- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01208844
Study of Physical Health for Women With Posttraumatic Stress or Depression
April 27, 2015 updated by: Jeffrey Kibler, Ph.D., Nova Southeastern University
Cardiovascular Risk in Relation to Posttraumatic Stress Disorder in Young Women
The purpose of this study is to obtain a better understanding of how stress is related to health risks.
Study Overview
Status
Completed
Detailed Description
Participants complete up to two study visits of approximately 3-4 hours each.
The first study visit involves an interview about life experiences and emotions.
If the participant is eligible for the second assessment, the average length of time between visit 1 and visit 2 will be 1-7 days.
The second visit included physical measurements such as cholesterol and blood pressure, performing math and speaking tasks, and surveys to help us learn about healthy behaviors and emotions.
No further follow-up of participants is conducted beyond the two study visits.
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33314-7796
- Center for Psychological Studies, Nova Southeastern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Community sample, psychology clinics
Description
Inclusion Criteria:
- Pre-menopausal
- Must be able to speak and read English fluently
Exclusion Criteria:
- Specific medications and chronic diseases
- History of heart attack (myocardial infarction)
- Pregnant or given birth in last 3 months
- Peri-menopausal or post-menopausal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Depression
|
Healthy
|
Posttraumatic Stress
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Cardiovascular Risk Factors
Time Frame: Single assessment timepoint
|
This primary outcome will be assessed at the second study visit (1-7 days from first study visit for those who are eligible).
|
Single assessment timepoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey L Kibler, PhD, Nova Southeastern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 30, 2010
First Submitted That Met QC Criteria
September 23, 2010
First Posted (Estimate)
September 24, 2010
Study Record Updates
Last Update Posted (Estimate)
April 29, 2015
Last Update Submitted That Met QC Criteria
April 27, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPS06230812Exp.
- 1R15HL085121-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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