PTSDNCT00439322
Post Traumatic Stress Disorder Among VA Ambulatory Care Patients
An observational study of PTSD, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) occurs in response to an extreme traumatic stressor. It is estimated that as many as 1 million VA patients who were exposed to combat may have PTSD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PTSD
- How many people
- 473 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans enrolled at hospitals where study is implemented.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
Posttraumatic stress disorder (PTSD) occurs in response to an extreme traumatic stressor. It is estimated that as many as 1 million VA patients who were exposed to combat may have PTSD. VA patients with PTSD recently have been designated as a �Special Emphasis� population for which health care resources are allocated at approximately 14 times those allocated to patients without such chronic, complex, and intensive health care needs (i.e., �Basic Care� groups). Despite recognition of its substantial impact upon VA resources, the extent and means by which PTSD affects health and health care use remain unclear. This study seeks to enhance understanding of both the extent and means by which PTSD affects the health and the health care use of patients in VA ambulatory care. To meet this goal, we build on an ongoing HSR\&D project, the Veterans Health Study (VHS), a prospective longitudinal study of 2,425 VA ambulatory care patients.
Read the detailed description
Background:
Posttraumatic stress disorder (PTSD) occurs in response to an extreme traumatic stressor. It is estimated that as many as 1 million VA patients who were exposed to combat may have PTSD. VA patients with PTSD recently have been designated as a �Special Emphasis� population for which health care resources are allocated at approximately 14 times those allocated to patients without such chronic, complex, and intensive health care needs (i.e., �Basic Care� groups). Despite recognition of its substantial impact upon VA resources, the extent and means by which PTSD affects health and health care use remain unclear. This study seeks to enhance understanding of both the extent and means by which PTSD affects the health and the health care use of patients in VA ambulatory care. To meet this goal, we build on an ongoing HSR\&D project, the Veterans Health Study (VHS), a prospective longitudinal study of 2,425 VA ambulatory care patients.
Objectives:
Posttraumatic stress disorder (PTSD) often afflicts victims of traumatic events such as combat. Growing evidence suggests that PTSD is related to poorer health status and to increased use of health care services. However, the extent of these effects and the means by which they occur remain unclear. The goal of this study is to enhance our understanding of both the extent and means by which PTSD affects the health and the health care use of patients in VA ambulatory care. To meet this goal, we built on an HSR\&D service-directed project, the Veterans Health Study (VHS), a prospective longitudinal study of 2,425 male VA ambulatory care patients.
Methods:
This project consisted of two phases. In Phase 1, we conducted clinical interviews (CAPS) assessing PTSD with 474 patients participating in the VHS at 1-year follow-up (T12). This phase validated a brief 17-item self-report PTSD screening measure (PCL-C) against a PTSD clinical interview diagnosis. We used the results of this validation study to estimate the prevalence of PTSD in VA primary care, and to propose the use of a brief measure (PRIME-MD) as a screen for PTSD in primary care. In Phase 2, we used the PCL-C to examine the impact of PTSD on health status and health care use. We tested the hypotheses that (a) PTSD has a direct effect on health status that is independent of the effects of comorbid medical conditions, depression, and alcohol use, and (b) that controlling for comorbid medical conditions, depression and alcohol use, PTSD has both a direct effect and an indirect effect (through health status) on health care utilization. These hypotheses are being tested using structural equation methods. If, as hypothesized, PTSD exerts direct and indirect effects on health services use, then both quality of care and efficiencies in health services delivery can be improved through appropriate detection, referral, and treatment of PTSD among patients in VA ambulatory care.
Status:
Completed.
- Conditions
- PTSD
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
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 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 473 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Avron Spiro, PhD MS, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MACheryl S Hankin, PhD, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MACheryl S Hankin, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439322
- Sponsor's protocol ID
- IIR 96-030
- Status last verified
- Feb 2007
- First submitted
- 21 Feb 2007
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hankin CS, Skinner KM, Sullivan LM, Miller DR, Frayne S, Tripp TJ. Prevalence of depressive and alcohol abuse symptoms among women VA outpatients who report experiencing sexual assault while in the military. J Trauma Stress. 1999 Oct;12(4):601-12. doi: 10.1023/A:1024760900213.
PubMed 10646179Chatterjee S, Rath ME, Spiro A 3rd, Eisen S, Sloan KL, Rosen AK. Gender differences in veterans health administration mental health service use: effects of age and psychiatric diagnosis. Womens Health Issues. 2009 May-Jun;19(3):176-84. doi: 10.1016/j.whi.2009.03.002.
PubMed 19447322
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Traumatic Stress Disorder Among VA Ambulatory Care Patients
- ClinicalTrials.gov ID
- NCT00439322
- Acronym / sponsor ID
- IIR 96-030
- Conditions
- PTSD
- Keywords
- PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Sep 2000 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic stress disorder (PTSD) occurs in response to an extreme traumatic stressor. It is estimated that as many as 1 million VA patients who were exposed to combat may have PTSD. VA patients with PTSD recently have been designated as a �Special Emphasis� population for which health care resources are allocated at approximately 14 times those allocated to patients without such chronic, complex, and intensive health care needs (i.e., �Basic Care� groups). Despite recognition of its substantial impact upon VA resources, the extent and means by which PTSD affects health and health care use remain unclear. This study seeks to enhance understanding of both the extent and means by which PTSD affects the health and the health care use of patients in VA ambulatory care. To meet this goal, we build on an ongoing HSR\&D project, the Veterans Health Study (VHS), a prospective longitudinal study of 2,425 VA ambulatory care patients.
Detailed description
Background:
Posttraumatic stress disorder (PTSD) occurs in response to an extreme traumatic stressor. It is estimated that as many as 1 million VA patients who were exposed to combat may have PTSD. VA patients with PTSD recently have been designated as a �Special Emphasis� population for which health care resources are allocated at approximately 14 times those allocated to patients without such chronic, complex, and intensive health care needs (i.e., �Basic Care� groups). Despite recognition of its substantial impact upon VA resources, the extent and means by which PTSD affects health and health care use remain unclear. This study seeks to enhance understanding of both the extent and means by which PTSD affects the health and the health care use of patients in VA ambulatory care. To meet this goal, we build on an ongoing HSR\&D project, the Veterans Health Study (VHS), a prospective longitudinal study of 2,425 VA ambulatory care patients.
Objectives:
Posttraumatic stress disorder (PTSD) often afflicts victims of traumatic events such as combat. Growing evidence suggests that PTSD is related to poorer health status and to increased use of health care services. However, the extent of these effects and the means by which they occur remain unclear. The goal of this study is to enhance our understanding of both the extent and means by which PTSD affects the health and the health care use of patients in VA ambulatory care. To meet this goal, we built on an HSR\&D service-directed project, the Veterans Health Study (VHS), a prospective longitudinal study of 2,425 male VA ambulatory care patients.
Methods:
This project consisted of two phases. In Phase 1, we conducted clinical interviews (CAPS) assessing PTSD with 474 patients participating in the VHS at 1-year follow-up (T12). This phase validated a brief 17-item self-report PTSD screening measure (PCL-C) against a PTSD clinical interview diagnosis. We used the results of this validation study to estimate the prevalence of PTSD in VA primary care, and to propose the use of a brief measure (PRIME-MD) as a screen for PTSD in primary care. In Phase 2, we used the PCL-C to examine the impact of PTSD on health status and health care use. We tested the hypotheses that (a) PTSD has a direct effect on health status that is independent of the effects of comorbid medical conditions, depression, and alcohol use, and (b) that controlling for comorbid medical conditions, depression and alcohol use, PTSD has both a direct effect and an indirect effect (through health status) on health care utilization. These hypotheses are being tested using structural equation methods. If, as hypothesized, PTSD exerts direct and indirect effects on health services use, then both quality of care and efficiencies in health services delivery can be improved through appropriate detection, referral, and treatment of PTSD among patients in VA ambulatory care.
Status:
Completed.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans enrolled at hospitals where study is implemented.
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 10646179Hankin CS, Skinner KM, Sullivan LM, Miller DR, Frayne S, Tripp TJ. Prevalence of depressive and alcohol abuse symptoms among women VA outpatients who report experiencing sexual assault while in the military. J Trauma Stress. 1999 Oct;12(4):601-12. doi: 10.1023/A:1024760900213.
- Results publication: PubMed 19447322Chatterjee S, Rath ME, Spiro A 3rd, Eisen S, Sloan KL, Rosen AK. Gender differences in veterans health administration mental health service use: effects of age and psychiatric diagnosis. Womens Health Issues. 2009 May-Jun;19(3):176-84. doi: 10.1016/j.whi.2009.03.002.
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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.
Avron Spiro, PhD MS principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Cheryl S Hankin, PhD principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Cheryl S Hankin, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
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 PTSD, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00439322, which also lists 2 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 7 Apr 2015.