Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients

April 21, 2015 updated by: US Department of Veterans Affairs
Those with traumatic brain injury (TBI) are at increased risk for suicidal behavior, and suicidality is associated with executive dysfunction. In the aim of highlighting an important risk factor, this study will assess decision making in the context of an interaction between suicide and TBI. Findings will also allow for exploratory analyses aimed at identifying associations between performance on measures of executive functioning and psychological distress. The long-term objective of this study is to increase understanding regarding executive dysfunction, as a multidimensional construct, with the ultimate goal of conceptualizing assessment tools and interventions aimed at decreasing suicidality in the at-risk population of veterans with a history of TBI.

Study Overview

Status

Completed

Detailed Description

Recent studies indicate that veterans who engage in suicidal behavior have a history of traumatic brain injury (TBI), and veterans with a history of TBI engage in suicidal behavior. Existing research also suggests an association between suicidality and executive dysfunction (e.g., impaired decision making). To date a clearly defined study has not been conducted to explore the relationship between executive dysfunction as a multidimensional construct (i.e., decision making, impulsivity, concept formation, and aggression) and suicidal behavior in the vulnerable population of those with a history of moderate to severe TBI. Increased understanding regarding this at-risk population is necessary to facilitate the creation of appropriate assessment strategies and interventions. This study will assess decision making in the context of an interaction between suicide and TBI. Findings will also allow for exploratory analyses aimed at identifying associations between performance on measures of executive functioning and psychological distress. Toward this end, the present study seeks to compare test performance among four well-defined groups of veterans: (1) those with moderate to severe TBI and a history of suicidal behavior; (2) those with moderate to severe TBI and no history of suicidal behavior; (3) those with no TBI and a history of suicidal behavior; (4) and those with no TBI and no history of suicidal behavior. This grant proposal is in direct support of the Rehabilitation Research and Development goal of maximizing functional recovery in those with TBI by potentially: 1) increasing clinicians' ability to identify neuropsychological correlates of suicidal behavior for those with moderate to severe TBI; 2) identifying psychometrically sound measures of executive functioning that correspond to real-life behaviors that impact treatment response and recovery; 3) facilitating the creation of innovative assessment techniques and psychosocial interventions (e.g., safety planning) to minimize complications in the management of suicidal behavior due to TBI-related impairments; and 4) creating a basis for further and much-needed research in this area. Ultimately, findings from this study would both contribute to clinicians' ability to identify veterans with TBI who are at risk for suicidal behavior, and create a foundation on which to base further research regarding the relationships between cognition, emotional distress, and suicidality in TBI survivors.

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Eastern Colorado Health Care System, Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants in this observational study will be all individuals willing and eligible from the following populations: 1) those admitted to the locked inpatient psychiatric unit at the Eastern Colorado Health Care System (ECHCS) Denver VA Medical Center (VAMC); 2) those seeking outpatient mental health, rehabilitative, or psychological or other services at the Denver VAMC or Colorado Springs Community Based Outpatient Clinic (CBOC) or other CBOC's; 3) those in an ECHCS domiciliary (e.g., Valor Point); 4) those on existing clinical and research databases; and 5) veterans in the community not seeking care within the Veterans Health Administration (VHA).

Description

Inclusion Criteria:

  • Age between 18 and 65
  • Ability to provide adequate effort (CARB score of Type 1 or 2)
  • Determination of positive or negative history of moderate or severe TBI
  • Determination of positive or negative history of suicidal behavior
  • Ability to adequately respond to questions regarding the informed consent procedure

Exclusion Criteria:

  • Diagnosis of neurological conditions other than moderate or severe TBI
  • Inability to adequately respond to questions regarding the informed consent procedure
  • Inability to provide adequate effort (CARB score of Type 3 or 4)
  • History of a psychotic or bipolar I mood disorder
  • History of drug or alcohol abuse in the past 7 days
  • Participating in another study in which the results of this study may be impacted
  • History of non-alcohol substance abuse within the last 30 days as identified on the SCID substance use module
  • History of same-day drug or alcohol abuse as identified on the UWRAP pre-administration questionnaire Veterans who report using substances the day of the study visit will be placed on hold and will be rescreened in 30 and 60 days
  • History of mild TBI only

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Moderate/severe TBI and history of suicidal behavior Group 1
Moderate/severe TBI and history of suicidal behavior
Moderate/Severe TBI and no history of suicidal behaviorGroup
Moderate/Severe TBI and no history of suicidal behavior
No TBI and a history of suicidal behavior Group 3
No TBI and a history of suicidal behavior
No TBI and no history of suicidal behavior Group 4
No TBI and no history of suicidal behavior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iowa Gambling Test
Time Frame: One time - for the vast majority of participants the research protocol was initiated directly after informed consent procedures were completed (within hours). Negative values are possible with this measure, see Outcome Description.
Iowa Gambling Test - Total Raw Score The Iowa Gambling task requires examinees to sit in front of a computer screen displaying four decks of cards (Decks A, B, C, and D) and select a card from any of the four decks. Decks A and B are the disadvantageous decks because they produce high immediate gains however over time examinees will experience a higher loss. Decks C and D are the advantageous decks because they produce lower gains but over time examinees will experience smaller losses. Examinees will make 100 choices (trials). To measure performance, the 100 trials are divided, in order, into 5 'blocks' of 20. A net score is calculated for each block as the number of cards selected from the advantageous decks minus the disadvantageous decks and the total raw score is the sum of the scores for blocks 1-5. The overall total score can range from -100 (worst outcome) to 100 (best outcome)and the score for each block can range from -20 to 20
One time - for the vast majority of participants the research protocol was initiated directly after informed consent procedures were completed (within hours). Negative values are possible with this measure, see Outcome Description.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lisa Anne Brenner, PhD, VA Eastern Colorado Health Care System, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Traumatic Brain Injury

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