NCT00285246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
838

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 6, 2014

Completed
Last Updated

May 12, 2015

Status Verified

April 1, 2015

Enrollment Period

5.2 years

First QC Date

January 30, 2006

Results QC Date

August 28, 2014

Last Update Submit

April 23, 2015

Conditions

Combat Disorders

Keywords

combat disordersstress, psychologicalsomatoform disorderslife change eventsutilization

Outcome Measures

Primary Outcomes (4)

  • 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.

    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)

  • 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.

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

  • 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.

    pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return

  • 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.

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

Study Arms (1)

Group 1

Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

Jackson, Mississippi, 39216, United States

Location

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, 07018, United States

Location

Related Publications (4)

  • 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.

    PMID: 23631419RESULT

  • 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.

    PMID: 23807064RESULT

  • 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.

    PMID: 23272950RESULT

  • 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.

    PMID: 22588478RESULT

Biospecimen

Retention: NONE RETAINED

Saliva

MeSH Terms

Conditions

Combat DisordersStress, PsychologicalSomatoform DisordersPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorTreatment Adherence and ComplianceHealth Behavior

Limitations and Caveats

The sample was comprised of only Army National Guard and Reserve military personnel, and therefore results may not generalize to the broader population of military personnel from other Service branches or components.

Results Point of Contact

Title
Karen S. Quigley, Ph.D., Research Physiologist
Organization
Edith Nourse Rogers Memorial VA Hospital
karen.quigley@va.gov
781-687-2273

Study Officials

  • Karen S. Quigley, PhD

    East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2006

First Posted

February 1, 2006

Study Start

December 1, 2005

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 12, 2015

Results First Posted

October 6, 2014

Record last verified: 2015-04

Locations

US(2)