Post-Traumatic Stress Disorder (PTSD) Symptom Study

PTSD Clinical Trial

Official title:

Longitudinal Evaluation of Chronic Combat-Related PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018798
• Other study ID #: MHBS-001-99F
• Status: Completed
• Start date: April 1, 2000
• Est. completion date: April 1, 2005

Study information

• Verified date: September 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 1, 2005
• Est. primary completion date: April 1, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Vietnam vets who served in combat

2. 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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Doron-LaMarca S, Niles BL, King DW, King LA, Pless Kaiser A, Lyons MJ. Temporal Associations Among Chronic PTSD Symptoms in U.S. Combat Veterans. J Trauma Stress. 2015 Oct;28(5):410-7. doi: 10.1002/jts.22039. Epub 2015 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	For past two weeks