- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01043432
Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients
21 aprile 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
133
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Colorado
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Denver, Colorado, Stati Uniti, 80220
- VA Eastern Colorado Health Care System, Denver
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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).
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Iowa Gambling Test
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Lisa Anne Brenner, PhD, VA Eastern Colorado Health Care System, Denver
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2010
Completamento primario (Effettivo)
1 marzo 2014
Completamento dello studio (Effettivo)
1 luglio 2014
Date di iscrizione allo studio
Primo inviato
4 gennaio 2010
Primo inviato che soddisfa i criteri di controllo qualità
4 gennaio 2010
Primo Inserito (Stima)
6 gennaio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
12 maggio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 aprile 2015
Ultimo verificato
1 aprile 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D7210-R
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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