Improving Executive Functioning After Traumatic Brain Injury (TBI): A Trial of the Short Term Executive Plus Program

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of an intensive short term cognitive rehabilitation program aimed towards improving executive functioning in individuals with traumatic brain injury (TBI).

Detailed Description
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Executive dysfunction following brain injury (BI) is commonly observed and has been well documented in the literature (Mateer, 1999; Prigatano, 1999; Levine et al., 2000; Shallice & Burgess, 1991; Cicerone & Giacino, 1992; Goldman-Rakic, 1993; Lezak, 1995, Riegal & Gauggel, 2002; McDonald, 2002; Stuss and Levine, 2003). Level of functioning such as vocational success, community reintegration, and social autonomy are associated with executive functioning abilities following BI (Mazaux et al. 1997, Sohlberg, Mateer, & Stuss, 1993; (Stuss & Levine, 2002, McDonald, 2002). Studies describing the rehabilitation of executive dysfunction have been limited to mostly single case or small group designs (Cicerone, et al., 2000). However, there have been three small randomized clinical trials that have had promising results suggesting the need for more research in this area. When considering all of the studies, it is evident that emphasis has been placed on three areas of intervention: attention remediation, emotional regulation and problem-solving. Consequently, given the pervasive disability found in individuals with BI that is secondary to executive function disorders and the promising, but limited, success of problem-solving-based interventions for executive functions, a randomized controlled trial (RCT) of the efficacy of a short-term, intensive executive function training program (Short-Term Executive Plus) is proposed. The Short-Term Executive Plus (STEP) program will combine treatments and treatment approaches that have proved to be effective in previous studies and will be compared to wait-list control group. This design was chosen because no appropriate control intervention exists. In other words there is no standard rehabilitation treatment available to these individuals that could serve as an appropriate control condition/treatment. As discussed earlier, cognitive remediation is typically delivered in extended full-time day treatment programs or weekly/bi-weekly individual sessions. Using more traditional extended treatments as a control condition would be inappropriate, as persons who can participate in extended, full-time are not the target of the proposed intervention. It is hypothesized that the STEP program will result in significant improvements in executive functioning (and related areas of attention, memory, community participation, and life satisfaction).

Official Title
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Short-Term Executive Plus (STEP): A Randomized Controlled Trial of Short Term Intensive Cognitive Rehabilitation.

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Immediate Start
* Behavioral: Waitlist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years old or older; 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); Being at least three months post-injury; Being English-speaking (treatment sessions will be conducted in English); Reporting executive dysfunction (by self or family); Being willing and able to participate in and travel to the program daily for three months; Being oriented to time, place and person; Having a full-scale 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); Being willing to complete questionnaires and interviews about mood, thinking skills, participation and the like; AND Agreeing to participate, i.e., completion of informed consent and HIPAA documents. Exclusion Criteria: Have diminished mental capacity and as a result, are unable to sign informed consent; Active substance abuse; Active psychosis; Active suicidality; Disruptive or violent behavior to self or others; Current cognitive rehabilitation (this will not include current psychotherapy); No impairment on the FRSBE or WCST; OR Showing evidence of or a diagnosis of dementia or mild cognitive impairment.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate start<br>Starts the 12 week intervention immediately after enrollment | Behavioral: Immediate Start<br>* Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.<br>|
| Experimental: Waitlist group<br>Starts the 12 week intervention 12 weeks after initial enrollment | Behavioral: Waitlist<br>* Participation in an intensive cognitive rehabilitation program 3 days a week (3 hours a day) for 12 weeks. Each day consists of a 50 minutes of problem solving group, 50 minutes of individualized attention training, and a 50 minute emotional regulation group session with 10 minutes breaks between each module.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive functioning |  | At the beginning of the intervention | 
| Executive functioning |  | At 12 weeks | 
| Executive functioning |  | At 24 weeks | 
| Executive functioning |  | At 6 months | 
| Executive functioning |  | At 1 year post-intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention |  | At the beginning of the intervention | 
| Attention |  | At 12 weeks | 
| Attention |  | At 24 weeks | 
| Attention |  | At 6 months | 
| Attention |  | At 1 year post-intervention | 
| Depression and anxiety |  | At the beginning of the intervention | 
| Depression and anxiety |  | At 12 weeks | 
| Depression and anxiety |  | At 24 weeks | 
| Depression and anxiety |  | At 6 months | 
| Depression and anxiety |  | At 1 year post-intervention | 
| Memory and learning |  | At the beginning of the intervention | 
| Memory and learning |  | At 12 weeks | 
| Memory and learning |  | At 24 weeks | 
| Memory and learning |  | At 6 months | 
| Memory and learning |  | At 1 year post-intervention | 
| Participation, life satisfaction, and self-efficacy |  | At the beginning of the intervention | 
| Participation, life satisfaction, and self-efficacy |  | At 12 weeks | 
| Participation, life satisfaction, and self-efficacy |  | At 24 weeks | 
| Participation, life satisfaction, and self-efficacy |  | At 6 months | 
| Participation, life satisfaction, and self-efficacy |  | At 1 year post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Injuries, Cognitive Rehabilitation, Executive Functioning