assessed PTSD Scale (CAPS-2)
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.
Mean change from baseline to post-treatment (5-6 weeks later)
Clinical Global Impressions Scale (CGI)
Time Frame: Baseline severity to post-treatment (4 weeks later) Change
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic Stress Disorder Checklist (PCL-M)
Time Frame: Baseline to following 4-week treatment
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.
Baseline to following 4-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Arizona State University

Investigators

  • Principal Investigator: Shawn D. Youngstedt, PhD, Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

November 21, 2012

Study Completion (Actual)

September 2, 2019

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHBA-008-08S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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