Improving Outcomes After Traumatic Injury: A Goal Management Approach
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Telephone-Based Goal Management Training; Telephone-Based Attention-Control
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): GMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild TBI