Clinical trial NCT01123642: Project SERVE: Post Deployment Functioning
Official title: Functional Outcomes in OEF/OIF Veterans With PTSD and Alcohol Misuse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-traumatic Stress Disorder
Depressive Disorder
Alcoholism
Keywords: post-traumatic stress disorder
depressive disorder
alcoholism
Longitudinal studies
readjustment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Texas A&M University
name: Boston University
First posted: 2010-05-14
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Operation Enduring Freedom and Operation Iraqi Freedom Veterans

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.

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.

Primary outcomes:
measure: World Health Organization Disability Assessment Schedule II (WHODAS II)
timeFrame: one year
Secondary outcomes:
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: one year
measure: Quality of Life Scale (QLS)
timeFrame: one year
measure: Clinician Administered PTSD Scale (CAPS-5)
timeFrame: one year
Other outcomes:
Locations:
city: Waco
country: United States
facility: Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
state: Texas
Study officials:
affiliation: Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
name: Sandra B Morissette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dolan S, Martindale S, Robinson J, Kimbrel NA, Meyer EC, Kruse MI, Morissette SB, Young KA, Gulliver SB. Neuropsychological sequelae of PTSD and TBI following war deployment among OEF/OIF veterans. Neuropsychol Rev. 2012 Mar;22(1):21-34. doi: 10.1007/s11065-012-9190-5. Epub 2012 Feb 18.
citation: Konecky B, Meyer EC, Marx BP, Kimbrel NA, Morissette SB. Using the WHODAS 2.0 to assess functional disability associated with DSM-5 mental disorders. Am J Psychiatry. 2014 Aug;171(8):818-20. doi: 10.1176/appi.ajp.2014.14050587. No abstract available.
citation: Greenawalt DS, Tsan JY, Kimbrel NA, Meyer EC, Kruse MI, Tharp DF, Gulliver SB, Morissette SB. Mental Health Treatment Involvement and Religious Coping among African American, Hispanic, and White Veterans of the Wars of Iraq and Afghanistan. Depress Res Treat. 2011;2011:192186. doi: 10.1155/2011/192186. Epub 2011 Jul 18.
citation: Morissette SB, Woodward M, Kimbrel NA, Meyer EC, Kruse MI, Dolan S, Gulliver SB. Deployment-related TBI, persistent postconcussive symptoms, PTSD, and depression in OEF/OIF veterans. Rehabil Psychol. 2011 Nov;56(4):340-50. doi: 10.1037/a0025462.
citation: Debeer BB, Kimbrel NA, Meyer EC, Gulliver SB, Morissette SB. Combined PTSD and depressive symptoms interact with post-deployment social support to predict suicidal ideation in Operation Enduring Freedom and Operation Iraqi Freedom veterans. Psychiatry Res. 2014 May 30;216(3):357-62. doi: 10.1016/j.psychres.2014.02.010. Epub 2014 Feb 17.
citation: Stock EM, Kimbrel NA, Meyer EC, Copeland LA, Monte R, Zeber JE, Gulliver SB, Morissette SB. A Bayesian model averaging approach to examining changes in quality of life among returning Iraq and Afghanistan veterans. Int J Methods Psychiatr Res. 2014 Sep;23(3):345-58. doi: 10.1002/mpr.1442. Epub 2014 Jun 18.
citation: Grosso JA, Kimbrel NA, Dolan S, Meyer EC, Kruse MI, Gulliver SB, Morissette SB. A test of whether coping styles moderate the effect of PTSD symptoms on alcohol outcomes. J Trauma Stress. 2014 Aug;27(4):478-82. doi: 10.1002/jts.21943.
citation: Kimbrel NA, Evans LD, Patel AB, Wilson LC, Meyer EC, Gulliver SB, Morissette SB. The critical warzone experiences (CWE) scale: initial psychometric properties and association with PTSD, anxiety, and depression. Psychiatry Res. 2014 Dec 30;220(3):1118-24. doi: 10.1016/j.psychres.2014.08.053. Epub 2014 Sep 6.
citation: Kimbrel NA, Morissette SB, Meyer EC, Chrestman R, Jamroz R, Silvia PJ, Beckham JC, Young KA. Effect of the 5-HTTLPR polymorphism on posttraumatic stress disorder, depression, anxiety, and quality of life among Iraq and Afghanistan veterans. Anxiety Stress Coping. 2015;28(4):456-66. doi: 10.1080/10615806.2014.973862. Epub 2014 Nov 14.
citation: Wilson LC, Kimbrel NA, Meyer EC, Young KA, Morissette SB. Do child abuse and maternal care interact to predict military sexual trauma? J Clin Psychol. 2015 Apr;71(4):378-86. doi: 10.1002/jclp.22143. Epub 2014 Dec 22.
citation: Kimbrel NA, DeBeer BB, Meyer EC, Silvia PJ, Beckham JC, Young KA, Morissette SB. An examination of the broader effects of warzone experiences on returning Iraq/Afghanistan veterans' psychiatric health. Psychiatry Res. 2015 Mar 30;226(1):78-83. doi: 10.1016/j.psychres.2014.12.007. Epub 2014 Dec 13.
citation: Hiraoka R, Meyer EC, Kimbrel NA, DeBeer BB, Gulliver SB, Morissette SB. Self-Compassion as a prospective predictor of PTSD symptom severity among trauma-exposed U.S. Iraq and Afghanistan war veterans. J Trauma Stress. 2015 Apr;28(2):127-33. doi: 10.1002/jts.21995. Epub 2015 Mar 21.