Study of Physical Health for Women With Posttraumatic Str... | NCT01208844

Studies
Study of Physical Health for Women With Posttraumatic Stress or Depression

NCT01208844

Sponsor

Nova Southeastern University

Status

Completed

Last Update Posted

Apr 29, 2015Estimated

Enrollment

59Actual

Phase

Not provided

Conditions

Healthy
Stress, Psychological
Depression
Posttraumatic Stress Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R15HL085121-01A2	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Aug 30, 2010

First Submission Date that Met QC Criteria

Sep 23, 2010

First Posted Date

Sep 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2015

Last Update Posted Date

Apr 29, 2015Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	Single assessment timepoint

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Community sample, psychology clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey L Kibler, PhD	Nova Southeastern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Psychological Studies, Nova Southeastern University		Fort Lauderdale	Florida	33314-7796	United States

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological
D003863	Depression
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided