Status:
COMPLETED
Improving Executive Functioning After Traumatic Brain Injury (TBI): A Trial of the "Short Term Executive Plus" Program
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the efficacy of an intensive short term cognitive rehabilitation program aimed towards improving executive functioning in individuals with traumatic brain inj...
Detailed Description
Executive dysfunction following brain injury (BI) is commonly observed and has been well documented in the literature (Mateer, 1999; Prigatano, 1999; Levine et al., 2000; Shallice \& Burgess, 1991; Ci...
Eligibility Criteria
Inclusion
- Be 18 years old or older;
- 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);
- Being at least three months post-injury;
- Being English-speaking (treatment sessions will be conducted in English);
- Reporting executive dysfunction (by self or family);
- Being willing and able to participate in and travel to the program daily for three months;
- Being oriented to time, place and person;
- Having a full-scale 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);
- Being willing to complete questionnaires and interviews about mood, thinking skills, participation and the like; AND
- Agreeing to participate, i.e., completion of informed consent and HIPAA documents.
Exclusion
- Have diminished mental capacity and as a result, are unable to sign informed consent;
- Active substance abuse;
- Active psychosis;
- Active suicidality;
- Disruptive or violent behavior to self or others;
- Current cognitive rehabilitation (this will not include current psychotherapy);
- No impairment on the FRSBE or WCST; OR
- Showing evidence of or a diagnosis of dementia or mild cognitive impairment.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00627237
Start Date
January 1 2008
End Date
July 1 2013
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