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

The Psychophysiology and Neurobiology of PTSD Across the Menstrual Cycle

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130-4817
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women, ages 18-55.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PTSD group; Individuals in this group meet criteria for PTSD as defined by DSM-IV
trauma control group; individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prepulse Inhibition	To calculate prepulse inhibition (PPI), first an O-EMG response score (O-EMG-R) for each trial was calculated. O-EMGR was measured in microvolts and each value was subjected to a square root transformation. For each participant, the mean O-EMG-R scores were calculated for both startle alone and prepulse + startle trials across the entire session. PPI is a ratio and was calculated by the formula below: PPI=(mean OEMG-R score on prepulse+startle trials-mean OEMG-R on Startle alone trials)/mean OEMG-R on startle alone trials. A negative value on this PPI ratio is indicative of greater prepulse inhibition. Means and SEs below reflect estimated means and SEs for the PTSD group and trauma control group from the ANOVA conducted with menstrual phase and the PTSD group X menstrual phase interaction included in the model.	This measure was assessed twice for each participant, once in the midluteal phase of the menstrual cycle and once in the early follicular phase of the menstrual cycle, up to approximately 20 days apart.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Boston University; Boston VA Research Institute, Inc.; VA Boston Healthcare System
• Investigators: Principal Investigator: Suzanne Pineles, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2008
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimated): February 28, 2011

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Stress; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: CDA-2-042-07F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No