- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043432
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
Conditions
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D7210-R
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
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueRecruitingTBI (Traumatic Brain Injury)France
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
University of Texas Southwestern Medical CenterAlbert Einstein College of Medicine; National Institute of Neurological Disorders... and other collaboratorsRecruitingTBI (Traumatic Brain Injury) | TBI | Traumatic Brain Injury With Loss of Consciousness | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateUnited States
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
BrainScope Company, Inc.Active, not recruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
Queen Mary University of LondonCompleted
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationRecruitingBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada