Executive Dysfunction & Suicide: An Exploration Of Risk F... | NCT01118195

Studies
Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans

NCT01118195

Sponsor

VA Eastern Colorado Health Care System

Status

Completed

Last Update Posted

Apr 26, 2011Estimated

Enrollment

54Estimated

Phase

Not provided

Conditions

Traumatic Brain Injury (TBI)
Suicidal Behavior

Interventions

Not provided

Countries

Not provided

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

Status Module

Record Verification Date

Apr 2011

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

Jan 2007

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

May 4, 2010

First Submission Date that Met QC Criteria

May 5, 2010

First Posted Date

May 6, 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 21, 2011

Last Update Posted Date

Apr 26, 2011Estimated

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

This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The purpose of this research is to find out more about the issues related to these conditions. This study seeks to explore the relationship between executive dysfunction and suicidal behavior in an outpatient population.

Detailed Description

Not provided

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

54Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of traumatic brain injury, history of suicidal behavior.
Age 18-74.
Currently receiving care through the Eastern Colorado Health Care System (ECHCS) Denver VA TBI Interdisciplinary Team.

Exclusion Criteria:

History of other significant neurological disease.
Diagnosis of Schizophrenia.
Test of Memory Malingering (TOMM) performance lower than 50%.
Behavior which could be described as Substance Abuse in the 7 days prior to participation.
Current guardianship or mention of recommendation for guardianship in medical chart within the past six months.
Inability to read the informed consent document.
Inability to adequately respond to questions regarding the informed consent procedure.
Significant hearing impairment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

outpatient veterans with a history of traumatic brain injury

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
TBI and Suicidal Behavior
TBI and No Suicidal Behavior