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Women's Post Traumatic Stress Disorder (PTSD) Research Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304940
First Posted: February 28, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
VA Office of Research and Development
VA Boston Healthcare System
Boston VA Research Institute, Inc.
Boston University
Information provided by (Responsible Party):
Suzanne Pineles, VA Boston Healthcare System
  Purpose
The purpose of this study is to examine the relationship between trauma and startle. The investigators are also looking at the effect of menstrual phase on this relationship.

Condition
Posttraumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Psychophysiology and Neurobiology of PTSD Across the Menstrual Cycle

Resource links provided by NLM:


Further study details as provided by Suzanne Pineles, VA Boston Healthcare System:

Biospecimen Retention:   Samples Without DNA
Urine, blood and saliva samples are taken. Only blood and saliva samples are retained and used to measure stress hormone levels.

Enrollment: 50
Actual Study Start Date: December 2008
Study Completion Date: February 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Detailed Description:
The investigators are trying to understand if there is a relationship between the experience of traumatic events such as those experienced by people with post traumatic stress disorder and reactivity to startling noises or mild threats. So, the investigators are looking at startle reflex, heart rate, and stress hormone responses to short noises and small shocks in people exposed to trauma and who either do or do not have PTSD. Additionally, the investigators will be looking at how the menstrual cycle impacts these processes. The investigators know that women have twice the risk for developing PTSD and some research suggests that stress hormones change during the menstrual cycle and may have an effect on risk.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women, ages 18-55.
Criteria

Inclusion Criteria:

  • Women, ages 18-55 years old who have a regular menstrual cycle and who can come in to participate in the afternoon

Exclusion Criteria:

  • Long-term medications, oral or steroid contraceptives, irregular menstrual cycle
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304940


Locations
United States, Massachusetts
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA ORD
VA Office of Research and Development
VA Boston Healthcare System
Boston VA Research Institute, Inc.
Boston University
Investigators
Principal Investigator: Suzanne L. Pineles, PhD VA Boston Healthcare System, National Center for PTSD, Boston University School of Medicine
  More Information

Responsible Party: Suzanne Pineles, Psychologist, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT01304940     History of Changes
Other Study ID Numbers: IRB# 2107
First Submitted: February 25, 2011
First Posted: February 28, 2011
Last Update Posted: October 12, 2017
Last Verified: August 2017

Keywords provided by Suzanne Pineles, VA Boston Healthcare System:
Stress
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders