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

NCT00748995 | Active Not Recruiting DMC

• 1 other identifier: 566
• Study Type: observational
• Target: 817
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

• Post-traumatic stress disorder (PTSD) diagnosis (current CAPS dx); PTSD threshold (PCL derived screening estimate)

  1. PTSD dx (current CAPS dx at T3) 2. PTSD threshold dx (PCL-derived screening estimate) for T3 vs. T1 comparison 3. Trajectory patterns of PTSD threshold dx\* (PCL-derived screening estimate) at T1, T2, and/or T3: * never (T1-,T2-,T3-) * persistent (T1-,T2+,T3+) * recovered (T1-,T2+,T3-) * late onset (T1-,T2-,T3+) * all others, e.g., pre- existing (T1+,T2+,T3+) \[\* +/- regarding PTSD threshold at time T1,2,3\]

  5 years

• Neuropsych performance

  * Neuropsych performance (T1 v. T2 v. T3) * Post-traumatic stress disorder (PTSD) diagnosis (CAPS dx); PTS symptom severity (PCL summary scores) (T3)

  5 years

Secondary Outcomes (2)

• Association of early/deploy/post-deploy stress exposures and PTSD, MDD, panic

  5 years

• Association from pre-deploy to long-term follow-up (T3)

  5 years

Study Arms (1)

Neurocognition Deployment Health Study (NDHS) participants

Surviving NDHS participants who returned from their initial deployment to Iraq or Afghanistan.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surviving members of the Neurocognition Deployment Health Study (NDHS) cohort of 1595 participants

You may qualify if:

• Deployment to Iraq with completed Neurocognition Deployment Health Study (NDHS) baseline assessments

You may not qualify if:

• non-deployed
• sensory-motor or cognitive loss sufficiently profound to permit meaningful participation in the study

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

CERC (VISN1, West Haven, CT)

West Haven, Connecticut, 06516, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (9)

• Vasterling JJ, Aslan M, Proctor SP, Ko J, Marx BP, Jakupcak M, Schnurr PP, Gleason T, Huang GD, Concato J. Longitudinal Examination of Posttraumatic Stress Disorder as a Long-Term Outcome of Iraq War Deployment. Am J Epidemiol. 2016 Dec 1;184(11):796-805. doi: 10.1093/aje/kww151. Epub 2016 Nov 16.

  PMID: 27852604 RESULT

• Alosco ML, Aslan M, Du M, Ko J, Grande L, Proctor SP, Concato J, Vasterling JJ. Consistency of Recall for Deployment-Related Traumatic Brain Injury. J Head Trauma Rehabil. 2016 Sep-Oct;31(5):360-8. doi: 10.1097/HTR.0000000000000201.

  PMID: 26580696 RESULT

• Vasterling JJ, Aslan M, Lee LO, Proctor SP, Ko J, Jacob S, Concato J. Longitudinal Associations among Posttraumatic Stress Disorder Symptoms, Traumatic Brain Injury, and Neurocognitive Functioning in Army Soldiers Deployed to the Iraq War. J Int Neuropsychol Soc. 2018 Apr;24(4):311-323. doi: 10.1017/S1355617717001059. Epub 2017 Dec 4.

  PMID: 29199924 RESULT

• Aslan M, Concato J, Peduzzi PN, Proctor SP, Schnurr PP, Marx BP, McFall M, Gleason T, Huang GD, Vasterling JJ. Design of "neuropsychological and mental health outcomes of operation Iraqi freedom: a longitudinal cohort study". J Investig Med. 2013 Mar;61(3):569-77. doi: 10.2310/JIM.0b013e31828407ff.

  PMID: 23392054 RESULT

• Vasterling JJ, Proctor SP, Aslan M, Ko J, Jakupcak M, Harte CB, Marx BP, Concato J. Military, demographic, and psychosocial predictors of military retention in enlisted army soldiers 12 months after deployment to Iraq. Mil Med. 2015 May;180(5):524-32. doi: 10.7205/MILMED-D-14-00468.

  PMID: 25939106 RESULT

• Vasterling JJ, Aslan M, Proctor SP, Ko J, Leviyah X, Concato J. Long-term negative emotional outcomes of warzone TBI. Clin Neuropsychol. 2020 Aug;34(6):1088-1104. doi: 10.1080/13854046.2020.1749935. Epub 2020 Apr 17.

  PMID: 32301397 RESULT

• Jackson CE, Ciarleglio MM, Aslan M, Marx BP, Ko J, Concato J, Proctor SP, Vasterling JJ. Associations Among Increases in Posttraumatic Stress Symptoms, Neurocognitive Performance, and Long-Term Functional Outcomes in U.S. Iraq War Veterans. J Trauma Stress. 2021 Jun;34(3):628-640. doi: 10.1002/jts.22663. Epub 2021 Mar 2.

  PMID: 33650202 RESULT

• Vasterling JJ, Franz MR, Lee LO, Kaiser AP, Proctor SP, Marx BP, Schnurr PP, Ko J, Concato J, Aslan M. Early predictors of chronic posttraumatic stress disorder symptom trajectories in U.S. Army soldiers deployed to the Iraq war zone. J Trauma Stress. 2023 Oct;36(5):955-967. doi: 10.1002/jts.22964. Epub 2023 Aug 22.

  PMID: 37608526 RESULT

• Bottari SA, Pless Kaiser A, Lee LO, Aslan M, Vasterling JJ. Pre-deployment sleep duration predicts longitudinal posttraumatic stress disorder symptom trajectories in US Army soldiers deployed to the Iraq war zone. J Anxiety Disord. 2026 Aug;122:103198. doi: 10.1016/j.janxdis.2026.103198. Epub 2026 Jun 3.

  PMID: 42284953 RESULT

Related Links

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Biospecimen

Retention: NONE RETAINED

No Biospecimens were collected

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jennifer J Vasterling, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: August 31, 2010
• Primary Completion: July 10, 2014
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)