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Completed

NCT Number: NCT01714531

Improving Outcomes After Traumatic Injury: 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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone-Based Goal Management Training

Behavioral

Other names: GMT

Telephone-Based Attention-Control

Behavioral

Primary outcomes

  1. D-KEFs Tower Test

    Time frame: 7 months after hospital discharge

    cognitive test for executive functioning

  2. Trail Making Test B

    Time frame: 7 months after hospital discharge

    Cognitive test for set shifting and cognitive flexibility

  3. Sustained Attention to Response Test

    Time frame: 7 months after hospital discharge

    Cognitive test for failures of sustained attention

  4. FAS Verbal Fluency Test

    Time frame: 7 months after hospital discharge

    Cognitive test for verbal fluency

Secondary outcomes

  1. Dysexecutive Questionnaire

    Time frame: 7 months after hospital discharge

    Self-reported executive functioning

  2. Functional Activities Questionnaire

    Time frame: 7 months after hospital discharge

    Self-reported functional status

Other outcomes

  1. Patient Health Questionnaire-9

    Time frame: 7 months after hospital discharge

    Self-reported measure of depressive symptoms

  2. PTSD Checklist-Civilian Version (PCL-C)

    Time frame: 7 months after hospital discharge

    Self-reported measure of PTSD symptoms

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

Improving Trauma Outcomes: A Goal Management Approach

Acronym: GMT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2012
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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