Clinical trial NCT00233129: Improving Executive Functions After Traumatic Brain Injury (TBI): A Clinical Trial of the "Executive Plus" Program
Official title: Improving Executive Functions After TBI: A Randomized Clinical Trial of the "Executive Plus" Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Day treatment
executive function
problem solving
attention
participation
TBI
brain injury
traumatic brain injury
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2005-10-05
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 focus on problem solving and emotional self-regulation, as well as systematic treatment of post-TBI attention deficits. It relies on modular, contextual, and embedded approaches to treatment. It will be compared to Mount Sinai's currently operating day treatment program. The 26-week programs will run concurrently and potential participants will be randomly assigned to Executive Plus or the standard program, using rolling admissions. Program staffs will be separate. Outcomes will be assessed using measures that focus on functioning within cognitive domains, across domains and in everyday life, and that assess long-term outcomes. Detailed manuals will be developed to guide the implementation of each program's operation.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Cognitive function
timeFrame: At baseline
measure: Cognitive function
timeFrame: 5 weeks into treatment
measure: Cognitive function
timeFrame: At treatment end (6 months after baseline)
measure: Cognitive function
timeFrame: 6 months after completing treatment
measure: Cognitive function
timeFrame: 12 months after completing treatment
Secondary outcomes:
measure: Memory
timeFrame: At baseline
measure: Memory
timeFrame: 5 weeks into treatment
measure: Memory
timeFrame: At treatment end (6 months after baseline)
measure: Memory
timeFrame: 6 months after completing treatment
measure: Memory
timeFrame: 12 months after completing treatment
measure: Learning
timeFrame: At baseline
measure: Learning
timeFrame: 5 weeks into treatment
measure: Learning
timeFrame: At treatment end (6 months after baseline)
measure: Learning
timeFrame: 6 months after completing treatment
measure: Learning
timeFrame: 12 months after completing treatment
measure: Participation
timeFrame: At baseline
measure: Participation
timeFrame: 5 weeks into treatment
measure: Participation
timeFrame: At treatment end (6 months after baseline)
measure: Participation
timeFrame: 6 months after completing treatment
measure: Participation
timeFrame: 12 months after completing treatment
measure: Affective distress
timeFrame: At baseline
measure: Affective distress
timeFrame: 5 weeks into treatment
measure: Affective distress
timeFrame: At treatment end (6 months after baseline)
measure: Affective distress
timeFrame: 6 months after completing treatment
measure: Affective distress
timeFrame: 12 months after completing treatment
measure: Life satisfaction and self-efficacy
timeFrame: At baseline
measure: Life satisfaction and self-efficacy
timeFrame: 5 weeks into treatment
measure: Life satisfaction and self-efficacy
timeFrame: At treatment end (6 months after baseline)
measure: Life satisfaction and self-efficacy
timeFrame: 6 months after completing treatment
measure: Life satisfaction and self-efficacy
timeFrame: 12 months after completing treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Wayne A Gordon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: