CSP #566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study

This study is currently recruiting participants.
Verified January 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00748995
First received: September 5, 2008
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

This is a research study examining health effects of the Iraq War, especially those effects involving mental health. This study is a follow-up to the Neurocognition Deployment Health Study (NDHS), also called "Prospective Assessment of Neurocognition in Future Gulf-deployed and Gulf-nondeployed Military Personnel: A Pilot Study." The specific purpose of this research study is to find out more about the longer lasting effects of war on mood and stress symptoms, thinking and reaction skills, and different aspects of day to day life, such as work and daily activities. Survey and test results from previous participation in the NDHS will be compared to the new information that will be obtained from participants as part of this study. We expect that a total of about 817 military personnel and military veterans will participate in the study. There are two parts to this study: (1) mail/internet/phone survey and (2) in-person assessment. We will invite all NDHS participants who deployed to Iraq to participate in the survey component. The survey component of the study involves being interviewed by phone about mood and stress symptoms and head injuries and completing written survey questions by either mail or on the internet that address basic personal history (such as age, military status, gender, combat injury history), mood, stress symptoms, and stressful experiences. The phone interview will take about 2 to 2.5 hours to complete. The questionnaire part will take about 20 to 30 minutes to complete, and can be completed either by mailing back completed questionnaires or by internet using a private, individual log-in/password combination. We will invite approximately 200 selected at random from the larger group of survey responders to take part in the in-person assessment. The in-person assessment involves taking a small subset of neuropsychological tasks. The tasks will be given on a computer or using paper and pencil. Participants will also be asked to complete questionnaires about work, daily activities, and health history, as well as basic health measures such as height, weight, blood pressure, heart rate, and waist size. Potential participants will be given the option of completing the in-person assessment at one of the two study sites (Seattle or Boston), or in a private setting in their community (e.g., a hotel small conference room). Altogether, this part of the study will take about 120 minutes to 140 minutes to complete.


Condition
Stress Disorders, Post-Traumatic

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: CSP #566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PTSD diagnosis (current CAPS dx) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD threshold (PCL derived screening estimate) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Neuropsych performance [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 817
Study Start Date: August 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Surviving members of the NDHS cohort of 1595 participants

Criteria

Inclusion Criteria:

  • Deployment to Iraq with completed NDHS baseline assessments

Exclusion Criteria:

  • non-deployed,
  • sensory-motor or cognitive loss sufficiently profound to permit meaningful participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748995

Contacts
Contact: Mihaela Aslan, PhD (203) 932-5711 ext 5679 mihaela.aslan@va.gov
Contact: Patricia Crutchfield (203) 932-5711 ext 5854 patricia.crutchfield@va.gov

Locations
United States, Connecticut
CERC (VISN1, West Haven, CT) Active, not recruiting
West Haven, Connecticut, United States, 06516
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus Recruiting
Boston, Massachusetts, United States, 02130
Contact: Jennifer J Vasterling, PhD    857-364-6522    Jennifer.Vasterling@va.gov   
Contact: Christopher B Harte    (857) 364-4022    Christopher.Harte@va.gov   
Study Chair: Jennifer J. Vasterling, PhD         
VA Medical Center, Jamaica Plain Campus Recruiting
Boston, Massachusetts, United States, 02130
Contact: Mary ALice Mills, PhD    857-364-6291    MaryAlice.Mills@va.gov   
United States, Washington
VA Puget Sound Health Care System, Seattle Completed
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Study Chair: Jennifer J. Vasterling, PhD VA Medical Center, Jamaica Plain Campus
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00748995     History of Changes
Other Study ID Numbers: 566
Study First Received: September 5, 2008
Last Updated: January 27, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014