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Prospective Study of Veteran Health in Previously Deployed Soldiers

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00285246
Enrollment
838
Registered
2006-02-01
Start date
2005-12-31
Completion date
2011-02-28
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combat Disorders

Keywords

combat disorders, stress, psychological, somatoform disorders, life change events, utilization

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.

Interventions

None listed

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Non-Specific Physical Symptomspre-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 Statuspre-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 Statuspre-deployment, immediate post-deployment, 3 months post-return, 1 year post-returnMental 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 Utilizationpre-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
All Participants
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
838
Total838

Baseline characteristics

CharacteristicAll Participants
Age, Continuous27.9 years
STANDARD_DEVIATION 8.3
Race/Ethnicity, Customized
American Indian or Alaskan Native
46 participants
Race/Ethnicity, Customized
Asian
12 participants
Race/Ethnicity, Customized
Black/African American/Hispanic
1 participants
Race/Ethnicity, Customized
Black/African American/Non-Hispanic
72 participants
Race/Ethnicity, Customized
Hispanic/Latino
33 participants
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
10 participants
Race/Ethnicity, Customized
Unknown/Not Provided
100 participants
Race/Ethnicity, Customized
White/Causasian
564 participants
Region of Enrollment
United States
838 participants
Sex: Female, Male
Female
96 Participants
Sex: Female, Male
Male
742 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 838
serious
Total, serious adverse events
0 / 838

Outcome results

Primary

Health Care Utilization

This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.

Time frame: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)

Population: Not all of the 790 completers has complete data on the healthcare utilization measure.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsHealth Care UtilizationPhase 10.78 number of visits in prior 12 monthsStandard Deviation 0.87
All ParticipantsHealth Care UtilizationPhase 20.68 number of visits in prior 12 monthsStandard Deviation 0.81
All ParticipantsHealth Care UtilizationPhase 30.69 number of visits in prior 12 monthsStandard Deviation 0.74
All ParticipantsHealth Care UtilizationPhase 41.11 number of visits in prior 12 monthsStandard Deviation 0.97
Primary

Mental Functional Status

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.

Time frame: pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return

Population: Not all of the 790 completers has complete data on the mental functional status measure.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsMental Functional StatusPhase 148.0 units on a scaleStandard Deviation 9.1
All ParticipantsMental Functional StatusPhase 245.7 units on a scaleStandard Deviation 10.7
All ParticipantsMental Functional StatusPhase 345.0 units on a scaleStandard Deviation 11.5
All ParticipantsMental Functional StatusPhase 444.9 units on a scaleStandard Deviation 12.4
Primary

Non-Specific Physical Symptoms

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.

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)

Population: Not all of the 790 completers has complete data on the non-specific physical symptoms measure.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsNon-Specific Physical SymptomsPhase 15.2 units on a scaleStandard Deviation 3.9
All ParticipantsNon-Specific Physical SymptomsPhase 27.9 units on a scaleStandard Deviation 4.9
All ParticipantsNon-Specific Physical SymptomsPhase 37.7 units on a scaleStandard Deviation 5.1
All ParticipantsNon-Specific Physical SymptomsPhase 47.7 units on a scaleStandard Deviation 5.4
Primary

Physical Functional Status

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.

Time frame: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)

Population: Not all of the 790 completers has complete data on this physical functional status measure.

ArmMeasureGroupValue (MEAN)Dispersion
All ParticipantsPhysical Functional StatusPhase 155.5 Units on a scaleStandard Deviation 5.2
All ParticipantsPhysical Functional StatusPhase 253.7 Units on a scaleStandard Deviation 6.9
All ParticipantsPhysical Functional StatusPhase 352.8 Units on a scaleStandard Deviation 7.6
All ParticipantsPhysical Functional StatusPhase 451.5 Units on a scaleStandard Deviation 8.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026