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Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients

2015年4月21日 更新者: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.

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

133

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Denver、Colorado、美国、80220
        • VA Eastern Colorado Health Care System, Denver

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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).

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Iowa Gambling Test
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lisa Anne Brenner, PhD、VA Eastern Colorado Health Care System, Denver

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年6月1日

初级完成 (实际的)

2014年3月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2010年1月4日

首先提交符合 QC 标准的

2010年1月4日

首次发布 (估计)

2010年1月6日

研究记录更新

最后更新发布 (估计)

2015年5月12日

上次提交的符合 QC 标准的更新

2015年4月21日

最后验证

2015年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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