Post-traumatic Stress DisorderNCT01123642
Project SERVE: Post Deployment Functioning
An observational study of Post-traumatic Stress Disorder and Depressive Disorder, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder, Depressive Disorder, Alcoholism
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Operation Enduring Freedom and Operation Iraqi Freedom Veterans
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, 76711
About this study
Official title: Functional Outcomes in OEF/OIF Veterans With PTSD and Alcohol Misuse
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.
Read the 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.
- Keywords
- post-traumatic stress disorder, depressive disorder, alcoholism, Longitudinal studies, readjustment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Operation Enduring Freedom and Operation Iraqi Freedom Veterans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (3)
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.
Measured: 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.
Measured: one year
Clinician Administered PTSD Scale (CAPS-5)
Total scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Texas A&M University, Boston University
- Responsible party
- Sponsor
- Investigators
- Sandra B Morissette, PhD, Principal investigator, Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123642
- Sponsor's protocol ID
- D7202-R
- Other IDs
- 1I01RX000304-01A1
- Status last verified
- Aug 2018
- First submitted
- 5 May 2010
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22350690Konecky 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.
PubMed 25082488Greenawalt 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.
PubMed 21785719Morissette 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.
PubMed 22121940Debeer 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.
PubMed 24612971Stock 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.
PubMed 24942672Grosso 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.
PubMed 25158641Kimbrel 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.
PubMed 25238984Kimbrel 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.
PubMed 25314020Wilson 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.
PubMed 25534500Kimbrel 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.
PubMed 25541538Hiraoka 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.
PubMed 25808565Myers 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.
PubMed 39509229
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes in OEF/OIF Veterans With PTSD and Alcohol Misuse
- ClinicalTrials.gov ID
- NCT01123642
- Acronym / sponsor ID
- D7202-R
- Keywords
- post-traumatic stress disorder, depressive disorder, alcoholism, Longitudinal studies, readjustment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Texas A&M University, Boston University
- Study start
- Oct 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Posted 14 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Operation Enduring Freedom and Operation Iraqi Freedom Veterans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Operation Enduring Freedom and Operation Iraqi Freedom Veterans
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Inventory of Psychosocial Functioning (IPF)
Time frame: one year
Quality of Life Scale (QLS)
Time frame: one year
Clinician Administered PTSD Scale (CAPS-5)
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22350690Dolan 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.
- Background: PubMed 25082488Konecky 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.
- Results publication: PubMed 21785719Greenawalt 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.
- Results publication: PubMed 22121940Morissette 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.
- Results publication: PubMed 24612971Debeer 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.
- Results publication: PubMed 24942672Stock 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.
- Results publication: PubMed 25158641Grosso 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.
- Results publication: PubMed 25238984Kimbrel 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.
- Results publication: PubMed 25314020Kimbrel 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.
- Results publication: PubMed 25534500Wilson 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.
- Results publication: PubMed 25541538Kimbrel 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.
- Results publication: PubMed 25808565Hiraoka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra B Morissette, PhD principal investigator
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Stress Disorder and Depressive Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Disability Assessment Schedule II (WHODAS II) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01123642, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.