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| ID | Type | Description | Link |
|---|---|---|---|
| #H133B040033 |
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| Name | Class |
|---|---|
| U.S. Department of Education | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | cognitive rehabilitation day treatment program |
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| Top-Down | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Top Down | Behavioral | Six months |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Memory | At baseline | |
| Memory | 5 weeks into treatment | |
| Memory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne A 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 |
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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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| cognitive rehabilitation day treatment program | Other | six months |
|
| 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 |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |