Clinical Trial: Prospective Study of Veteran Health in Previously Deployed Soldiers

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed 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, 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 c
Sponsor: VA Office of Research and Development

Current Primary Outcome:

• Non-Specific Physical Symptoms [ Time Frame: pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4) ]
  Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer & Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.
• Physical Functional Status [ Time Frame: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4) ]
  Physical Component Summary Score (PCS) from the Veterans RAND (VR) 36 measure (Kazis, 2000). Composite scores are normed to a mean of 50 and a SD of 10. Scores can range from 0-100. Higher scores indicate better physical function.
• Mental Functional Status [ Time Frame: pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return ]
  Mental Component Summary Score (MCS) from the Veterans-RAND (VR) 36 (Kazis, 2000). MCS is a composite score with a mean of 50 and a standard deviation of 10. Scale scores range from 0-100 with higher scores reflecting better mental function.
• Health Care Utilization [ Time Frame: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4) ]
  This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: VA Office of Research and Development
  

  Dates:
  Date Received: January 30, 2006
  Date Started: December 2005
  Date Completion:
  Last Updated: April 23, 2015
  Last Verified: April 2015