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

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

This study is currently recruiting participants.
Verified by Mount Sinai School of Medicine, October 2007

Sponsors and Collaborators:	Mount Sinai School of Medicine National Institute of Disability and Rehabilitation Research
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00233129

Purpose

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.

Condition	Intervention
Traumatic Brain Injury	Behavioral: Executive Plus Day Treatment Program

MedlinePlus related topics:

Head and Brain Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Improving Executive Functions After TBI: A Randomized Clinical Trial of the "Executive Plus" Program

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

Cognitive function

Secondary Outcome Measures:

Memory
Learning
Participation
Affective distress
Life satisfaction

Estimated Enrollment:	200
Study Start Date:	October 2005
Estimated Study Completion Date:	March 2009

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233129

Contacts


Contact: Wayne A Gordon, Ph.D.		wayne.gordon@mssm.edu

Locations


United States, New York
	Mount Sinai School of Medicine	Recruiting
	New York, New York, United States, 10029-6574
	Contact: Wayne A Gordon, Ph.D. wayne.gordon@mssm.edu

Sponsors and Collaborators

Mount Sinai School of Medicine

National Institute of Disability and Rehabilitation Research

Investigators


Principal Investigator:	Wayne A Gordon, Ph.D.	Mount Sinai School of Medicine

More Information

study website This link exits the ClinicalTrials.gov site

Study ID Numbers:	GCO# 04-0782, #H133B040033
First Received:	October 3, 2005
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00233129
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Day treatment

executive function

problem solving

attention

participation

TBI

brain injury

traumatic brain injury

Study placed in the following topic categories:

Craniocerebral Trauma

Wounds and Injuries

Disorders of Environmental Origin

Central Nervous System Diseases

Trauma, Nervous System

Brain Diseases

Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008