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| ID | Type | Description | Link |
|---|---|---|---|
| CE001171 |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate start | Experimental | Starts the 12 week intervention immediately after enrollment |
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| Waitlist group | Experimental | Starts the 12 week intervention 12 weeks after initial enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Start | Behavioral | 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Attention | At the beginning of the intervention | |
| Attention | At 12 weeks | |
| Attention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne Gordon, Ph.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6574 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23988395 | Derived | Cantor J, Ashman T, Dams-O'Connor K, Dijkers MP, Gordon W, Spielman L, Tsaousides T, Allen H, Nguyen M, Oswald J. Evaluation of the short-term executive plus intervention for executive dysfunction after traumatic brain injury: a randomized controlled trial with minimization. Arch Phys Med Rehabil. 2014 Jan;95(1):1-9.e3. doi: 10.1016/j.apmr.2013.08.005. Epub 2013 Aug 27. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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|
| Waitlist | Behavioral | 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. |
|
| 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 |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |