Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients

NCT01043432 | Completed Results

• 1 other identifier: D7210-R
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Suicidality

Keywords

Traumatic Brain Injury; Suicide; Executive Function

Outcome Measures

Primary Outcomes (1)

• Iowa Gambling Test

  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.

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Suicidal Ideation; Suicide

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

Majority of control group had lifetime history of psychiatric disorders Significant challenges with recruiting

Results Point of Contact

• Title: Lisa A. Brenner
• Organization: Rocky Mountain MIRECC

lisa.brenner@va.gov

303-399-8020

Study Officials

• Lisa Anne Brenner, PhD

  VA Eastern Colorado Health Care System, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 6, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 12, 2015
• Results First Posted: May 12, 2015

Record last verified: 2015-04

Locations

US (1)