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OpenTrials
Completed

NCT Number: NCT01123642

Project SERVE: Post Deployment Functioning

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, 76711, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Inventory of Psychosocial Functioning (IPF)

    Time frame: one year

    80-item self-report measure of psychosocial functioning across multiple domains (e.g., family, social, day-to-day activities). Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). Lower scores indicate more positive outcomes.

  2. Quality of Life Scale (QLS)

    Time frame: one year

    Quality of life measure of functioning scored on a 1 (delighted) to 7 (terrible) scale. Scores are summed with higher scores indicating lower quality of life. Total scores range from 16 - 112.

  3. Clinician Administered PTSD Scale (CAPS-5)

    Time frame: one year

    Total scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Boston University
  • Texas A&M University

Registry information

Official study title

Functional Outcomes in OEF/OIF Veterans With PTSD and Alcohol Misuse

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 14, 2010
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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