Project SERVE: Post Deployment Functioning

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Texas A&M University
Boston University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01123642
First received: May 5, 2010
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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
Post-traumatic Stress Disorder
Depressive Disorder
Alcoholism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Outcomes in OEF/OIF Veterans With PTSD and Alcohol Misuse

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • World Health Organization Disability Assessment Schedule II (WHODAS II) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inventory of Psychosocial Recovery (IPR) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Quality of Life scale [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Clinician Administered PTSD Scale [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 309
Study Start Date: October 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Operation Enduring Freedom and Operation Iraqi Freedom Veterans

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Operation Enduring Freedom and Operation Iraqi Freedom Veterans

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123642

Locations
United States, Texas
Central Texas Veterans Health Care System - Waco
Waco, Texas, United States, 76711
Sponsors and Collaborators
Texas A&M University
Boston University
Investigators
Principal Investigator: Sandra Morissette, PhD Central Texas Veterans Health Care System - Waco
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01123642     History of Changes
Other Study ID Numbers: D7202-R, 1 I01 RX000304-01A1
Study First Received: May 5, 2010
Last Updated: May 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
post-traumatic stress disorder
depressive disorder
alcoholism
Longitudinal studies
readjustment

Additional relevant MeSH terms:
Alcoholism
Depressive Disorder
Depression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Anxiety Disorders

ClinicalTrials.gov processed this record on August 27, 2014