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

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Other: cognitive rehabilitation day treatment program; Behavioral: Top Down

• Registration Number: NCT00233129
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-05
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment	cognitive rehabilitation day treatment program	cognitive rehabilitation day treatment program
Top-Down	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.

Primary Outcome Measures

Name	Time	Method
Cognitive function	12 months after completing treatment

Secondary Outcome Measures

Name	Time	Method
Memory	12 months after completing treatment
Participation	12 months after completing treatment
Life satisfaction and self-efficacy	12 months after completing treatment
Affective distress	12 months after completing treatment
Learning	12 months after completing treatment

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States