Prospective Study of Veteran Health in Previously Deployed Soldiers

Combat Disorders Clinical Trial

Official title: Prospective Study of Functional Status in Veterans at Risk for Unexplained Illnesses

Status Completed

Clinical Trial Summary

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, when this study began there was virtually no pre-war, prospective data on risk and resilience factors associated with MUI. This study is attempting 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.

Clinical Trial 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, was virtually no pre-war, prospective data on risk and resilience factors associated with MUI before 2001. 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 more than 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: Publications and presentations are being prepared. 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Combat Disorders

• NCT number: NCT00285246
• Study type: Observational
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: December 2005
• Completion date: February 2011