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

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ClinicalTrials.gov Identifier: NCT00748995
Recruitment Status : Active, not recruiting
First Posted : September 9, 2008
Last Update Posted : September 8, 2022
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease
Stress Disorders, Post-Traumatic

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Study Type : Observational
Actual Enrollment : 817 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: CSP #566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study
Actual Study Start Date : August 31, 2010
Actual Primary Completion Date : July 10, 2014
Estimated Study Completion Date : September 30, 2023

Neurocognition Deployment Health Study (NDHS) participants
Surviving NDHS participants who returned from their initial deployment to Iraq or Afghanistan.

Primary Outcome Measures :
  1. PTSD diagnosis (current CAPS dx); PTSD threshold (PCL derived screening estimate) [ Time Frame: 5 years ]
    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]

  2. Neuropsych performance [ Time Frame: 5 years ]
    • Neuropysch performance (T1 v. T2 v. T3)
    • PTSD diagnosis (CAPS dx); PTS symptom severity (PCL summary scores) (T3)

Secondary Outcome Measures :
  1. Association of early/deploy/post-deploy stress exposures and PTSD, MDD, panic [ Time Frame: 5 years ]
    • PTSD (CAPS current dx) (T3)
    • Mood Disorders, Panic Disorder, Agoraphobia, and Generalized Anxiety Disorders (MINI) (T3)
    • PTS symptom severity (PCL summary scores) (T3)
    • Depression symptom severity (CES-D summary scores) (T3)
    • Anxiety symptoms severity (DASS anxiety subscale) (T3)

  2. Association from pre-deploy to long-term follow-up (T3) [ Time Frame: 5 years ]
    • Employment (T3)
    • Absenteeism (HPQ) (T3)
    • Work performance (HPQ) (T3)
    • Health-related functioning (SFv12) (T3)
    • Cognitive-related functioning (MOS CF) (T3)

Biospecimen Retention:   None Retained
No Biospecimens were collected

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surviving members of the NDHS cohort of 1595 participants

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

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): NCT00748995

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United States, Connecticut
CERC (VISN1, West Haven, CT)
West Haven, Connecticut, United States, 06516
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
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Study Chair: Jennifer J Vasterling, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Additional Information:
Publications of Results:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00748995    
Other Study ID Numbers: 566
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders