NCT01123642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 14, 2015

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

3.7 years

First QC Date

May 5, 2010

Results QC Date

June 4, 2015

Last Update Submit

August 17, 2018

Conditions

Post-traumatic Stress DisorderDepressive DisorderAlcoholism

Keywords

post-traumatic stress disorderdepressive disorderalcoholismLongitudinal studiesreadjustment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Inventory of Psychosocial Functioning (IPF)

    one year

  • Quality of Life Scale (QLS)

    one year

  • Clinician Administered PTSD Scale (CAPS-5)

    one year

Study Arms (1)

Group 1

Operation Enduring Freedom and Operation Iraqi Freedom Veterans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Operation Enduring Freedom and Operation Iraqi Freedom Veterans

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Waco, Texas, 76711, United States

Location

Related Publications (13)

  • 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.

    PMID: 22350690BACKGROUND

  • 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.

    PMID: 25082488BACKGROUND

  • 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.

    PMID: 21785719RESULT

  • 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.

    PMID: 22121940RESULT

  • 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.

    PMID: 24612971RESULT

  • 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.

    PMID: 24942672RESULT

  • 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.

    PMID: 25158641RESULT

  • 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.

    PMID: 25238984RESULT

  • 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.

    PMID: 25314020RESULT

  • 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.

    PMID: 25534500RESULT

  • 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.

    PMID: 25541538RESULT

  • 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.

    PMID: 25808565RESULT

  • Myers MN, Kurz AS, Paul J, Wild MG, O'Brien SF. Gender differences in reported potentially morally injurious events among post-9/11 U.S. combat veterans, using two measures. Psychol Trauma. 2025 Nov;17(8):1751-1761. doi: 10.1037/tra0001782. Epub 2024 Nov 7.

    PMID: 39509229DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressive DisorderAlcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersMood DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Results Point of Contact

Title
Sandra B. Morissette, Ph.D.
Organization
VISN 17 Center of Excellence for Research on Returning War Veterans
sandra.morissette@va.gov
254-297-5170

Study Officials

  • Sandra B Morissette, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 14, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

August 20, 2018

Results First Posted

August 14, 2015

Record last verified: 2018-08

Locations

US(1)