NCT00651872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
740

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 6, 2014

Status Verified

August 1, 2013

Enrollment Period

5 years

First QC Date

April 1, 2008

Last Update Submit

March 5, 2014

Conditions

Keywords

Posttraumatic Stress DisorderFunctional ImpairmentVeteransMilitary Personnel

Outcome Measures

Primary Outcomes (1)

  • Functional Impairment

    following1st and only session

Secondary Outcomes (4)

  • PTSD Diagnosis

    during 1st and only session

  • General Life Satisfaction

    during 1st and only session

  • Malingering

    during 1st and only session

  • Disability

    during 1st and only session

Study Arms (1)

Marx

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans and Active Duty Military Personnel

You may qualify if:

  • Veteran or Active Duty Military Personnel

You may not qualify if:

  • Inability to read

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Walter Reed Army Institute of Research

Silver Springs, Maryland, 20910, United States

Location

VA Boston Healthcare System (Jamaica Plain Campus)

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Brian P Marx, PhD

    BUSM; VA Boston Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 6, 2014

Record last verified: 2013-08

Locations