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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Top Down
* Other: cognitive rehabilitation day treatment program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment<br>cognitive rehabilitation day treatment program | Other: cognitive rehabilitation day treatment program<br>* six months<br>|
| Experimental: Top-Down<br>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<br>* Six months<br>* Other names: Executive Plus Day Treatment Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Day treatment, executive function, problem solving, attention, participation, TBI, brain injury, traumatic brain injury