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| Sponsor: | Mount Sinai School of Medicine |
|---|---|
| Collaborator: |
Centers for Disease Control and Prevention |
| Information provided by (Responsible Party): | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00627237 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury |
Behavioral: Immediate Start Behavioral: Waitlist |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Short-Term Executive Plus (STEP): A Randomized Controlled Trial of Short Term Intensive Cognitive Rehabilitation. |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immediate start
Starts the 12 week intervention immediately after enrollment
|
Behavioral: Immediate Start
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.
|
|
Experimental: Waitlist group
Starts the 12 week intervention 12 weeks after initial enrollment
|
Behavioral: Waitlist
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.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Elissa Flannery | 212-241-4706 | elissa.flannery@mountsinai.org |
| Contact: Theo Tsaousides, Ph.D. | 212-241-6547 | theo.tsaousides@mountsinai.org |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029-6574 | |
| Contact: Wayne Gordon, Ph.D. 212-659-9372 wayne.gordon@mssm.edu | |
| Contact: Joshua Cantor, Ph.D. 212-241-8850 joshua.cantor@mountsinai.org | |
| Principal Investigator: Wayne Gordon, Ph.D. | |
| Sub-Investigator: Joshua Cantor, Ph.D. | |
| Principal Investigator: | Wayne Gordon, Ph.D. | Mount Sinai School of Medicine |
More Information
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00627237 History of Changes |
| Other Study ID Numbers: | 06-0939, CE001171 |
| Study First Received: | February 20, 2008 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Brain Injuries Cognitive Rehabilitation Executive Functioning |
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |