Improving Outcomes After Traumatic Injury: A Goal Management Approach
Status: | Completed |
---|---|
Conditions: | Hospital, Neurology |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 21 - 80 |
Updated: | 7/11/2015 |
Start Date: | January 2013 |
End Date: | June 2015 |
Contact: | Lori Haislip, MA, CCRP |
Email: | lori.haislip@vanderbilt.edu |
Phone: | 615-936-3312 |
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials