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

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

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 Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Immediate Start; Behavioral: Waitlist

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).

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029-6574
      • Icahn School of Medicine at Mount Sinaï

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Executive functioning	At the beginning of the intervention
Executive functioning	At 12 weeks
Executive functioning	At 24 weeks
Executive functioning	At 6 months
Executive functioning	At 1 year post-intervention.

Secondary Outcome Measures

Outcome Measure	Time Frame
Attention	At the beginning of the intervention
Attention	At 12 weeks
Attention	At 24 weeks
Attention	At 6 months
Attention	At 1 year post-intervention
Depression and anxiety	At the beginning of the intervention
Depression and anxiety	At 12 weeks
Depression and anxiety	At 24 weeks
Depression and anxiety	At 6 months
Depression and anxiety	At 1 year post-intervention
Memory and learning	At the beginning of the intervention
Memory and learning	At 12 weeks
Memory and learning	At 24 weeks
Memory and learning	At 6 months
Memory and learning	At 1 year post-intervention
Participation, life satisfaction, and self-efficacy	At the beginning of the intervention
Participation, life satisfaction, and self-efficacy	At 12 weeks
Participation, life satisfaction, and self-efficacy	At 24 weeks
Participation, life satisfaction, and self-efficacy	At 6 months
Participation, life satisfaction, and self-efficacy	At 1 year post-intervention

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Wayne Gordon, Ph.D., Icahn School of Medicine at Mount Sinaï

Publications and helpful links

General Publications

• Cantor J, Ashman T, Dams-O'Connor K, Dijkers MP, Gordon W, Spielman L, Tsaousides T, Allen H, Nguyen M, Oswald J. Evaluation of the short-term executive plus intervention for executive dysfunction after traumatic brain injury: a randomized controlled trial with minimization. Arch Phys Med Rehabil. 2014 Jan;95(1):1-9.e3. doi: 10.1016/j.apmr.2013.08.005. Epub 2013 Aug 27.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 20, 2008
• First Submitted That Met QC Criteria: February 28, 2008
• First Posted (Estimate): February 29, 2008

Study Record Updates

• Last Update Posted (Estimate): September 24, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Executive Functioning; Cognitive Rehabilitation; Brain Injuries
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: GCO 06-0939; CE001171