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Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients

Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01043432
Enrollment
133
Registered
2010-01-06
Start date
2010-06-30
Completion date
2014-07-31
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidality, Traumatic Brain Injury

Keywords

Traumatic Brain Injury, Suicide, Executive Function

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.

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.

Interventions

None listed

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Iowa Gambling TestOne 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Moderate/Severe TBI and History of Suicidal Behavior Group 1
Moderate/severe TBI and history of suicidal behavior
22
Moderate/Severe TBI and no History of Suicidal behaviorGroup 2
Moderate/Severe TBI and no history of suicidal behavior
51
No TBI and a History of Suicidal Behavior Group 3
No TBI and a history of suicidal behavior
12
No TBI and no History of Suicidal Behavior Group 4
No TBI and no history of suicidal behavior
48
Total133

Baseline characteristics

CharacteristicModerate/Severe TBI and History of Suicidal Behavior Group 1Moderate/Severe TBI and no History of Suicidal behaviorGroup 2No TBI and a History of Suicidal Behavior Group 3No TBI and no History of Suicidal Behavior Group 4Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
22 Participants51 Participants12 Participants48 Participants133 Participants
Age, Continuous49.5 years
STANDARD_DEVIATION 10.3
53 years
STANDARD_DEVIATION 8.5
51.7 years
STANDARD_DEVIATION 12
54.2 years
STANDARD_DEVIATION 7.6
52.7 years
STANDARD_DEVIATION 8.9
History of TBI (Present or Absent) - Lifetime OSU TBI-ID22 participants51 participants0 participants0 participants73 participants
Region of Enrollment
United States
22 participants51 participants12 participants48 participants133 participants
Sex: Female, Male
Female
3 Participants0 Participants4 Participants8 Participants15 Participants
Sex: Female, Male
Male
19 Participants51 Participants8 Participants40 Participants118 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 133
serious
Total, serious adverse events
0 / 133

Outcome results

Primary

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.

ArmMeasureValue (MEAN)Dispersion
Group 1Iowa Gambling Test-4.2 Total Raw on a scale from -100 to 100Standard Deviation 27.7
Group 2Iowa Gambling Test1.7 Total Raw on a scale from -100 to 100Standard Deviation 26.6
Group 3Iowa Gambling Test3.5 Total Raw on a scale from -100 to 100Standard Deviation 24.5
Group 4Iowa Gambling Test5.3 Total Raw on a scale from -100 to 100Standard Deviation 25.5
Comparison: Linear regressions were utilized to model the outcomes of interest as a function of SA, TBI group, and the interaction between the two groups.p-value: >0.05Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026