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

NCT ID: NCT00233129

Last Updated: 2013-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2010-11-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Treatment

cognitive rehabilitation day treatment program

Group Type: ACTIVE_COMPARATOR

cognitive rehabilitation day treatment program

Intervention Type: OTHER

six months

Top-Down

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.

Group Type: EXPERIMENTAL

Top Down

Intervention Type: BEHAVIORAL

Six months

Interventions

Top Down

Six months

Intervention Type: BEHAVIORAL

cognitive rehabilitation day treatment program

six months

Intervention Type: OTHER

Other Intervention Names

Executive Plus Day Treatment Program

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wayne A Gordon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

#H133B040033

Identifier Type: -

Identifier Source: secondary_id

GCO# 04-0782

Identifier Type: -

Identifier Source: org_study_id