Expired Study
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New York, New York 10029


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).


Study summary:

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).


Criteria:

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.


Study is Available At:


Original ID:

GCO 06-0939


NCT ID:

NCT00627237


Secondary ID:

CE001171


Study Acronym:

STEP


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mount Sinai School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

101


Enrollment Type:

Actual


Overall Contact Information

Official Name:Wayne Gordon, Ph.D.
Principal Investigator
Mount Sinai School of Medicine

Study Dates

Start Date:January 2008
Completion Date:July 2013
Completion Type:Actual
Primary Completion Date:July 2012
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 23, 2013
First Received Date:February 20, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Executive functioning
Time Frame:At the beginning of the intervention
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Executive functioning
Time Frame:At 12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Executive functioning
Time Frame:At 24 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Executive functioning
Time Frame:At 6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Executive functioning
Time Frame:At 1 year post-intervention.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Attention
Time Frame:At the beginning of the intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Attention
Time Frame:At 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Attention
Time Frame:At 24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Attention
Time Frame:At 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Attention
Time Frame:At 1 year post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Depression and anxiety
Time Frame:At the beginning of the intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Depression and anxiety
Time Frame:At 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Depression and anxiety
Time Frame:At 24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Depression and anxiety
Time Frame:At 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Depression and anxiety
Time Frame:At 1 year post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Memory and learning
Time Frame:At the beginning of the intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Memory and learning
Time Frame:At 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Memory and learning
Time Frame:At 24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Memory and learning
Time Frame:At 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Memory and learning
Time Frame:At 1 year post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Participation, life satisfaction, and self-efficacy
Time Frame:At the beginning of the intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Participation, life satisfaction, and self-efficacy
Time Frame:At 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Participation, life satisfaction, and self-efficacy
Time Frame:At 24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Participation, life satisfaction, and self-efficacy
Time Frame:At 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Participation, life satisfaction, and self-efficacy
Time Frame:At 1 year post-intervention
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Immediate Start
Description: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.
Arm Name:Immediate start
Intervention Type:Behavioral
Name:Waitlist
Description: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.
Arm Name:Waitlist group

Study Arms

Study Arm Type:Experimental
Arm Name:Immediate start
Description:Starts the 12 week intervention immediately after enrollment
Study Arm Type:Experimental
Arm Name:Waitlist group
Description:Starts the 12 week intervention 12 weeks after initial enrollment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mount Sinai School of Medicine
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Centers for Disease Control and Prevention

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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