Project SERVE: Post Deployment Functioning

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123642
• Other study ID #: D7202-R
• Secondary ID: 1I01RX000304-01A
• Status: Completed
• Start date: October 2010
• Est. completion date: September 2014

Study information

• Verified date: August 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism
• Depression
• Depressive Disorder
• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX	Waco	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Boston University, Texas A&M University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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 — View 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. Review. — View 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 Tr — View 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. — View 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/j — View 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: 10.101 — View 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. — View 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 — View 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. — View 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. — View 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 — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Clinician Administered PTSD Scale (CAPS-5)	Total scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe).	one year