Experiential Avoidance in Combat Veterans With and Withou... | NCT01652430

Studies
Experiential Avoidance in Combat Veterans With and Without Posttraumatic Stress Disorder

NCT01652430

Sponsor

VA Eastern Colorado Health Care System

Status

Completed

Last Update Posted

Jan 8, 2015Estimated

Enrollment

78Actual

Phase

Not provided

Conditions

PTSD
Suicidal Ideation

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

Status Module

Record Verification Date

Jul 2012

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

Oct 2010

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Dec 9, 2011

First Submission Date that Met QC Criteria

Jul 25, 2012

First Posted Date

Jul 30, 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

Jan 6, 2015

Last Update Posted Date

Jan 8, 2015Estimated

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 study plans to examine if symptoms of PTSD affect how Veterans who have served in combat think and react to certain information, and whether or not this has an influence on suicidal thoughts.

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

78Actual

Measure	Description	Time Frame
Beck Scale for Suicidal ideation		One time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of combat service
Diagnosis of PTSD confirmed by the CAPS or
No current diagnosis of PTSD
Age 18-65

Exclusion Criteria:

Inability to adequately respond to questions regarding the informed consent procedure.
History of significant neurological disease
Diagnosis of Schizophrenia or other Psychosis
Alcohol abuse/dependence or illicit drug use in the two weeks prior to testing
No history of combat service

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

The sample for the current project will be recruited from the group of veterans receiving or eligible to receive outpatient mental health services at the Denver VA Medical Center who have served in combat who may or may not have a diagnosis of PTSD.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nazanin Bahraini, Ph.D.	VA Eastern Colorado Healthcare System/MIRECC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denver VA Medical Center		Denver	Colorado	80220	United States

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic
D059020	Suicidal Ideation

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D013405	Suicide

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
PTSD cohort
No PTSD cohort