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

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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: cognitive rehabilitation day treatment program; Behavioral: Top Down

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029-6574
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Executive Plus Day Treatment Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cognitive function	At baseline
Cognitive function	5 weeks into treatment
Cognitive function	At treatment end (6 months after baseline)
Cognitive function	6 months after completing treatment
Cognitive function	12 months after completing treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Memory	At baseline
Memory	5 weeks into treatment
Memory	At treatment end (6 months after baseline)
Memory	6 months after completing treatment
Memory	12 months after completing treatment
Learning	At baseline
Learning	5 weeks into treatment
Learning	At treatment end (6 months after baseline)
Learning	6 months after completing treatment
Learning	12 months after completing treatment
Participation	At baseline
Participation	5 weeks into treatment
Participation	At treatment end (6 months after baseline)
Participation	6 months after completing treatment
Participation	12 months after completing treatment
Affective distress	At baseline
Affective distress	5 weeks into treatment
Affective distress	At treatment end (6 months after baseline)
Affective distress	6 months after completing treatment
Affective distress	12 months after completing treatment
Life satisfaction and self-efficacy	At baseline
Life satisfaction and self-efficacy	5 weeks into treatment
Life satisfaction and self-efficacy	At treatment end (6 months after baseline)
Life satisfaction and self-efficacy	6 months after completing treatment
Life satisfaction and self-efficacy	12 months after completing treatment

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: Wayne A Gordon, Ph.D., Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 3, 2005
• First Submitted That Met QC Criteria: October 3, 2005
• First Posted (Estimate): October 5, 2005

Study Record Updates

• Last Update Posted (Estimate): September 24, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: TBI; brain injury; traumatic brain injury; executive function; problem solving; attention; participation; Day treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: GCO# 04-0782; #H133B040033