- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01043432
Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients
21. April 2015 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
133
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80220
- VA Eastern Colorado Health Care System, Denver
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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).
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Iowa Gambling Test
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Lisa Anne Brenner, PhD, VA Eastern Colorado Health Care System, Denver
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juni 2010
Primärer Abschluss (Tatsächlich)
1. März 2014
Studienabschluss (Tatsächlich)
1. Juli 2014
Studienanmeldedaten
Zuerst eingereicht
4. Januar 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Januar 2010
Zuerst gepostet (Schätzen)
6. Januar 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
12. Mai 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. April 2015
Zuletzt verifiziert
1. April 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- D7210-R
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