HealthyNCT01208844
Study of Physical Health for Women With Posttraumatic Stress or Depression
An observational study of Healthy and Stress, Psychological, run by Nova Southeastern University at 1 site in United States.
Trial summary
The purpose of this study is to obtain a better understanding of how stress is related to health risks. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Stress, Psychological, Depression
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample, psychology clinics
Who may be able to join
- Pre-menopausal
- Must be able to speak and read English fluently
Who cannot join
- Specific medications and chronic diseases
- History of heart attack (myocardial infarction)
- Pregnant or given birth in last 3 months
- Peri-menopausal or post-menopausal
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Psychological Studies, Nova Southeastern University
Fort Lauderdale, Florida, 33314-7796
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Stress, Psychological, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Posttraumatic Stress | Not described | |
| Depression | Not described | |
| Healthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cardiovascular Risk Factors
This primary outcome will be assessed at the second study visit (1-7 days from first study visit for those who are eligible).
Measured: Single assessment timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startJun 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeffrey Kibler, Ph.D., Nova Southeastern University
- Investigators
- Jeffrey L Kibler, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208844
- Sponsor's protocol ID
- CPS06230812Exp.
- Other IDs
- 1R15HL085121-01A2
- Status last verified
- Apr 2015
- First submitted
- 30 Aug 2010
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk in Relation to Posttraumatic Stress Disorder in Young Women
- ClinicalTrials.gov ID
- NCT01208844
- Acronym / sponsor ID
- CPS06230812Exp.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to obtain a better understanding of how stress is related to health risks.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Posttraumatic Stress | – | – |
| Depression | – | – |
| Healthy | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample, psychology clinics
Key inclusion criteria (2 listed)
- Pre-menopausal
- Must be able to speak and read English fluently
Key exclusion criteria (4 listed)
- Specific medications and chronic diseases
- History of heart attack (myocardial infarction)
- Pregnant or given birth in last 3 months
- Peri-menopausal or post-menopausal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Kibler, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Stress, Psychological, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cardiovascular Risk Factors (time frame: Single assessment timepoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.