Clinical trial NCT00285246: Prospective Study of Veteran Health in Previously Deployed Soldiers
Official title: Prospective Study of Functional Status in Veterans at Risk for Unexplained Illnesses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Combat Disorders
Keywords: combat disorders
stress, psychological
somatoform disorders
life change events
utilization
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-02-01
Enrollment: 838
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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 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.

Eligibility criteria: Inclusion Criteria:

* Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, New Jersey (NJ) and Camp Shelby, Mississippi (MS)

Exclusion Criteria:

* There are some drug exclusions for anything that substantially affects cardiovascular function.

Primary outcomes:
measure: Non-Specific Physical Symptoms
timeFrame: 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)
measure: Physical Functional Status
timeFrame: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)
measure: Mental Functional Status
timeFrame: pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return
measure: Health Care Utilization
timeFrame: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
state: Mississippi
city: East Orange
country: United States
facility: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
state: New Jersey
Study officials:
affiliation: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
name: Karen S. Quigley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McAndrew LM, D'Andrea E, Lu SE, Abbi B, Yan GW, Engel C, Quigley KS. What pre-deployment and early post-deployment factors predict health function after combat deployment?: a prospective longitudinal study of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) soldiers. Health Qual Life Outcomes. 2013 Apr 30;11:73. doi: 10.1186/1477-7525-11-73.
citation: Yan GW, McAndrew L, D'Andrea EA, Lange G, Santos SL, Engel CC, Quigley KS. Self-reported stressors of National Guard women veterans before and after deployment: the relevance of interpersonal relationships. J Gen Intern Med. 2013 Jul;28 Suppl 2(Suppl 2):S549-55. doi: 10.1007/s11606-012-2247-6.
citation: Falvo MJ, Serrador JM, McAndrew LM, Chandler HK, Lu SE, Quigley KS. A retrospective cohort study of U.S. service members returning from Afghanistan and Iraq: is physical health worsening over time? BMC Public Health. 2012 Dec 28;12:1124. doi: 10.1186/1471-2458-12-1124.
citation: Quigley KS, McAndrew LM, Almeida L, D'Andrea EA, Engel CC, Hamtil H, Ackerman AJ. Prevalence of environmental and other military exposure concerns in Operation Enduring Freedom and Operation Iraqi Freedom veterans. J Occup Environ Med. 2012 Jun;54(6):659-64. doi: 10.1097/JOM.0b013e3182570506.