Improving Executive Functions After Traumatic Brain Injury (TBI): A Clinical Trial of the "Executive Plus" Program

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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 self-regulation and problem solving. The goal of the Executive Plus program is to maximize executive functioning, as well as the long-term outcomes of community participation and satisfaction with daily life.

Key facts

Study ID

NCT00233129

Run by

Icahn School of Medicine at Mount Sinai

People needed

77

Starts

2005-10-01

Expected to finish

2010-11-01

Last updated by the study team

2013-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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