Stress Disorders, Post-TraumaticNCT00748995
Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study
An observational study of Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- How many people
- 817 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Aug 2010to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surviving members of the Neurocognition Deployment Health Study (NDHS) cohort of 1595 participants
Who may be able to join
- Deployment to Iraq with completed Neurocognition Deployment Health Study (NDHS) baseline assessments
Who cannot join
- non-deployed
- sensory-motor or cognitive loss sufficiently profound to permit meaningful participation in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
CERC (VISN1, West Haven, CT)
West Haven, Connecticut, 06516
About this study
Official title: CSP #566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study
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.
Read the detailed description
As of August 2007, approximately 1.5 million U.S. service members had been deployed to either Iraq (Operation Iraqi Freedom, OIF) or Afghanistan (Operating Enduring Freedom, OEF). The sacrifices of these service members include >3500 fatalities and >35,000 injuries resulting in medical air transports. Medical sequelae, such as those involving traumatic amputations and traumatic brain injury, have been common. Contemporary military operations have also been linked to significant adverse mental health consequences. In particular, recent evidence suggests that both overt psychiatric symptoms and other functionally-relevant problems, such as attention and memory impairment, occur. These adverse mental health consequences, already observed in the immediate aftermath of war, could constitute a significant public health problem if prevalent and persistent.
In this context, Cooperative Studies Program (CSP) study #566 proposes an observational cohort design to examine war-related mental health dysfunction beyond the immediate aftermath of war. The proposed work builds on a unique data set available from the Neurocognition Deployment Health Study (NDHS), an interagency collaboration between the Department of Defense (DoD) and the Department of Veterans Affairs (VA). Initiated in April 2003, with an initial enrollment of 1595 participants, the NDHS has focused on short-term mental health outcomes of OIF deployment. To date, the NDHS is the only deployment health study of U.S. troops that includes both prospectively-gathered pre-deployment (baseline) and post-deployment (within 90 days after return from the war) data, as well as objective, performance-based measures of mental functioning.
The proposed work would collect new "long-term follow-up" data 3 to 5 years after NDHS participants returned from their initial deployment to Iraq. The newly acquired data from the proposed work will be analyzed with data available from the previous waves of the NDHS. The two primary objectives of CSP #566 are to: (1) determine the prevalence and course of posttraumatic stress disorder (PTSD) among Iraq War Veterans 3-5 years following return from their Iraq War deployment; and (2) assess the persistence of previously observed neuropsychological changes (in attention, verbal learning, visual memory, and reaction time) following war-zone participation and their relationships to the subsequent development of PTSD as the end-point. The second primary objective also evaluates traumatic brain injury (TBI) as a possible neural risk factor for PTSD.
The two secondary objectives are to: (1) examine the association of risk and resilience factors, including the impact of war zone stressors, with the outcomes of PTSD, major depressive disorder (MDD), and panic disorder; and (2) determine whether changes in PTSD symptoms or neuropsychological function are associated with subsequent day-to-day functioning, including health-related functional activities and occupational functioning.
The proposed study includes two hierarchical participant sampling frames: (1) a "full sample" (N=817) for examination of PTSD and related outcomes; and (2) a "neuropsychological subsample" (N=200) for examination of neuropsychological and functional outcomes. Both samples are drawn from the anticipated 1149 participants from the original NDHS cohort who deployed to Iraq and consented to be contacted for future research. The "full sample" component includes clinician-administered structured psychiatric phone interviews to determine clinically significant cases of PTSD, major depressive disorder, and panic disorder; a mail questionnaire survey will provide assessment of posttraumatic stress (PTS) symptom severity. The "neuropsychological sample" component includes in-person performance-based assessment of neuropsychological outcomes, shown previously to be affected by deployment to Iraq. In addition, participants in the neuropsychological sample will complete questionnaires relevant to health-related functional impact and occupational functioning.
The planned duration of the study is 5.5 years, including a 6 month start-up period, 42 months to locate, contact, and complete assessments on participants, 6 months to lock and close the database, and 12 months to complete the primary and secondary analyses. The attributes of the established study population, in combination with the scope of the proposed work, offer a unique opportunity to answer scientific questions with direct relevance to healthcare policy for returning OIF Veterans. Specifically, this study can 1) identify quantifiable and objective measures associated with subsequent outcome and functioning, 2) determine early potentially modifiable factors that may be used to promote resilience, 3) optimize treatment "windows," and 4) help project future resource allocation based on the frequency and impact of the mental health problems identified.
- Conditions
- Stress Disorders, Post-Traumatic
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neurocognition Deployment Health Study (NDHS) participants | Surviving NDHS participants who returned from their initial deployment to Iraq or Afghanistan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic stress disorder (PTSD) diagnosis (current CAPS dx); PTSD threshold (PCL derived screening estimate)
- PTSD dx (current CAPS dx at T3)
- PTSD threshold dx (PCL-derived screening estimate) for T3 vs. T1 comparison
- 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]
Measured: 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)
Measured: 5 years
Secondary outcomes (2)
Association of early/deploy/post-deploy stress exposures and PTSD, MDD, panic
- Post-traumatic stress disorder (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)
Measured: 5 years
Association from pre-deploy to long-term follow-up (T3)
- Employment (T3)
- Absenteeism (HPQ) (T3)
- Work performance (HPQ) (T3)
- Health-related functioning (SFv12) (T3)
- Cognitive-related functioning (MOS CF) (T3)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study start31 Aug 2010
- Primary completion10 Jul 2014
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer J Vasterling, PhD, Study chair, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748995
- Sponsor's protocol ID
- 566
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2008
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27852604Alosco 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.
PubMed 26580696Vasterling 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.
PubMed 29199924Aslan 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.
PubMed 23392054Vasterling 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.
PubMed 25939106Vasterling 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.
PubMed 32301397Jackson 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.
PubMed 33650202Vasterling 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.
PubMed 37608526Bottari 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.
PubMed 42284953
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #566 - Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT00748995
- Acronym / sponsor ID
- 566
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 817 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Aug 2010 (actual)
- Primary completion
- 10 Jul 2014 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As of August 2007, approximately 1.5 million U.S. service members had been deployed to either Iraq (Operation Iraqi Freedom, OIF) or Afghanistan (Operating Enduring Freedom, OEF). The sacrifices of these service members include >3500 fatalities and >35,000 injuries resulting in medical air transports. Medical sequelae, such as those involving traumatic amputations and traumatic brain injury, have been common. Contemporary military operations have also been linked to significant adverse mental health consequences. In particular, recent evidence suggests that both overt psychiatric symptoms and other functionally-relevant problems, such as attention and memory impairment, occur. These adverse mental health consequences, already observed in the immediate aftermath of war, could constitute a significant public health problem if prevalent and persistent.
In this context, Cooperative Studies Program (CSP) study #566 proposes an observational cohort design to examine war-related mental health dysfunction beyond the immediate aftermath of war. The proposed work builds on a unique data set available from the Neurocognition Deployment Health Study (NDHS), an interagency collaboration between the Department of Defense (DoD) and the Department of Veterans Affairs (VA). Initiated in April 2003, with an initial enrollment of 1595 participants, the NDHS has focused on short-term mental health outcomes of OIF deployment. To date, the NDHS is the only deployment health study of U.S. troops that includes both prospectively-gathered pre-deployment (baseline) and post-deployment (within 90 days after return from the war) data, as well as objective, performance-based measures of mental functioning.
The proposed work would collect new "long-term follow-up" data 3 to 5 years after NDHS participants returned from their initial deployment to Iraq. The newly acquired data from the proposed work will be analyzed with data available from the previous waves of the NDHS. The two primary objectives of CSP #566 are to: (1) determine the prevalence and course of posttraumatic stress disorder (PTSD) among Iraq War Veterans 3-5 years following return from their Iraq War deployment; and (2) assess the persistence of previously observed neuropsychological changes (in attention, verbal learning, visual memory, and reaction time) following war-zone participation and their relationships to the subsequent development of PTSD as the end-point. The second primary objective also evaluates traumatic brain injury (TBI) as a possible neural risk factor for PTSD.
The two secondary objectives are to: (1) examine the association of risk and resilience factors, including the impact of war zone stressors, with the outcomes of PTSD, major depressive disorder (MDD), and panic disorder; and (2) determine whether changes in PTSD symptoms or neuropsychological function are associated with subsequent day-to-day functioning, including health-related functional activities and occupational functioning.
The proposed study includes two hierarchical participant sampling frames: (1) a "full sample" (N=817) for examination of PTSD and related outcomes; and (2) a "neuropsychological subsample" (N=200) for examination of neuropsychological and functional outcomes. Both samples are drawn from the anticipated 1149 participants from the original NDHS cohort who deployed to Iraq and consented to be contacted for future research. The "full sample" component includes clinician-administered structured psychiatric phone interviews to determine clinically significant cases of PTSD, major depressive disorder, and panic disorder; a mail questionnaire survey will provide assessment of posttraumatic stress (PTS) symptom severity. The "neuropsychological sample" component includes in-person performance-based assessment of neuropsychological outcomes, shown previously to be affected by deployment to Iraq. In addition, participants in the neuropsychological sample will complete questionnaires relevant to health-related functional impact and occupational functioning.
The planned duration of the study is 5.5 years, including a 6 month start-up period, 42 months to locate, contact, and complete assessments on participants, 6 months to lock and close the database, and 12 months to complete the primary and secondary analyses. The attributes of the established study population, in combination with the scope of the proposed work, offer a unique opportunity to answer scientific questions with direct relevance to healthcare policy for returning OIF Veterans. Specifically, this study can 1) identify quantifiable and objective measures associated with subsequent outcome and functioning, 2) determine early potentially modifiable factors that may be used to promote resilience, 3) optimize treatment "windows," and 4) help project future resource allocation based on the frequency and impact of the mental health problems identified.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurocognition Deployment Health Study (NDHS) participants | – | –Surviving NDHS participants who returned from their initial deployment to Iraq or Afghanistan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surviving members of the Neurocognition Deployment Health Study (NDHS) cohort of 1595 participants
Key inclusion criteria (1 listed)
- Deployment to Iraq with completed Neurocognition Deployment Health Study (NDHS) baseline assessments
Key exclusion criteria (2 listed)
- non-deployed
- sensory-motor or cognitive loss sufficiently profound to permit meaningful participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-traumatic stress disorder (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]
Neuropsych performance
Time frame: 5 years
* Neuropsych performance (T1 v. T2 v. T3) * Post-traumatic stress disorder (PTSD) diagnosis (CAPS dx); PTS symptom severity (PCL summary scores) (T3)
2 secondary outcomes
Association of early/deploy/post-deploy stress exposures and PTSD, MDD, panic
Time frame: 5 years
Association from pre-deploy to long-term follow-up (T3)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 27852604Vasterling 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.
- Results publication: PubMed 26580696Alosco 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.
- Results publication: PubMed 29199924Vasterling 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.
- Results publication: PubMed 23392054Aslan 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.
- Results publication: PubMed 25939106Vasterling 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.
- Results publication: PubMed 32301397Vasterling 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.
- Results publication: PubMed 33650202Jackson 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.
- Results publication: PubMed 37608526Vasterling 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.
- Results publication: PubMed 42284953Bottari 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer J Vasterling, PhD study chair
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic stress disorder (PTSD) diagnosis (current CAPS dx); PTSD threshold (PCL derived screening estimate) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00748995, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.