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Improving Outcomes After Traumatic Injury: A Goal Management Approach (GMT)

21 aprile 2017 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

91

Fase

  • Non applicabile

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

    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37232
        • Vanderbilt University Medical Center

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 21 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Determination of mild TBI using American Congress of Rehabilitation Medicine guidelines;
  2. No history of schizophrenia, or other psychotic disorder or suicidal intent;
  3. English speaking due to feasibility of employing study personnel to deliver and assess the study intervention;
  4. Age 21 years or older;
  5. Able to provide a telephone number and a stable address; and
  6. 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:

  1. Having a CT scan showing an intracranial hemorrhage;
  2. Current alcohol or substance abuse dependence (within the last 6 months);
  3. Persons with neurological history other than TBI (e.g., premorbid epilepsy, multiple sclerosis, Alzheimer's disease);
  4. 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;
  5. History of pre-morbid learning disability;and
  6. Involvement in current litigation

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

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • GMT
Comparatore attivo: 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
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
D-KEFs Tower Test
Lasso di tempo: 7 months after hospital discharge
cognitive test for executive functioning
7 months after hospital discharge
Trail Making Test B
Lasso di tempo: 7 months after hospital discharge
Cognitive test for set shifting and cognitive flexibility
7 months after hospital discharge
Sustained Attention to Response Test
Lasso di tempo: 7 months after hospital discharge
Cognitive test for failures of sustained attention
7 months after hospital discharge
FAS Verbal Fluency Test
Lasso di tempo: 7 months after hospital discharge
Cognitive test for verbal fluency
7 months after hospital discharge

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dysexecutive Questionnaire
Lasso di tempo: 7 months after hospital discharge
Self-reported executive functioning
7 months after hospital discharge
Functional Activities Questionnaire
Lasso di tempo: 7 months after hospital discharge
Self-reported functional status
7 months after hospital discharge

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Health Questionnaire-9
Lasso di tempo: 7 months after hospital discharge
Self-reported measure of depressive symptoms
7 months after hospital discharge
PTSD Checklist-Civilian Version (PCL-C)
Lasso di tempo: 7 months after hospital discharge
Self-reported measure of PTSD symptoms
7 months after hospital discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Kristin Archer, PhD, Vanderbilt School of Medicine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

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 gennaio 2013

Completamento primario (Effettivo)

1 settembre 2016

Completamento dello studio (Effettivo)

1 settembre 2016

Date di iscrizione allo studio

Primo inviato

22 ottobre 2012

Primo inviato che soddisfa i criteri di controllo qualità

23 ottobre 2012

Primo Inserito (Stima)

26 ottobre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 aprile 2017

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 111484
  • H133G120052 (Altro numero di sovvenzione/finanziamento: NIDRR)

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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