- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01043432
Executive Dysfunction and Suicide in Psychiatric Outpatients and Inpatients
21. april 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
133
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80220
- VA Eastern Colorado Health Care System, Denver
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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).
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Iowa Gambling Test
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lisa Anne Brenner, PhD, VA Eastern Colorado Health Care System, Denver
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2010
Primær færdiggørelse (Faktiske)
1. marts 2014
Studieafslutning (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først indsendt
4. januar 2010
Først indsendt, der opfyldte QC-kriterier
4. januar 2010
Først opslået (Skøn)
6. januar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. maj 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D7210-R
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Traumatisk hjerneskade
-
Virginia Polytechnic Institute and State UniversityTrukket tilbage
-
University of MinnesotaRekruttering
-
Assistance Publique Hopitaux De MarseilleUkendt
-
BraindexClinique de la SauvegardeAfsluttetAnæstesi | Brain MonitorFrankrig
-
National Institute of Mental Health (NIMH)AfsluttetKÆLEDYR | Brain Imaging | Cannabinoid | CB1Forenede Stater
-
GE HealthcareAfsluttetBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Truway Health, Inc.Tilmelding efter invitationEvaluering af In-Vitro Cryo Terapeutiske Protokoller på Humane Celleprøver (TWH-CRYO-001) (CRYO-IVT)Cellular Injury and Post-Cryogenic Recovery | Kryogenisk cellulær stress | Kuldeinduceret cellulær skade | Termisk Skade Reaktion | Post-thaw levedygtighedsforringelse | Osmotisk Stressskade | Biomekanisk Skadesmodellering (In-Vitro) | Blunt Force Injuries to the Extremities (Cellular Injury Model) | Vævsskade... og andre forholdForenede Stater
-
Mayo ClinicAfsluttetBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Hospital Universitari Son DuretaEspen; This research prize was funded by Nestle Nutrition Institute and...AfsluttetModerat til alvorligt traume, som defineret af en | Injury Severity Score (ISS) > 12 point var inkluderet i undersøgelsen.Spanien
-
Tang-Du HospitalIkke rekrutterer endnuPsykisk lidelse | Sociale medier | Brain Imaging