Icahn School of Medicine at Mount Sinai
New York, 10029-6574, United States
NCT Number: NCT00233129
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10029-6574, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Six months
Other names: Executive Plus Day Treatment Program
six months
Time frame: At baseline
Time frame: 5 weeks into treatment
Time frame: At treatment end (6 months after baseline)
Time frame: 6 months after completing treatment
Time frame: 12 months after completing treatment
Time frame: At baseline
Time frame: 5 weeks into treatment
Time frame: At treatment end (6 months after baseline)
Time frame: 6 months after completing treatment
Time frame: 12 months after completing treatment
Time frame: At baseline
Time frame: 5 weeks into treatment
Time frame: At treatment end (6 months after baseline)
Time frame: 6 months after completing treatment
Time frame: 12 months after completing treatment
Time frame: At baseline
Time frame: 5 weeks into treatment
Time frame: At treatment end (6 months after baseline)
Time frame: 6 months after completing treatment
Time frame: 12 months after completing treatment
Time frame: At baseline
Time frame: 5 weeks into treatment
Time frame: At treatment end (6 months after baseline)
Time frame: 6 months after completing treatment
Time frame: 12 months after completing treatment
Time frame: At baseline
Time frame: 5 weeks into treatment
Time frame: At treatment end (6 months after baseline)
Time frame: 6 months after completing treatment
Time frame: 12 months after completing treatment
Icahn School of Medicine at Mount Sinai
Other
Improving Executive Functions After TBI: A Randomized Clinical Trial of the "Executive Plus" Program
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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