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

Posttraumatic Stress Disorder Clinical Trial

Official title:

The Psychophysiology and Neurobiology of PTSD Across the Menstrual Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304940
• Other study ID #: CDA-2-042-07F
• Status: Completed
• Start date: December 1, 2008
• Est. completion date: February 1, 2013

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2013
• Est. primary completion date: February 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Boston University, Boston VA Research Institute, Inc., VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.