Neuropsychological and Mental Outcomes of Operation Iraqi Freedom (OIF): A Longitudinal Cohort Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | August 31, 2010 |
| End Date: | September 30, 2019 |
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.
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.
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.
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.
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
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