- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00018798
Post-Traumatic Stress Disorder (PTSD) Symptom Study
Longitudinal Evaluation of Chronic Combat-Related PTSD
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
Actively psychosis, currently suicidal or homicidal, without telephone access, or had experienced substance or alcohol abuse or dependence within the previous six months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Bi-weekly telephone calls
34 participants received bi-weekly telephone calls in addition to the annual reviews
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Annual review only
23 participants received annual reviews only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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PTSD Checklist - Military Version
Time Frame: For past two weeks
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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.
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For past two weeks
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHBS-001-99F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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