An observational study in Traumatic Brain Injury and Suicidality, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by US Department of Veterans Affairs · Observational
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 133 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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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).
Exclusion Criteria:
Moderate/severe TBI and history of suicidal behavior
Moderate/Severe TBI and no history of suicidal behavior
No TBI and a history of suicidal behavior
No TBI and no history of suicidal behavior
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
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.
| Milestone | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Started | 22 | 51 | 12 | 48 |
| Completed | 22 | 51 | 12 | 48 |
| Not completed | 0 | 0 | 0 | 0 |
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
| Total Raw on a scale from -100 to 100 | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Iowa Gambling Test | -4.2 ± 27.7 | 1.7 ± 26.6 | 3.5 ± 24.5 | 5.3 ± 25.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Groups | — | 0/133 (0%) | 0/133 (0%) |
| Age, Categorical(Participants) | Moderate/Severe TBI and History of Suicidal Behavior Group 1 | Moderate/Severe TBI and no History of Suicidal behaviorGroup 2 | No TBI and a History of Suicidal Behavior Group 3 | No TBI and no History of Suicidal Behavior Group 4 | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 51 | 12 | 48 | 133 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Moderate/Severe TBI and History of Suicidal Behavior Group 1 | Moderate/Severe TBI and no History of Suicidal behaviorGroup 2 | No TBI and a History of Suicidal Behavior Group 3 | No TBI and no History of Suicidal Behavior Group 4 | Total |
|---|---|---|---|---|---|
| Mean | 49.5 ± 10.3 | 53 ± 8.5 | 51.7 ± 12 | 54.2 ± 7.6 | 52.7 ± 8.9 |
| Sex: Female, Male(Participants) | Moderate/Severe TBI and History of Suicidal Behavior Group 1 | Moderate/Severe TBI and no History of Suicidal behaviorGroup 2 | No TBI and a History of Suicidal Behavior Group 3 | No TBI and no History of Suicidal Behavior Group 4 | Total |
|---|---|---|---|---|---|
| Female | 3 | 0 | 4 | 8 | 15 |
| Male | 19 | 51 | 8 | 40 | 118 |
| Region of Enrollment(participants) | Moderate/Severe TBI and History of Suicidal Behavior Group 1 | Moderate/Severe TBI and no History of Suicidal behaviorGroup 2 | No TBI and a History of Suicidal Behavior Group 3 | No TBI and no History of Suicidal Behavior Group 4 | Total |
|---|---|---|---|---|---|
| United States | 22 | 51 | 12 | 48 | 133 |
| History of TBI (Present or Absent) - Lifetime OSU TBI-ID(participants) | Moderate/Severe TBI and History of Suicidal Behavior Group 1 | Moderate/Severe TBI and no History of Suicidal behaviorGroup 2 | No TBI and a History of Suicidal Behavior Group 3 | No TBI and no History of Suicidal Behavior Group 4 | Total |
|---|---|---|---|---|---|
| Number | 22 | 51 | 0 | 0 | 73 |
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