Post-Traumatic Stress Disorder (PTSD) Symptom Study

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00018798

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
PTSD

Detailed Description

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

Study Type:

Observational

Actual Enrollment :

57 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Longitudinal Evaluation of Chronic Combat-Related PTSD

Actual Study Start Date :

Apr 1, 2000

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

PTSD Checklist - Military Version [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator: Barbara L. Niles, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00018798

Other Study ID Numbers:

MHBS-001-99F

First Posted:

Jul 5, 2001

Last Update Posted:

Sep 19, 2018

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Keywords provided by VA Office of Research and Development

Combat-Related PTSD, Vietnam Veterans

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 19, 2018