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Project SERVE: Post Deployment Functioning

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ClinicalTrials.gov Identifier: NCT01123642
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : August 14, 2015
Last Update Posted : August 14, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Functional recovery is of the utmost importance to evaluate in our returning Operation Enduring and Iraqi Freedom Veterans so that we can better understand their needs and experiences during the readjustment process from warzone to civilian life. Although most soldiers are resilient, concerning rates of PTSD (12-20%) and depression (14-15%) have been found, and as many as 24-35% report drinking more alcohol than they intended (Hoge et al., 2004). The current study proposes to follow returning Veterans for a one-year period to evaluate factors that influence the readjustment process and functional impairment. This information should guide the development of early intervention and treatment programs to help recovery.

Condition or disease
Post-traumatic Stress Disorder Depressive Disorder Alcoholism

Detailed Description:
The proposed longitudinal study aims to better understand the functioning of returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) OEF/OIF Veterans over time and to identify potentially malleable resilience factors associated with higher levels of functioning. A total of 300 returning OEF/OIF Veterans will be followed for a one-year period. Veterans will complete a baseline assessment, followed by three follow-up assessments (two self-report assessments mailed at 4- and 8-months post-baseline and a one-year in-person follow-up assessment that repeats many of the baseline clinician-administered assessments). Multiple functional outcomes will be evaluated, including occupational, family, social, and physical functioning. The specific aims include: 1) identifying whether a "dose-response" relationship exists between level of exposure to stressors (pre-deployment, deployment-related, and post-deployment) and functioning over time; 2) examining whether potentially malleable resilience factors predict higher levels of functioning in returning Veterans over time; 3) examining whether psychopathology predicts lower levels of functioning in returning Veterans over time; 4) testing the theoretical model that psychopathology partially mediates the effects of stress, social support, coping, and neurocognition on functioning over time; 5) examining whether changes in the use of healthy coping strategies, social support, post-deployment stress, and psychopathology predict changes in functioning over time; and 6) exploring whether stress, social support, coping, neurocognition, and psychopathology have differential effects on specific aspects of functioning (e.g., occupational, family, social, and physical functioning) over time. The long-term aim of this research is to develop evidence-based early intervention and treatment programs designed to assist returning OEF/OIF Veterans with achieving optimal functioning when reintegrating into civilian life. In keeping with the VHA's goal of operationalizing principles of recovery and rehabilitation in treatment planning, this research should provide a platform of empirical data to assist with the further development of meaningful early intervention and treatment programs to assist OEF/OIF Veterans with the post-war readjustment process over time.

Study Design

Study Type : Observational
Actual Enrollment : 345 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Outcomes in OEF/OIF Veterans With PTSD and Alcohol Misuse
Study Start Date : October 2010
Primary Completion Date : June 2014
Study Completion Date : September 2014
Groups and Cohorts

Group 1
Operation Enduring Freedom and Operation Iraqi Freedom Veterans

Outcome Measures

Primary Outcome Measures :
  1. World Health Organization Disability Assessment Schedule II (WHODAS II) [ Time Frame: one year ]
    Participants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.

Secondary Outcome Measures :
  1. Inventory of Psychosocial Recovery (IPR) [ Time Frame: one year ]
  2. Quality of Life Scale [ Time Frame: one year ]
  3. Clinician Administered PTSD Scale [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Operation Enduring Freedom and Operation Iraqi Freedom Veterans

Inclusion Criteria:

To be eligible, participants must be:

  • enrolled returning OEF/OIF Veteran within CTVHCS;
  • English-speaking Veterans;
  • able to comprehend and sign the informed consent form;
  • able to complete the structured interviews and self-report assessments;
  • willing to be contacted for follow-up assessments;
  • deemed stable on psychotropic medications and in psychotherapy.

Exclusion Criteria:

Veterans will be excluded if they:

  • plan to relocate out of the Central Texas area within four months of protocol initiation;
  • meet criteria for a diagnoses of schizophrenia, other psychotic disorders, or bipolar disorder;
  • report current hallucinations or delusions that are clearly not trauma-related; or
  • report current suicidal or homicidal risk warranting crisis intervention.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123642

United States, Texas
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, United States, 76711
Sponsors and Collaborators
VA Office of Research and Development
Texas A&M University
Boston University
Principal Investigator: Sandra B Morissette, PhD Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
More Information


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01123642     History of Changes
Other Study ID Numbers: D7202-R
1I01RX000304-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2010    Key Record Dates
Results First Posted: August 14, 2015
Last Update Posted: August 14, 2015
Last Verified: August 2015

Keywords provided by VA Office of Research and Development:
post-traumatic stress disorder
depressive disorder
Longitudinal studies

Additional relevant MeSH terms:
Depressive Disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Trauma and Stressor Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders