search
Back to results

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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Top Down
cognitive rehabilitation day treatment program
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Day treatment, executive function, problem solving, attention, participation, TBI, brain injury, traumatic brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Treatment

Top-Down

Arm Description

cognitive rehabilitation day treatment program

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.

Outcomes

Primary Outcome Measures

Cognitive function
Cognitive function
Cognitive function
Cognitive function
Cognitive function

Secondary Outcome Measures

Memory
Memory
Memory
Memory
Memory
Learning
Learning
Learning
Learning
Learning
Participation
Participation
Participation
Participation
Participation
Affective distress
Affective distress
Affective distress
Affective distress
Affective distress
Life satisfaction and self-efficacy
Life satisfaction and self-efficacy
Life satisfaction and self-efficacy
Life satisfaction and self-efficacy
Life satisfaction and self-efficacy

Full Information

First Posted
October 3, 2005
Last Updated
September 23, 2013
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
U.S. Department of Education
search

1. Study Identification

Unique Protocol Identification Number
NCT00233129
Brief Title
Improving Executive Functions After Traumatic Brain Injury (TBI): A Clinical Trial of the "Executive Plus" Program
Official Title
Improving Executive Functions After TBI: A Randomized Clinical Trial of the "Executive Plus" Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Day treatment, executive function, problem solving, attention, participation, TBI, brain injury, traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
cognitive rehabilitation day treatment program
Arm Title
Top-Down
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Top Down
Other Intervention Name(s)
Executive Plus Day Treatment Program
Intervention Description
Six months
Intervention Type
Other
Intervention Name(s)
cognitive rehabilitation day treatment program
Intervention Description
six months
Primary Outcome Measure Information:
Title
Cognitive function
Time Frame
At baseline
Title
Cognitive function
Time Frame
5 weeks into treatment
Title
Cognitive function
Time Frame
At treatment end (6 months after baseline)
Title
Cognitive function
Time Frame
6 months after completing treatment
Title
Cognitive function
Time Frame
12 months after completing treatment
Secondary Outcome Measure Information:
Title
Memory
Time Frame
At baseline
Title
Memory
Time Frame
5 weeks into treatment
Title
Memory
Time Frame
At treatment end (6 months after baseline)
Title
Memory
Time Frame
6 months after completing treatment
Title
Memory
Time Frame
12 months after completing treatment
Title
Learning
Time Frame
At baseline
Title
Learning
Time Frame
5 weeks into treatment
Title
Learning
Time Frame
At treatment end (6 months after baseline)
Title
Learning
Time Frame
6 months after completing treatment
Title
Learning
Time Frame
12 months after completing treatment
Title
Participation
Time Frame
At baseline
Title
Participation
Time Frame
5 weeks into treatment
Title
Participation
Time Frame
At treatment end (6 months after baseline)
Title
Participation
Time Frame
6 months after completing treatment
Title
Participation
Time Frame
12 months after completing treatment
Title
Affective distress
Time Frame
At baseline
Title
Affective distress
Time Frame
5 weeks into treatment
Title
Affective distress
Time Frame
At treatment end (6 months after baseline)
Title
Affective distress
Time Frame
6 months after completing treatment
Title
Affective distress
Time Frame
12 months after completing treatment
Title
Life satisfaction and self-efficacy
Time Frame
At baseline
Title
Life satisfaction and self-efficacy
Time Frame
5 weeks into treatment
Title
Life satisfaction and self-efficacy
Time Frame
At treatment end (6 months after baseline)
Title
Life satisfaction and self-efficacy
Time Frame
6 months after completing treatment
Title
Life satisfaction and self-efficacy
Time Frame
12 months after completing treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne A Gordon, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs