NCT01502436

Brief Summary

The purpose of this study is to explore the relationship between attempted and/or completed suicide and reported experience of chronic pain among an adult veteran population. Specific aims include a) examining the experience of chronic pain between patients who have either attempted and/or completed suicide, non-suicide attempt mental health patients, and non-mental health chronic pain patients and b) determining possible differences in reported experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity, occupation, and patient's recorded perceptions of depression and/or quality of life. As articulated in the Amendment approved on June 13, 2008, additional areas of interest include histories of neurological disease (e.g. traumatic brain injury) and/or mental health diagnoses. History of both neurologic disease and mental health diagnoses will also be identified by chart review (per approval obtained June 13, 2008). As such this study will also compare differences (e.g., mental health, neurological disease) between veterans who have history of a suicide attempt, completion, or a lifetime history of suicidality and matched control veterans without a history of suicide attempts, completions, or lifetime history of suicide. The relationship between suicidal behavior, attempted/completed suicide, and reported Post Traumatic Stress Disorder (PTSD) symptoms among an adult veteran population is also of interest. Additionally, this data set will be used to complete a validation study regarding the Self-Directed Violence Classification System (SDVCS). Specifically, relevant information in subject chart notes regarding self-directed violence (SDV) will be used to categorize thoughts and behaviors according to the SDVCS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

2.5 years

First QC Date

December 28, 2011

Last Update Submit

December 27, 2023

Conditions

Keywords

posttraumatic stress disordertraumatic brain injurySuicide AttemptVeterans

Outcome Measures

Primary Outcomes (1)

  • Suicidal Ideation

    Baseline

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Veterans who received care in the VA.

You may qualify if:

  • Over the age of 18
  • Record of a suicide attempt or completion between October 2004 and February 2006

You may not qualify if:

  • For cases: upon chart review, no record of a suicide attempt or completion within the specified time frame

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Colorado Healthcare System

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticBrain Injuries, TraumaticSuicide, Attempted

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Lisa Brenner, PhD

    VA VISN 19 MIRECC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2011

First Posted

December 30, 2011

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Study Completion

November 1, 2014

Last Updated

December 28, 2023

Record last verified: 2023-12

Locations