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

StatusActive, Not Recruiting
PhaseNot specified
Started2010-08-31
View on ClinicalTrials.gov ↗
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. The investigators 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. The investigators 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. The investigators 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.

Amendment history 2 changes detected by DataLookout

2026-09-15
critical
Primary endpoint(s) modified
WasNeuropsych performance, PTSD diagnosis (current CAPS dx); PTSD threshold (PCL derived screening estimate)
NowNeuropsych performance, Post-traumatic stress disorder (PTSD) diagnosis (current CAPS dx); PTSD threshold (PCL derived screening estimate)
2026-09-15
minor
Completion pushed: 2026-09-30 → 2027-09-30
Trial Details
NCT Number NCT00748995
Lead Sponsor VA Office of Research and Development
Conditions Stress Disorders, Post-Traumatic
Enrollment 817 participants
Start Date 2010-08-31
Primary Completion 2014-07-10 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-14