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Improving Outcomes After Traumatic Injury: A Goal Management Approach (GMT)
21 april 2017 bijgewerkt door: Kristin Archer, Vanderbilt University Medical Center
Improving Trauma Outcomes: A Goal Management Approach
The majority of trauma survivors experience prolonged and profound physical and psychosocial disability, with up to 50% unable to return to productive employment.
The Centers for Disease Control (CDC) estimates that more than 1 million of these individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year.
Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that can lead to vocational and social disability.
Long-term cognitive deficits include problems with memory and attention, and most importantly executive functioning.
Depressive and post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with cognitive impairment, occurring in up to 50% and 33% of individuals, respectively.
The investigators have found that 55% of trauma patients with mild TBI have profound cognitive impairments in executive functioning at one-year survival.
Executive functioning is defined as "a cognitive domain that controls the execution of complex activities of daily living essential for purposeful, goal directed behaviors."
Deficits in executive functioning are the most disabling of all cognitive impairments and affect a person's ability to manage effectively in one's personal and professional life.
Current literature shows that deficits in executive functioning contribute to reduced quality of life, difficulty in returning to work, and persistent psychological distress in various medical and surgical populations.
Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment and functional disability in patients with TBI.
The overall goal of cognitive rehabilitation is not only to improve a person's ability to process and interpret information but to increase self-confidence and self-efficacy for coping with emotional distress.
Despite evidence supporting the use of cognitive rehabilitation, few studies have systematically addressed cognitive treatment for individuals with mild TBI.
Therefore, the investigators propose to conduct a three-group randomized controlled trial to determine the efficacy of Goal Management Training (GMT), a structured manual-based intervention targeting executive functions that impact a person's ability to carry out daily tasks.
The investigators hypothesize that telephone-based GMT will improve cognitive functioning, functional status, and psychological health in trauma survivors with mild TBI.
Emerging research suggests that telephone rehabilitation is a feasible and effective alternative (with much broader applicability) to clinic-based interventions.
Trauma survivors with mild TBI have limited access to rehabilitation services due to financial constraints and mobility and geographic restrictions that render clinic-based rehabilitation impractical.
This clinical trial will recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning.
Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2) telephone-based attention-control; or (3) usual care.
Primary outcomes will include observed and self-reported executive functioning and self-reported functional status as measured by a battery of standardized and previously validated cognitive tests and instruments, including the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and the Functional Activities Questionnaire.
Secondary outcomes will consist of depressive and PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist - Civilian Version, respectively.
Outcome data will be collected at baseline (6 weeks after hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital discharge.
Our cognitive rehabilitation intervention will serve to broadly disseminate evidenced-based cognitive strategies to a trauma population that has difficulty returning to productive life both inside and outside the home due to profound functional and psychological disability.
Findings from this study will support future research to improve the cognitive, functional and psychological health of patients following major trauma through innovative rehabilitation interventions and delivery methods.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
91
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt University Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
21 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Determination of mild TBI using American Congress of Rehabilitation Medicine guidelines;
- No history of schizophrenia, or other psychotic disorder or suicidal intent;
- English speaking due to feasibility of employing study personnel to deliver and assess the study intervention;
- Age 21 years or older;
- Able to provide a telephone number and a stable address; and
- Presence of cognitive deficits in executive functioning (defined as 1 SD below the norm referenced mean on any 2 of the following neuropsychological tests, the D-KEF Tower Test, Trails B, and FAS)
Exclusion Criteria:
- Having a CT scan showing an intracranial hemorrhage;
- Current alcohol or substance abuse dependence (within the last 6 months);
- Persons with neurological history other than TBI (e.g., premorbid epilepsy, multiple sclerosis, Alzheimer's disease);
- Pre-existing cognitive impairment as determined by a validated surrogate or patient questionnaire (defined as a score greater than 3.3 on the IQCODE instrument;
- History of pre-morbid learning disability;and
- Involvement in current litigation
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Telephone-Based Goal Management Training
The GMT intervention targets cognitive deficits in executive functioning that impact a person's ability to carry out daily tasks.
Participants learn how to recognize and stop absentmindedness and automatic pilot and how to reduce daily errors and 'slips' through goal setting.
The telephone-based GMT condition includes 7 sessions delivered over the phone for 10 weeks.
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Andere namen:
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Actieve vergelijker: Telephone-Based Attention-Control
The attention group receives an educational intervention that is matched to the GMT intervention in terms of session length and contact with the study therapist.
The telephone-based attention condition includes 7 sessions delivered over 10 weeks.
Sessions address education on brain function and cognitive principles of memory, attention, language, perception, and motor skills.
Education on stress reduction, sleep hygiene, energy management, exercise, communication, and nutrition are also provided
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Geen tussenkomst: Usual Care Control
Participants in the control group will receive usual care as determined by the treating surgeon.
Usual care may include referral to a physical therapist, occupational therapist, psychiatrist, and/or psychologist and utilization of health services will be recorded during follow-up assessments.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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D-KEFs Tower Test
Tijdsspanne: 7 months after hospital discharge
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cognitive test for executive functioning
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7 months after hospital discharge
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Trail Making Test B
Tijdsspanne: 7 months after hospital discharge
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Cognitive test for set shifting and cognitive flexibility
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7 months after hospital discharge
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Sustained Attention to Response Test
Tijdsspanne: 7 months after hospital discharge
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Cognitive test for failures of sustained attention
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7 months after hospital discharge
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FAS Verbal Fluency Test
Tijdsspanne: 7 months after hospital discharge
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Cognitive test for verbal fluency
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7 months after hospital discharge
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Dysexecutive Questionnaire
Tijdsspanne: 7 months after hospital discharge
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Self-reported executive functioning
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7 months after hospital discharge
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Functional Activities Questionnaire
Tijdsspanne: 7 months after hospital discharge
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Self-reported functional status
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7 months after hospital discharge
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Patient Health Questionnaire-9
Tijdsspanne: 7 months after hospital discharge
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Self-reported measure of depressive symptoms
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7 months after hospital discharge
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PTSD Checklist-Civilian Version (PCL-C)
Tijdsspanne: 7 months after hospital discharge
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Self-reported measure of PTSD symptoms
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7 months after hospital discharge
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Kristin Archer, PhD, Vanderbilt School of Medicine
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2013
Primaire voltooiing (Werkelijk)
1 september 2016
Studie voltooiing (Werkelijk)
1 september 2016
Studieregistratiedata
Eerst ingediend
22 oktober 2012
Eerst ingediend dat voldeed aan de QC-criteria
23 oktober 2012
Eerst geplaatst (Schatting)
26 oktober 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 april 2017
Laatste update ingediend die voldeed aan QC-criteria
21 april 2017
Laatst geverifieerd
1 april 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 111484
- H133G120052 (Ander subsidie-/financieringsnummer: NIDRR)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .