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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
133
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Colorado
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Denver、Colorado、アメリカ、80220
- VA Eastern Colorado Health Care System, Denver
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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).
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Moderate/severe TBI and history of suicidal behavior Group 1
Moderate/severe TBI and history of suicidal behavior
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Moderate/Severe TBI and no history of suicidal behaviorGroup
Moderate/Severe TBI and no history of suicidal behavior
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No TBI and a history of suicidal behavior Group 3
No TBI and a history of suicidal behavior
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No TBI and no history of suicidal behavior Group 4
No TBI and no history of suicidal behavior
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Iowa Gambling Test
時間枠: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.
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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
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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.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Lisa Anne Brenner, PhD、VA Eastern Colorado Health Care System, Denver
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年6月1日
一次修了 (実際)
2014年3月1日
研究の完了 (実際)
2014年7月1日
試験登録日
最初に提出
2010年1月4日
QC基準を満たした最初の提出物
2010年1月4日
最初の投稿 (見積もり)
2010年1月6日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月12日
QC基準を満たした最後の更新が送信されました
2015年4月21日
最終確認日
2015年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。