ClinicalTrials.gov
ClinicalTrials.gov Menu

Development and Validation of a PTSD-Related Functional Impairment Scale

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.
ClinicalTrials.gov Identifier: NCT00651872
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : March 6, 2014
Sponsor:
Collaborators:
United States Department of Defense
VA Boston Healthcare System
Boston University
Information provided by (Responsible Party):
Boston VA Research Institute, Inc.

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This project has the long-term goal of designing and validating a psychometrically sound inventory of PTSD-related functional impairment for active duty service members and veterans. The inventory will include assessments of multiple dimensions of functional impairment and their impact on quality of life and explicitly show how PTSD symptoms are related to functional impairment. By creating and validating an inventory to assess PTSD-related functioning--as they are perceived and reported by active military personnel and veterans--we hope to offer a useful tool for clinicians, researchers and military leaders. A measure of PTSD-related functional impairment will have enormous value from a health care perspective in terms of identifying individuals with the disorder and for promoting more efficient allocation of resources and efforts towards those who are in most need. We anticipate that the end product of this study, an efficient, empirically-based measure of PTSD-related functional impairment will have an immediate impact on the assessment and treatment of military-related PTSD, in terms of promoting more efficient allocation of resources and efforts towards those who are in most need. Such a measure will also assist with PTSD-related compensation and pension procedures and decisions by providing a means to more accurately assess PTSD-related functional impairment.

Condition or disease
Stress Disorders, Post-Traumatic

  Show Detailed Description

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 740 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development and Validation of a PTSD-Related Functional Impairment Scale
Study Start Date : June 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Marx


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Functional Impairment [ Time Frame: following1st and only session ]

Secondary Outcome Measures :
  1. PTSD Diagnosis [ Time Frame: during 1st and only session ]
  2. General Life Satisfaction [ Time Frame: during 1st and only session ]
  3. Malingering [ Time Frame: during 1st and only session ]
  4. Disability [ Time Frame: during 1st and only session ]

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Veterans and Active Duty Military Personnel
Criteria

Inclusion Criteria:

  • Veteran or Active Duty Military Personnel

Exclusion Criteria:

  • Inability to read
Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00651872


Locations
United States, Maryland
Walter Reed Army Institute of Research
Silver Springs, Maryland, United States, 20910
United States, Massachusetts
VA Boston Healthcare System (Jamaica Plain Campus)
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston VA Research Institute, Inc.
United States Department of Defense
VA Boston Healthcare System
Boston University
Investigators
Principal Investigator: Brian P Marx, PhD BUSM; VA Boston Healthcare System
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00651872     History of Changes
Other Study ID Numbers: PT074941
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: August 2013

Keywords provided by Boston VA Research Institute, Inc.:
Posttraumatic Stress Disorder
Functional Impairment
Veterans
Military Personnel

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders