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

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00233129
First received: October 3, 2005
Last updated: September 23, 2013
Last verified: September 2013
  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: Top Down
Other: cognitive rehabilitation day treatment program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Executive Functions After TBI: A Randomized Clinical Trial of the "Executive Plus" Program

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cognitive function [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: 5 weeks into treatment ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: At treatment end (6 months after baseline) ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: 6 months after completing treatment ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: 12 months after completing treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Memory [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Memory [ Time Frame: 5 weeks into treatment ] [ Designated as safety issue: No ]
  • Memory [ Time Frame: At treatment end (6 months after baseline) ] [ Designated as safety issue: No ]
  • Memory [ Time Frame: 6 months after completing treatment ] [ Designated as safety issue: No ]
  • Memory [ Time Frame: 12 months after completing treatment ] [ Designated as safety issue: No ]
  • Learning [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Learning [ Time Frame: 5 weeks into treatment ] [ Designated as safety issue: No ]
  • Learning [ Time Frame: At treatment end (6 months after baseline) ] [ Designated as safety issue: No ]
  • Learning [ Time Frame: 6 months after completing treatment ] [ Designated as safety issue: No ]
  • Learning [ Time Frame: 12 months after completing treatment ] [ Designated as safety issue: No ]
  • Participation [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Participation [ Time Frame: 5 weeks into treatment ] [ Designated as safety issue: No ]
  • Participation [ Time Frame: At treatment end (6 months after baseline) ] [ Designated as safety issue: No ]
  • Participation [ Time Frame: 6 months after completing treatment ] [ Designated as safety issue: No ]
  • Participation [ Time Frame: 12 months after completing treatment ] [ Designated as safety issue: No ]
  • Affective distress [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Affective distress [ Time Frame: 5 weeks into treatment ] [ Designated as safety issue: No ]
  • Affective distress [ Time Frame: At treatment end (6 months after baseline) ] [ Designated as safety issue: No ]
  • Affective distress [ Time Frame: 6 months after completing treatment ] [ Designated as safety issue: No ]
  • Affective distress [ Time Frame: 12 months after completing treatment ] [ Designated as safety issue: No ]
  • Life satisfaction and self-efficacy [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Life satisfaction and self-efficacy [ Time Frame: 5 weeks into treatment ] [ Designated as safety issue: No ]
  • Life satisfaction and self-efficacy [ Time Frame: At treatment end (6 months after baseline) ] [ Designated as safety issue: No ]
  • Life satisfaction and self-efficacy [ Time Frame: 6 months after completing treatment ] [ Designated as safety issue: No ]
  • Life satisfaction and self-efficacy [ Time Frame: 12 months after completing treatment ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: October 2005
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Treatment
cognitive rehabilitation day treatment program
Other: cognitive rehabilitation day treatment program
six months
Experimental: 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.
Behavioral: Top Down
Six months
Other Name: Executive Plus Day Treatment Program

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Mount Sinai School of Medicine
U.S. Department of Education
Investigators
Principal Investigator: Wayne A Gordon, Ph.D. Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00233129     History of Changes
Other Study ID Numbers: GCO# 04-0782, #H133B040033
Study First Received: October 3, 2005
Last Updated: September 23, 2013
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

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014