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

NCT01304940 | Completed Results

• 1 other identifier: CDA-2-042-07F
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Keywords

Stress; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women, ages 18-55.

You may qualify if:

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

You may not qualify if:

• Long-term medications, oral or steroid contraceptives, irregular menstrual cycle

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Boston Healthcare System: collaborator
• Boston VA Research Institute, Inc.: collaborator
• Boston University: collaborator

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood and saliva samples are taken. Only blood and saliva samples are retained and used to measure stress hormone levels.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Suzanne Pineles
• Organization: VA ORD

suzanne.pineles@va.gov

857-364-5906

Study Officials

• Suzanne Pineles, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: December 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 11, 2024
• Results First Posted: April 19, 2019

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)