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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by VA Boston Healthcare System.
Recruitment status was:  Recruiting
VA Office of Research and Development
Boston VA Research Institute, Inc.
Boston University
Information provided by:
VA Boston Healthcare System Identifier:
First received: February 25, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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.

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 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.

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: June 2013
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.

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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01304940

United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Maggie Bauer    857-364-2790      
Principal Investigator: Suzanne L. Pineles, PhD         
Sponsors and Collaborators
VA Boston Healthcare System
VA Office of Research and Development
Boston VA Research Institute, Inc.
Boston University
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, PhD Identifier: NCT01304940     History of Changes
Other Study ID Numbers: IRB# 2107
Study First Received: February 25, 2011
Last Updated: February 25, 2011

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders processed this record on July 27, 2017