Identifying the Needs of Operation Enduring Freedom/Opera... | NCT01502852

ID	Type	Description	Link
PO IHA TBIP1125855	Other Grant/Funding Number	HRSA

Status Module

Record Verification Date

Nov 2014

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

Aug 2011

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Dec 29, 2011

First Submission Date that Met QC Criteria

Dec 29, 2011

First Posted Date

Jan 2, 2012Estimated

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

Nov 24, 2014

Last Update Posted Date

Nov 25, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lisa Brenner, MIRECC Director, VA Eastern Colorado Health Care SystemPrincipal Investigator

Lead Sponsor

VA Eastern Colorado Health Care SystemFED

Collaborators

Not provided

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 explore and potentially increase the capacity of the non-VA community mental health system within the state of Colorado to provide a comprehensive and coordinated service delivery system for Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans and their families. The specific population of interest is OEF/OIF Veterans with a history of traumatic brain injury (TBI) and co-occurring behavioral health issues.

Detailed Description

The focus of this project is on qualitative data collection to facilitate product development including assessment and treatment guidelines to improve non-VA community mental health care for OEF/OIF Veterans with TBI and co-occurring behavioral health issues within the state of Colorado. In addition to the development of assessment and treatment guidelines, other products developed through this study will include a training and accompanying toolkit, which may be used for annual educational training of mental health providers. As such, there are no hypotheses associated with this study. This statewide initiative may not only improve quality and access to non-VA community mental health care for persons with TBI and co-occurring behavioral health issues within Colorado, but also serve as a model for implementation across the country.

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

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OEF/OIF Veterans with TBI
Family Members and Friends		Family Members and Friends of OEF/OIF Veterans with TBI
Community Mental Health Center Providers		Community Mental Health Center providers working with OEF/OIF Veterans with TBI

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Focus Groups		One Time

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colorado Behavioral Health Organization (BHO) mental health providers
OEF/OIF United States Veterans
Family members and/or friends of OEF/OIF United States Veterans
Ages 18-65

Exclusion Criteria:

- N/A

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

OEF/OIF Veterans with a history of TBI, their family members/friends, and community mental health providers working with these Veterans.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lisa A Brenner, PhD	VISN 19 MIRECC; University of Colorado, School of Medicine, Dept. of Psychiatry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VISN 19 MIRECC, Denver VAMC		Denver	Colorado	80220	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

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
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D014947	Wounds and Injuries