Prospective Study of Veteran Health in Previously Deployed Soldiers

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00285246
First received: January 30, 2006
Last updated: April 15, 2014
Last verified: April 2014
  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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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
Study Population

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)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285246

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
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
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: April 15, 2014
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 July 31, 2014