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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00627237
First received: February 20, 2008
Last updated: September 23, 2013
Last verified: September 2013
  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.

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Executive functioning [ Time Frame: At the beginning of the intervention ] [ Designated as safety issue: No ]
  • Executive functioning [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Executive functioning [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]
  • Executive functioning [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Executive functioning [ Time Frame: At 1 year post-intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Attention [ Time Frame: At the beginning of the intervention ] [ Designated as safety issue: No ]
  • Attention [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Attention [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]
  • Attention [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Attention [ Time Frame: At 1 year post-intervention ] [ Designated as safety issue: No ]
  • Depression and anxiety [ Time Frame: At the beginning of the intervention ] [ Designated as safety issue: No ]
  • Depression and anxiety [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Depression and anxiety [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]
  • Depression and anxiety [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Depression and anxiety [ Time Frame: At 1 year post-intervention ] [ Designated as safety issue: No ]
  • Memory and learning [ Time Frame: At the beginning of the intervention ] [ Designated as safety issue: No ]
  • Memory and learning [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Memory and learning [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]
  • Memory and learning [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Memory and learning [ Time Frame: At 1 year post-intervention ] [ Designated as safety issue: No ]
  • Participation, life satisfaction, and self-efficacy [ Time Frame: At the beginning of the intervention ] [ Designated as safety issue: No ]
  • Participation, life satisfaction, and self-efficacy [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Participation, life satisfaction, and self-efficacy [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]
  • Participation, life satisfaction, and self-efficacy [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Participation, life satisfaction, and self-efficacy [ Time Frame: At 1 year post-intervention ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: January 2008
Study Completion Date: July 2013
Primary Completion Date: July 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.

Detailed Description:

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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627237

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Wayne Gordon, Ph.D. Mount Sinai School of Medicine
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00627237     History of Changes
Other Study ID Numbers: GCO 06-0939, CE001171
Study First Received: February 20, 2008
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Brain Injuries
Cognitive Rehabilitation
Executive Functioning

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 29, 2014