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

Mount Sinai Health System

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Other: cognitive rehabilitation day treatment program; Behavioral: Top Down

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00233129

GCO# 04-0782

#H133B040033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 2 patient groups

Standard Treatment

Active Comparator group

Description:

cognitive rehabilitation day treatment program

Treatment:

Other: cognitive rehabilitation day treatment program

Top-Down

Experimental group

Description:

cognitive rehabilitation day treatment program that incorporates systematic "top down" treatment of executive function deficits (problem solving and emotional regulation training), systematic treatment of attention deficits, and modular, contextual and embedded approaches to treatment.

Treatment:

Behavioral: Top Down