Status:
COMPLETED
Improving Executive Functions After Traumatic Brain Injury (TBI): A Clinical Trial of the "Executive Plus" Program
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized clinical trial which compares a standard day treatment program for individuals with TBI with the "Executive Plus" program; the latter emphasizes training of attention, emotional s...
Detailed Description
This is a randomized clinical trial comparing two approaches to post-TBI comprehensive day treatment. Executive Plus offers systematic treatment of post-TBI executive function deficits, through a focu...
Eligibility Criteria
Inclusion
- At least 18 years old
- Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury).
- At least three months post-injury
- English-speaking (treatment sessions will be conducted in English)
- Reporting executive dysfunction (by self or family)
- Willing and able to participate in and travel to the program daily for six months
- Oriented to time, place and person
- Having a full-scale intelligence quotient (IQ) of at least 75
- Having a score on the Galveston Orientation and Amnesia Test of 75 or more
- Having communication skills adequate to participate in groups
- Having at least a sixth-grade reading level (for testing and use of written materials)
- Willing to complete questionnaires and interviews about mood, thinking skills, participation and the like
- Agree to participate, i.e., completion of informed consent and Health Insurance Portability and Accountability Act (HIPAA) documents
Exclusion
- Active substance abuse
- Active psychosis
- Active suicidality
- Disruptive or violent behavior to self or others
- Current cognitive rehabilitation (this does not include psychotherapy)
- No impairment on the Frontal Systems Behavior Scale (FRSBE) or Wisconsin Card Sorting Test (WCST)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00233129
Start Date
October 1 2005
End Date
November 1 2010
Last Update
September 24 2013
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574