Prospective Study of Veteran Health in Previously Deployed Soldiers
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Purpose
Background: Previous deployments like that to the Persian Gulf in 1991 produced veterans with post-deployment symptom-based health problems with no medical explanation. This was termed Gulf War illness or medically unexplained illness (MUI). If previous wars are any indication, some soldiers currently deployed to hostile areas also will return home with unexplained symptom-based illnesses. However, there is virtually no pre-war, prospective data on risk and resilience factors associated with MUI. This study will attempt to fill that gap.
Objectives: Our goals are to: (a) determine pre- and immediate post-deployment factors predicting later MUI and poor functional status, (b) improve previous methodological problems (e.g., selection bias, recall bias and lack of baseline controls) in studies of MUI, and (c) relate pre-deployment risk factors (e.g., personality, stressor reactivity) and resilience factors (e.g., coping style, social support) to post-deployment functional status.
| Condition |
|---|
|
Combat Disorders |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Study of Functional Status in Veterans at Risk for Unexplained Illnesses |
- Symptoms, functional status (self-reported health), healthcare utilization [ Time Frame: pre-deployment, immediately post-deployment, 3 months post-return from deployment, 1 year post-return from deployment ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Saliva
| Enrollment: | 800 |
| Study Start Date: | December 2005 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Group 1
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
|
Detailed Description:
Background: Previous deployments like that to the Persian Gulf in 1991 produced veterans with post-deployment symptom-based health problems with no medical explanation. This was termed Gulf War illness or medically unexplained illness (MUI). If previous wars are any indication, some soldiers currently deployed to hostile areas also will return home with unexplained symptom-based illnesses. However, there is virtually no pre-war, prospective data on risk and resilience factors associated with MUI. This study will attempt to fill that gap. Objectives: Our goals are to: (a) determine pre- and immediate post-deployment factors predicting later MUI and poor functional status, (b) improve previous methodological problems (e.g., selection bias, recall bias and lack of baseline controls) in studies of MUI, and (c) relate pre-deployment risk factors (e.g., personality, stressor reactivity) and resilience factors (e.g., coping style, social support) to post-deployment functional status. Methods: This study uses a prospective, longitudinal observational design to assess risk and resilience factors for post-war MUI in Reserve and National Guard enlisted personnel. A stratified random sample of 700 subjects will be drawn from those undergoing pre- and post-mobilization readiness processing at Fort Dix, NJ and Camp Shelby, MS. Personnel will be tested pre-mobilization (Phase 1), immediately after mobilization (Phase 2) and at 3 months and 1 year post-deployment (Phases 3 & 4). Predictor variables include personality, social support, coping style, non-specific symptoms, sympathetic cardiac stress reactivity, and cortisol stress reactivity. Control variables include prior traumatic events, current distress, PTSD symptoms, socially desirable responding, body mass index, deployment experiences, environmental exposures and demographics (e.g., age, gender). Outcome variables include functional status, healthcare utilization, and MUI status (using CDC criteria for chronic multisymptom illness developed after the first Gulf War). Status: Project work is ongoing. Impact: The larger, prospective study with soldiers will help us to identify pre- and early post-deployment risk and resilience factors important in MUI, functional status, and healthcare utilization. There is an urgent need for both pre- and post-deployment predictors of later MUI uncontaminated by recall bias, and the selection bias of studying only treatment-seekers. If we are to understand how to best treat veterans presenting with unexplained symptoms, then we need to know which pre-war factors are most useful in predicting who is most likely to be resilient and who is most likely to be at risk for later unexplained illness.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Army National Guard & Reserves Soldiers deploying to either Iraq or Afghanistan. Outcome measures assessed at all 4 time points (pre-deployment, immediately post-deployment, 3 months post-return, 1 year post-return)
Inclusion Criteria:
- Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Exclusion Criteria:
- There are some drug exclusions for anything that substantially affects cardiovascular function.
Contacts and Locations| United States, Mississippi | |
| G.V. (Sonny) Montgomery VA Medical Center, Jackson | |
| Jackson, Mississippi, United States, 39216 | |
| United States, New Jersey | |
| VA New Jersey Health Care System, East Orange | |
| East Orange, New Jersey, United States, 07018 | |
| Principal Investigator: | Karen S. Quigley, PhD | Edith Nourse Rogers Memorial Veterans Hospital |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00285246 History of Changes |
| Other Study ID Numbers: | IIR 02-296 |
| Study First Received: | January 30, 2006 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
combat disorders stress, psychological somatoform disorders life change events utilization |
Additional relevant MeSH terms:
|
Combat Disorders Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013