Project SERVE: Post Deployment Functioning

Study Overview
=================
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.

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.

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

Conditions
-----------------
Post-traumatic Stress Disorder, Depressive Disorder, Alcoholism

Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Operation Enduring Freedom and Operation Iraqi Freedom Veterans | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Disability Assessment Schedule II (WHODAS II) | 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inventory of Psychosocial Functioning (IPF) | 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. | one year | 
| Quality of Life Scale (QLS) | 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. | one year | 
| Clinician Administered PTSD Scale (CAPS-5) | Total scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe). | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-traumatic stress disorder, depressive disorder, alcoholism, Longitudinal studies, readjustment