PTSDNCT00018798
Post-Traumatic Stress Disorder (PTSD) Symptom Study
An observational study of PTSD, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with stressful life events; and (3) change in PTSD symptoms associated with perceived social support. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2000to 1 Apr 2005
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vietnam combat veterans
Who may be able to join
- Vietnam vets who served in combat
- Diagnosis of current or lifetime PTSD
- Excluded if severe psychosis, current diagnosis of acute substance dependence, if no stable residence in past 6 months
Who cannot join
- Actively psychosis, currently suicidal or homicidal, without telephone access, or had experienced substance or alcohol abuse or dependence within the previous six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
Official title: Longitudinal Evaluation of Chronic Combat-Related PTSD
The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with stressful life events; and (3) change in PTSD symptoms associated with perceived social support.
Read the detailed description
The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with stressful life events; and (3) change in PTSD symptoms associated with perceived social support.
Despite increased sophistication in measurement of PTSD, little is known about the long-term longitudinal course of this disorder or the fluctuation of symptoms over time. Because previous studies have focused on the development and persistence of symptoms immediately following a stressor, the course of the chronic disorder has been largely unexplored. Although there is evidence of both persistence and fluctuation of PTSD symptom presentation in Vietnam veterans, little is known about how much and in what ways symptoms change over time. This investigation will increase understanding of the nature and extent of symptom fluctuation as well as the longitudinal course of PTSD as first steps in determining which variables affect that course and how clinicians might intervene to alter it.
Aversive life events may constitute one factor that influences the course of chronic PTSD. Researchers and clinicians have frequently hypothesized that stressful life events account for much of the variability in course of chronic PTSD; individuals with PTSD may have a compromised ability to cope with stressors, and such events may worsen existing symptoms. Social support is another variable thought to affect the course of post-trauma symptomatology. Support from other persons has been shown to both promote psychological health in general and to protect against psychological deterioration in times of stress. This investigation will examine aversive life events and perceived social support to determine their relationships over time to symptoms of PTSD.
- Conditions
- PTSD
- Keywords
- Combat-Related PTSD, Vietnam Veterans
- 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 |
|---|---|---|
| Bi-weekly telephone calls | 34 participants received bi-weekly telephone calls in addition to the annual reviews | |
| Annual review only | 23 participants received annual reviews only |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist - Military Version
The PTSD Checklist-Military Version is a self-report questionnaire comprising 17 items corresponding to the 17 DSM-IV symptoms for PTSD. Respondents are instructed to specify the extent to which they have been bothered by each symptom during the past month on a Likert-type scale ranging from 1 - not at all to 5 = extremely. Weathers et al. (1993) reported a full scale internal consistency reliability (coefficient alpha) for the PCL-M of .97 and test-retest reliability (2- to 3-day interval) of .96.
Measured: For past two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study start1 Apr 2000
- Primary completion1 Apr 2004
- Study completion1 Apr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Barbara L. Niles, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018798
- Sponsor's protocol ID
- MHBS-001-99F
- Status last verified
- Nov 2024
- First submitted
- 3 Jul 2001
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Chronic Combat-Related PTSD
- ClinicalTrials.gov ID
- NCT00018798
- Acronym / sponsor ID
- MHBS-001-99F
- Conditions
- PTSD
- Keywords
- Combat-Related PTSD, Vietnam Veterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2000 (actual)
- Primary completion
- 1 Apr 2004 (actual)
- Study completion
- 1 Apr 2005 (actual)
- First posted
- 5 Jul 2001 (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.
The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with stressful life events; and (3) change in PTSD symptoms associated with perceived social support.
Detailed description
The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with stressful life events; and (3) change in PTSD symptoms associated with perceived social support.
Despite increased sophistication in measurement of PTSD, little is known about the long-term longitudinal course of this disorder or the fluctuation of symptoms over time. Because previous studies have focused on the development and persistence of symptoms immediately following a stressor, the course of the chronic disorder has been largely unexplored. Although there is evidence of both persistence and fluctuation of PTSD symptom presentation in Vietnam veterans, little is known about how much and in what ways symptoms change over time. This investigation will increase understanding of the nature and extent of symptom fluctuation as well as the longitudinal course of PTSD as first steps in determining which variables affect that course and how clinicians might intervene to alter it.
Aversive life events may constitute one factor that influences the course of chronic PTSD. Researchers and clinicians have frequently hypothesized that stressful life events account for much of the variability in course of chronic PTSD; individuals with PTSD may have a compromised ability to cope with stressors, and such events may worsen existing symptoms. Social support is another variable thought to affect the course of post-trauma symptomatology. Support from other persons has been shown to both promote psychological health in general and to protect against psychological deterioration in times of stress. This investigation will examine aversive life events and perceived social support to determine their relationships over time to symptoms of PTSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-weekly telephone calls | – | –34 participants received bi-weekly telephone calls in addition to the annual reviews |
| Annual review only | – | –23 participants received annual reviews only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vietnam combat veterans
Key inclusion criteria (3 listed)
- Vietnam vets who served in combat
- Diagnosis of current or lifetime PTSD
- Excluded if severe psychosis, current diagnosis of acute substance dependence, if no stable residence in past 6 months
Key exclusion criteria (1 listed)
- Actively psychosis, currently suicidal or homicidal, without telephone access, or had experienced substance or alcohol abuse or dependence within the previous six months.
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
PTSD Checklist - Military Version
Time frame: For past two weeks
The PTSD Checklist-Military Version is a self-report questionnaire comprising 17 items corresponding to the 17 DSM-IV symptoms for PTSD. Respondents are instructed to specify the extent to which they have been bothered by each symptom during the past month on a Likert-type scale ranging from 1 - not at all to 5 = extremely. Weathers et al. (1993) reported a full scale internal consistency reliability (coefficient alpha) for the PCL-M of .97 and test-retest reliability (2- to 3-day interval) of .96.
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 15 Nov 2024.
- Temporal Associations Among Chronic PTSD Symptoms in U.S. Combat VeteransLink provided by the sponsor.
- Posttraumatic stress disorder symptomatology in Vietnam veterans before and after September 11Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Barbara L. Niles, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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 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 3 inclusion and 1 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 15 Nov 2024. 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.
What does the primary outcome measure?
PTSD Checklist - Military Version (time frame: For past two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.